Himplant® subcutaneous penile implant improves penile appearance and erectile dysfunction after radical prostatectomy: a case series.

Erectile dysfunction is a major postoperative complication following radical prostatectomy. Various treatments for post- radical prostatectomy erectile dysfunction including nonsurgical phosphodiesterase-5 inhibitors, intraurethral alprostadil, intracavernosal injections and penile implant prosthesis, often yield suboptimal results. In this prospective single-center case series, we examine the efficacy and outcomes of Himplant®, a subcutaneous silicone penile implant, placement in four patients with post-radical prostatectomy erectile dysfunction who experienced limited benefits with phosphodiesterase-5 inhibitors. Patient data including demographics, prostate cancer diagnoses, erectile dysfunction characteristics, previous treatments, and outcomes were collected. Himplant® placement was performed in a standardized manner through a high scrotal incision in all cases. Follow-up evaluations were conducted to assess the effectiveness of the procedure and any associated complications. Patients were contacted and asked 15 questions regarding satisfaction and erectile function with the responses recorded. This study presents findings of high patient satisfaction, increases in flaccid penile length and girth, no incidence of adverse events, and improved erectile function following Himplant® placement post-radical prostatectomy. Accordingly, we suggest Himplant® placement in patients who are frustrated by their penile appearance and suffering from erectile dysfunction after radical prostatectomy. Further multicenter studies are warranted to validate these findings and assess long-term outcomes and patient-reported satisfaction.

Use of Himplant® for correction of residual deformity following prior treatment of peyronie's disease: a case series.

Over the years, numerous non-surgical and surgical treatment options have been explored for Peyronie's disease. Current options may result in incomplete correction of the deformity, which can be bothersome to the patient. This is a two-center case series of three patients who had previously undergone treatment for Peyronie's disease. Patient 1 underwent plication with extratunical grafting. Patient 2 underwent a series of Xiaflex® injections and then subsequent surgical plication for residual curvature. Patient 3 underwent a series of Xiaflex® injections. The Himplant® subcutaneous silicone penile prosthesis was placed in a standardized manner through a scrotal incision in all cases to mask residual penile deformities and enhance penile girth after Peyronie's disease treatment. Patients were contacted and asked 18 questions regarding satisfaction and erectile function with the responses recorded. This pilot study presents findings of high patient satisfaction, increases in flaccid penile length and girth, and an acceptable profile of adverse events following Himplant® placement. Based on our limited experience, we would consider offering Himplant® implantation when residual curvature is <40° and the penile indentation does not cause instability/buckling during penetrative sexual activity. Further research and larger studies are warranted to validate these findings and assess long-term outcomes and patient-reported satisfaction.

Correction of retractile penis with subcutaneous soft silicone penile implant.

We report a novel solution for patients suffering from adult acquired retractile penis. Three patients complained of retractile penis (when standing) and/or prepubic recession. Physical examination confirmed the shaft of the penis was buried with only the glans visible. All three patients reported lower levels of self-confidence, self-esteem, and sexual confidence prior to their procedure. The three patients received surgical treatment with the insertion of a subcutaneous soft silicone penile implant and two of the three also received removal of the suprapubic fat pad. Over one year post operatively, the penile shaft and glans was visible and appeared natural. All patients reported an increase in self-confidence and self-esteem. The insertion of a subcutaneous soft silicone penile implant may prove to be a viable solution to reverse retractile penis and to increase patient quality of life when compared to more invasive current surgical treatments.

A Single-Surgeon Retrospective and Preliminary Evaluation of the Safety and Effectiveness of the Penuma Silicone Sleeve Implant for Elective Cosmetic Correction of the Flaccid Penis.

BACKGROUND: Silicone blocks and sleeves are simple devices used in cosmetic surgery. They are generally viewed as safe and effective; however, there is little information on their use in the penis. AIM: This study evaluates a large single-surgeon series using a novel silicone sleeve penile implant (Penuma) to cosmetically correct the flaccid penis. METHODS: 526 patients underwent elective cosmetic penile surgery using a silicone sleeve penile implant between 2009 and 2014. Institutional Review Board approval was obtained for a retrospective analysis, and study consent was obtained from 400 patients. Penile circumference was measured before surgery, immediately after surgery, and 30-90 days after the implant surgery. Using the nonvalidated Augmentation Phalloplasty Patient Selection and Satisfaction Inventory (APPSSI), changes in self-confidence, self-esteem, and satisfaction scores were assayed 6-8 weeks postoperatively. Scores were again assayed 2-6 years postoperatively in 77% of patients. The questionnaires rated patient self-confidence, self-esteem, and satisfaction as very low, low, medium, high, or very high. MAIN OUTCOME MEASURE: Outcomes include changes in penile measurements; changes in APPSSI satisfaction, self-confidence, and self-esteem scores; and incidences of adverse events. RESULTS: In the 400 patients, the implantation of the Penuma silicone implant increased midshaft circumference from an average of 8.5 ± 1.2 cm to 13.4 ± 1.9 cm (56.7% increase; P < .001). A 2-category improvement in self-confidence and self-esteem was noted in 83% of patients 6-8 weeks postoperatively. On long-term follow-up (2-6 years; mean 4 years), 72% patients remained improved (2-category improvement in APPSSI scoring), and 81% of subjects reported "high" or "very high" levels of satisfaction. The most frequently reported postoperative complications were seroma (4.8%), scar formation (4.5%), and infection (3.3%). No patients reported any changes in sexual function, erections, or ejaculation. 3% experienced adverse events necessitating device removal. CLINICAL IMPLICATIONS: The Penuma silicone implant can help patients cosmetically correct the penis with increased flaccid penile girth and achieve enhanced self-confidence and self-esteem over the short- and long term. STRENGTHS AND LIMITATIONS: Strengths include the large number of subjects (400 men) and the long-term follow-up period (2-6 years). Limitations include the retrospective and single-surgeon (inventor) nature of the study; the presence of 126 non-consenting subjects, potentially impacting the complication rate; and the APPSSI's lack of validation. CONCLUSION: Retrospective analysis of 400 men electing to have penile cosmetic correction with the Penuma device demonstrates improvements in girth (56.7% increase) and high and sustained patient satisfaction, self-confidence, and self-esteem with minimal and manageable adverse events. Elist JJ, Valenzuela R, Hillelsohn J, et al. A Single-Surgeon, Retrospective, and Preliminary Evaluation of the Safety and Effectiveness of the Penuma Silicone Sleeve Implant for Elective Cosmetic Correction of the Flaccid Penis. J Sex Med 2018;15:1216-1223.