Penile Prosthesis Implantation in Patients With Peyronie's Disease: Results of the PROPPER Study Demonstrates a Decrease in Patient-Reported Depression.

BACKGROUND: Although there is a strong correlation between erectile dysfunction and Peyronie's disease (PD), there are limited data on the efficacy and satisfaction of inflatable penile prosthesis (IPP) placement in this population. AIM: To assess the efficacy and overall satisfaction of IPP placement in men with erectile dysfunction and concomitant PD using the Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration (PROPPER). METHODS: Data from the PROPPER study were examined to determine patient baseline characteristics and primary and secondary etiologies before IPP treatment and included type and size of implant received, presence of corporal fibrosis, and operative time. Men completed 5 validated questionnaires at baseline and annually out to 5 years. OUTCOMES: IPP placement was performed in 250 patients with PD with comparable surgical times and outcomes as in patients without PD. RESULTS: 1,180 men underwent IPP insertion at 11 sites; of these, 250 (21.2%) were diagnosed with PD. This is an ongoing study; 1- and 2-year data are available for 177 (70.8%) and 130 (52.0%) patients, respectively. Intraoperatively, 51.2% patients with PD had corporal fibrosis, with an average operative time of 52.8 minutes. At baseline, 19.3% of men (36 of 187) with PD reported being depressed, with a decrease to 10.5% (6 of 57; P = .02) and 10.9% (5 of 46; P = .07) at 1- and 2-year follow-ups, respectively. More than 80% of patients with PD were satisfied or very satisfied at 1- and 2-year follow-ups. In addition, more than 88% of patients with PD were using their device at the 1- and 2-year follow-up visits. CLINICAL IMPLICATIONS: Patients with concomitant PD and erectile dysfunction can safely and effectively have an IPP placed with similar outcomes as patients without PD. STRENGTHS AND LIMITATIONS: The 1st limitation was that all participating prosthetic urologists were high-volume implanters and these results might not be representative of those of general urologists. A 2nd limitation was that none of the patients were randomized. A 3rd limitation was that although most study points were mandatory, some of the data collection, including depression data, was optional, with not all sites participating. A 4th limitation was that depression data were self-reported. CONCLUSION: IPP can be inserted in patients with PD with acceptable patient satisfaction and usage and depressive symptoms appear to lessen in patients with PD after IPP placement. Khera M, Bella A, Karpman E, et al. Penile Prosthesis Implantation in Patients With Peyronie's Disease: Results of the PROPPER Study Demonstrates a Decrease in Patient-Reported Depression. J Sex Med 2018;15:786-788.

The Who, How and What of Real-World Penile Implantation in 2015: The PROPPER Registry Baseline Data.

PURPOSE: To date, the published data on patients treated with penile implantation generally consist of small series of single surgeon, retrospective experiences rather than prospective or large, multicenter evaluations. This study establishes a baseline of data collection from the PROPPER (Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration). The PROPPER is the first large, prospective, multicenter, multinational, monitored, and internal review board approved study of real-world outcomes for patients with penile implants. MATERIALS AND METHODS: Data from the PROPPER study were examined to determine patient baseline characteristics and primary and secondary etiologies before treatment of erectile dysfunction. Data include type and size of implant received, surgical steps/techniques used during implantation, and duration of hospital stay. RESULTS: Through April 2, 2015 a total of 1,019 patients were enrolled in the study at 11 sites, with radical prostatectomy being the predominant etiology in 285 (28%). Of those 285 patients treated with radical prostatectomy 280 (98.2%) received an AMS 700™. Of these patients 65.0% (182 of 280) had placement of the reservoir in the traditional retropubic space vs 31.8% (89 of 280) in a submuscular location. Of those patients not treated with radical prostatectomy receiving an AMS 700, fewer underwent reservoir placement in the submuscular location (17.7%, 124 of 702, vs 80.9%, 568 of 702; p <0.001). Of those patients receiving an AMS 700, those treated with radical prostatectomy and those with diabetes had more outpatient admissions (less than 24 hours, 56.8% and 52.1%, respectively) compared to those with cardiovascular disease and Peyronie's disease (42.0% and 35.6%, respectively, p <0.001). CONCLUSIONS: This first-of-its-kind, large, prospective, multicenter study reveals most penile implant cases in North America receive an inflatable penile prosthesis and that radical prostatectomy is the most common primary etiology of penile implant surgery. Moreover, patients treated with radical prostatectomy were more likely to have the reservoir placed in a submuscular location, have a longer operating room time and be admitted to the hospital overnight compared with other patient groups.

Reservoir alternate surgical implantation technique: preliminary outcomes of initial PROPPER study of low profile or spherical reservoir implantation in submuscular location or traditional prevesical space.

PURPOSE: Alternative reservoir site placement has become an accepted technique for patients who require an inflatable penile prosthesis. To our knowledge there has been no prospective evaluation of this technique, which is currently off label. We performed a prospective, multicenter, multinational, internal review board approved study to evaluate the effectiveness and safety of alternative reservoir site placement. MATERIALS AND METHODS: PROPPER initiated in June 2011, is a database containing patient outcomes of inflatable penile prosthesis implantation. Patients with AMS® penile prostheses continue to be enrolled at 13 North American sites. We examined PROPPER study data to determine surgical implantation use patterns for the AMS 700™ series. We evaluated reservoir implantation site and complications by implantation site. RESULTS: A total of 759 patients had been implanted with an AMS 700 series implant by the time of evaluation. Mean patient followup was 17.8 months (range 0 to 36). There was no reported case of revision surgery for a palpable reservoir and no report of vascular or hollow viscous injury associated with alternative reservoir site placement. Two cases of reservoir herniation in the alternative reservoir site placement group and 2 in the space of Retzius group were treated with reservoir reimplantation. Patients with 1-year assessment available were satisfied or very satisfied with the device and reported a frequency of use of more than once per month. CONCLUSIONS: Alternative reservoir placement in the submuscular location is an option in patients who undergo inflatable penile prosthesis surgery. Implant surgeons should consider alternative reservoir site placement a safe, effective alternative to reservoir placement in the space of Retzius.

A multi-institutional update on surgical outcomes after penile silicone sleeve implantation.

Background: The increasing popularity of the silicone sleeve penile implant has been accompanied by concerns over potential risks and adverse events. Objectives: To provide multi-institutional data on safety outcomes in patients undergoing silicone sleeve penile implant surgery across high-volume implant surgeons. In addition, we discuss preventative techniques to minimize postoperative complications and the management of these events. Design and methods: We performed a retrospective analysis of men undergoing penile silicone sleeve implants between November 2020 and November 2022 with four surgeons, each from a separate institution. Perioperative and postoperative adverse events, including unsatisfactory cosmetic outcomes requiring revision, were determined by physician follow-up. Flaccid penile length and girth were measured preoperatively and postoperatively. Results: A total of 299 male patients underwent silicone sleeve implant surgery, with an average age of 42.5 ± 10.5 years and an average body mass index of 28.5 ± 4.0. The patient cohort exhibited minimal comorbidities, with 5% having hyperlipidemia, 2% being smokers, 2% having cardiovascular disease, and 1% having diabetes. Patients experienced an average increase of 4.1 ± 1.5 cm in their flaccid penile length (a 50% increase) and an average increase of 3.4 ± 1.5 cm in their flaccid girth (a 37% increase) (p < 0.01). Complication rates included new-onset postoperative erectile dysfunction (0%), infection (1.3%), seroma (2.0%), and erosion (5.0%). The average follow-up time was 11.6 months. Notably, our rates of infection and seroma were lower than those reported in a previous single-center review, while erosion rates were higher. Conclusion: This is the largest study to characterize the safety of the penile silicone sleeve implant across multiple institutions. In men who desire cosmetic size augmentation, silicone sleeve implant surgery is associated with significantly increased flaccid penile length and girth. Complications are mainly cosmetic and may be corrected; however, patients should be appropriately counseled on the risk of erosion, which appears to be higher than previously reported.

Outcomes for penile silicone sleeve surgery This is the largest study to characterize the safety of the penile silicone sleeve implant across multiple institutions. In men who desire cosmetic penile size improvement, the silicone sleeve implant surgery is associated with significantly increased flaccid penile length and girth. Complications are mainly cosmetic and may be corrected, however, patients should be appropriately counseled on the risk of erosion, which appears to be higher than previously reported.

Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study.

BACKGROUND: "Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration" (PROPPER) is a large, multi-institutional, prospective clinical study to collect, analyze, and report real-world outcomes for men implanted with penile prosthetic devices. We prospectively correlated co-morbid conditions and demographic data with implanted penile prosthesis size to enable clinicians to better predict implanted penis size following penile implantation. We present many new data points for the first time in the literature and postulate that radical prostatectomy (RP) is negatively correlated with penile corporal length. METHODS: Patient demographics, medical history, baseline characteristics and surgical details were compiled prospectively. Pearson correlation coefficient was generated for the correlation between demographic, etiology of ED, duration of ED, co-morbid conditions, pre-operative penile length (flaccid and stretched) and length of implanted penile prosthesis. Multivariate analysis was performed to define predictors of implanted prosthesis length. RESULTS: From June 2011 to June 2017, 1,135 men underwent primary implantation of penile prosthesis at a total of 11 study sites. Malleable (Spectra), 2-piece Ambicor, and 3-piece AMS 700 CX/LGX were included in the analysis. The most common patient comorbidities were CV disease (26.1%), DM (11.1%), and PD (12.4%). Primary etiology of ED: RP (27.4%), DM (20.3%), CVD (18.0%), PD (10.3%), and Priapism (1.4%), others (22.6%). Mean duration of ED is 6.2¡À4.1 years. Implant length was weakly negatively correlated with White/Caucasian (r=-0.18; P<0.01), history of RP (r=-0.13; P<0.01), PD as comorbidity (r=-0.16; P<0.01), venous leak (r=-0.08; P<0.01), and presence of stress incontinence (r=-0.13; P<0.01). Analyses showed weak positive correlations with Black/AA (r=0.32; P<0.01), CV disease as primary ED etiology (r=0.08; P<0.01) and pre-operative stretched penile length (r=0.18; P<0.01). There is a moderate correlation with pre-operative flaccid penile length (r=0.30; P<0.01). CONCLUSIONS: Implanted penile prosthesis length is negatively correlated with some ethnic groups, prostatectomy, and incontinence. Positive correlates include CV disease, preoperative stretched penile length, and flaccid penile length.

Immediate postoperative complications of combined penetrating rectal and bladder injuries.

BACKGROUND: Combined penetrating trauma involving the rectum and bladder has been associated with increased postoperative morbidity. Specific complications resulting from these injuries include colovesical fistula, urinoma, and abscess formation. METHODS: A retrospective review of Temple University Hospital trauma database was performed. Patients were categorized by having an isolated rectal (n = 29), isolated bladder (n = 16), or combined injury (n = 24). Records were reviewed for sex, age, site of injury, location of rectal and bladder injuries, operative intervention, fistula formation, urinoma formation, abscess formation, time to urinary catheter removal, length of intensive care unit stay, and length of hospital stay. RESULTS: Patient sex and age did not differ significantly between groups, nor was there a significant difference in location of rectal injury between groups. Presacral drainage was utilized in all patients with extraperitoneal injuries. Fecal diversion was performed in all patients, except two with intraperitoneal rectal injuries. Omental flap interposition between rectal and bladder injuries was utilized in one patient. No significant difference was noted in immediate postoperative complications between groups including fistula, urinoma, and abscess formation. However, all cases of colovesical fistula (n = 2) and urinoma (n = 2) formation were noted in those patients with rectal and posterior bladder injuries. CONCLUSIONS: Combined rectal and bladder injuries were not associated with an increase in immediate postoperative complications compared with isolated rectal and bladder injuries. However, postoperative fistula and urinoma formation occurred only in patients with a combined rectal and posterior bladder injury. Consequently, these patients may benefit from omental flap interposition between injuries to decrease fistula and urinoma formation.

Delayed diagnosis of traumatic ureteral injuries.

PURPOSE: We review our experience with traumatic ureteral injuries missed at exploration. We also conduct meta-analysis to define factors contributing to missed injury, comparing outcomes of early vs late diagnosis. MATERIALS AND METHODS: Our genitourinary trauma database was retrospectively reviewed from 1995 through 2004. A total of 40 ureteral injuries were identified including 5 with delayed diagnosis. Previously published series of ureteral trauma were then analyzed for injuries with delayed diagnosis, with data extracted and collated for meta-analysis. RESULTS: A total of 40 patients with traumatic ureteral injuries was identified, all of whom underwent laparotomy. Five (12.5%) injuries were discovered at a mean of 6.0 +/- 3.0 days after laparotomy. The number of associated injuries for early and delayed diagnosis was 3.2 and 2.6 (p = 0.25), respectively. Mean hospital stay was 19.2 vs 36.6 days (p = 0.18) for those with immediate vs delayed diagnosis, respectively. Only 2 of 5 (40%) patients achieved satisfactory results during initial hospitalization. Literature review revealed 48 missed ureteral injuries, representing 11.1% of all patients with ureteral injuries who underwent laparotomy. Rates of nephrectomy for early and late diagnosis were 2.4% and 18.4% (p = 0.0001). Mortality related to traumatic injuries occurred in 6.1% with early diagnosis and 13.2% with missed injuries (p = 0.089). CONCLUSIONS: Despite preoperative studies and intraoperative inspection, ureteral injury may remain undiagnosed until after laparotomy. We report intraoperative exploration to have a sensitivity of 88.9% across multiple series for traumatic ureteral injuries. Delayed diagnosis of ureteral injuries produces an association with prolonged hospital stay, and meta-analysis reveals a statistically significant increase in the rate of nephrectomy when ureteral injury is missed at exploration.

Incidence and management of penetrating renal trauma in patients with multiorgan injury: extended experience at an inner city trauma center.

PURPOSE: Patients with penetrating trauma often have multiorgan involvement that may complicate the management of any single organ system. Here we review the incidence of associated injuries in patients with penetrating renal trauma and our extended experience treating these patients at a busy inner city trauma center. MATERIALS AND METHODS: All trauma cases presenting to Temple University Trauma Center during a 6-year period were identified through our institutional databases and were reviewed (5,276). Penetrating trauma represented 41% of all cases (2,163). Of these we identified 123 patients with penetrating renal trauma (5.7%). A total of 93 cases were available for review. Multiorgan injury was staged in the operating room if patients were hemodynamically unstable or radiographically if they were stable. Renal injuries were staged by high dose, single shot excretory urogram in patients taken immediately to surgery or by computerized tomography if stable. Renal injuries were classified using the American Association for Surgery of Trauma (AAST) grading system. AAST classifications were subcategorized for purposes of streamlining. Grade 1 and 2 injuries were grouped as low grade, grades 3 and 4 nonvascular injuries were grouped as intermediate grade, and AAST grade 4 vascular and grade 5 injuries were grouped as high grade. Demographic, clinical and intraoperative variables, as well as number and severity of associated injuries, were then assessed to determine the relationship with various renal surgical outcomes including the requirement of surgical intervention, type of surgical intervention, need for nephrectomy and associated adverse outcomes. RESULTS: The median age of injured patients was 28 years (range 14 to 80). The majority of victims were male (93%). The mechanism of injury was predominantly gunshot wound (GSW, 86%) while 14% were due to stab wounds. Renal injuries were low grade (19%), intermediate grade (44%) and high grade (37%). Nearly all patients with penetrating renal injury had associated multiorgan injury (94.6%). Associated injuries for penetrating renal trauma on the right side predominately involved the liver, small bowel and vertebra while injury to the left kidney was most often associated with trauma to the stomach, colon and spleen. Patients suffered extensive renal injury as evidenced by the high rate of intraoperative urinomas (30.1%) and hematomas (97.5%) identified. In the absence of an expanding hematoma and/or hemodynamic instability, associated injuries by themselves did not increase the risk of nephrectomy. Despite multiorgan penetrating injury 54% of kidneys were salvageable. CONCLUSIONS: Isolated penetrating trauma to the kidney is rare. The majority of patients with penetrating renal trauma have associated adjacent organ injuries that may complicate treatment. In the absence of an expanding hematoma with hemodynamic instability, associated multiorgan injuries did not increase the risk of nephrectomy. With appropriate radiographic and/or surgical staging, it is possible to repair and salvage many of these kidneys despite extensive associated intraabdominal trauma.