A contemporary systematic review of penile lengthening procedures with penile prosthesis.

Background: Penile prosthetic devices are the standard treatment for erectile dysfunction (ED) after failure of maximum medical therapy and conservative options. Several penile lengthening procedures (PLPs) can be performed concurrently with penile prosthesis (PP) insertion in patients with severe ED, penile shortening, and/or Peyronie's disease to help combat negative emotional and psychological concerns from penile length loss with penile prosthetic device placement. Methods: An extensive, systematic literature review of the various pre-, intra-, and post-operative techniques that can be applied to preserve, restore or enhance penile length at the time of penile prosthetic implantation. Results: Numerous pre-operative and post-operative inflation protocols exists with vacuum erection devices and penile traction therapy. Intraoperative surgical techniques include cavernosal sparing and channeling without dilatation, subcoronal incision with circumferential penile degloving and grafting, the sliding technique, the modified sliding technique, the multiple-slit technique, the tunical expansion procedure (TEP), modified TEP, and the auxetic expansion procedure. These approaches can be meaningful to restore and/or preserve length for patients undergoing PP insertion. Conclusions: PLPs can be performed by surgeons who have extensive penile reconstruction experience and have been trained to do these procedures, as there is significant risk to the patient and limitations to what can be expected. Each patient must be counseled in detail about the risks and benefits of these procedures and have their expectations managed as the average postoperative penile length recovery is around 3 cm and can range from 0-4.0 cm. Future research is needed to identify the appropriate candidate for each approach, and how much length gain the patient can expect.

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.

Experience With Extra-Tunical Grafting and Tunica Albuginea Plication for Correction of Indentation Deformity in Men With Peyronie's Disease.

OBJECTIVE: To further evaluate extra-tunical grafting (ETG), a relatively new surgical option to treat corporal indentation in those with Peyronie's disease without buckling or hinge effect, we report our experience, patient satisfaction, and surgical outcomes. METHODS: Retrospective review of patients following ETG, including pre-operative deformity, type of graft, graft location (under or over Buck fascia), patient characteristics, and satisfaction. Overall cosmetic satisfaction with deformity correction between patients undergoing 2 different ETG locations and 3 different types of grafts, as well as perceived bother of graft visibility and palpability were assessed. RESULTS: From 2018-2023, 35 patients underwent ETG and tunica albuginea plication (TAP) with 89.6% of patients having persistent correction on office examination at a median (interquartile range) follow-up of 23.5 (15.2) months. Overall satisfaction with penile appearance by grafting location via patient-reported questionnaires showed no statistical difference (P = .47). Patients undergoing TAP and ETG were satisfied with their erect appearance regardless of graft material. Patients reported grafting tissue was palpable (74.3%) and visible (48.6%) in the flaccid state as compared to the erect state (8.6% and 5.7%). CONCLUSION: ETG presents a less invasive surgical option than traditional approaches to correct indentation deformities not associated with instability. Our experience shows high patient satisfaction rate following correction of indentation using graft tissue when placed under or over Buck fascia. At a median follow-up of almost 2 years, patients had persistent correction, and while some report visibility of the graft and palpability in the flaccid state, this tends to disappear in the erect state.

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.

Transdermal application of H100 gel to the penile shaft in patients with Peyronie's disease infiltrates the tunica albuginea.

Treatment options for Peyronie's disease (PD) remain limited. Topical H100 gel, (Hybrid Medical, Edina, USA), which contains nicardipine, super oxide dismutase and emu oil showed safety and efficacy in a previous small double-blind placebo-controlled pilot study. The present study evaluates if topically applied H100 gel applied to the penile shaft infiltrates the tunica albuginea. Nicardipine is a key active ingredient in H100 and serves as a surrogate marker. Three men already scheduled to undergo a planned surgical procedure for PD applied commercially available H100 gel twice daily to the penile shaft for up to 30 days prior to the procedure. Tunica albuginea samples were obtained at surgery. Nicardipine evaluation was performed using isotope dilution technique via liquid-chromatograph-mass spectrometry (LCMS). All three patients tolerated H100 gel application without side effects. All three tunica albuginea specimens showed detectable nicardipine in the tunical tissue. Transdermal application of commercially available H100 gel is able to penetrate the tunica albuginea tissue and is detectable in men with acute and chronic PD. This finding may support the encouraging results found in the prior H100 pilot study.

A contemporary assessment of the evaluation and management of patients presenting to a tertiary medical center with Peyronie's disease.

Peyronie's disease continues to be poorly understood. We characterize the presenting features of Peyronie's disease within a large cohort and elucidate the factors that correlate with surgical intervention. Univariate and multivariate analyses were performed on 1483 consecutive patients to assess pre-operative predictors of surgical intervention for Peyronie's disease. Overall, 1263 patients met inclusion criteria. Mean age was 55.4 ± 11.1 years with a mean duration of disease at presentation of 33.2 ± 42.5 months. Mean primary curvature was 49.8 ± 20.8°. Primary ventral curvature was present in 11.4% and 36.5% of patient had a multiplanar curvature. During penile duplex ultrasound evaluation indentation/narrowing deformities were appreciated in 76.0%, hourglass deformity in 10.1%, and hinge effect in 33.0% of patients. Calcification was seen in 30.1% of patients. Operative intervention occurred in 35.3% of patients. Degree of primary curvature (1.03 OR, p < 0.001), hourglass deformity (1.82 OR, p = 0.01), decreased tunical elasticity (1.20 OR, p = 0.03), and prior intralesional collagenase clostridium histolyticum injections (2.94 OR, p < 0.001) predicted surgical correction on multivariate analysis. Compared to historical studies, we found a higher incidence of severe degree of curvature (27.5% >60°), indentation deformities, hinge-effect, multiplanar curvature and penile calcifications. Ultimately, predictors of surgical intervention included those with worse erectile function and more severe characteristics.

Long-term outcomes after plaque excision grafting for Peyronie's disease and subanalysis of patients who undergo the procedure despite preoperative counseling against it.

BACKGROUND: Plaque excision and grafting (PEG) has been recommended for patients with Peyronie's disease (PD) with >60° curvature and/or hinge effect and strong preoperative erections, while placement of an inflatable penile prosthesis (IPP) is recommended when rigidity is suboptimal. Nevertheless, many patients counseled to undergo an IPP decline and insist on proceeding with PEG due to personal preference or desire to avoid an implant. AIM: We aim to review long-term outcomes in patients who underwent PEG for PD at our institution and investigate whether there is any difference in long-term outcomes in patients who undergo PEG despite a recommendation to undergo IPP. METHODS: We conducted a retrospective chart review from 2007 to 2021 on PEG surgery performed at a single tertiary care institution in patients ≥18 years old who had >3 months of follow-up. OUTCOMES: Postoperative information was gathered from the electronic medical record, including postoperative erectile function, patient satisfaction, and the ability to engage in penetrative sexual intercourse. RESULTS: An overall 251 patients underwent PEG with a median follow-up of 12 months (IQR, 6-54). Among these, 54 (22%) were initially advised to undergo IPP but elected for PEG. Patients who underwent PEG despite counseling to undergo IPP reported lower postoperative ability to engage in intercourse (51% vs 76%). Seven (13%) patients initially advised to undergo IPP eventually received an IPP, relative to 7 (4%) initially advised to undergo PEG. CLINICAL IMPLICATIONS: Thorough preoperative assessment of erectile function and penile deformity can guide clinician counseling and manage patient expectations during decision making between PEG surgery and IPP implantation for PD. STRENGTHS AND LIMITATIONS: Limitations of this study include its retrospective nature, high attrition to follow-up, and risk of recall and selection bias. This is a large study with a median follow-up of 12 months, with a high-volume single surgeon who treats patients in a specialized population of complex cases. CONCLUSION: Patients who were initially counseled to undergo IPP due to suboptimal erectile rigidity but elected for PEG had worse postoperative ability to engage in penetrative intercourse, and a higher proportion of these patients eventually received an IPP.

Quality of life and sexuality with penile prosthesis: a systematic review and pooled analysis.

INTRODUCTION: Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) is the first validated questionnaire to specifically evaluate the satisfaction of patients undergoing penile prosthesis implantation. Our primary aim was to conduct a systematic review and pooled analysis of articles reporting QoLSPP. EVIDENCE ACQUISITION: A comprehensive bibliographic search on the MEDLINE, Scopus, Web of Science, and Cochrane Library databases was performed in April 2023. Studies were selected if they assessed male subjects (P) undergoing penile prosthesis implantation (I) with or without comparison with other treatments (C), reporting the patient satisfaction according to QoLSPP (O). Prospective and retrospective original studies were included (S). The risk of bias was assessed using the ROBINS-I tool and the Knoll method. Means and standard deviations (SDs) of QoLSPP scores were included in the pooled analysis. PROSPERO ID: "CRD42023427261." EVIDENCE SYNTHESIS: A total of 10 studies investigating 1105 patients were included in the systematic review; of these, eight articles describing the outcomes of 693 subjects were eligible for the pooled analysis. Overall serious risk of bias was found in 2/3 of nonrandomized comparative studies (66%), while seven single-arm studies (100%) were classified as having a high risk of bias. Pooled analysis of the QoLSPP-Functional domain revealed an overall effect size (ES) of 4.22 points (95% CI 4.04-4.40; P<0.001). The QoLSPP-Relational pooled score was 4.17 points (95% CI 4.03-4.31; P<0.001). The QoLSPP-Social pooled score corresponded to 4.21 points (95% CI 4.02-4.40; P<0.001). Pooled analysis of the QoLSPP-Personal domain showed an overall ES of 3.97 points (95% CI 3.61-4.32; P<0.001). There was insufficient data to pool QoLSPP total scores. CONCLUSIONS: Patients undergoing penile prosthesis implantation report positive scores in all QoLSPP domains, demonstrating high satisfaction levels. Future studies are needed to improve the evidence on the topic.

Predictors of hinge effect in patients with Peyronie's disease.

BACKGROUND: Patients with Peyronie's disease present with a variety of penile deformities. Those with hinge effect can experience bothersome buckling of the erection and instability during penetrative sex; however, the actual characteristics and clinical implications are not fully understood. AIM: To determine the factors that cause hinge effect and to assess the role on surgical intervention. METHODS: This retrospective review included 1223 consecutive patients who were examined by a single surgeon and had a complete penile duplex evaluation with curvature and hinge assessment. Baseline demographics, penile duplex findings, and clinical outcomes were used to assess for predictors of hinge effect. OUTCOMES: Analyses were performed to assess preoperative predictors of hinge effect and surgical intervention. RESULTS: Hinge effect was observed at the time of penile duplex Doppler examination in 33% of patients. Circumferential girth discrepancy at point of indentation (odds ratio [OR] 1.82; P < .001), rigidity of erection (OR, 0.82; P = .002), and degree of primary curvature (OR, 1.03; P < .001) predicted the presence of hinge effect. When controlling for rigidity, a girth discrepancy >1 cm did appear to be associated with a hinge. CLINICAL IMPLICATIONS: Circumferential girth discrepancy >1 cm, regardless of erectile rigidity, can be associated with hinge effect. STRENGTHS AND LIMITATIONS: As a strength, this study included the largest cohort of patients with Peyronie's disease, all of whom were examined in a rigorous and uniform manner via the same operative counseling. However, the study is limited by its retrospective nature and potential for selection and observer bias, given that the treating physician was also assessing all penile deformities as well as performing operative intervention. CONCLUSIONS: The presence of hinge effect can cause instability of erections during penetrative sex. Multiple factors may predispose patients to a hinge effect, including the quality of erection and severity of curvature. But when controlling for rigidity, a girth discrepancy >1 cm did appear to be associated with a hinge. While many factors, such as baseline erectile dysfunction and severity of curvature, are important in determining the optimal surgical intervention, assessing for preoperative hinge effect also influenced the surgical approach.

Subcoronal inflatable penile prosthesis implantation: indications and outcomes.

BACKGROUND: While implantation of an inflatable penile prosthesis (IPP) is commonly performed via infrapubic or penoscrotal approaches, the subcoronal (SC) approach for IPP implantation may safely and reliably allow for additional reconstructive procedures through a single incision. AIM: The aim of this study is to report outcomes, including complications, of the SC approach and to determine common characteristics of patients undergoing the SC approach. METHODS: A retrospective chart review from May 11, 2012, to January 31, 2022, was performed at a single, tertiary care institution to identify patients with IPP implantation via the SC approach. OUTCOMES: Postoperative information was reviewed and extracted from all clinic notes available following the date of IPP implantation in the electronic medical record, detailing any complications including wound complications, need for revision or removal, device malfunction, and infections. RESULTS: Sixty-six patients had IPP implantation via the SC approach. Median follow-up duration was 29.4 (interquartile range 14.9-50.1) months. One (1.8%) patient had a simple wound complication. Two (3.6%) experienced postoperative infection of the prosthesis, which resulted in explantation of the device. One of these infected prostheses later experienced partial glans necrosis. Revision for mechanical failure or unsatisfactory cosmetic result was performed in 3 (7.3%) IPPs placed via a SC incision. CLINICAL IMPLICATIONS: The SC approach for implantation of IPP is safe and feasible with low complication and revision rates. It offers urologists an alternative to the classic infrapubic and penoscrotal approaches, both of which would require a second incision for additional reconstructive procedures required to adequately address deformities associated with severe Peyronie's disease. Therefore, urologists who treat these specialized populations of men may benefit from having the SC approach in their array of techniques for IPP implantation. STRENGTHS AND LIMITATIONS: The limitations of this study include its retrospective nature, risk of selection bias, lack of comparison groups, and sample size. This study reports on early experience with the SC approach performed by a single high-volume reconstructive surgeon, who treats a specialized population of patients requiring complex repair during implantation of an IPP, particularly those with Peyronie's disease. CONCLUSION: The SC incision for IPP implantation has low rates of complications and remains our approach of choice for IPP implantation in patients with severe Peyronie's disease, including curvatures >60°, severe indentation with hinge, and grade 3 calcification, which are unlikely to respond adequately to manual modeling alone.

Comparison of patient-reported outcomes after penile prosthesis placement in men with and without Peyronie's disease.

We evaluated outcomes in patients undergoing penile prothesis (PP) implantation for erectile dysfunction (ED) and concurrent Peyronie's Disease (PD). A clinician-developed survey to assess satisfaction was sent to 354 patients who underwent PP placement from 2012-2018 by a single-surgeon. Results were compared based on the presence or absence of concurrent PD. 79 patients completed the survey (response rate 22%), including 38 patients (48%) with concurrent ED and PD (ED/PD). Mean follow-up was 31 months (standard deviation 19). 87% felt their condition was "very much" or "much" improved. There was no significant difference in patient-reported overall satisfaction with their PP or satisfaction with current penile length/girth based on the presence or absence of PD. 87% of patients with PD were satisfied with their degree of penile straightening after PP plus or minus concurrent straightening maneuvers such as modeling, plication, or incision/grafting. Sub-group analyses were performed to evaluate outcomes in those with concurrent PD/ED who required plaque incision/grafting at the time of PP placement for more severe deformity (n = 19). 47% of these patients were dissatisfied with their current penile length, compared with only 16% of those patients with PD/ED who did not require grafting (p = 0.05). In conclusion, the presence of PD alone may not impact PP satisfaction, but patients with more severe baseline deformity who require incision/grafting may be less satisfied with outcomes including penile length.

A Consistent Lack of Consistency in Defining the Acute and Chronic Phases of Peyronie's Disease: A Review of the Contemporary Literature.

INTRODUCTION: Treatment recommendations for Peyronie's Disease (PD) differ based on whether a patient is in the acute/active versus chronic/stable phase of the disease, yet there are no agreed upon criteria for defining these clinical entities. OBJECTIVES: To review the criteria used to define acute and chronic phase PD in modern PD intervention studies METHODS: We performed a search engine review to identify indexed publications for PD intervention studies and review articles / meta-analyses from the year 2011-2020. Outcomes results were catalogued and summarized across articles. As a result of the substantial heterogeneity of outcome measures and follow-up intervals, meta-analytic techniques were not applied to the data analysis. RESULTS: We identified a total of 104 studies that met inclusion criteria and had available information for review (n = 79 primary intervention studies; n = 25 review articles/meta-analyses/guidelines). Among the queried studies, we were unable to identify a consensus with respect to the criteria used to define acute and chronic phases of PD. 33% of primary intervention studies did not specifically define their criteria for acute and chronic phase PD, despite referencing these populations as part of the inclusion criteria in many instances. Studies used heterogenous criteria including total symptom duration, duration of "stable" symptoms, and presence/absence of pain. CONCLUSION: Due to varying definitions across the literature, we were unable to create a standardized definition of acute and chronic phase Peyronie's in terms of time. Our findings emphasize the need for greater consensus in defining the treatment cohorts with future studies that assess treatment for men with PD. Piraino J, Chaudhray H, Ames K, et al. A Consistent Lack of Consistency in Defining the Acute and Chronic Phases of Peyronie's Disease: A Review of the Contemporary Literature. Sex Med Rev 2022;10:698-713.

A Critical Analysis of Reporting in Systematic Reviews and Meta-Analyses in the Peyronie's Disease Literature.

BACKGROUND: Despite an increasing number of publications on Peyronie's disease (PD), evidence-based clinical decision-making remains challenging due to the small number of well-designed clinical trials. AIM: To perform a critical analysis of reporting quality in PD systematic reviews (SR) and meta-analyses (MA). METHODS: Study protocol registration was performed on the Open Science Framework platform. In January 2021, a systematic electronic search of the Medline/PubMed, Embase, Ovid, Scopus, Joanne Briggs Institute, and Cochrane databases was performed. Search terms included "Peyronie's disease" and "systematic review OR meta-analysis OR meta-analysis." Eligibility criteria were English-language, relevance to PD and specification of "systematic review" or "meta-analysis" in the title or abstract. Oxford Center for Evidence-Based Medicine levels of evidence were used to classify original studies reviewed within each publication. Risk of bias was assessed using the ROBIS tool. Data were tabulated and reported as means with standard deviation, median with interquartile range and t-testing as appropriate. Strength of association between variables was calculated using Pearson correlation coefficient. Statistical analyses were performed on RStudio (version 1.4.1106). OUTCOMES: Outcomes included review type, level of evidence, authorship, journal, publication date, "A MeaSurement Tool to Assess systematic Reviews" (AMSTAR-2) score and "Preferred Reporting Items for Systematic Reviews and Meta-Analyses" (PRISMA) score. RESULTS: From 1974 to 2021, 340 articles were identified. After review, 17 full length articles were included. Thirteen were SR, 2 MA and 2 was combined. Significant heterogeneity was seen in evidence level of included studies. There was median 54% adherence to AMSTAR-2 criteria and 74% adherence to PRISMA criteria. Overall AMSTAR-2 confidence rating was Critically Low in 11 of 17 studies. Correlation analysis revealed very high positive association between AMSTAR 2 and PRISMA adherence (+0.95). ROBIS revealed "High" concern regarding methods used to collect data and appraise 12/17 studies (71%), and "High" concern regarding synthesis and findings in 8 of 17 studies (47%). CLINICAL IMPLICATIONS: Many SR include markedly heterogenous levels of evidence and fail to meet accepted methodological criteria for reporting. STRENGTHS AND LIMITATIONS: Main strengths include extensive literature review and analysis of standardized study reporting. One limitation is that aggregate scoring of AMSTAR-2 and PRISMA is not intended as primary method of quality assessment; however effect was minimized by reporting critical domains, overall quality assessments and specifics on globally poorly reported domains. CONCLUSION: More high quality randomized controlled PD trials are necessary; SR and MA should focus on these studies alone. Bole R, Gottlich HC, Ziegelmann MJ, et al. A Critical Analysis of Reporting in Systematic Reviews and Meta-Analyses in the Peyronie's Disease Literature. J Sex Med 2022;19:629-640.

Safety and Efficacy of Inflatable Penile Prostheses for the Treatment of Erectile Dysfunction: Evidence to Date.

Erectile dysfunction (ED) is a common problem, and prevalence rates are expected to rise as life expectancy increases worldwide. In more severe cases of ED, penile prosthesis implantation has been an excellent option for patients. Over the past few decades, significant design improvements have been made to the penile prosthesis and modifications to surgical technique to improve clinical outcomes. The purpose of this review is to summarize the safety and efficacy of FDA-approved penile implants in the US market. Design modifications have greatly improved the safety and reliability of the implant. Development of improved surgical techniques has decreased intraoperative injuries and reservoir-related complications. With its high overall satisfaction rates and low risk of complications, the inflatable penile prosthesis remains an excellent option for patients with erectile dysfunction.