Simultaneous Penile Lengthening and Penile Prosthesis Implantation in Patients with Peyronie's Disease, Refractory Erectile Dysfunction, and Severe Penile Shortening

Simultaneous Penile Lengthening and Penile Prosthesis Implantation in Patients with Peyronie's Disease, Refractory Erectile Dysfunction, and Severe Penile Shortening

316 Simultaneous Penile Lengthening and Penile Prosthesis Implantation in Patients with Peyronie’s Disease, Refractory Erectile Dysfunction, and Seve...

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Simultaneous Penile Lengthening and Penile Prosthesis Implantation in Patients with Peyronie’s Disease, Refractory Erectile Dysfunction, and Severe Penile Shortening jsm_2509

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Salvatore Sansalone, MD,*,** Giulio Garaffa, MD,†,** Rados Djinovic, MD, PhD,‡ Paulo Egydio, MD,§ Giuseppe Vespasiani, MD,* Roberto Miano, MD,* Carla Loreto, MD,¶ and David J. Ralph, BSc, MS, FRCS(Urol)† *Department of Urology, School of Medicine Tor Vergata University of Rome, Rome, Italy; †St Peter’s Andrology, University College London Hospitals, London, UK and Broomfield Hospital, Chelmsford, UK; ‡Department of Urology, School of Medicine, Serbian Academy of Science and Arts, University of Belgrade, Belgrade, Serbia; §Urology Institute, São Paulo, Brazil; ¶Department of Biomedical Sciences, University of Catania, Italy DOI: 10.1111/j.1743-6109.2011.02509.x

ABSTRACT

Introduction. Due to loss of length, patients who had penile prosthesis implantation for Peyronie’s disease (PD) show a statistically significant reduction in their levels of satisfaction when compared with the general implant population. Aim. The aim of this study is to report our experience of penile lengthening with circumferential graft during penile prosthesis implantation in patients with PD and severe penile shortening. Methods. Between March 2006 and February 2008, 23 patients with PD, refractory erectile dysfunction, and severe penile shortening underwent penile lengthening with circumferential graft and concomitant implantation of an inflatable penile prosthesis. Main Outcome Measures. Surgical outcome and complications have been recorded during postoperative follow-up. Patients’ satisfaction has been assessed 6 months postoperatively with the administration of the modified Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire. Results. After an average follow-up of 22 months (range 6–36), 20 patients attended all the postoperative follow-up visits and returned the EDITS questionnaire. An average length gain of 2.8 cm (range 2.2–4.5) was recorded, and all patients were able to cycle the device and engage in penetrative sexual intercourse. Patient recorded complications included diminished glans sensitivity in four (20%) and persistent dorsal curvature of less than 15° in three (15%). Overall, 18 patients (90%) were satisfied with the cosmetic and functional result of surgery. Conclusion. Penile lengthening with circumferential graft during penile prosthesis implantation in patients with PD represents a safe and reproducible technique that yields higher satisfaction rates than penile prosthesis implantation alone in patients with severe penile shortening. Sansalone S, Garaffa G, Djinovic R, Egydio P, Vespasiani G, Miano R, Loreto C, and Ralph DJ. Simultaneous penile lengthening and penile prosthesis implantation in patients with Peyronie’s disease, refractory erectile dysfunction, and severe penile shortening. J Sex Med 2012;9:316–321. Key Words. Peyronie’s Disease; Erectile Dysfunction; Inflatable Penile Prosthesis; Graft; Circumferential Penile Graft for Penile Lengthening

**Both authors have contributed equally to the production of this article.

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© 2011 International Society for Sexual Medicine

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Implantation of Prosthesis with Penile Elongation in Peyronie’s Disease Introduction

P

eyronie’s disease (PD) is a benign, localized connective tissue disorder characterized by the formation of fibrous, inelastic plaques in the tunica albuginea of the corpora cavernosa, which causes a characteristic penile deformity during erection. The condition is frequently associated with anatomical alterations of the shaft and penile shortening and has a major impact on quality of life and significant psychological effects [1]. A variable degree of erectile dysfunction (ED) is a common finding in patients affected by PD. This may be caused by the plaque itself, as a consequence of the loss of the veno-occlusive mechanism, or by the coexistence of cardiovascular risk factors including smoking, hypertension, diabetes, hypercholesterolemia, and diffuse vascular disease, which are present in two-thirds of patients affected by PD [2,3]. In particular, ED prevalence in patients affected by PD varies according to different studies and can be as high as 54% [2]. Frequently men who present ED and PD do not respond to oral erectogenic medications, and therefore straightening operations may not provide any benefit to the patient, as he will continue to have inadequate rigidity for intercourse. Surgery is the most effective treatment for PD and should be offered only when the acute, inflammatory phase is settled and the condition is completely stable. Penile prosthesis implantation is indicated in patients with refractory ED. Also patients with mild ED and complex anatomical deformities and/or short penis are best served with penile prosthesis implantation as the risk of worsening of erectile function after graft surgery is significant [3–8]. Although penile prosthesis implantation ⫾ manual modeling ⫾ additional straightening maneuvers guarantees a functionally straight penis and a rigidity adequate for penetrative sexual intercourse in virtually all patients, overall satisfaction rates are low with up to 50% of patients dissatisfied with their postoperative penile length [8]. The rationale of simultaneous penile lengthening and of a penile prosthesis implantation is therefore to increase postoperative patients’ satisfaction due to an increased postoperative penile length. This series reports the long-term outcome from patient’s and surgeon perspective of simultaneous penile lengthening and penile prosthesis implantation in patients with PD, refractory ED, and severe penile shortening.

Methods and Main Outcome Measures

Between March 2006 and February 2008, 23 patients with stable PD, refractory ED, and severe penile shortening underwent penile lengthening with circumferential graft and concomitant penile prosthesis implantation. Penile prosthesis implantation was offered when the deformity was stable for at least 6 months and patients had failed to obtain a degree of rigidity adequate for penetrative sexual intercourse after several attempts with phosphodiesterase type 5 inhibitors at maximum dosing. All patients either failed to respond or refused to use the vacuum constriction device and intracavernosal injection therapy. Overall, 80% of patients presented at least one cardiovascular risk factor with diabetes (52%), hypertension (43%), and dyslipidemia (26%) being the most common factors. Preoperative assessment of the quality of the erection included dynamic eco color Doppler ultrasound scan (ECDUSS) after the administration of 20 mg of prostaglandin E1 (PGE1) to assess the quality of the erection, the degree of deformity, and the penile length. All patients showed an inadequate response to PGE1 with evidence of arterial insufficiency (peak systolic velocity < 30 cm/second) while the average penile length, which is measured on the dorsal aspect of the shaft from the pubic bone to the most distal aspect of the glans, was 8.5 cm (range 7–10 cm). Measured curvature during ECDUSS was on average 70° (range 45–100) and the direction is reported in Table 1. In all patients, after the administration of PGE1, a compression of the crura has been necessary to achieve the rigidity necessary to accurately assess the degree of curvature. The mean preoperative International Index of Erectile Function–five questionnaire score was nine (range 4–15), and all patients were complaining of severe penile shortening due to PD. Prior to surgery all patients have been adequately counseled about the potential complications of surgery, including incomplete straightening, recurrent curvature, changes in glans Table 1

The preoperative degree of curvature

Type of curvature

Number of patients

Dorsal Lateral Dorsolateral

14 4 5

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318 Table 2

Sansalone et al. Type of inflatable penile prosthesis implanted

Type of prosthesis

Number of patients

AMS* 700 CX® Coloplast† Titan® AMS* Ambicor® Total

12 9 2 23

netonka, MN, USA) patch graft using a continuous 4-0 polydioxanone suture; the average graft size was 3.1 cm (range 2.7–4.5) in width and 12.4 cm (range 10.3–14.2) in circumference. InteXen® (American Medical Systems) grafts have been used and they do not need imbibition to

*American Medical Systems, Minnetonka, MN, USA. † Coloplast, Humlebaek, Denmark.

sensation, penile prosthesis infection, and mechanical failure of the erectile device. In particular, patients were aware of the potential increased risk of prosthesis infection and mechanical failure associated with the use of grafts for penile lengthening. Patients were also shown the various types of semirigid and inflatable penile prosthesis during the preoperative consultation and counseled about the pros and cons of each device. Surgical Technique

All patients opted to undergo insertion of an inflatable device after intravenous administration of gentamicin® (Gentamicin sandoz, Sandoz, Holzkirchen, Germany) and coamoxiclav® (Augmentin, GlaxoSmithKline, London, UK) and 10-minutes scrub of the surgical field with povidone-iodine® (Betadine, Purdue Pharma, Stamford, Connecticut, USA); the type of penile prosthesis implanted is reported in Table 2. Surgery was carried out through a combined subcoronal and penoscrotal approach in order to guarantee an adequate exposure of the penile shaft. Once Buck’s fascia and urethra have been completely dissected off the corpora, a full erection was induced with saline solution injection (Figure 1). Once the penile circumference was measured in order to determine the girth of the graft, two lines tangential to the penile axis were drawn on the proximal and distal straight segments of the shaft and their intersection indicated the point of maximum curvature. A circumferential incision of the tunica albuginea was then carried out at the level of maximum curvature, and the width of the tunical defect was measured on the convex and concave aspect of the shaft with the penis in full stretch [1,9,10] (Figure 2). Penile length gain has been limited in all cases by the length of the neurovascular bundle, as the urethra stretched easily. The tunical defect was then covered with an InteXen® (American Medical Systems, MinJ Sex Med 2012;9:316–321

Figure 1 Once Buck’s fascia and urethra have been completely dissected off the corpora, the point of maximum curvature is identified after induction of an artificial erection.

Figure 2 A circumferential incision is carried out at the level of maximum curvature and the dimension of the defect are measured with the penis in traction.

Implantation of Prosthesis with Penile Elongation in Peyronie’s Disease

Figure 3 The graft presents a trapezoidal shape with largew width at the level of maximum curvature.

survive and therefore tend to heal better than vein and dermal grafts. The patch presented a trapezoidal shape in all cases with maximum width at the point of maximum curvature (Figures 3 and 4). The girth was equal to the penile circumference, while the maximum and minimum widths were equal to the widths of the tunical defect measured, respectively, on the concave and convex sides of the shaft. The corpora were then dilated through two proximal para-urethral corporotomies and the cylinders of the inflatable device inserted. This technique was therefore different from the one described by Rigaud and Berger in 1995, where

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the penile prosthesis was implanted before the corporal circumferential incision and grafting [11]. The cylinders were then inflated to around 80% of maximum capacity in order to confirm the straightening of the penis. None of the patients presented with a residual curvature of more than 15° and therefore no additional straightening maneuver was required, as previously suggested by various authors [3,8]. The procedure was then completed with the closure of Buck’s and Dartos’ fascias and of the skin with polyglactin® (Vicryl, Ethicon, Somerville, New Jersey, USA). Patients were discharged home on postoperative day 1 with 2 weeks of oral antibiotics and the cylinders were left semi-inflated for 2 weeks in order to prevent scarring contracture and consequent recurrent deformity or shortening. Postoperative follow-up was started 4–6 weeks postoperatively and patients were encouraged to cycle the device on a daily basis. Sexual activity was encouraged once the skin wounds were completely healed and the patient was comfortable with inflating and deflating the device. Surgical outcome and postoperative complications were recorded in the postoperative follow-up that was scheduled at 6 months and every year thereafter. Erect penile length was measured at the 6-month postoperative follow-up visit when patients’ satisfaction was assessed with the administration of the modified Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire [8,12,13]. Results

Figure 4 The tunical defect is covered with the graft that is sutured with graft using a continuous 4-0 Polydioxanone suture.

The average age at the time of surgery was 53 years (range 38–64 years) and the mean duration of PD was 35 months (range 8–24). After an average follow-up of 22 months (range 6–36), all patients were able to cycle the device correctly and to achieve a rigidity adequate for penetrative sexual intercourse. The average length gain was 2.8 cm (range 2.2–4.5). There was no intraoperative complication although postoperatively three patients (13%) developed a minor wound dehiscence that was managed conservatively with antibiotic administration, four patients (20%) had diminished glans sensitivity, and three patients (13%) had residual curvature of less than 15°. Overall, 20 patients returned the modified EDITS questionnaire at the 6-month postoperaJ Sex Med 2012;9:316–321

320 Table 3

Sansalone et al. Patients’ satisfaction 6 months postoperatively

Domain

Outcome measure(s)

Outcome

Overall satisfaction (domain #1)

Satisfied (1–2) Half way (3) Somewhat dissatisfied (4–5) Confident (1–2) Half way (3) Somewhat dissatisfied (4–5) Significant loss of sensation (1–2) Minimal loss of sensation (3) Unsure/no loss of sensation (4–5) Satisfied (1–2) Half way (3) Dissatisfied (4–5) Yes No

18 0 2 18 0 2 0 4 16 19 0 1 0 20

Overall confidence (domain #4)

Postoperative loss of sensation (domain #8)

Postoperative penile length (domain #9)

Loss of length due to surgery (domain #10)

(90%) (10%)* (90%) (10%)* (20%) (80%) (95%) (5%) (100%)

*Causes of dissatisfaction and poor confidence: residual dorsal curvature (N = 1); inadequate penile length (N = 1).

tive review and the results are shown in Table 3. Overall, 18 patients (90%) were satisfied with the cosmetic and functional result of surgery. Although no patient complained of postoperative shortening, one (5%) was very dissatisfied with the amount of length gained. Discussion

Indications for a penile prosthesis implantation in patients with PD are refractory ED, complex curvature and mild ED, and a short penis. It is not advisable to do a grafting procedure in any patient with ED as it may ultimately need the implantation of a prosthesis as their ED progresses [3,7,14– 16]. Satisfaction with inflatable penile prostheses ranges between 60% and 96% and is higher than with semirigid devices [7,8,17,18]. Overall, patients who had penile prosthesis implantation for PD show a statistically significant reduction in their levels of satisfaction when compared with the general implant population [19]. Lower satisfaction rates in patients with PD are consequences of penile shortening with up to 50% of patients dissatisfied with their postoperative penile length [8]. In a recently published series, Levine et al. reported that almost 60% of patients felt that they have lost penile length before surgery due to PD and up to 54% felt that they had potentially lost further length following penile prosthesis implantation [8]. Apart from PD that induces penile shortening as a consequence of the progressive fibrosis of the tunica albuginea and the corpora, penile prosthesis implantation is also associated with loss of penile J Sex Med 2012;9:316–321

length. In particular, a recent series of Wang et al. has shown an average reduction of postoperative penile length of 0.74 cm when compared with preoperative penile size, which is assessed after induction of artificial erection with PGE1 [20]. The present series confirms that penile lengthening with a circumferential graft during penile prosthesis implantation is a safe and reliable technique in patients with PD, refractory ED, and severe penile shortening. The fact that no patient developed penile prosthesis infection and ultimately required explantation of the device confirms that there is no increased risk of complications when a graft is used in patients with an inflatable penile prosthesis as compared with an inflatable penile prosthesis alone [21]. The modified EDITS questionnaire score in the present series confirms how postoperative penile length plays a more significant impact on overall patient’s satisfaction than the presence of minor residual curvature and the partial loss of glans sensation as reported in Table 3. The modeling procedure is also a very effective way of treating any residual intraoperative curvature [22,23]. However, the authors do not believe that this maneuver results in any length gain, which is a central issue for satisfaction when dealing with patients with PD. We believe that length gain can only be achieved by this type of corporoplasty in combination with the penile prosthesis. The use of a circumferential graft while implanting a penile prosthesis not only prevented further shortening but allowed an average length gain of 2.8 cm, and this has translated into a patient’s satisfaction rate of 90%.

Implantation of Prosthesis with Penile Elongation in Peyronie’s Disease Conclusion

This series confirms that penile lengthening with circumferential graft during penile prosthesis implantation is a safe and reliable procedure. The average increase in postoperative length together with realistic patient’s expectations can guarantee higher satisfaction rates when compared with penile prosthesis implantation alone. Corresponding Author: Salvatore Sansalone, MD, Senior Lecturer in Urology, Policlinico di Tor Vergata, University of Rome, Viale Oxford 81, 00133 Rome, Italy. Tel: +(39) 3471792019; Fax: +39 0620902975; E-mail: [email protected] Conflict of Interest: No. References 1 Egydio PH. Surgical treatment of Peyronie’s disease: Choosing the best approach to improve patient satisfaction. Asian J Androl 2008;10:158–66. 2 Usta MF, Bivalaqua TJ, Tokatli Z, Rivera F, Gulkesen KH, Sikka SC, Hellstrom WJ. Stratification of penile vascular pathologies in patients with Peyronie’s disease and in men with erectile dysfunction according to age: A comparative study. J Urol 2004;172:259–62. 3 Ralph DJ, Gonzalez-Cadavid N, Mirone V, Perovic S, Sohn M, Usta M, Levine L. The management of Peyronie’s disease: Evidence based 2010 guidelines. J Sex Med 2010;7:2359–74. 4 Montorsi F, Adaikan G, Becher E, Giuliano F, Khoury S, Lue TF, Sharlip I, Althof SE, Andersson KE, Brock G, Broderick G, Burnett A, Buvat J, Dean J, Donatucci C, Eardley I, FuglMeyer KS, Goldstein I, Hackett G, Hatzichristou D, Hellstrom W, Incrocci L, Jackson G, Kadioglu A, Levine L, Lewis RW, Maggi M, McCabe M, McMahon CG, Montague D, Montorsi P, Mulhall J, Pfaus J, Porst H, Ralph D, Rosen R, Rowland D, Sadeghi-Nejad H, Shabsigh R, Stief C, Vardi Y, Wallen K, Wasserman M. Summary of the recommendations on sexual dysfunctions in men. J Sex Med 2010;7:3572–88. 5 Ralph DJ, Minhas S. The management of Peyronie’s disease. BJU Int 2004;93:208–15. 6 Pryor J, Akkus E, Alter G, Jordan G, Lebret T, Levine L, Mulhall J, Perovic S, Ralph D, Stackl W. Peyronie’s disease. J Sex Med 2004;1:110–5. 7 Garaffa G, Minervini A, Christopher AN, Minhas S, Ralph DJ. The management of residual curvature after penile prosthesis implantation in patients with Peyronie’s disease. BJU Int 2011;108:1152–6.

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