Research Papers

[Larry10625]

Hi everyone;
A while back I mentioned that my surgeon had been published and was well known and highly respected by his colleagues in the industry. He sent me a few of his papers and I decided that nobody other than me would be interested in reading them. Yesterday, while wearing my moderators hat, I saw a post from someone saying they would like to read some research on ... (I can't remember). I decided that I would create it's own topic and if people wanted to read them, great and if not, they don't have to. If anyone else has or sees research papers that are relevant to Frank Talk, please feel free to post.

Have a great day

Larry

[Larry10625]

So here is the first one - Scientific advances and evidence-based management in erectile dysfunction

I can't seem to figure out how to attach the file, so I will just cut and paste.

Preface

Scientific advances and evidence-based management in erectile dysfunction
Significant advances have been made in the diagnosis and treatment of erectile dysfunction (ED) over the last half century. In the early 1970’s, ED or previously known as impotence, was thought to be related to psychogenic causes as popularised by Masters and Johnson; however, advances in our understanding of molecular biological factors and mechanisms governing sexual function have demonstrated that the underlying pathogenesis for ED is frequently multifactorial in nature. Furthermore, published literature has shown that ED is closely linked to underlying cardiovascular dysfunction and endothelial dysfunction, highlighting the need to screen men with ED for coronary risk factors and disease.
Scientific evaluation in this field is needed to increase our knowledge and foster evidence-based best practice in men with ED. The current state of ED research is exciting and, in this issue, we present the state of art papers that address various aspects in medical and surgical management of ED. We aim to address the various controversies surrounding key issues such as reviewing the current evidence to support penile rehabilitation; examining the facts on ED, endothelial dysfunction and cardiovascular disease; raising awareness on the risks of counterfeit ED medications; exploring new pharmacotherapeutic agents; and revisiting the advances in the last 40 decades in penile prosthesis implant surgery. Novel and exciting topics in this edition include the concept of masculinity in men with ED, the role of traditional medicine in complementing modern ED treatment, and how to assess and manage fit and healthy men under 40 years old who have ED. As ED is invariably associated with penile length loss, separate topics dedicated to Peyronie’s disease and ED, and penile lengthening surgery are discussed too.
We thank the authors and reviewers who concentrated their expertise, time, and effort on this stimulating edition. We hope the readers will find this edition highly educative and inspirational, and provide evidence-based guidance to manage and improve the overall healthcare in men with ED.
We take this opportunity to wish TAU readers a happy, safe and festive New Year celebration.




Gerald Brock Eric Chung


Gerald Brock, MD, FRCSC

President-Elect, Canadian Urological Association; Secretary-General, International Society of Sexual Medicine; Professor of Surgery,
University of Western Ontario, London, Canada.
(Email: gebrock@sympatico.ca)
Eric Chung, MBBS, FRACS
Chair for Andrology section, Urological Society of Australia and New Zealand; Associate Professor of Surgery, University of Queensland,
Princess Alexandra Hospital; AndroUrology Centre, Brisbane, QLD, Australia.
(Email: ericchg@hotmail.com)
doi: 10.21037/tau.2017.01.11
Conflicts of Interest: The authors have no conflicts of interest to declare.
View this article at: http://dx.doi.org/10.21037/tau.2017.01.11




© Translational Andrology and Urology. All rights reserved.

tau.amegroups.com

Transl Androl Urol 2017;6(1):1

[Larry10625]

DOI 10.1007/s00345-013-1102-7

Clinical outcomes and patient satisfaction rates among elderly male aged ‡75 years with inflatable penile prosthesis implant for medically refractory erectile dysfunction

Eric Chung • Matt Solomon • Ling DeYoung •
Gerald B. Brock



Received: 15 February 2013 / Accepted: 20 May 2013 / Published online: 26 May 2013
© Springer-Verlag Berlin Heidelberg 2013


Abstract
Purpose The purpose of the study is to assess the clinical outcomes and patient satisfaction rate between men aged under and over 75 years who underwent inflatable penile prosthesis (IPP) implantation.
Methods and materials A retrospective review of clinical database and follow-up independent telephone survey was undertaken in all men who underwent first-time IPP implantation between January 2006 and November 2010. Patient demographics, surgical outcomes, and patient sat- isfaction rate using Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were recorded.
Results A total of 216 first-time IPP were implanted. Of these, 30 patients were aged C75 years. In men aged C75 years, 3 patients had IPP revision surgery for mechanical malfunction (average 18.6 months; 12–24 months). While the 2-year Kaplan–Meier estimates of mechanical survival showed better outcome in men aged
C75 years than men aged \75 years (95 vs. 92 %;
p = 0.38), there was no difference in the IPP mechanical survival between the 2 groups at 3 years follow-up. There were no statistically significant differences in the ease of IPP use, and EDITS scores among the two groups. The majority of men were satisfied and would recommend the IPP surgery to other men.
Conclusions Men aged C75 years reported satisfactory
outcome with IPP surgery with no statistical significant

E. Chung (&) M. Solomon L. DeYoung G. B. Brock Division of Urology, St Joseph’s Health Care, London,
ON, Canada
e-mail: ericchg@hotmail.com

E. Chung M. Solomon
Department of Urology, Princess Alexandra Hospital and
St Andrew’s War Memorial Hospital, Brisbane, QLD, Australia

difference identified across device survival and satisfaction rates compared to men aged \75 years.

Keywords Erectile dysfunction • Penile prosthesis • Men older than 75 years • Elderly male • Clinical outcome • Patient satisfaction


Introduction

The United Nation reported a steady increase in the ageing population and demand for health care services [1]. Many large-scale population studies on global presence of erec- tile dysfunction (ED) showed a close relationship with ageing [2–4]. Many older men become unresponsive to medical therapy due to the development and/or progression of their medical co-morbidities, and therefore require penile prosthesis implantation to remain sexually active [5–7].
However, in spite of this, many surgeons may be reluctant to offer prosthesis implantation to older men due to various concerns such as misperception and prejudices of an ‘‘asexual’’ old age with diminished and lack of sexual intercourse, and those regarding impaired dexterity and manual handling of an inflatable penile prosthesis (IPP). The increasing longevity of men and women, increasing awareness of sexual health function as part of general health and improved medical care in conditions such as hypogonadism, has resulted in increasing health care demands to meet the sexual expectations in the ageing population. In men aged 70 and older, it has been shown that ED, and not loss of sexual desire, was the commonest factor cited for being sexually inactive and that the low sexual function scores were found in the domains of erectile function, orgasm, and overall satisfaction [7].



At present, there is limited published literature in men aged C75 years who underwent penile prosthesis implant. The following study examines the clinical outcomes and patient satisfaction rates in men aged C75 years who have medical refractory ED and undergone IPP implantation. We compare the clinical outcomes, IPP mechanical mal- function, and satisfaction rates between men aged C75 and \75 years.

Methods and materials

Following institutional ethics review board approval, all men who received first-time IPP between January 2006 and November 2010 were identified. A retrospective chart review of patient demographics was carried out. The IPP implantation was performed using standard penoscrotal approach and surgical care as described in the literature [8]. A survey instrument was developed by the one of the authors (EC) based on the comprehensive review of per- tinent literature and sexuality-related measures [9, 10]. The validity of this survey was reviewed and revised by the senior author (GBB) to ensure that the questions were appropriate and clear. An independent third-party tele- phone interview was conducted to complete the question- naire survey. Patients were surveyed on the frequency of

not contactable, resulting in a non-response rate of 17 %. Only 5 patients who are sexually active and were contacted on the telephone interview declined participation. All 5 men reported that they were happy with the IPP implantation.
The assessment of the questionnaire developed by the authors showed that the majority of men (83 %) reported
sexual intercourse rate at least twice per month. Among men aged C75 years, 21 out of 30 men have sex more than twice per month (Table 1).

Surgical outcomes

At the time of review, 18 (8 %) patients had additional operations for either IPP revision or removal. Twelve (6 %) patients underwent IPP revisions for mechanical malfunction (11 patients) and personal dissatisfaction (1 patient). The average time to IPP revision was 31.2 (6–48) months. The IPP cylinder wear and subsequent fluid loss were the predominant reason for mechanical failure. In
men aged C75 years, 3 patients had IPP revision surgery
for mechanical malfunction (average 18.6 months;

Table 1 Selected variables on IPP use and satisfaction rates between men aged \ and C75 years


\75 years C75 years

and ease of IPP use, and patient satisfaction with IPP for

sexual activity with Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores. If the patient refused to respond to the entire survey, he was asked if he was satisfied with the IPP and whether he is currently using the IPP.
Categorical variables were tested using a chi-squared and non-paired Student’s t test. All statistical analyses were conducted using STATA®10 (StataCorp, College Station,
TX, USA), and a significance level of p \ 0.05 was uti- lized and all tests were two-sided.

Numbers (complete information) 150 30
Frequency of IPP use
At least weekly 25 (17 %) 3 (10 %)
C2 monthly 95 (63 %) 21 (70 %)
Once a month 25 (17 %) 3 (10 %)
Infrequently 5 (3 %) 3 (10 %)
Ease of IPP use scores
1–3 7 (5 %) 1 (3 %)
4–5 143 (95 %) 29 (97 %)



Results

Patient characteristics

A total of 216 first-time IPP were implanted during the 5-year period. We identified 30 men aged C75 years
(average 77.1; 75–84 years old) at IPP implantation. The average length of follow-up for men aged \75 years was
39.0 (1–72) months and in men aged C75 years was 38.8
(8–72) months.

Complete information was obtained in 180 patients (including 30 men aged C75 years). The remaining 36 patients replied either by not having a sexual partner, refused to reply, or were not sexually active, and/or were

Ease of IPP use—on a scale from 1 to 5, with 5 meaning very easy to
use; Overall satisfaction—on a scale from 1 to 5, with 5 meaning very satisfied; EDITS questionnaires on ‘‘Overall, how satisfied are you with this treatment’’—on a scale of 0 (no satisfaction or dissatisfac- tion) to 4 (high satisfaction)



12–24 months). All IPP infection occurred in men aged \75 years, and 6 (3 %) IPPs were removed during the 5-year period.
While the 2-year Kaplan–Meier estimates of mechanical survival showed better outcome in men aged C75 years than men aged \75 years (95 vs. 92 %; p = 0.38), there
was no difference in the IPP mechanical survival between the 2 groups at 3 years follow-up (Fig. 1).

Patient satisfaction

Selected characteristics of full survey responders between men under and over 75 years of age are summarized in the Table 1.
The majority of patients rated the IPP use at an average of 4.1 (out of 5), and there was no statistical significant difference between the 2 groups including the types of IPP
devices (p = 0.76). The overall satisfaction was 4.2 (out of
5) with 160 of 180 patients (89 %) rated their overall sat- isfaction as either 4 or 5. On question one of the EDITS questionnaires on ‘‘Overall, how satisfied are you with this treatment’’ on a scale of 0 (no satisfaction or dissatisfac- tion) to 4 (high satisfaction) [11], more than two-thirds scored at least 3 on the ratings. The most common com- plaint was dissatisfaction with the erect penile length on inflation of the IPP. There was no difference between the 2
groups (p = 0.60).
More than 90 % reported that they would undergo the operation again (higher in men aged C75 years; 29 out of 30 men) and that they would recommend the surgery for
other men (no difference found between men aged \ and
C75 years). Those declining the offer reported poor IPP rigidity and partner dissatisfaction.

Fig. 1 The Kaplan–Meier estimates of mechanical survival showed better outcome in men aged C75 years than men aged \75 years at 2-year (95 vs. 92 %; p = 0.38), but no significant difference in the IPP mechanical survival was found by 3 years of follow-up. Y-axis does not start at 0.0

Discussion

A survey of sexuality and health in the ageing population showed older men remain sexually active even into the eight decades of life [12]. However, the progression and/or development of new medical co-morbidities increase the risk of ED and diminish the efficacy of medical therapy [13]. As a result, it is likely that there is considerable increase in the number of elderly men seeking IPP implantation in the very near future.
Current literature on IPP in elderly male is limited especially in men aged C75 years. Older publications such as Levine et al. [14] reported that decrease dexterity of
elderly patients and/or presence of other medical condi- tions such as arthritis and neuropathy pose concern when choosing an IPP in the older patients. Akin-Olugbade et al.
[15] found lower satisfaction rate in men aged C70 years
than the general population, while Villarreal et al. [8] and Al-Najar et al. [16] showed that IPP was well tolerated with high satisfaction rate and ease of use among elderly men. Similarly, in our cohort, the overall satisfaction rate showed high satisfaction rate among elderly men, and more
importantly, there was no significant difference in the satisfaction rates between men aged \ and C75 years (p = 0.60).
Several reasons for patient dissatisfaction include reduced penile length, post-operative appearance of the penis, insufficient firmness, altered penile and erection sensation, decreased sensation during ejaculation, and dif- ficulty with using the prosthetic devices. In our study, patient dissatisfaction with erect penile length on inflated IPP was the most common complaint and accounted for the majority of patient dissatisfaction with the outcome of surgery. The decrease in penile length following surgery compared with recalled preoperative penile dimensions highlighted that the patient’s expectation in terms of penile size was not met often even when the outcome of penile prosthesis implantation was excellent according to the surgeon [17]. Among elderly men, increasing truncal obesity and lack of glans tumescence in a prosthetic erec- tion may also play a role in the overall decrease in penile length.
While long-term safety and efficacy of the IPP are well- documented [18], the data on IPP mechanical failure among elderly men are limited. With a median follow-up period of 68.5 months, Al-Najar et al. [16] showed that 17 of the 18 penile prostheses remained functioning and did not require surgical repair, while Villarreal et al. [8]
reported that one IPP was removed for infection 8 months after implantation. In our study, 3 men aged C75 years had IPP revision surgery for mechanical malfunction at a mean
follow-up of 38.8 months. None of the men aged
C75 years had prosthesis infection and/or erosion. While



surgical complications relating to IPP implantation cannot be neglected in an older patient, our study did not find any significant increase in the rate of intra- and post-operative
IPP complications among men aged C75 years compared
to men aged \75 years. At 3 years follow-up, there was no significant difference in the IPP mechanical survival
between the 2 groups.
Brinkman et al. [10] reported that only 66 % among 248 patients used the IPP on regular basis, and recent update from the group [19] found that more than 60 % of patients reported using their IPP at least once a week. In contrast, Al-Najar et al. [16] reported that of the 18 men aged
C70 years, more than two-thirds used their penile pros-
theses at least once every 2 weeks; three men (20 %) used the penile prosthesis more than twice every 2 weeks, and
eight men (53 %) used it at least once every 2 weeks. Our study also found that 21 out of 30 men aged C75 years (70 %) had sex more than twice per month.
The direct comparison in the surgical outcomes and patient satisfaction rate between men aged \ and C75 years can be biased, and observation may be limited for several
reasons. The significantly higher proportion of men aged \75 years potentially biased some of the observation. However, in a relatively matched 1:4 ratio with no statistical
significant difference in patient demographics apart from a higher percentage of pure ED causes in men aged C75 years, we found that men aged C75 years have similar clinical
outcomes and patient satisfaction rate to men aged \75 - years. Furthermore, this study demonstrated that men aged
C75 years reported similar frequency of IPP use to men
aged \75 years and that the IPP mechanical survival was similar at 3 year follow-up. We acknowledged that the rel-
atively short-term follow-up and absence of other sexual performance information such as duration of sexual inter- course may affect the IPP mechanical survival. The intro- duction of recall bias and retrospective review of clinical database also present limitation to our study. While EDITS questionnaire is a validated instrument to evaluate erectile treatment satisfaction, it has not been validated in the context of IPP implant satisfaction [20]. Despite these limitations, the excellent patient response rate and complete data col- lection (83 %) with independent interviewer and the use of standardized questionnaire, we believe our study has shown that the surgical outcomes and patient satisfaction rate were
not dissimilar between men aged \ and C75 years.
There are several determinant factors in deciding whe- ther men aged C75 years should be consented for penile prosthesis implantation. We identified in our cohort that
adequate preoperative counselling on patient expectation of penile prosthesis and critical evaluation of his current sexual health are two very important key aspects. True interest and motivation in being sexual, having a willing partner, generally good health, and reasonable life

expectancy play critical roles in ensuring the best candi- dates for penile prosthesis in elderly men. In an ageing population with increasing awareness and high demands to remain sexually active, the implantation of penile pros- thesis in men with medically refractory ED should not be biased by patient age. In fact, elderly patients with ED are often grateful and reported high satisfaction rate with IPP use. Indeed, we did not find any substantial differences in the surgical outcomes and patient satisfaction rate between
men aged \ and C75 years.

Conclusions

Older age should not be a limiting factor for IPP implan- tation in the current ageing population. Our study demon- strates that men aged C75 years have similar IPP clinical
outcomes and excellent satisfaction rate compared to men aged \75 years.
Conflict of interest None.


References

1. http://www.un.org/esa/population/public ... A2009/WPA2 009_WorkingPaper.pdf
2. Travison TG, Sand MS, Rosen RC, Shabsigh R, Eardley I, McKinlay JB (2011) The natural progression and regression of erectile dysfunction: follow-up results form the MMAS and MALES studies. J Sex Med 8(7):1917–1924
3. Corona G, Lee DM, Forti G, O’Connor DB, Maggi M, O’Neill TW et al (2010) Age-related changes in general and sexual health in middle-aged and older men: results from the European male ageing study (EMAS). J Sex Med 7:1362–1380
4. Shiri R, Koskimaki J, Hakkinen J, Tammela TL, Huhtala H, Hakama M, Auvinen A (2004) Tampere ageing male urological study. Effects of age, comorbidity and lifestyle factors on erectile dysfunction: tampere ageing male urological study (TAMUS). Eur Urol 45(5):628–633
5. Hellstrom WJG, Montague DK, Moncada I, Carson C, Minhas S, Faria G, Krishnamurti S (2010) Implants, mechanical devices and vascular surgery for erectile dysfunction. J Sex Med 7:501–523
6. Henry GD (2009) Historical review of penile prosthesis design and surgical techniques: part 1 of a three-part review series on penile prosthetic surgery. J Sex Med 6(3):675–681
7. Smith LJ, Mulhall JP, Deveci S, Monaghan N, Reid MC (2007) Sex after seventy: a pilot study of sexual function in older per- sons. J Sex Med 4(5):1247–1253
8. Villarreal HG, Jones LR (2012) Outcomes of and satisfaction with the inflatable penile prosthesis in the elderly male. Adv Urol 2012:240963
9. Davis CM, Yarber WL, Bauserman RB et al (1998) Handbook of sexuality-related measures, 2nd edn. SAGE Publications, Inc., Thousand Oaks, California
10. Brinkman MJO, Henry GD, Wilson SK et al (2005) A survey of patients with inflatable penile prostheses for satisfaction. J Urol 174:253–257
11. Althof SE, Corty ED, Levine SB et al (1999) EDITS: develop- ment of questionnaires for evaluating satisfaction with treatments fir erectile dysfunction. Urology 53:793–799



12. Lindau ST, Schumm LP, Launmann EO, Levinson W, O’Mu- ircheartaigh CA, Waite LJ (2007) A study of sexuality and health among older adults in the United States. N Engl J Med 357(8):762–774
13. Araujo AB, Mohr BA, McKinlay JB (2004) Changes in sexual function in middle-aged and older men: longitudinal data from the Massachusetts male aging study. J Am Geriatr Soc 52(9):1502–1509
14. Levine LA, Estrada CR, Morgentaler A (2001) Mechanical reli- ability and safety of, and patient satisfaction with the ambicor inflatable penile prosthesis: results of a 2 center study. J Urol 166(3):932–937
15. Akin-Olugbade O, Parker M, Guhring P, Mulhall J (2006) Determinants of patient satisfaction following penile prosthesis surgery. J Sex Med 3:743–748
16. Al-Najar A, Naumann CM, Kaufmann S, Steinbach-Jensch A, Hamann MF, Junemann KP, van der Horst C (2009) Should being

aged over 70 years hinder penile prosthesis implantation? BJU Int 104:834–837
17. Montague DK (2007) Penile prosthesis implantation: size mat- ters. Eur Urol 51:887–888
18. Wilson SK, Delk JR, Salem EA, Cleves MA (2007) Long-term survival of inflatable penile prostheses: single surgical group experience with 2,384 first-time implants spanning two decades. J Sex Med 4:1074–1079
19. Henry GD, Brinkman MJ, Mead SF, Delk JR 2nd, Cleves MA, Jennermann C, Wilson SK, Kramer AC (2012) A survey of patients with inflatable penile prostheses: assessment of timing and frequency of intercourse and analysis of implant durability. J Sex Med 9(6):1715–1721
20. Althof SE, Corty EW, Levine SB et al (1999) Development of questionnaire for evaluating satisfaction with treatments for erectile dysfunction (EDITS). Urology 53(4):793–799

[Larry10625]

Review Article

Strategies for maintaining penile size following penile implant

King Chien Joe Lee1, Gerald B. Brock2

1Department of Urology, National University Hospital, Singapore; 2Division of Urology, St Joseph’s Health Care, London, ON, Canada Correspondence to: Dr King Chien Joe Lee. National University Hospital, 1E Kent Ridge Road, NUHS Tower Block, Level 8, Singapore 119228; Prof Gerald B. Brock. St Joseph’s Hospital, Division of Urology, 268 Grosvenor Street, London, ON, N6A4V2. Email: joe_kc_lee@nuhs.edu.sg; gebrock@sympatico.ca.



Introduction: Loss of penile size is a common complaint that can negatively affect patient satisfaction rates following successful penile prosthetic implant surgery.
Objective: The aim of this review is to describe the various strategies that have been used to maintain penile length or girth after the insertion of a penile prosthetic implant.
Methods: An extensive systematic literature review was performed, based on a search of the PUBMED database for articles published between 2002 to 2012. The following key words were used: penile prosthesis, implant, penile length, size, penis, enhancement, enlargement, phalloplasty, girth, lengthening, and augmentation. Only English-language articles that were related to penile prosthetic surgery and penile size were sought.
Discussion: Based on the results of our search, strategies were classified into 3 groups based on the timepoint in relation to the primary penile prosthetic insertion surgery, which included pre-insertion, intraoperative and post-insertion.
Conclusions: Strategies to preserve and potentially increase penile size are of great importance to all implanters. Besides traction therapies and surgeries to enhance perceived penile size, refinements in the surgical approach are simple ways to optimize penile length. A direct comparison of treatment outcomes evaluating the various approaches is not currently possible, owing to divergent study techniques. The implanting surgeon can best serve his patient by adopting a combination of different strategies that are individualized and specific to the patient’s needs.
Keywords: Penile prosthesis; implant; penis size; length; enhancement


Submitted Dec 12, 2012. Accepted for publication Jan 15, 2013. doi: 10.3978/j.issn.2223-4683.2013.01.05
Scan to your mobile device or view this article at: http://www.amepc.org/tau/article/view/1459/2434



Introduction

Penile size has been associated with male self-esteem and ego since ancient times. Across different cultures, references to penile enhancement exist in various forms. The Sadhus holy men of India and males of the Cholomec tribe in Peru used weights to increase their penile lengths. In the 16th century, men of the Topinama tribe of Brazil allowed poisonous snakes to bite their penises in order to enlarge them. The injection of exogenous substances or implants of foreign bodies under the genital skin to cause penile enlargement remains a common phenomenon in some parts of the world (1).

Insertion of a penile prosthetic implant (PPI) is typically reserved as the last line of treatment for drug-refractory erectile dysfunction (ED). Loss of penile length as a result of penile prosthesis placement is the most common postoperative patient complaint shown to reduce overall satisfaction with the procedure. There are several reasons for this (Table 1).
Firstly, the pathology behind the severe ED such
as Peyronie’s disease, neglected ischemic priapism, loss of cavernosal smooth muscle and previous radical prostatectomy may have resulted in tunical scarring or fibrosis that severely limits the elasticity of the tunica

68 Lee and Brock. Strategies for maintaining penile size following penile implant

Table 1 Causes for loss of penile size
Objective loss of penile size Subjective loss of penile size

Conditions causing tunical scarring (Peyronie’s disease) Long history of ED with inaccurate recollection of erect penile size

Corporal fibrosis or loss of cavernous smooth muscle (ischemic priapism, previous radical prostatectomy)
Loss of glanular engorgement

Increased prepubic fat distribution






albuginea. While not apparent in a flaccid penis, it becomes obvious after a PPI has been inserted and inflated.
Secondly, many patients who underwent PPI insertion may have a history of ED lasting many months or years. This could affect the accuracy of their recollection of what their penile sizes were prior to the onset of their condition.
Thirdly, an inflated PPI fills up only the corporal bodies of the penis and has no impact on glanular engorgement, which is a physiological phenomenon in normal erections. This lack of glanular swelling may contribute to the perception of decreased penile size.
Fourthly, men who require PPI are usually in the older age group. As a man ages or puts on weight, the fat in the prepubic region has a tendency to increase and engulf the penile shaft. This phenomenon of a partially “buried penis” may affect the patient’s perception of penile length after PPI.
As with other sexual dysfunction therapies, the outcome of PPI surgery are largely dependent on patient and partner satisfaction. Most frequent implanters will realize that perceived inadequacy of penile size, be it penile girth or penile length, are practical issues that need to be addressed in clinical practice, and may be best suited for a full discussion pre-operatively, to set realistic expectations.
In this review article, we will look at the evidence evaluating penile shortening after PPI, including the technical aspects of PPI insertion which can lead to the loss of postoperative penile size.
We will also review the various techniques that have been described in literature to address patient concerns. Some of these techniques can produce a measurable change in penile size, while others may merely work by producing a subjective perception of change, which nonetheless, is often sufficient to address patient concerns.


Does PPI insertion really cause a loss of penile size?
There are studies in the literature that seek to answer this question in an objective manner.
In normal men, a close correlation between stretched


penile length with erect penile length has been shown (2).
Deveci S et al. measured the stretched flaccid penile length (SPL) of 56 patients undergoing their first implant surgery pre-operatively and 6 months after (3). Although 40 out of 56 patients (72%) reported a subjective decrease in penile length, there was no significant difference in terms of objective SPL measurements taken before and after surgery. Despite the perceived shortening, there was no overall difference in EF domain scores between men who complained of penile length loss and those who did not.
In a study by Wang et al., the penile lengths of 11 patients
who had full erections after intracavernous injections (ICI) done at the time of penile duplex ultrasonography before surgery was compared with measurements 1 year after PPI insertion (4). The mean penile length with PPI was 12.5 cm compared to that induced by ICI, which was 13.2 cm, suggesting a mean erect length loss of 0.7 cm.
Based on the results of our search, strategies were classified into 3 groups based on the timepoint in relation to the primary penile prosthetic insertion surgery, which included pre-insertion, intraoperative and post-insertion (Table 2).

Pre-insertion strategies

Traction therapy has been used in the fields of plastic, maxillofacial and orthopedic surgery for decades. The effect of prolonged traction has been studied in skin, bone, muscle and Dupuytren’s contractures. The underlying mechano- transduction induces actual tissue growth, and not just merely stretching the tissue (5).
The regular application of an external penile traction device can provide some degree of penile length gain in men with short penises (6,7).
In a pilot study involving 10 men with penile length loss due to radical prostatectomy, prosthesis explantation or Peyronie’s disease, Levine et al. found that applying external traction therapy (ETT) 2-4 hours daily for 2-4 months prior to prosthesis surgery can increase SPL by an average of 1.5 cm. No subjective or objective penile length loss was observed in this group of patients after the surgery (5).

Translational Andrology and Urology, Vol 2, No 1 March 2013 69


Table 2 3-stage strategies for maintaining penile size after PPI
Pre-insertion External traction therapy
Vacuum erection device Surgery at center of excellence
Immediate PPI (for refractory ischemic priapism) Intraoperative New length measurement technique for IPP
Non-corporal dilation technique Ventral phalloplasty Suspensory ligament release Suprapubic lipectomy Augmentation corporoplasty
Post-insertion MUSE
PDE5 inhibitors
Revision of IPP with larger cylinders after intracorporal stretching
Delayed enhancement surgeries (ventral phalloplasty, suspensory ligament release, suprapubic lipectomy)



The early and daily use of a vacuum erection device (VED) soon after radical prostatectomy may lower the likelihood of penile length loss. In a study of post-radical prostatectomy patients, Dalkin et al. found that only 1/36 (3%) of patients had a decrease in SPL of > or =1.0 cm when VED is used regularly after surgery. This decrease in penile length loss is significant when compared to earlier studies where 48% of men after surgery had a significant reduction in SPL (P<0.0001) (8). In recent months, there has been interest in the use of VED pump 2-3 months prior to PPI surgery because preliminary studies suggest that preoperative stretching with a VED may allow longer cylinder placements at the time of the penile prosthetic surgery (9).
The choice of surgeon is likely to have an impact on eventual penile length after PPI. A frequent implanter (widely considered as a surgeon who inserts more than 25 PPIs per year) is likely to use a longer PPI cylinder compared to an infrequent implanter. In an outcome analysis study comparing 57 penile prostheses implanted by a multiple surgeon group versus 57 penile prostheses placed by a single surgeon in a center of excellence (COE), Henry et al. found that the median cylinder length of implants placed by the COE surgeon was 2 cm greater than those placed by the multiple surgeon group (P<0.0001). More than 82% of implants placed by the COE surgeon had cylinders that were 17 cm or longer, with 37% having cylinder lengths between 20-22 cm. This was in contrast to the multiple surgeon group, whereby more than 55% of implants had cylinders that were less than 17 cm with only 14.3% having cylinder lengths between 20-22 cm. Median operative time was also considerably shorter


for the COE surgeon (34 vs. 94 minutes, P<0.0001) (10).
In patients with refractory ischemic priapism and corporal smooth muscle necrosis, where subsequent erectile dysfunction, corporal smooth muscle fibrosis and penile shortening are almost certain, Ralph DJ et al. advocates immediate insertion of PPI as a way to preserve penile length and restore sexual function. In his study involving 50 patients managed with immediate PPI, overall treatment satisfaction rate was 96% with no complaint of penile shortening. While this approach offers the advantages of an expedious restoration of sexual function and the avoidance of a potentially difficult implant surgery brought on by dense corporal fibrosis, one may have to contend with a possibly higher rate of infection, which was 6% in this study (11).


Intra-operative strategies

When choosing the size of cylinders to be used, inadequate sizing or intentional downsizing by surgeons will have a direct impact on the final erect penile length. Before the arrival of IPP, synthetic intracavernosal semirigid rod penile prostheses were used extensively. Surgeons trained in the insertion of semirigid prostheses are often taught to downsize the rods to avoid distal erosions. This is not necessary with IPPs, where the risk of distal erosion is minimal.
In fact, a new length measurement technique for IPP has allowed larger cylinders to be inserted in primary implants with no increased risk of distal erosion after 24 months. The key points of this new technique are the addition of 1 cm length to the total measurement when the dilator

70 Lee and Brock. Strategies for maintaining penile size following penile implant

from 37 patients who did not have ventral phalloplasty during PPI, where 31/37 (83.8%) patients complained of penile shortening and only 1 (2.7%) reporting an increase in penile length.
The difference in patients reporting an increase in length compared to decreased length in both groups was statistically significant (P<0.001) (14).


Suspensory ligament release




Figure 1 A. Identifying the ventral insertion of scrotum; B. Check mark incision for ventral phalloplasty.


does not drop down proximally into the lateral crux of the corpora onto a firm bone stopping point, and the addition of another 1 cm if the dilator does not go all the way out into the glans (12).
Conserving cavernous tissue during PPI surgery can help to preserve residual sexual function and penile length. And this can be achieved by withholding unnecessary corporeal dilation in primary implants, where corporal fibrosis is minimal. In a randomized study of 100 patients with PPI, half had corporeal dilation while the other half did not. Average postoperative penile length improved by 1.1 cm in the group without corporeal dilation and decreased by 1.2 cm in the group with corporeal dilation at 6 months (P<0.05) (13). A more intact spongy cavernosal tissue can become engorged and contribute to a more natural response during sexual stimulation.
To improve patient satisfaction and the overall perception of greater penile length, several penile enhancement procedures have been described.


Ventral phalloplasty

In pediatrics, scrotoplasty has been used to improve the projection of an inconspicuous penis. Using the same principle, ventral phalloplasty, which involved the “check mark” excision of penoscrotal web (Figure 1) followed by reapproximation of the dartos along the axis of the penile shaft, has been performed concurrently with PPI to enhance the perception of greater penile length. In a study by Miranda-Sousa et al., 36/43 (83.7%) patients who had ventral phalloplasty during PPI reported an increase in their perception of penile length while 2/43 (4.6%) patients reporting a decrease. This was compared to the response

Incision of the penile suspensory ligament allows the penis to drop into a more dependent position, giving a perceived increase in penile length (15). This procedure is commonly used in combination with inverted V-Y skin plasty.
Borges et al. released the penile suspensory ligaments
of 303 patients who underwent implantation of IPPs via the infrapubic approach. There was no complaint of penile shortening in all the patients. Penile lengths of 18 patients were measured in a substudy before and after PPI. A mean increase of 2.4 cm flaccid penile length and 1.7 cm erect penile length was observed.
Upon implantation, the device was inflated and the penis pressed downwards. This allowed the fundiform ligament to be incised, so that the suspensory ligament can be exposed and detached from the pubis (16).
To prevent reattachment of the suspensory ligament to the pubic bone, the implant was left partially inflated so that patient could apply downward pressure after surgery to maintain the distance between the pubis and the base of the penis. The use of a silicon spacer to prevent reattachment has also been described (17).
Data on the therapeutic benefits of penile suspensory ligament release is currently inconclusive. Implanters performing this procedure as part of PPI surgery will need to take into consideration the extended operative time, the risks of penile shortening from ligament reattachment contractures, the risk of wound infection and the potential complications associated with the use of a foreign body such as a silicon spacer.


Suprapubic lipectomy

In older men, weight gain together with changes in body fat deposition may cause the penis to be buried under excess skin of the panniculus, thus causing an apparent loss in penile length. Excision of the suprapubic fat pad with release of penile suspensory ligaments can create the perception of greater penile length (18). In a team setting,

Translational Andrology and Urology, Vol 2, No 1 March 2013 71


where the plastic surgeon works alongside the urologist, suction lipectomy of the abdomen and pubic area combined with penile suspensory ligament release and abdominoplasty can yield satisfactory results (19).


Augmentation corporoplasty

Patch grafting is an established method to correct penile curvature in Peyronie’s surgery. In augmentation corporoplasty, tissue grafts are used to elongate the penis during PPI insertion. The use of synthetic materials (Gore-Tex, silicone), human grafts (venous, dermal), and treated biological materials (InteXen, Tutoplast, AlloDerm) have been described (20,21). Synthetic materials are less preferred because of the intense fibrosis associated with their use. Human autologous grafts are good options if longer operative time and donor site complications are not of major concerns. Treated biological materials do not require harvesting and are less likely to incite fibrosis, but they are generally more costly. Augmentation corporoplasty is not commonly done as an adjunct to PPI, due to the costs and usually marginal improvement in final outcome.


Post-insertion strategies

The mechanical erections brought on by PPI are sometimes perceived as inadequate because of absent glans tumescence. This has a negative impact on patient satisfaction after PPI. To overcome this concern, intraurethral alprostadil, in the form of MUSE (medicated urethral system for erection) can be used with a functioning prosthesis to improve glans penis temperature, sensation and engorgement (22,23).
Besides alprostadil, PDE5 inhibitors such as sildenafil have also been used to achieve this goal. In a study by Mulhall et al. 32 post-PPI patients reported a statistically significant improvement in satisfaction score when PPI is used in conjunction with sildenafil (24). The benefit arose mainly from better glans engorgement.
The use of intracavernosal injections and vacuum erection devices are generally not used after PPI surgery as there is an inherent risk of prosthetic cylinder damage. In some centers, subcutaneous injection of polyacrelamide gel into the glans are offered as a relief measure. Through one needle point, polyacrelamide gel is injected using a fanning technique and the injection site is sealed with 5/0 vicryl to prevent seeping of the gel and bleeding (25). The usefulness of glans injection is limited by its short-lived results (average 5 months).


If not yet done at the time of PPI insertion, ventral phalloplasty, suprapubic lipectomy and penile suspensory ligament release procedures can be contemplated as part of an overall post-insertion strategy to recover perceptual penile length.
In cases of prolonged ischemic priapism or removal of a previously infected implant, severe corporal fibrosis may preclude the use of larger cylinders. In a study of 37 such patients, where it was impossible to dilate the corporal to 12 mm for standard-sized cylinders, smaller downsized cylinders were inserted to act as tissue expanders. Patients were encouraged to inflate their implant for up to 3 hours daily. After several months of intracorporal stretching, the patients were reoperated and wider and often longer standard-sized prosthetic cylinders can be substituted. For patients with previous infected explants, the substituted cylinders may be 2-4 cm longer (26).
In a separate case report, a patient with post-PPI penile shortening underwent vacuum erection device therapy twice daily for 10 minutes per session for approximately 1 year as well as 8 hours of penile traction therapy daily for 8 months. At the time of PPI revision, a prosthesis that was 20% longer in length was used which improved erect penile length by 4.4 cm. The post-PPI traction therapy also increased SPL by 2.3 cm (27).


Conclusions

Patient’s perception of decreased penile size after PPI can negatively influence overall satisfaction and sexual quality of life measures. Strategies to preserve and potentially increase penile size are of great importance to all implanters. The strategies in this review target 3 stages of patient care; pre-insertion, intraoperative and post-insertion. Besides traction therapies and surgeries to enhance perceived penile size, refinements in the surgical approach to allow greater conservation of cavernosal smooth muscle and optimal sizing of the implant cylinders are simple ways to optimize penile length. A direct comparison of treatment outcomes evaluating the various approaches is not currently possible, owing to divergent study techniques across the small numbers of small studies with limited reported measures. The implanting surgeon can best serve his patient by adopting a combination of different strategies that are individualized and specific to the patient’s needs.
We are hopeful that advancements in stem cell technology may one day allow surgeons to pre-operatively increase cavernosal smooth muscle content and improve

72 Lee and Brock. Strategies for maintaining penile size following penile implant


tunica albuginea elasticity, which are the bane of contemporary penile shortening after PPI.


Acknowledgements

None.


Footnote
Conflicts of Interest: The authors have no conflicts of interest
to declare.


References

1. Vardi Y, Har-Shai Y, Gil T, et al. A critical analysis of penile enhancement procedures for patients with normal penile size: surgical techniques, success, and complications. Eur Urol 2008;54:1042-50.
2. Wessells H, Lue TF, McAninch JW. Penile length in the flaccid and erect states: guidelines for penile augmentation. J Urol 1996;156:995-7.
3. Deveci S, Martin D, Parker M, et al. Penile length alterations following penile prosthesis surgery. Eur Urol 2007;51:1128-31.
4. Wang R, Howard GE, Hoang A, et al. Prospective and long-term evaluation of erect penile length obtained with inflatable penile prosthesis to that induced by intracavernosal injection. Asian J Androl 2009;11:411-5.
5. Levine LA, Rybak J. Traction therapy for men with shortened penis prior to penile prosthesis implantation: a pilot study. J Sex Med 2011;8:2112-7.
6. Gontero P, Di Marco M, Giubilei G, et al. A pilot phase- II prospective study to test the ‘efficacy’ and tolerability of a penile-extender device in the treatment of ‘short penis’. BJU Int 2009;103:793-7.
7. Nikoobakht M, Shahnazari A, Rezaeidanesh M, et al. Effect of penile-extender device in increasing penile size in men with shortened penis: preliminary results. J Sex Med 2011;8:3188-92.
8. Dalkin BL, Christopher BA. Preservation of penile length after radical prostatectomy: early intervention with a vacuum erection device. Int J Impot Res 2007;19:501-4.
9. Pahlajani G, Raina R, Jones S, et al. Vacuum erection devices revisited: its emerging role in the treatment of erectile dysfunction and early penile rehabilitation following prostate cancer therapy. J Sex Med 2012;9:1182-9.
10. Henry GD, Kansal NS, Callaway M, et al. Centers of excellence concept and penile prostheses: an outcome

analysis. J Urol 2009;181:1264-8.
11. Ralph DJ, Garaffa G, Muneer A, et al. The immediate insertion of a penile prosthesis for acute ischaemic priapism. Eur Urol 2009;56:1033-8.
12. Henry G, Houghton L, Culkin D, et al. Comparison of a new length measurement technique for inflatable penile prosthesis implantation to standard techniques: outcomes and patient satisfaction. J Sex Med 2011;8:2640-6.
13. Moncada I, Martínez-Salamanca JI, Jara J, et al. Inflatable penile prosthesis implantation without corporeal dilation: a cavernous tissue sparing technique. J Urol 2010;183:1123-6.
14. Miranda-Sousa A, Keating M, Moreira S, et al. Concomitant ventral phalloplasty during penile implant surgery: a novel procedure that optimizes patient satisfaction and their perception of phallic length after penile implant surgery. J Sex Med 2007;4:1494-9.
15. Hakky TS, Suber J, Henry G, et al. Penile enhancement procedures with simultaneous penile prosthesis placement. Adv Urol 2012;2012:314612.
16. Borges F, Hakim L, Kline C. Surgical technique to maintain penile length after insertion of an inflatable penile prosthesis via infrapubic approach. J Sex Med 2006;3:550-3.
17. Li CY, Kayes O, Kell PD, et al. Penile suspensory ligament division for penile augmentation: indications and results. Eur Urol 2006;49:729-33.
18. Horton CE, Vorstman B, Teasley D, et al. Hidden penis release: adjunctive suprapubic lipectomy. Ann Plast Surg 1987;19:131-4.
19. Adham MN, Teimourian B, Mosca P. Buried penis release in adults with suction lipectomy and abdominoplasty. Plast Reconstr Surg 2000;106:840-4.
20. Austoni E, Guarneri A, Cazzaniga A. A new technique for augmentation phalloplasty: albugineal surgery with bilateral saphenous grafts--three years of experience. Eur Urol 2002;42:245-53; discussion 252-3.
21. Sansalone S, Garaffa G, Djinovic R, et al. Simultaneous penile lengthening and penile prosthesis implantation in patients with Peyronie’s disease, refractory erectile dysfunction, and severe penile shortening. J Sex Med 2012;9:316-21.
22. Chew KK, Stuckey BG. Use of transurethral alprostadil (MUSE) (prostaglandin E1) for glans tumescence
in a patient with penile prosthesis. Int J Impot Res 2000;12:195-6.
23. Benevides MD, Carson CC. Intraurethral application of alprostadil in patients with failed inflatable penile prosthesis. J Urol 2000;163:785-7.

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24. Mulhall JP, Jahoda A, Aviv N, et al. The impact of sildenafil citrate on sexual satisfaction profiles in men with a penile prosthesis in situ. BJU Int 2004;93:97-9.
25. Shaeer O. Supersizing the penis following penile prosthesis implantation. J Sex Med 2010;7:2608-16.
26. Wilson SK, Delk JR 2nd, Mulcahy JJ, et al. Upsizing of


inflatable penile implant cylinders in patients with corporal fibrosis. J Sex Med 2006;3:736-42.
27. Moskovic DJ, Pastuszak AW, Lipshultz LI, et al. Revision of penile prosthesis surgery after use of penile traction therapy to increase erect penile length: case report and review of the literature. J Sex Med 2011;8:607-11.

[Larry10625]

Reconstructive Urology
North American Consensus Document on Infection of Penile Prostheses
Rabih O. Darouiche, Anthony J. Bella, Timothy B. Boone, Gerry Brock, Gregory A. Broderick, Arthur L. Burnett, Raphael Carrion, Culley Carson III, Brian Christine, Chipriya B. Dhabuwala, Lawrence S. Hakim, Gerard Henry, LeRoy A. Jones, Mohit Khera, Drogo K. Montague, and Ajay Nehra
OBJECTIVE To issue a consensus document on the prevention, management, and research of infection associated with penile prostheses, as neither professional associations nor governmental entities have issued guidelines that are specific to this infection.
METHODS Sixteen North American experts on infection of penile prostheses were identified and assembled to select and discuss certain issues related to infection of penile prostheses. After performing an extensive search of clinically important issues in published reports, the 16 experts met twice in person to finalize the selection, discuss the issues that were deemed most important, and issue pertinent recommendations.
RESULTS Although many subjects relevant to infection of penile prostheses were initially identified, the experts selected 10 issues as currently being the most important issues and for which there exists some support in the published data. The examined issues involved prevention, management, or research of infections associated with penile prostheses.
CONCLUSION In the absence of pertinent guidelines, the consensus document issued by experts in the field of prosthetic urology is anticipated to improve the quality of patient care, streamline the prevention and management of infected penile prostheses, and stimulate collaborative research. Although this consensus document could serve as best practice recommendations, the lack of adherence to these recommendations would not indicate improper care. UROLOGY 82: 937e942, 2013. Published by Elsevier Inc.




f the tens of millions of American men with erectile dysfunction, up to 25,000 of them currently undergo implantation of inflatable
penile prostheses each year in the United States.1 Infec-
tion is the most common serious complication of

Financial Disclosure: The authors declare that they have no relevant financial interests. Funding Support: This work was supported in part by the not-for-profit Multidisci- plinary Alliance Against Device-Related Infections (MADRI), which was not involved in the writing of this consensus statement.
From the Department of Urology, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX; the Department of Urology, University of Ottawa, Ottawa, Ontario, Canada; the Department of Urology, The Methodist Hospital and Baylor College of Medicine, Houston, TX; the Department of Urology, University of Western Ontario, London, Ontario, Canada; the Department of Urology, Mayo Clinic College of Medicine, Jacksonville, FL; the Department of Urology, Johns Hopkins Hospital, Baltimore, MD; the Department of Urology, University of South Florida, College of Medicine, Tampa, FL; the Department of Urology, University of North Carolina, Chapel Hill, NC; Urology Centers of Alabama, Homewood, AL; the Department of Urology, Harper University Hospital and Hutzel Women’s Hospital, Detroit, MI; the Department of Urology, Cleveland Clinic Foun- dation, Weston, FL; Regional Urology, Shreveport, LA; Urology San Antonio, San Antonio, TX; the Department of Urology, Baylor College of Medicine, Houston, TX; the Department of Urology, Cleveland Clinic, Cleveland, OH; and the Department of Urology, Rush University Medical Center, Chicago, IL
Reprint requests: Rabih O. Darouiche, M.D., Center for Prostheses Infection, Baylor College of Medicine, 1333 Moursund Avenue, Suite A221, Houston, TX 77030. E-mail: rdarouiche@aol.com
Submitted: April 29, 2013, accepted (with revisions): May 30, 2013


implanted penile prostheses, as it can result in prolonged and repeated hospitalizations, multiple operations, addi- tional comorbid conditions owing to secondary inter- ventions, and loss of work. Although the average rate of infection of virgin penile prostheses in patients at low risk of infection does not exceed 2%-3%, the likelihood of infection can be several folds higher in those who have replacement prostheses, undergo repeated surgical proce- dures, or with underlying medical conditions that predispose to infection, or a combination of these.2
Unfortunately, neither professional associations nor governmental entities have issued guidelines or even best practice recommendations that are specific to the prevention and management of infection of penile pros- theses. The lack of established guidelines could be attrib- uted, at least in part, to the relatively low rate of infection of penile prostheses (as compared, for example, with a 10%-20% incidence of catheter-associated urinary tract infection) or the relatively small absolute number of cases of infection of penile prostheses that occur each year in the United States ( a thousand cases of infected penile pros- theses vs hundreds of thousands of episodes of catheter- associated urinary tract infection), or a combination of both.3 The purpose of this communication is to provide

Published by Elsevier Inc. 0090-4295/13/$36.00 937
http://dx.doi.org/10.1016/j.urology.2013.05.048

Table 1. Examined issues

(A) Prevention of infection
(1) Perioperative systemic antibiotic prophylaxis
(2) Antiseptic cleansing of the skin
(3) Preoperative showering or bathing
(4) Preoperative scrubbing of patients’ skin
(5) Surgeons’ scrubbing vs hand rubbing
(6) Surface modification of prostheses
(B) Management of infection or colonization
(1) Salvage strategy
(2) Revision procedure
(C) Future research
(1) Limitations of research
(2) Microbiology of infection


a consensus document on the prevention, management, and research of infection associated with penile prostheses.

MATERIALS AND METHODS
A total of 16 North American (14 Americans and 2 Cana- dians) experts on infection of penile prostheses (including 15 practicing urologists and 1 infectious disease specialist) agreed to participate in this endeavor. All assembled experts have implanted penile prostheses in a large number of patients or frequently called on to help manage infection of penile pros- theses, or both, and have published and lectured on this subject.
Of the dozens of issues related to infection of penile pros- theses that were initially identified as being possibly suitable for discussion, the experts selected for further examination 10 issues that were regarded as being most important and for which there exists some support in the published data. As shown in Table 1, the 10 examined issues focused on prevention, management, or research of infections of penile prostheses. A comprehensive Medline search was performed using the MeSH index headings from January 2000 through March 2013 (Table 2). The expert panel did not rely on letters and abstracts. The experts described their practices, expressed their preferences, and stated the scientific basis or clinical logic for their recommendations. Because there exist minimal published data for many examined issues, the panel was not expected to qualify the strength of the issued recommendations.

RESULTS
The expert panel selected and discussed the following 10 issues that belong to the 3 categories of prevention of infection (6 issues), management of infection (2 issues), and future research (2 issues).

Prevention of Infection
Although the overall rate of infection of penile prostheses is not that high, these infections can lead to serious medical sequelae, tragic psychologic trauma, and disas- trous economic consequences. Because 1 case of infection of penile prostheses is one too many, preventing these infectious complications is a top priority.

Table 2. MeSH index headings used for Medline search


Penile AND implant (OR prosthesis) AND antibiotic Penile AND implant (OR prosthesis) AND prophylaxis Penile AND implant (OR prosthesis) AND systemic AND
antibiotic AND prophylaxis
Penile AND implant (OR prosthesis) AND antisepsis (OR antiseptic)
Penile AND implant (OR prosthesis) AND shower Penile AND implant (OR prosthesis) AND scrub Penile AND implant (OR prosthesis) AND surface
Penile AND implant (OR prosthesis) AND antimicrobial (OR Inhibizone OR rifampin OR minocycline)
Penile AND implant (OR prosthesis) AND salvage (OR salvaging OR removal OR replacement OR no removal)
Penile AND implant (OR prosthesis) AND revision Penile AND implant (OR prosthesis) AND colonization Penile AND implant (OR prosthesis) AND biofilm Penile AND implant (OR prosthesis) AND capsule Penile AND implant (OR prosthesis) AND infection (OR
infected)




Perioperative Systemic Antibiotic Prophylaxis. Background. The American Urological Association Prac- tice Guidelines Committee indicated that there were insufficient data to formulate a guideline on antimicrobial prophylaxis for urologic surgery and issued in 2007 a Best Practice Policy Statement on Urologic Surgery Antimi- crobial Prophylaxis that was updated in 2008.4 Taking into consideration that no randomized controlled trials had assessed the type and duration of systemic antibiotic prophylaxis for “implanted urologic prostheses”, the American Urological Association Best Practice Policy Statement recommended the use of a first- or second- generation cephalosporin (or vancomycin) and an ami- noglycoside (or aztreonam) for 24 hours. Our expert panel was also cognizant of the fact that guidelines from other surgical associations and quality-focused organiza- tions recommended stopping systemic antibiotic prophy- laxis within 24 hours after surgery.5 Not unexpectedly, there exist no prospective or retrospective data that assess the choice and duration of systemic antibiotic prophylaxis around the time of implanting penile prostheses. This helps explain the great variation in perioperative practices among urologists who implant penile prostheses.6
Recommendation. There was a consensus among the experts to provide antimicrobial coverage against gram- positive (mainly staphylococci) and gram-negative bacteria and to continue antibiotics, preferably intrave- nously while patients still hospitalized, for at least 24 hours after surgery. Although most experts preoperatively administer vancomycin rather than cephalosporins that are inherently inactive against methicillin-resistant Staphylo-
coccus aureus (MRSA), the panel unanimously expressed
the need to adjust the choice of vancomycin vs a cephalo- sporin on the basis of the prevalence of MRSA in the individual hospital and community. Preoperative admin- istration of systemic antibiotics must be timed to allow therapeutic antibiotic levels before making the surgical incision in blood and manipulated tissues. All expert

urologists provided oral antibiotic prophylaxis for 5-14 days postoperatively. A variety of oral antibiotics (including quinolones, cephalosporins, penicillins, and sulfa drugs) are currently being used for postoperative prophylaxis. However, in environments in which MRSA is prevalent, the consensus among experts was to use trimethoprim- sulfamethoxazole (bactrim) in patients with no allergy to sulfa drugs, in which case doxycycline could be used.
Antiseptic Cleansing of the Skin.
Background. The panel acknowledged the variability of practices when cleansing the patients’ skin before implanting penile prostheses. A randomized, controlled, multicenter study showed that patients embarking on clean-contaminated surgery have a significantly lower rate of surgical site infection if their skin is preoperatively cleansed with chlorhexidine-alcohol vs aqueous povi- done-iodine.7 Another randomized clinical trial in patients undergoing clean, clean-contaminated, or dirty surgery also demonstrated the superior protection afforded by chlorhexidine-alcohol vs aqueous povidone-iodine.8 A single quasi cross-over study suggested that antiseptic cleansing of the patients’ skin with chlorhexidine-alcohol may reduce the rate of infection of penile prostheses.9 Furthermore, in a recent randomized controlled trial, chlorhexidine-alcohol was superior to povidone-iodine in eradicating skin flora at the surgical skin site before genitourinary prosthetic implantation.10
Recommendation. The panel unanimously recommended cleansing of the patients’ skin with alcohol-based anti- septic preparation whenever available, with the under- standing that aqueous but not alcohol-based preparations would be applied to mucosal membranes. The alcohol- based antiseptic preparation should be allowed to dry for at least 3 minutes before making the surgical incision.
Preoperative Showering or Bathing.
Background. Although a bit controversial, extensive recent assessments in Cochrane reviews11 and meta- analysis12 disclosed no convincing evidence that preoperative showering or bathing with certain agents (chlorhexidine, povidone-iodine preparations, soap and
water, and so forth) reduces the incidence of surgical site infection. Although a randomized, controlled, multi- center trial demonstrated a significant reduction in the incidence of surgical site infections because of Staphylo- coccus aureus among nasal carriers who preoperatively
received for 5 days chlorhexidine bodily wash daily and nasal mupirocin twice a day as compared with no inter- vention, the degree of protection afforded by chlorhex- idine alone is unknown.13 The value of this strategy of preoperative showering or bathing has not been exam- ined in patients receiving penile prostheses.
Recommendation. The panel agreed that patients with poor skin condition should receive a preoperative shower or bath. However, there was a unanimous agreement

among the experts that, in the absence of relevant data, the operating urologist has the ultimate say as to whether patient should shower or bath, with which agent(s), and for how long.
Preoperative Scrubbing of Patient’s Skin.
Background. Preoperative local scrubbing of the patient’s skin has been generally studied much less than preoper- ative showering or bathing, and there exist no pertinent data specific to penile prostheses. A prospective cohort study in patients receiving artificial urinary sphincters (not penile prostheses) showed that scrubbing the patient’s skin with 4% chlorhexidine for 5 minutes twice a day for 5 days reduces perineal colonization by 4 folds as compared with the usual hygiene practice of cleansing the skin with soap and water, but this study did not assess the effect on clinical infection.14
Recommendation. The panel acknowledged the lack of data comparing the effect of preoperative scrubbing vs showering or bathing vs no skin preparation on the occurrence of infection of penile prostheses. As is the case with the strategy of preoperative showering or bathing, the panel unanimously stated that the operating surgeon would determine the need, type, and duration of preop- erative scrubbing of patients’ skin.
Surgeons’ Scrubbing Vs Hand Rubbing.
Background. There exists an emerging trend for surgeons scrubbing their hands with aqueous preparations before the first surgery of the day, then hand rubbing with an alcohol- based preparation before subsequent surgeries unless their hands become grossly dirty. This strategy, however, has not been assessed at the time of implanting penile prostheses. Furthermore, there are no strong comparative data to indicate that the use of various antiseptic preparations for scrubbing (including chlorhexidine, povidone-iodine, and chloroxylenol) or hand rubbing with various alcoholic- based solutions significantly affects the occurrence of surgical site infection. Surgical hand antisepsis with alcohol-based hand rubbing for 1.5 minutes vs 3 minutes resulted in comparable bacterial reduction.15
Recommendation. In the absence of convincing data, the panel experts unanimously recommended that urologists scrub their hands before the first surgery of the day and whenever their hands become grossly dirty. However, the experts could not reach an agreement as to whether the hands of urologists implanting penile prostheses should, after the first surgery of the day, be routinely scrubbed instead of being rubbed, and with which antiseptic preparation.
Surface Modification of the Penile Prosthesis. Background. Penile prostheses that are antimicrobial- impregnated (with minocycline and rifampin) or antibiotic-dipped (by bonding various antibiotics such as gentamicin plus rifampin to a hydrophilic surface that contains polyvinyl pyrolidone) were shown in retrospective

studies to cut down on average the rate of infection by at least half, as compared with control nonmodified pros- theses. The efficacy of surface modification was documented with long-term follow-up,16,17 in diabetics,2,18 with replacement implantation,19 in combination with a no touch technique,20 and in a meta-analysis.21 Not unex- pectedly, the requirement for a large sample size prohibits the performance of sufficiently powered randomized controlled trials that would compare the clinical efficacy of these 2 types of surface-modified penile prostheses.
Recommendation. Although there are established factors (including diabetes mellitus, replacement surgery, spinal cord injury, severe vascular insufficiency, active infection, and so forth) that clearly predispose to infection of penile prostheses, the expert panel acknowledges the fact that infection can still occur and cause serious complications in patients at a low risk for infection. Accordingly, the experts unanimously recommended the use of surface- modified penile prostheses, whenever available, possible, and free of allergic reactions. The choice to use one type of antimicrobial-modified prosthesis vs another ought to be based on factors including allergic reactions to the used antibiotics, likelihood of antimicrobial coverage against infecting pathogens, durability of antimicrobial activity, and historic success when applying a certain surface modification not just to the penile prostheses but also to other types of foreign devices.

Management of Infection or Colonization
A number of other surgical specialties, including ortho- pedics and vascular surgery, commonly practice the 2-stage surgical management of infected implants by first removing the infected prosthesis, possibly placing antimicrobial- containing spacers or beads, and then implanting a new prosthesis at a later time when infection is deemed to have been cured. Although delayed replacement of infected penile prostheses can decrease the penile size because of corporal fibrosis, a recently reported patient initially received a calcium sulfate spacer that contains vancomycin and tobramycin, then subsequently had a successful and uneventful replacement of the penile prosthesis 6 weeks later without corporal fibrosis.22 However, at the present time, most urologists perform a single-stage “salvage” procedure during which the infected penile prosthesis is removed, the surgical field is washed, and a new penile prosthesis is placed. These observations prompt the anal- ysis of 2 important issues related to the management of infected or colonized penile prostheses.

Salvage Strategy.
Background. Vigorous intraoperative mechanical and antimicrobial irrigation is a key to successful salvage of infected penile prostheses. The original protocol for salvage irrigation that comprised removal of all foreign materials, a 7-step antimicrobial wound irrigation (including 3 steps using antibiotics and 4 steps using

antiseptics), changing the operating setup, insertion of a new prosthesis, and a 1-month postoperative course of an oral quinolone was successful in 82% in highly selected cases.23 A subsequent smaller study that used the same 7-step antimicrobial wound irrigation, but did not mention the change in operation setup or the 1-month course of oral quinolone, reported a similar degree of efficacy of 87% in also highly selected patients.24 Some experts shared their nonpublished lower rates of success when using such irrigation protocols. The efficacy of these original or modified irrigation protocols has not been compared with other irrigation strategies. Because most infected penile prostheses currently undergo a single-stage salvage procedure rather than a 2-stage surgical replace- ment, it is essential to maximize the chance of cure.
Recommendation. The expert panel unanimously acknowledged the fact that a salvage procedure is more likely to fail in the presence of factors such as sepsis, purulence, extruded device, urethral perforation, and uncontrolled diabetes mellitus. That is why the experts recommended that infected patients should be involved in making the decision as to whether a salvage procedure should be performed. There was a universal recommen- dation by the panel to remove the whole penile pros- theses if any component is clinically infected. A vigorous mechanical (to remove biofilm) and antimicrobial irri- gation (aimed at eradicating bacterial presence) is essential in salvage surgery. However, some experts opined that modified (using different antimicrobials and, perhaps, using a lower concentration of potentially tissue- irritating antiseptics) or more practical (less irrigation steps) versions of the original irrigation protocol, or both, could also be protective. All experts recommended the use of systemic antibiotics guided by the results of intra- operative cultures for 2-4 weeks after surgery.
Revision Procedure.
Background. Even in the absence of clinical infection, mechanically failed components of penile prostheses can become grossly covered by biofilm or colonized by biofilm-embedded bacteria.25,26 Because intraoperative bacterial cultures are reportedly less likely to be positive after irrigation than before, and taking into consideration that bacterial absence could correlate with revision-free survival,25 antimicrobial washout is commonly,27 but not always,28 done.
Recommendation. Although the experts expressed split opinions as to whether some but not all colonized components of the penile prostheses could be left in place in the absence of clinical infection, they unanimously agreed on the need for antimicrobial irrigation. Regard- less, the components’ spaces should be irrigated with antimicrobials before placing new components. Despite the absence of supporting data, all experts opined that a 5-7eday course of properly selected oral antibiotics would be appropriate after surgical revision for

noninfectious reasons. Although intraoperative cultures are not routinely obtained from patients undergoing revision surgery, the antimicrobial profile of colonizing organisms detected by intraoperative cultures could help guide the choice of postoperative systemic antibiotics.

Future Research
Limitations of Research. Although randomized con- trolled trials are a superior methodology in the hierarchy of evidence, the relatively small number of penile prostheses that are inserted each year combined with the relatively low rate of infection, makes it almost impos- sible to conduct randomized controlled trials on the prevention or management of infection of penile pros- thesis. For instance, it takes 5028 evaluable patients to have a sufficiently powered study that would demon- strate a significant reduction in the rate of infection when comparing an experimental preventive strategy with a 1% rate of infection vs a baseline rate of infection of 2% in the control group.29 Even if the baseline rate of infection in the control arm is higher, at 3% or 4%, and the experimental arm has an infection rate of 1.5% or 2%, respectively, it would still be prohibitive to conduct an adequately powered randomized trial of 3328 or 2478 evaluable patients, respectively.29 Another limitation to conducting randomized controlled studies is that, according to the Centers for Disease Control and Prevention guidelines, surgical site infection in patients with indwelling prostheses needs to be assessed at 1 year as compared with only 1 month in surgical patients without an implanted prosthesis.30 Not even a cross- over study design may yield itself well to the study of patients with penile prostheses. This helps explain why most studies that assess infection of penile prostheses are cohort or observational studies.
Microbiology of Infection. It would be important to determine whether exposure to certain systemic or local antibiotics changes the microbiology of infection of penile prostheses. Because this issue would be difficult to examine in a prospective fashion, it would be best assessed in a retrospective multicenter study that has 3 objectives: (1) compare the current vs past microbiology of infection of penile prostheses, (2) assuming a change in microbiology is detected, it would be important to explore whether changes in the microbiology of infection of penile pros- theses simply reflect the hospital-wide microbiology alter- ations over time rather than the use of certain antibiotics, and (3) potentially update the optimal choice of antimi- crobials for prevention and treatment of infection.

COMMENT
This consensus document is not intended to address all issues related to prevention, management, and research of infection of penile prostheses. Instead, the expert panel decided to focus on certain clinically important issues. We did not include in the consensus statement univer- sally applied preventive practices, such as limiting traffic

in the operating room, optimizing control of diabetes mellitus, and postoperative sealing of wounds. We dis- cussed but excluded from the consensus statement important but rather controversial issues such as insertion of drains and handling of hair (clipping vs shaving). This presented information and issued recommendations in the consensus document do not sanction the off-label use of products.

CONCLUSION
The issued North American Consensus Document on Infection of Penile Prostheses aims at enhancing prevention of infection, optimizing management of established infection, and stimulating collaborative research. In the absence of existing guidelines, the recommendations listed in this consensus document could serve as best practice recommendations. Lack of adherence to these recommendations does not indicate improper care.

Acknowledgment. This work was supported in part by the not-for-profit Multidisciplinary Alliance Against Device- Related Infections (MADRI).

References
1. Darouiche RO. Treatment of infections associated with surgical implants. N Engl J Med. 2004;350:1422-1429.
2. Wilson SK, Zumbe J, Henry GD, et al. Infection reduction using antibiotic-coated inflatable penile prosthesis. Urology. 2007;70: 337-340.
3. Gould CV, Umscheid CA, Agarwal RK, et al. Guidelines for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010;31:319-326.
4. Wolf JS, Bennett CJ, Hollenbeck BK, et al. Best Practice Policy Statement on urologic surgery antimicrobial prophylaxis. J Urol. 2008;179:1379-1390.
5. Bratzler DW, Houck PM, Surgical Infection Prevention Guideline Writers Workgroup. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Am J Surg. 2005;189:395-404.
6. Katz DJ, Stember DS, Nelson CJ, et al. Perioperative prevention of penile prosthesis infection: practice patterns among surgeons of SMSNA and ISSM. J Sex Med. 2012;9:1705-1714.
7. Darouiche RO, Wall MJ Jr, Itani KMF, et al. Chlorhexidine-alcohol versus povidone iodine for surgical-site antisepsis. N Engl J Med. 2010;362:18-26.
8. Paocharoen V, Mingmalairak C, Apisarnthanarak A. Comparison of surgical wound infection after preoperative skin preparation with 4% chlorhexidine and povidone iodine: a prospective randomized trial. J Med Assoc Thai. 2009;92:898-901.
9. Kava BR, Kanagaraiah P, Ayyathurai R. Contemporary revision penile prosthesis surgery is not associated with a high risk of implant colonization or infection: a single-surgeon series. J Sex Med. 2011;8: 1540-1546.
10. Yeung LL, Grewal S, Bullock A, et al. A comparison of chlorhexidine-alcohol versus povidone-iodine for eliminating skin flora before genitourinary prosthetic surgery: a randomized controlled trial. J Urol. 2013;189:136-140.
11. Webster J, Osborne S. Preoperative bathing or showering with skin antiseptics to prevent surgical site infection. Cochrane Database Syst Rev. 2012;9:CD0044985.
12. Chlebiki MP, Safdar N, O’Horo JC, et al. Preoperative chlorhex- idine shower or bath for prevention of surgical site infection: a meta-analysis. Am J Infect Control. 2013;41:167-173.

13. Bode LG, Kluytmans JA, Wertheim HF, et al. Preventing surgical- site infections in nasal carriers of Staphylococcus aureus. N Engl J Med. 2010;362:9-17.
14. Magera JS, Inman BA, Elliott DS. Does preoperative topical anti- microbial scrub reduce positive surgical site culture rates in men undergoing artificial urinary sphincter placement? J Urol. 2007;178: 1328-1332.
15. Weber WP, Reck S, Neff U, et al. Surgical hand antisepsis with alcohol-based hand rub: comparison of effectiveness after 1.5 and 3 minutes of application. Infect Control Hosp Epidemiol. 2009;30: 420-426.
16. Carson CC III, Mulcahy JJ, Harsch MR. Long-term infection outcomes after original antibiotic impregnated inflatable penile prosthesis implants: up to 7.7 years of followup. J Urol. 2011;185: 614-618.
17. Serefoglu EC, Mandava SH, Gokce A, et al. Long-term revision rate due to infection in hydrophilic-coated inflatable penile pros- theses: 11-year follow-up. J Sex Med. 2012;9:2182-2186.
18. Mulcahy JJ, Carson CC III. Long-term infection rates in diabetic patients implanted with antibiotic-impregnated versus non- impregnated inflatable penile prostheses: 7-year outcomes. Eur Urol. 2011;60:167-172.
19. Abouassaly R, Angermeier KW, Montague DK. Risk of infection with an antibiotic coated penile prosthesis at device replacement for mechanical failure. J Urol. 2006;176:2471-2473.
20. Eid JF, Wilson SK, Cleves M, et al. Coated implants and “no touch” surgical technique decreases risk of infection in inflatable penile prosthesis implantation to 0.46%. Urology. 2012;79:1310-1315.
21. Mandava SH, Serefoglu EC, Freier MT, et al. Infection retardant coated inflatable penile prostheses decrease the incidence of infection: a systematic review and meta-analysis. J Urol. 2012;188:1855-1860.
22. Swords K, Martinez DR, Lockhart JL, et al. A preliminary report on the usage of an intracorporal antibiotic cast with synthetic high purity CaSO4 for the treatment of infected penile implant. J Sex Med. 2013;10:1162-1169.
23. Mulcahy JJ. Long-term experience with salvage of infected penile implants. J Urol. 2000;163:481-482.
24. Bryan DE, Mulcahy JJ, Simmons GR. Salvage procedure for infected noneroded artificial urinary sphincters. J Urol. 2002;168:2464-2466.
25. Henry GD, Carson CC, Wilson SK, et al. Revision washout decreases implant capsule tissue culture positivity: a multicenter study. J Urol. 2008;179:186-190.
26. Silverstein AD, Henry GD, Evans B, et al. Biofilm formation on clinically noninfected penile prostheses. J Urol. 2006;176:1008- 1011.
27. Henry GD, Donatucci CF, Conners W, et al. An outcome analysis of over 200 revision surgeries for penile prosthesis implantation: a multicenter study. J Sex Med. 2012;9:309-315.
28. Bartley J, Zimmerman WB, Dhabuwala CB. Inflatable penile pros- thesis and salvage protocol for mechanical failure: is it really necessary? J Sex Med. 2012;9:2175-2181.
29. Darouiche RO. Antimicrobial approaches for preventing infections associated with surgical implants. Clin Infect Dis. 2003;36:1284- 1289.
30. Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of surgical site infection, 1999: Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epi- demiol. 1999;20:250-278.

EDITORIAL COMMENT
This consensus statement will be a valuable reference for the penile prosthetic implanter to consult to prevent and manage

penile prosthesis infection. The authors are made up of leaders in sexual medicine and an authority in infectious disease. With up to 25,000 patients undergoing penile prosthesis implantation and an expected infection rate of 2%-3%, or higher in complex cases, managing infection is a considerable challenge, and we are best served by avoiding it altogether when possible.1,2 The fact that the authors did not assign levels of evidence to their recommendations speaks to the quality of the available evidence. In most cases, expert opinion is the best guidance we
have. The authors point out methodological challenges of per- forming randomized trials with limited case numbers and a relatively rare outcome.
All urologists whether they implant prosthetics should be concerned about the epidemic of antibiotic resistance and the paucity of new antimicrobial drugs in development. Fewer new antimicrobials are being delivered to the market place. Between 1962 (nalidixic acid) and 2000 (linezolid) no new classes of antimicrobials were developed; drugs that entered the market place during this time were simply modifications of available molecules.3 Most large pharmaceutical companies no longer
invest in antimicrobial research and development, given the long lead time to market place (up to 20 years), the cost ($1 billion), and a market potentially limited by regulatory constraints.
The Health and Human Services Department of the United States is providing $40 million to drug maker GlaxoSmithKline to help develop agents that will combat antibiotic resistance or those used for bioterrorism.4 The government program could give up to $200 million over the next 5 years to the company. A similar program in Europe is underway with AstraZeneca and GlaxoSmithKline with companies working together to pool
resources and research data. In addition, creating a stream-lined, faster drug approval process similar to those used for orphan drugs to treat rare conditions is being considered for antimi- crobials. Finally, tighter regulation of distribution and marketing will be needed to protect these new antimicrobials from overuse and the development of resistance. Urologists will want to monitor the landscape of antimicrobial development and resis- tance closely as this dilemma evolves.

Benjamin N. Breyer, M.D., M.A.S., Department of Urology, University of California, San Francisco, San Francisco, CA


References
1. Darouiche RO. Treatment of infections associated with surgical implants. N Engl J Med. 2004;350:1422-1429.
2. Wilson SK, Zumbe J, Henry GD, et al. Infection reduction inflatable penile prosthesis. Urology. 2007;70:337-340.
3. Rai J, Randhawa GK, Kaur M. Recent advances in antibacterial drugs. Int J Appl Basic Med Res. 2013;3:3-10.
4. Barry Meier. Pressure Grows to Create Drugs for “Superbugs.” New York
Times. June 2, 2013. Available at: http://www.nytimes.com/2013/06/03/ health/experts-debate-plan-to-speed-antibiotic-development.html? pagewanted¼all&_r¼0. Accessed June 25, 2013.
http://dx.doi.org/10.1016/j.urology.2013.05.053
UROLOGY 82: 942, 2013. Published by Elsevier Inc.

[Larry10625]

ORIGINAL RESEARCH—SURGERY


Prospective Evaluation of Patient Satisfaction, and Surgeon and Patient Trainer Assessment of the Coloplast Titan One Touch Release Three-Piece Inflatable Penile Prosthesis

Dana A. Ohl, MD,* Gerald Brock, MD, FRCSC,† David Ralph, BSc, MS, FRCS(Urol),‡
William Bogache, MD,§ LeRoy Jones, MD,¶ Ricardo Munarriz, MD,** Laurence Levine, MD,†† and Chad Ritenour, MD‡‡
*Division of Sexual and Reproductive Medicine, Department of Urology, University of Michigan, Ann Arbor, MI, USA;
†Department of Surgery, Division of Urology, University of Western Ontario, London, ON, Canada; ‡St. Peter’s Hospital and the Institute of Urology, University College London, London, UK; §Carolina Urologic Research, Myrtle Beach, SC, USA; ¶Urology San Antonio, San Antonio, TX, USA; **Boston Medical Center, Boston, MA, USA; ††Department of Urology, Rush University Medical Center, Chicago, IL, USA; ‡‡Department of Urology, School of Medicine, Emory University, Atlanta, GA, USA

DOI: 10.1111/j.1743-6109.2012.02819.x


A B S T R A C T

Introduction. A single-armed, prospective, multicenter international study evaluated the redesigned Coloplast Titan One Touch Release (OTR) pump inflatable penile prosthesis. The OTR pump has a unique release valve that permits deflation of the implant with one squeeze of opposing touch pads.
Aims. To assess the impact of a new penile prosthesis design, the Titan OTR, on patient ease of operation. Furthermore, to assess patient satisfaction, surgeon acceptance, and the ease with which patients were trained in device operation in the clinic setting.
Methods. A total of 113 eligible patients from eight centers were recruited from men presenting with erectile dysfunction without prior prosthetic implantation. The subjects had a mean age of 61 years, and had a number of comorbidities, including diabetes (31.9%), hypertension (34.5%), and Peyronie’s disease (23.9%). All underwent implantation of the study device.
Main Outcome Measures. Questionnaires were used to capture patient satisfaction as well as physician feedback on
ease of implantation and patient education. A paired analysis was completed for patient satisfaction at 6 (N = 96) and 12 (N = 90) months.
Results. Overall satisfaction with the device was 90.6% and 90.0% at 6 and 12 months, respectively. The primary end
point, ease of deflation, was seen in 70.8% and 73.3% at these two time points, with the 12-month value statistically better than historical controls. Physicians overwhelmingly reported straightforward/simple intraoperative product preparation (97.3%) and equivalent or easier training compared with their previous pump of choice (96.4%). Adverse events for all subjects (N = 113) included removal of the device in four cases (3.5%) for infection and one case for chronic pain (0.8%).
Conclusions. The Titan OTR represents an advance in penile prosthetic technology that is well accepted by patients
and physicians. The study design allowed for realistic evaluation of the new technology aimed at enhancing clinical outcomes. Ohl DA, Brock G, Ralph D, Bogache W, Jones L, Munarriz R, Levine L, and Ritenour C. Prospective evaluation of patient satisfaction, and surgeon and patient trainer assessment of the Coloplast Titan One Touch Release three-piece inflatable penile prosthesis. J Sex Med 2012;9:2467–2474.
Key Words. Erectile Dysfunction; Three-Piece Inflatable Penile Prosthesis; Patient Satisfaction; Surgical Treatment






© 2012 International Society for Sexual Medicine J Sex Med 2012;9:2467–2474



Introduction

rectile dysfunction (ED) is a prevalent condi- tion. The Massachusetts Male Aging Study estimated that 52% of men aged 40–70 suffered from some degree of erectile impairment [1]. In a large survey of men of all ages in the United States, Laumann et al. found that the incidence of clini- cally significant ED was 7% in men aged 18–29 and rose to 18% in men aged 50–59, trailing pre- mature ejaculation, which was the most common sexual dysfunction seen in the survey [2]. ED has many causes, including vascular inflow disease, veno-occlusive dysfunction, neuropathy, and psy-
chogenic issues.
Medical management of ED was vastly improved with the introduction of the type 5 phos- phodiesterase inhibitors in 1998 [3]. However, efficacy rates with these agents only range from 60% to70% at best, and poorer results are seen in men with diabetic neuropathy and those who have undergone radical prostatectomy [4]. In many men, other treatments, including intraurethral alprostadil, penile injection therapy, and vacuum constriction devices, are needed [5]. All these treatments have advantages and disadvantages. Furthermore, patient acceptance of those medical treatments varies widely.
Since the introduction of the inflatable penile prosthesis (IPP) by Scott et al. in the 1970s [6], there have been multiple modifications in device design. Device failures during the early experi- ence were numerous, and most of the device modi- fications have been successful efforts directed toward increasing the mechanical reliability of the implants [7,8]. The most recent revision of the device described in the current paper is aimed to improve the ease of inflation and deflation of the device.

Aims
The purpose of this study was to determine the impact of a new penile prosthesis design, the Colo- plast Titan One Touch Release (OTR; Coloplast Corporation, Minneapolis, MN, USA), on patient ease of operation. Furthermore, we sought to determine patient satisfaction, surgeon accep- tance, and the ease with which patients were trained in device operation in the clinic setting.

Methods
A total of 113 eligible patients dispersed over eight sites underwent implantation of the Titan OTR

J Sex Med 2012;9:2467–2474

IPP from November 2007 to April 2009 in this prospective, non-randomized, international multi- center clinical trial. Surgical technique was deter- mined by the individual surgeon and did not vary from typical implantation procedures. The study is prospective in nature, therefore limiting selection bias via adherence to predefined inclusion and exclusion criteria. Eligibility criteria included men at least 18 years of age willing to undergo implantation of a device to treat ED. Patients with compromised immune systems, active genitouri- nary infection, and severe coagulopathies were among those excluded from the study. Those who had previous devices implanted for ED were also excluded. All protocols received institutional review board approval, and all patients signed informed consent documents to participate in the study.
The Titan OTR prosthesis is a three-piece implant that involves cylinders placed in the corpora cavernosa of the penis, a pump placed in the scrotum, and a reservoir placed in the abdominal cavity of the patient (Figure 1). The entire device has a hydro- philic coating that rapidly absorbs aqueous solutions when soaked, and the cylinders and reservoir are manufactured from silicone and Bioflex (Coloplast Corporation). The hydraulic OTR pump transfers fluid between the cylinders and reservoir to allow for rigidity (inflation) and flaccidity (deflation) of the penis as appropriate.
The OTR pump has a unique release valve that permits deflation of the implant with one squeeze of the opposing touch pads (Figure 2). The size of the new pump is similar to the previous model. When the deflate mechanism is activated, the valve only allows fluid to be transferred from the

Figure 1 Titan One Touch Release three-piece penile prosthesis



















Figure 2 One Touch Release pump

cylinders to the reservoir. After activation, the pump is locked in the deflate function, preventing the need for continuous pressure to allow the flow toward the reservoir. The OTR pump’s predeces- sor required constant pressure to be held on the deflation pads during the deflation process, and the need for constant pressure was a consistent complaint of patients. The cost difference between the OTR pump and its predecessor is approxi- mately US $200.
Subjects and implanting surgeons completed baseline questionnaires, and data were collected by questionnaire at 6 weeks, 3 months, 6 months, and 12 months after implantation. Data were compiled, and standard statistical analyses were performed using SAS version 9.1 or above (SAS Institute, Cary, NC, USA) or another validated statistical software package.

Main Outcome Measures
The primary end point of the study was to assess the satisfaction with ease of deflation of the OTR pump at 6 months by subject questionnaire. Retrospective data from three comparator trials were used to create a weighted average of 64% for patient satisfaction with pump deflation as a threshold with which to compare the current study [9–11]. The primary end point is a binomial proportion of participants completely or mostly satisfied with deflation performance, similar to the criteria for satisfaction reported in the comparator studies. The end point was constructed as a one- sided test with a 0.05 alpha level and was analyzed by comparing the lower bound of the two-sided 90% confidence interval with the performance goal of 64%.

Assuming a true (expected) rate of satisfaction of 76%, an alpha level of 0.05 and a one-sided hypothesis test, this design provides 80% power to achieve the study objective with a total enrollment of 92 participants. Allowing for 20% participant attrition (participant lost to follow-up, participant death, visits outside the follow-up window), 115 participants needed to be enrolled to reach the minimum sample size of 92.
Secondary end points included overall satisfac- tion measures of the patient, implanting surgeon, and trainer. These were reported with standard statistical descriptions. For continuous variables, means, standard deviations, and confidence inter- vals were reported while categorical variables were summarized with frequency distributions. Adverse event data were reported and tabulated from all sites. Events were reported as procedure or device- related and classified based on severity.

Results
Patient Population
One hundred twenty-four patients signed consent forms for the study, but 9 were not implanted due to medical reasons, withdrawal of consent or lack of device availability, and 2 were excluded from analysis after it was determined they did not actually meet inclusion/exclusion criteria at baseline. The 113 patients included in the study were recruited from eight sites, including six in the United States, one in Canada, and one in the United Kingdom. Median enrollment per site was
13.5 patients, and no site was permitted to implant more than 25 patients. At 6 and 12 months there were 96 and 90 subjects available for analysis, respectively.
The patient population baseline characteristics are shown in Table 1. The primary cause of ED was vascular disease and/or diabetes in more than half the group. Of note, 34.5% of the patients had abnormal curvature of the penis, with 23.9% reported as having evidence of Peyronie’s disease. Prior ED treatments were given in all the subjects. These included oral medications (97.3%), penile injection therapy (63.7%), vacuum device (31%), intraurethral suppository (19.5%), and testoster- one administration (5.3%).

Surgical Data
All patients received preoperative and post- operative antibiotic prophylaxis. Furthermore, all devices were soaked in antibiotic-containing

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Table 1 Demographics and baseline characteristics
Characteristic N mean ± SD or % (n/N) Range
Age (years) 113 61.0 ± 9.1 (34.5, 81.2)
BMI (kg/m2) 113 29.4 ± 5.0 (18.4, 45.9)
Primary indications (not mutually exclusive)
Vascular disease 113 34.5% (39/113)
Diabetes mellitus 113 31.9% (36/113)
Post-cancer treatment 113 26.5% (30/113)
Pelvic surgery 113 8.8% (10/113)
Neurogenic 113 4.4% (5/113)
Psychological causes 113 4.4% (5/113)
Pelvic trauma 113 4.4% (5/113)
Iatrogenic 113 0.9% (1/113)
Other 113 31.9% (36/113)
Peyronie’s disease 113 23.9% (27/113)
Curvature abnormal 113 34.5% (39/113)
Stretched penile length (cm) 106 11.9 ± 2.5 (6.0, 19.0)
Single sexual partner 113 63.7% (72/113)
SD = standard deviation; BMI = body mass index



solution prior to implantation. The choice of anti- biotic solution was based on individual surgeon preference. The data on individual surgeon pref- erence were not recorded. A penoscrotal approach was used in 98% of cases, and operative time averaged 61.5 ± 22.6 minutes. Average cylinder length was 15.9 ± 2.0 cm, and reservoir volume 74 ± 11 mL. The average length of rear tip extenders was 1.9 cm, and in 16 subjects, no rear tip extenders were utilized. The pump was placed in the midline in 95% of cases, dartos pouch in 78%, and 65% were surgically secured in place to prevent migration. Devices were universally filled with normal saline, and a surgical drain was placed in 47% of cases.

Surgeon’s Assessment of New Device
Surgeons were asked to answer three questions regarding the intraoperative experience with the device. In 97.3% of the cases, the surgeon agreed that the implant preparation was straightforward. The surgeons felt that in 89.4% of the cases, the OTR pump was easier to prepare than their pre- vious pump of choice. It was determined that the patient’s scrotum was easily able to accommodate the pump placement 97.4% of the time. In all of the above queries, if a positive response was not given, the response was neutral. In no case was a negative impression of the device reported.

Trainer’s Assessment of the Device Activation Session At the 6-week follow-up appointment, patients were trained in the operation of the device. The person administering the training session, who was usually a clinic nurse, was asked to fill out a

J Sex Med 2012;9:2467–2474

questionnaire regarding their impression of the session. The results are shown in Table 2. As one can see, the trainers felt that the vast majority of men found the device somewhat/very/extremely easy to find the inflation and deflation mechanism and to operate the device. Ninety-nine point one percent of subjects reported to the trainer that they liked the pump. The practitioners felt that 97.2% of subjects found the operation of the device easy to learn, and in comparison with prior device training experience, the subject training with the OTR pump was easier than previous pumps 99.1% of the time.

Primary End Point Assessment
The primary end point in the study was patient ease of deflation at 6 months, at which time 70.8% found the ease of deflation to be satisfactory or somewhat satisfactory. When compared with historical controls, as described earlier (64% from pooled studies), the increase in satisfaction dem- onstrated a trend for improved satisfaction, but did not reach statistical significance (lower 95% con- fidence limit 62.7%, P = 0.082). When analyzing this end point at 12 months, the satisfaction rate rose to 73.3%, and this value was statistically significant to the 64% seen in historical controls (lower 95% confidence limit 65%, P = 0.033).
It is also important to point out that many
subjects were neutral on ease of deflation at 6 and 12 months. The numbers of men who were neutral or satisfied with ease of deflation at the two time points were 83.3% and 80.1%, respectively, with a minority reporting dissatisfaction (16.7% and 19.9%, respectively).



Table 2 Clinician/trainer 6-week questionnaire Characteristic N % (n/N) It was easy for the subject to find the inflation bulb?




It was easy for the subject to find the deflation touch pads?





It
Not at all 108 1.9 (2/108)
A little 108 0.9 (1/108)
Somewhat 108 4.6 (5/108)
Very 108 17.6 (19/108)
Extremely 108 75.0 (81/108)
It was easy for the subject to compress the deflation touch pads?

of patients were satisfied with the overall function of the device. At 12 months, 86.7% stated they would proceed with the operation again, and 94.5% were either neutral or positive when asked the question. Eighty-seven point eight percent would recommend the device to other men with ED, with 95.6% remaining at least neutral.
Adverse Events
Table 4 shows the total reported adverse events during the study. The serious adverse events are shown in Table 5. Overall, there were 41 adverse events in 30 patients (26.5% of patients experi- enced at least one adverse event).
Autoinflation was the most common problem seen at the early follow-up visits (14/113, 12.4%).

Table 3 Subject satisfaction at 6 and 12 months

Not at all 108 2.8 (3/108)

A little 108 1.9 (2/108)
Somewhat 108 10.2 (11/108)

6 months 12 months





Subject training with OTR pump was easier than with previous pump?

Overall function
Satisfactory and somewhat satisfactory
Neither
Soft enough to conceal when deflated

Satisfactory and somewhat satisfactory

96 76 (73/96) 90 82.2 (74/90)














How easy was it for the subject to learn?
Not at all 107 2.8 (3/107)
A little 107 8.4 (9/107)
Somewhat 107 7.5 (8/107)
Very 107 29.9 (32/107)
Extremely 107 51.4 (55/107)
OTR = One Touch Release

Secondary End Point Assessment
Table 3 shows patient satisfaction with various aspects of the device at 6 and 12 months. As one can see, satisfaction rates in all parameters exceeded 68.9%, with a large proportion of other responses remaining neutral. The lowest rates were seen with ease of deflation, as discussed in the previous section, and length when inflated, a commonly stated disappointment with all penile implant patients. At 6 and 12 months, 90.6%/90%

Neither 96 9.4 (9/96) 90 9.9 (8/90)
Ease of locating the deflation touch pads Satisfactory and somewhat
satisfactory Neither
Ease of inflation
Satisfactory and somewhat satisfactory
Neither
Ease of deflation
Satisfactory and somewhat satisfactory
Neither
Hardness of erection when inflated Satisfactory and somewhat
satisfactory Neither
Width when inflated Satisfactory and somewhat
satisfactory Neither
Length when inflated Satisfactory and somewhat
satisfactory Neither
Would you recommend this penile implant device to men with the same erectile difficulty that you had?
Yes and probably 96 86.5 (83/96) 90 87.8 (79/90)
Don’t know 96 5.2 (5/96) 90 7.8 (7/90)
If you had the decision to make again, would you undergo this penile implant procedure again?
Yes and probably 96 83.3 (80/96) 90 86.7 (78/90)
Don’t know 96 9.4 (9/96) 90 7.8 (7/90)



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Table 4 Total adverse events (AEs)
Number



Subjects with AE

patient satisfaction [7,10–12], although few studies have captured prospective data. The current study

Adverse event

of AEs

% (n/N)

provides significant information on satisfaction captured throughout the first year after surgical implantation of the Titan OTR IPP. It offers unique data based on specific collection from invested parties including surgeons, trainers, part- ners, and patients.
While oral medications for ED have revolution- ized the treatment paradigm, these therapies do not work for all patients. Likewise, other treatments, while highly effective for some, also do not provide correction of dysfunction for all [12,13]. Penile prostheses are reliable, effective devices that provide an alternative for men who wish to undergo surgical treatment of ED. However, understanding the issues related to satisfaction

However, 10 patients reporting autoinflation early on spontaneously resolved during the course of the study, leaving the final autoinflation rate of 3.5%. Many other complications were minor and also resolved spontaneously.
Infection occurred in four devices and all of these devices were explanted. Two infections occurred at a single center and the other two occurred at two different centers. Therefore, we could not deter- mine that infection was site-related. The small number of patients with infection did not allow any analysis of comorbidities that would put patients at risk for infection.
One patient with intractable chronic pain also had his device removed. Seven revision surgeries were performed, with successful resolution of the problem. Revisions were performed for device malfunction (2), discomfort (2), reservoir hernia- tion (1), and scrotal hematoma (2). The investiga- tors classified the two device malfunctions as device-related adverse events and the other revi- sions as procedure-related.

Discussion
IPPs are well-recognized treatments for ED. Previous studies have demonstrated high rates of

Table 5 Severe adverse events (SAEs)

Number Patients with SAE
SAE type of SAEs % (n/N)
Severe
Cylinder extrusion 1 0.9 (1/113)
Device malfunction 2 1.8 (2/113)
Hematoma 2 1.8 (2/113)
Infection 4 3.5 (4/113)
Pain—chronic 1 0.9 (1/113)
Total severe 10 7.1 (8/113)

J Sex Med 2012;9:2467–2474

and managing patient expectations are critical for the implanting surgeon to recognize. Patients who have IPP surgery but are unable to operate the device afterward are particularly frustrated. Therefore, constant assessment and modification of existing devices is important to provide the best options for patients.
The Titan OTR IPP was conceived as a safe, effective device that is easier for patients to use. While the basic design of the cylinders and res- ervoir is well established as an effective product, the IPP pump is the part of the device that requires the most patient interaction and control. Creating a pump that allows for easy cylinder inflation and deflation is an important goal. The touch pads of the OTR pump allow for a single- squeeze mechanism that is improved over the continuous manual pressure required for deflation of previous devices.
Improved ease of operation of the OTR pump was verified in a study of practitioners who perform penile prosthesis training in the clinic setting. In this study, an in vitro scrotal model with different pump designs was used to ask these indi- viduals their opinions of pump designs. The OTR pump was found to be easier to operate over other pump designs, and the differences were statistically significant [14].
Prosthetic surgeons are generally interested in decreasing operative time. More efficient use of resources is accomplished by this and some believe that decreasing operative time may lead to improved outcomes. Factors that make device preparation easier can decrease operative time. In this study, implanting surgeons reported that device preparation was straightforward/simple 97% of the time. In 89% of the cases, the physician



stated the pre-implant preparation was easier than other IPP pumps. These data reflect overall satis- faction with intraoperative device handling.
Likewise, postoperative training for IPP patients can require significant amounts of time. For Titan OTR study patients, training was completed around 6 weeks after implantation. The study represents one of the first to capture pro- spective data from those training the patient. With this pump design, the trainers reported that the process was easier than with previous IPP pumps in 96% of cases. The importance of ease of patient education for device use cannot be understated, as this will translate to less time required by the office staff, fewer remedial training sessions, and less frustration for patients. Indeed, Shaw and Garber demonstrated a statistically signifi- cant decrease in the number of training sessions required with the OTR pump, as compared with its predecessor [15].
Perhaps the most important measure of success after IPP implantation is that of patient satisfaction with use. Traditionally, IPP patient sat- isfaction rates have been around 90% [16], and the current study again shows 90% overall patient satisfaction at 6 and 12 months. Satisfaction regard- ing deflation with the OTR device in particular compares well with previous studies with 70.8% and 73.3% responding positively to this question at 6 and 12 months, respectively. At 12 months, the patient satisfaction with ease of deflation was sta- tistically better than historical controls. One could argue that this is not clinically significant, because the difference between the ease of deflation and historical controls is modest. However, any improvement in the satisfaction of the patient undergoing implant surgery is an advance in pros- thetic surgery.
It is possible that satisfaction rates may be affected by the type of disease present. For example, prior studies have suggested a lower rate of ED treatment satisfaction in men with Peyronie’s disease. At the time of this writing, analysis by disease state has not yet been completed but is planned. Other factors that have recently been shown to affect postoperative satisfaction include reasonable preoperative expectations [17] and favorable female sexual function [18].
The adverse events identified in this study are well recognized in patients undergoing penile prosthetic surgery. In particular, early autoinfla- tion was identified in 12.4%, but most of these cases resolved spontaneously with no further intervention needed such that the autoinflation

rate was 3.5% at the end of the study. This is similar to the rate of 4.3% identified in a previous study [19].
The number of infections in this study is higher than typically reported to implant company databases. Since report forms submitted to the implant companies are voluntary and incomplete, it is likely that underreporting of complications to such databases occurs. This study collected data prospectively and was complete. Nevertheless, the infection rate of 3.4% is higher than reported in recent publications, and may reflect the effects of a small number of patients presently included. More investigations are in order to assure that this infec- tion rate does not represent the true infection rate of this device. Since the materials are unchanged from the previous devices, the authors believe that the high infection rate seen here will not be seen in future studies. Standardized antibiotic coating of the hydrophilic surface of the Titan device may help. Dhabuwala’s group has suggested that rifampin and gentamicin may be the ideal choice of antibiotic solution [20].
This study represents one of the few prospective studies assessing penile implants. There are, however, several limitations of the trial. Due to staggered regulatory and Institutional Review Board (IRB) approvals of the protocol, several centers started surgical implantations earlier and entered higher subject numbers into the study. The comparison used for primary end point assessment relied on historical data. Furthermore, the com- parator trials assessed satisfaction data that were collected at much later time intervals after surgery. If, for example, there is a progressive improvement over time in patient acceptance, the 64% cut point in ease of deflation may be too high when compar- ing with 6- and 12-month data. Indeed, in the current study there was an improvement in primary end point data between the 6- and 12-month marks. Finally, it is important to recognize that there was no “head-to-head” comparisons in this trial, only historical controls from the literature. Ideally, a head-to-head comparison with two current devices would be interesting. Furthermore, iden- tical questionnaires were not used in this and prior studies, possibly confounding the comparison. Also, the number of centers utilized in this study was few, and if extended to more cooperating centers in future studies, a stronger data set could be generated in future studies. An ideal compara- tor study would be a prospective, randomized large multicenter study comparing two different devices
under the same conditions.

J Sex Med 2012;9:2467–2474



Conclusions
In this prospective study, the Coloplast Titan OTR performed well in all measures of patient and clinician satisfaction. The device was felt by the implanters to be easier to prepare than the previ- ous standard pump. The patient trainers found that it was easier to train patients in the operation of the device than previous devices, and this may lead to decreased training time and limitation of remedial training sessions. Finally, there was high satisfaction in all aspects of the device and higher satisfaction rates in the primary end point (ease of deflation) when compared with pooled historical controls at 12 months.
Corresponding Author: Dana A. Ohl, MD, A. Alfred Taubman Health Care Center, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5330, USA. Tel: 734-232-4863; Fax: 734-763-4349; E-mail: daohl@
med.umich.edu
Funding: Coloplast Corp. (Minneapolis, MN) provided funding for this study.
Conflict of Interest: All authors were funded by Coloplast Corporation to complete this research, but received no direct personal benefit for this work.


Statement of Authorship
Category 1
(a) Conception and Design
Dana A. Ohl; Gerald Brock; David Ralph; William Bogache; LeRoy Jones; Ricardo Munarriz;
Laurence Levine; Chad Ritenour
(b) Acquisition of Data
Dana A. Ohl; Gerald Brock; David Ralph; William Bogache; LeRoy Jones; Ricardo Munarriz; Laurence Levine; Chad Ritenour

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(c) Analysis and Interpretation of Data
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Category 2
(a) Drafting the Article
Dana A. Ohl; Chad Ritenour
(b) Revising It for Intellectual Content
Dana A. Ohl; Gerald Brock; David Ralph; William Bogache; LeRoy Jones; Ricardo Munarriz; Laurence Levine; Chad Ritenour

Category 3
(a) Final Approval of the Completed Article
Dana A. Ohl; Gerald Brock; David Ralph; William Bogache; LeRoy Jones; Ricardo Munarriz; Laurence Levine; Chad Ritenour

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J Sex Med 2012;9:2467–2474

[Anonymous3]

Larry
This link has 214 pages of articles on ed

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