Changes in the Effects of Peyronie's Disease After Treatment With Collagenase Clostridium histolyticum: Male Patients and Their Female Partners.

INTRODUCTION: Collagenase Clostridium histolyticum (CCH) intralesional injection was efficacious for the management of Peyronie's disease (PD) in the double-blinded, randomized, placebo-controlled Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies I and II (IMPRESS I and II). Little is known about the consequences of PD or treatment on the sexual partners of affected men. AIM: To assess the safety and efficacy of CCH treatment in men who received placebo in the IMPRESS I or II study and to evaluate the men's PD symptoms and partner bother as reported by female sexual partners. METHODS: In this phase 3, open-label study (NCT01685437), men (n = 189) received up to eight injections of CCH (0.58 mg/injection). Female sexual partners who provided informed consent at screening (n = 30) participated in the study. MAIN OUTCOME MEASURES: Co-primary end points were change or percentage of change in penile curvature deformity and change in PD symptom bother domain score of the Peyronie's Disease Questionnaire (PDQ) from baseline to week 36. Participating women completed the PDQ for female sexual partners (PDQ-FSP) and the Female Sexual Function Index (FSFI). RESULTS: Statistically significant mean improvements were observed in penile curvature deformity (36.3% decrease; 95% CI = -41.6 to -30.9) and PDQ symptom bother score (2.4-point decrease; 95% CI = -3.0 to -1.8) from baseline to week 36. Most treatment-emergent adverse events were mild or moderate. After CCH treatment of their male partners, female sexual partners reported improvement (using the PDQ-FSP) in their male partner's PD symptoms and female bother regarding their partner's PD. The percentage of female sexual partners with sexual dysfunction (FSFI total score ≤ 26.55) also decreased after male partner treatment, from 75.0% at baseline to 33.3%. CONCLUSIONS: These results support the safety and efficacy of CCH in the management of appropriate patients with PD and the potential benefits for patients' partners. Goldstein I, Knoll LD, Lipshultz LI, et al. Changes in the Effects of Peyronie's Disease After Treatment With Collagenase Clostridium histolyticum: Male Partners and Their Female Partners. Sex Med 2017;5:e124-e130.

Treatment of recurrent urinary incontinence after artificial urinary sphincter placement using the AdVance male sling.

OBJECTIVES: We report on the use of the AdVance male sling to treat men who had an artificial urinary sphincter placed and subsequently developed recurrent urinary incontinence. METHODS: Nineteen men who had undergone placement of an artificial urinary sphincter for post prostatectomy urinary incontinence, and who had developed recurrent incontinence, were treated by placing an AdVance sling. Self-reported pad use preoperatively was 2-5 pads per day. RESULTS: All 19 patients (100%) reported improvement in their incontinence as documented by decreased pad use. Of these men, 15 (79%) became dry, using no further pads, and four (21%) decreased pad use to 1 pad per day. Of the 15 dry patients, 8 remained dry without reactivation of the artificial sphincter (53%); the other 7 maintained complete continence with a combination of the sling and an activated artificial sphincter. CONCLUSIONS: Men who suffer from recurrent urinary incontinence secondary to cuff compression atrophy can be made continent by the placement of a male sling. The technique of sling placement requires no special modification in these patients. By not revising the artificial urinary sphincter the capsule surrounding the device is not violated, which may decrease the risk of postoperative infection. In addition, the patient may not need to rely upon the use of his artificial sphincter to maintain continence.

Physician and patient satisfaction with the new AMS 700 momentary squeeze inflatable penile prosthesis.

INTRODUCTION: A single-armed, prospective, multicenter study evaluated the redesigned American Medical Systems (AMS) 700 Momentary Squeeze (MS) pump inflatable penile prosthesis (IPP) with enhanced features for ease of implantation and patient manipulation. The device incorporates design changes to all components: pump, cylinders, rear-tip extenders, and reservoir. AIM: To assess physician and patient satisfaction with the new AMS 700 MS pump. METHODS: Patients were selected from the existing population experiencing erectile dysfunction (ED) without previous prosthetic implantation. MAIN OUTCOME MEASURES: Survey questionnaires were used to capture physician feedback on ease of implantation and patient education. Patient satisfaction with the device and existence of autoinflation were assayed. RESULTS: Sixty-nine patients were implanted at seven U.S. sites. Mean age was 60.1 +/- 9.6 years. History of ED was >5 years in 34 (44.7%) patients. Main ED etiology was organic, nonspecific (32%). Eighty-four percent of the physicians felt proximal cylinder insertion was easier because of the smaller angle of cylinder input tubing and narrower base diameter. The new pump was felt easier to implant than the previous model by 57% of the physicians. The patients found the manipulation of the pump simple at device activation, with 96% easily locating the inflation bulb and 94% deflating the device with one push of the deflation button. Reviews were mixed among physicians concerning ease of training compared with the Tactile pump. Patient training was easier in 71%, harder in 21%, and same in 8%. Nevertheless, 67% of the patients were trained in 6 minutes or less. At 6 months, 77% of the patients were very satisfied, 9% somewhat satisfied, and 14% dissatisfied. Autoinflation occurred in two patients (3%). CONCLUSION: The new AMS 700 MS IPP seems a distinct improvement over previous devices with most physicians feeling implantation and patient instruction were easier. The device also satisfied 86% of the users and virtually eliminated autoinflation.

Use of small intestinal submucosa graft for the surgical management of Peyronie's disease.

PURPOSE: We report on the long-term followup of porcine small intestinal submucosal graft as a closure material for the tunica albuginea after plaque incision. MATERIALS AND METHODS: A total of 162 patients with at least a 12-month history of Peyronie's disease with penile curvature of 60 degrees or more were evaluated. Patient age ranged from 33 to 69 years (mean 52). Preoperatively all patients underwent intracavernous injection and photographic documentation of curvature. Surgisis ES, derived from porcine small intestine, was immersed in normal saline and was used to graft the tunical deficit after plaque incision using a subcoronal incisional approach. RESULTS: Surgical correction of penile curvature was achieved in 148 of 162 patients (91%). At a mean followup of 38 months (range 6 to 96) 79% of the patients were fully potent with 21% requiring assistance. No reports of intraoperative penile shortening, long-term pain, infection, bulging at the graft site or evidence of a local immunogenic rejection reaction have been noted. CONCLUSIONS: Surgisis grafts for the coverage of cavernous defects after Peyronie's plaque incision allow for satisfactory clinical results in long-term followup. The ease of surgical handling and placement, no associated comorbidities from harvesting techniques, and no adverse reactions make this material an anatomical and functional tunical substitute.

Early experience with the American Medical Systems new tactile pump: results of a multicenter study.

INTRODUCTION: A new Tactile Pump for the American Medical Systems (AMS) 700 Inflatable Penile Prosthesis (IPP) had been developed in an effort to improve usability for the patient. Aim. To assess the ease of use of the new Tactile Pump. METHODS: A prospective, multicenter study was conducted at four investigative sites. Preoperatively, patients completed an evaluation of the new Tactile Pump vs. the current design 700 pump placed in scrotal models. Patients compared the ease of inflation and deflation of each model. All patients were implanted with the AMS 700 IPP including the new Tactile Pump. Patients returned at 6 weeks for activation of the device and for follow-up evaluation at 3 and 6 months. MAIN OUTCOME MEASURES: Preoperatively patients compared ease of use of the Tactile Pump vs. the current design. Postoperatively both physicians and patients assessed device functionality for inflation and deflation, ease of use of the pump, and time required to learn device operation. RESULTS: Thirty patients were implanted with the AMS 700 IPP and Tactile Pump. Thirty patients completed an activation visit, 20 patients completed the 3-month evaluation, and 9 patients completed the 6-month evaluation. The average age was 62.1 years. Primary erectile dysfunction etiologies included organic, nonspecific 10 (33.3%), vasculogenic 6 (20.0%), prostatectomy 6 (20.0%), diabetes mellitus 4 (13.3%), Peyronie's disease 3 (10.0%), and spinal cord injury 1 (3.3%). Preoperatively 93.3% (P < 0.001) of patients favored the Tactile Pump over the current pump on locating and working the inflation mechanism in the scrotal model. Patients also found the Tactile Pump deflation mechanism easier to find 100% (P < 0.001) and deflate 96.7% (P < 0.001). Most patients (86.7%) were trained to use their devices within 3 minutes. CONCLUSIONS: The AMS Tactile Pump provides benefit to patients and physicians by improving ease of use and training over the current IPP 700 pump.

Use of porcine small intestinal submucosal graft in the surgical management of tunical deficiencies with penile prosthetic surgery.

OBJECTIVES: To report the use of a new acellular xenographic porcine jejunal submucosal graft as a closure material for tunica albuginea deficiencies (distal erosion, attenuation) after penile prosthesis insertion. METHODS: Seventeen patients with at least a 36-month history of having an indwelling three-piece inflatable penile prosthesis developed tunica albuginea deficiencies. Nine patients with unilateral distal erosion of the tunica and eight with attenuation of the tunica underwent penile prosthesis revisionary surgery and tunical reconstruction using lyophilized small intestinal submucosa (Surgisis). The reconstructive techniques used a suprapubic and subcoronal incisional approach and a new three-piece inflatable prosthesis. RESULTS: Reconstructive surgical correction of the tunical defect was achieved in all 17 patients. At a mean follow-up of 21 months (range 6 to 34), no patient had had separation of the graft from the tunica or recurrence of the deficiency. All patients had a satisfactorily functioning prosthesis. Infection, pain, bulging, or evidence of a local inflammatory response at the graft site has not occurred. No patient required any additional surgery. CONCLUSIONS: At the initial long-term follow-up, acellular porcine jejunal submucosal grafts for coverage of tunical deficiencies with penile prosthetic surgery allow for satisfactory clinical results. The ease of surgical handling and placement, elimination of nonabsorbable synthetic grafting materials, and no associated comorbidities from graft harvesting techniques, coupled with no adverse reactions, make this graft an anatomic and functional tunical substitute.