Factors Affecting Implant Length in Primary Inflatable Penile Prosthesis Placement.

OBJECTIVE: To evaluate predictors of implant length for men undergoing primary IPP placement. METHODS: A multicenter, retrospective cohort study was performed for men undergoing primary IPP placement at 16 high-volume surgical centers. Patient demographics, comorbidities, operative approach, and implanted cylinder and rear-tip extender length were recorded. Associations between potential preoperative and intraoperative predictors of total device length were tested using non-parametric correlation and Kruskal-Wallis tests, followed by multiple regression. RESULTS: Of 3951 men undergoing primary IPP placement from July 2016 to July 2021, the median implant length was 20 cm (IQR: 19-22). Shorter implant length was associated with increasing age in years (ß = -0.01, P = .009), Asian ethnicity (ß = -2.34, P = .008), history of radical prostatectomy (ß = -0.35, P = .001), and use of an infrapubic surgical approach (ß = -1.02, P <.001). Black or African American ethnicity was associated with the implantation of longer devices (ß = 0.35, P <.001). No significant associations were recorded with BMI, history of intracavernosal injections, diabetes mellitus, tobacco use, radiation therapy, Peyronie's disease, priapism, or cavernosal dilation technique. CONCLUSION: The length of an implanted penile prosthesis was found to be associated with preoperative and intraoperative factors including history of radical prostatectomy and operative approach. The knowledge of these associations may assist in the preoperative counseling of patients receiving IPP and help create accurate postoperative expectations.

Variability in Methodology of Erectile Dysfunction Regenerative Therapy Trials on ClinicalTrials.gov.

OBJECTIVE: To evaluate the variability in the criteria of erectile dysfunction (ED) regenerative therapy trials registered on ClinicalTrials.gov. METHODS: Interventional trials on ClinicalTrials.gov with the keywords "erectile dysfunction" and variations of "shockwave," "platelet rich plasma," "stem cell," "regenerative," and "restorative" were examined. Inclusion/exclusion criteria and primary/secondary outcomes were compared between extracorporeal shockwave therapy (ESWT), platelet rich plasma and stem cell injections (PRP/SC), and other regenerative therapies (ORT) groups. RESULTS: Of the 92 trials analyzed, International Index of Erectile Function (IIEF) score was the most common primary outcome (72%), with a higher prevalence in ESWT trials than PRP/SC or ORT trials (89% vs 44% and 58%, P <.001). Safety/tolerability was a primary outcome for 44% of PRP/SC trials and 25% of ORT trials but no ESWT trials (P <.001). ESWT trials more frequently had sexual/romantic relationship-based inclusion criteria and cancer treatment-related exclusion criteria than PRP/SC and ORT trials. CONCLUSION: There is substantial variability in the inclusion/exclusion criteria and outcome measures among ED regenerative therapy trials. ESWT trials most frequently utilized IIEF and had the strictest inclusion/exclusion criteria, suggesting more rigorous and functional outcome-based studies. Conversely, PRP/SC and ORT trials, but not ESWT trials, had safety/tolerability as a primary outcome, likely due to the experimental nature of these therapies. The variability in inclusion/exclusion criteria and outcome measures limits comparison of the various ED regenerative therapies.

Short-term revision rate of Rigicon Testi10TM testicular prosthesis in adolescents and adults: a retrospective chart review.

Testicular prosthesis implantation is a valuable solution for the physical, cosmetic, and psychological challenges associated with testicular loss which may affect males of any age. We evaluated the safety and reliability of the new Rigicon Testi10TM testicular prosthesis in adults and adolescents by performing an IRB-approved retrospective study of data drawn from Patient Information Forms (PIFs). A total of 427 patients (382 adults and 45 adolescents) had at least one testicular prosthesis implanted. Only one adult patient required revision surgery due to rupture of the Rigicon Testi10 TM saline-filled prosthesis. A 40-year-old patient was found to have a leaking prosthesis approximately one week postoperatively, which was suspected to be due to inadvertently punctured by the surgeon during the sterile saline filling process. There were no post-implantation revisions required for adolescent patients. According to our results, Kaplan-Meier calculation of survival from removal or revision was 99.8% for all patients at 54 months (99.7% for adults and 100% for adolescents). The complication rates among patients in this study are lower than those reported in previous published studies. Our study underscores the generally safe nature of testicular prosthesis implantation, as well as the very rare incidence of revision surgery for this new device.

Penoscrotal inflatable penile prosthesis recipients often fully recover from pain at two weeks following placement.

The symptoms and duration of pain following inflatable penile prosthesis (IPP) surgery remains poorly understood. We characterize postoperative pain following penoscrotal 3-piece inflatable penile prosthesis placement in patients managed with a standardized pain management protocol. This is a single-center prospective analysis of 96 virginal penoscrotal 3-piece IPP recipients (9/2019 to 9/2021) excluding patients with chronic pain, IPPs performed with alternative approaches or concomitantly with other surgeries and those with infections. Standardized pain questionnaire was performed by phone on post-operative day (POD) 2, 7, 14, and 30. The primary outcome was self-reported pain scores, measured by pain score 0-10 (0 = no pain, 10 = unbearable, "worst pain you have ever felt") at various locations (incision, penile, scrotal, abdominal) over the first 30 days postoperatively. A majority of pain reported was outside the scrotal area with 67.6% of complaints in the shaft, glans, abdomen and incision. From POD2 to POD30, there was a significant decrease in severe pain from 46.2 to 11.1% (p = 0.05) with an increase in mild pain from 23.1 to 62.4% (p = 0.05). Roughly half of the participants (47.9%, n = 46) reported no pain by POD14. Penoscrotal IPP recipients often fully recover from pain at the two-week period following surgery and those with lingering discomfort predominantly complain of penile shaft and glans pain.

Does climate impact inflatable penile prosthesis infection (IPP) risk? Assessment of temperature and dew point on IPP infections.

BACKGROUND: Variations in climate have been associated with a greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome; however, limited data exist on the impact of climate on inflatable penile prosthesis (IPP) infections. AIM: We sought to evaluate the impact of climate on the risk of IPP infections in a large international, multicenter cohort. METHODS: We performed a multi-institutional, retrospective study of patients undergoing IPP surgery. We then evaluated whether the month or season, during which surgery was performed, affected device infections. Implant infections were defined as infections requiring device explantation. A univariate logistic regression analysis was undertaken. OUTCOMES: Our primary outcome was implant infection. RESULTS: A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. There was a fairly even distribution of implants performed in each season. A total of 103 (1.9%) infections were recorded. There were 32 (31.1%) IPP infections in patients who underwent surgery in the summer, followed by 28 (27.2%) in the winter, 26 (25.2%) in the spring, and 17 (16.5%) in the fall. No statistically significant differences were recorded in terms of season (P = .19) and month (P = .29). The mean daily temperature (P = .43), dew point (P = .43), and humidity (P = .92) at the time of IPP placement was not associated with infection. CLINICAL IMPLICATIONS: These findings provide reassurance to prosthetic urologists that infection reduction strategies do not need to be tailored to local climate. STRENGTHS AND LIMITATIONS: Climate data were not directly recorded for each hospital, but rather based on the monthly averages in the city where the surgery was performed. CONCLUSION: The climate at time of IPP placement and time of year of surgery is not associated with IPP infection risk.

Single Dilation in Primary Inflatable Penile Prosthesis Placement Is Associated With Fewer Corporal Complications Than Sequential Dilation.

OBJECTIVE: To assess the difference in outcomes between single dilation (SingD) and sequential dilation (SeqD) in primary penile implantation, hypothesizing that patients who undergo SeqD had higher rates of noninfectious complications. METHODS: We performed a multicenter, retrospective study of men undergoing primary inflatable penile prosthesis placement. Intraoperative complications and postoperative noninfectious outcomes were assessed between the two groups. Multivariable analysis was performed to identify predictors of complications. RESULTS: A total of 3293 patients met inclusion criteria. After matching, there were 379 patients who underwent SingD and 379 patients who underwent SeqD. There was no significant difference in intraoperative complications between patients who underwent SingD vs SeqD, nor was there any difference in cylinder length (20 cm with interquartile range [IQR] 18-21 cm vs 20 cm with IQR 18-20 cm respectively, P = .4). On multivariable analysis, SeqD (OR 5.23 with IQR 2.74-10, P < .001) and older age (OR 1.04 with IQR 1.01-1.06, P = .007) were predictive of postoperative noninfectious complications. There was no significant difference in intraoperative complications between patients who underwent SingD vs SeqD, nor was there any difference in cylinder length. SeqD and older age were predictive of postoperative noninfectious complications. CONCLUSION: During inflatable penile prosthesis placement in the uncomplicated patient without fibrosis, SingD is a safe technique to utilize during implantation that will minimize postoperative adverse events, and promote device longevity without loss of cylinder length.

Delayed placement of an inflatable penile prosthesis is associated with a high complication rate in men with a history of ischemic priapism.

BACKGROUND: Corporal fibrosis is known to result from prolonged priapism; however, the impact of the timing of penile prosthesis placement after priapism on complication rates is poorly understood. AIM: We sought to evaluate the impact of timing of inflatable penile prosthesis (IPP) placement on complications in men with a history of ischemic priapism. METHODS: We performed a multicenter, retrospective cohort study of patients with a history of priapism undergoing IPP placement by 10 experienced implantation surgeons. We defined early placement as ≤6 months from priapism to IPP. We identified a 1:1 propensity-matched group of men without a history of priapism and compared complication rates between men who had early placement, late placement, and no history of priapism. OUTCOMES: Our primary outcome was postoperative noninfectious complications, and secondary outcomes included intraoperative complications and postoperative infection. RESULTS: A total of 124 men were included in the study with a mean age of 50.3 ± 12.7 years. A total of 62 had a history of priapism and 62 were matched control subjects. The median duration of priapism was 37 (range, 3-168) hours and the median time from ischemic priapism to IPP placement was 15 months (range, 3 days to 23 years). Fifteen (24%) men underwent early (≤6 months) IPP placement at a median time of 2 months (range, 3 days to 6 months) following the ischemic priapism event. The remaining 47 (76%) underwent placement >6 months following priapism at a median time of 31.5 months (range, 7 months to 23 years). The complication rate in the delayed placement group was 40.5% compared with 0% in the early placement group and control group. Cylinder-related complications such as migration or leak accounted for 8 (57%) of 14 of the postoperative noninfectious complications. Full-sized cylinders were used in all patients who had a cylinder related complication. CLINICAL IMPLICATIONS: Priapism patients should be referred to prosthetic experts early to decrease complication rates in those needing an IPP. STRENGTHS AND LIMITATIONS: This is a multicenter study from experienced prosthetic urologists but is limited by the retrospective nature and small number of patients in the early placement group. CONCLUSION: IPP complication rates are high in men with a history of ischemic priapism, especially when implantation is delayed beyond 6 months.

Partner Involvement Reduces Postoperative Care Burden Following Penile Prosthesis Placement.

OBJECTIVE: To determine whether preoperative partner involvement at clinic appointments is associated with deviation from a standardized postoperative care pathway for patients undergoing an inflatable penile prosthesis placement. METHODS: This is a retrospective study of 170 patients undergoing primary inflatable penile prosthesis placement performed by a single surgeon between 2017 and 2020. A standardized postoperative clinical pathway was used, including planned follow-up visits at 2 weeks (for wound check and device deflation) and 6 weeks (for device teaching). Patient characteristics, including demographics, partner involvement, and the number of follow-up visits were obtained from the medical record. Logistic regression modeling was performed to determine whether partner involvement was associated with unanticipated follow-up visits. RESULTS: Partners were involved in preoperative visits for 92 patients (54%). Additional unplanned follow-up visits were observed for 58 patients (34%) between 0 and 6 weeks and for 28 patients (16%) after 6 weeks from surgery. Partner involvement was associated with reduced odds of unanticipated follow-up visits, both between 0 and 6 weeks (odds ratios 0.37, 95% CI 0.18-0.75) and after 6 weeks (odds ratios 0.33, 95% CI 0.13-0.81) in adjusted models. CONCLUSION: Having a patient's partner involved during the preoperative period is associated with a significant reduction in unanticipated follow-up. We would recommend that urologists routinely encourage patients considering the insertion of a penile prosthesis to involve their partners in perioperative visits. Further research needed is needed to determine how to best support patients during surgical decision-making and through the postoperative period.

Defining the incidence and management of postoperative scrotal hematoma after primary and complex three-piece inflatable penile prosthesis surgery.

Scrotal hematoma is a challenging complication of penile prosthesis surgery. We characterize the risk of hematoma formation with implementation of standardized techniques to mitigate hematomas and assess for any associated factors in a large multi-institutional penile implant cohort. This was a retrospective review from February 2018 to December 2020 of all patients who underwent inflatable penile prosthesis implantation at 2 high volume implant centers. Cases were defined as "complex" if they involved revision, salvage with removal/replacement, or were performed with concurrent penile, scrotal or intra-abdominal surgeries. The incidence of scrotal hematoma among primary and complex IPP recipients was measured and modifiable and innate risk factors associated with hematoma formation within the two cohorts were tracked. Of 246 men who underwent penile prosthesis surgery, 194 (78.9%) patients underwent primary implantation and 52 (21.1%) were complex. Although hematoma formers in the complex group had comparable drain outputs to primary patients on postoperative day 0 (66.8cc ± 32.5 vs 48.4 ± 27.7, p = 0.470) and postoperative day 1 (40.3cc ± 20.8vs 21.8 ± 11.3 p = 0.125), hematomas in the complex group had a higher propensity for OR evacuation (p = 0.03). Difference in duration of temporary device inflation between 2 (64, 26%) and 4 weeks (182, 74%) did not contribute to hematoma formation (p = 0.562). The incidence of postoperative hematoma formation in complex cases was 9.6% (5/52) and 3.6% in primary cases (7/194) (HR = 2.61, p = 0.072). Complex IPP surgery performed for revision or with ancillary procedures are more likely to result in clinically significant hematomas that require surgical management, suggesting a need for heightened caution in managing these individuals.

Technological advances in penile implants: past, present, future.

Attempts to "cure" erectile dysfunction (ED) are as old as recorded history. The history of penile prosthetic devices dates back over 500 years, when a French military surgeon designed the first known wooden prosthesis to support micturition. There have since been a great many technological advancements in penile prosthetics. Penile implants for the improvement of sexual function date to the twentieth century. Like all human endeavors, penile prosthesis innovations have progressed via trial and error. This review aims to provide an overview of penile prostheses for the treatment of ED since their introduction in 1936. More specifically, we aim to highlight important advances in penile prosthesis development and discuss dead ends that were abandoned. Highlights include two-piece inflatables, three-piece inflatables, and malleable/semirigid, along with modifications and updates to each basic design that improved both insertion and usability. Dead ends include innovative ideas that were lost to history due to a variety of factors. We also look to the future and discuss expected advances, including remotely activated devices and prostheses designed for special populations, including transgender men.

Partial Component Exchange of a Non-Infected Inflatable Penile Prosthesis is Associated With a Higher Complication Rate.

OBJECTIVE: To describe the infectious and non-infectious complications in men undergoing Inflatable penile prosthesis (IPP) revision with partial and complete component exchange for mechanical malfunction. METHODS: We performed a multicenter retrospective cohort study of patients who underwent IPP revision. Men undergoing procedures for implant infection were excluded. Patients were divided into those who had complete exchange of the entire device or partial exchange of only one or 2 components. Infectious and non-infectious complications were compared between groups. RESULTS: Three hundred sixty-eight men had complete exchange of the entire device and 85 had partial component exchange. Men undergoing partial exchange had a significantly higher infection rate (7.1% vs 2.2%, P = .031). The partial exchange group also was more likely to receive antifungals (51.8 vs 16.6%, P < .001), have a modified salvage washout (77.4 vs 60.2%, P = .004), and less likely to receive vancomycin and gentamicin (63.5 vs 83.7%, P < .001). Time to revision was significantly shorter in the partial exchange group (44.9 vs 168.2 months, P < .001). Mean follow-up was slightly longer in the complete exchange group (18.3 vs 13.0 months). In multivariable analysis, partial exchange surgery, vancomycin and gentamicin prophylaxis, modified salvage washout, and antifungal prophylaxis were no longer associated with postoperative infections. The partial exchange group had greater rates of non-infectious complications (21.2% vs 9.5%, P = .005) such as pump malfunction and tubing breakage. CONCLUSION: Patients undergoing partial component revision had more infectious and non-infectious complications. These findings suggest that partial component exchange increases complications in men undergoing IPP revision.