Characteristics of Men With Peyronie's Disease and Collagenase Clostridium Histolyticum Treatment Failure: Predictors of Surgical Intervention and Outcomes

BackgroundA subset of patients with Peyronie's disease (PD) treated with collagenase clostridium histolyticum (CCH) experience persistent bother and some require surgery.AimWe characterize patients experiencing persistent bother after CCH treatment and identify associations and predictors of surgical intervention/outcomes.MethodsWe retrospectively identified patients with PD from October 2014 to October 2019 and identified those presenting with persistent bother after CCH treatment by other urologists. Intracavernosal injection and penile Doppler ultrasonography were performed, and subsequent interventions/outcomes were recorded. Baseline characteristics were compared with Student t-test and chi-square test. Predictors of surgical intervention and complications were assessed using multivariable logistic regression.OutcomesThe primary outcome was surgery after CCH treatment. Secondary outcomes included worsened erectile function, sensory deficits, and penile length change.ResultsOf 573, 67 (11.7%) patients with PD had undergone prior CCH treatment with median 6 injections (range 2–24). Mean post-CCH PD Questionnaire bother score was 10.1 (SD: 3.1), and total International Index of Erectile Function-5 was 15.3 (SD: 8.7). Mean PD duration was 27.8 (SD: 35.7) months, with a mean composite curvature (MCC) of 69.0° (SD: 33.8) measured after injection. Of 67, 44 (65.7%) patients had MCC >60°. Of 67, 52 (77.6%) patients had indent, narrowing, or hourglass and 26 (38.8%) had hinge effect (buckling of the erect penis with axial pressure) on examination. Calcification was identified in 26 of 67 (38.8%) patients, with grade 3 calcifications comprising 6 of 23 (26.1%) patients. Of 67, 33 (49.3%) patients underwent surgery, with 20 (60.1%) undergoing partial plaque excision and grafting with/without tunica albuginea plication, 6 (18.2%) undergoing tunica albuginea plication alone, and 7 (21.2%) undergoing penile prosthesis with plaque incision and grafting. Surgical patients had greater mean curvature (82.6 vs 55.4, P = .001) and were more likely to have hinge (54.5% vs 20.6%, P = .005). On multivariable analysis, MCC ≥60° predicted patient’s decision for surgery (odds ratio: 2.99, P < .01, 95% confidence interval: 1.62–4.35). There were no associations between surgical complications and number of injections or CCH-associated adverse events.Clinical ImplicationsPatients presenting with persistent bother after CCH treatment often have narrowing and calcifications (despite calcifications being a contraindication to CCH treatment), and those who have hinge or severe curvature are more likely to undergo surgery with low rates of complications.Strengths/LimitationsThis study's generalizability is limited by selection bias, but useful data are provided for patient counseling.ConclusionPatients with persistent bother after CCH treatment had high rates of indentation/narrowing, plaque calcifications, and MCC >60° at completion of CCH treatment. Surgical intervention is more common with hinge and is safe and feasible in these patients, with low rates of complications. These findings suggest possible negative prognostic factors for CCH treatment, which merit further investigation.Bajic P, Wiggins AB, Ziegelmann MJ, et al. Characteristics of Men With Peyronie's Disease and Collagenase Clostridium Histolyticum Treatment Failure: Predictors of Surgical Intervention and Outcomes. J Sex Med 2020;17:1005–1011.     

Continuing Collagenase Clostridium Histolyticum Injections Among Initial Nonresponders Results in Significant Curvature Improvements in the Majority of Peyronie's Disease Men

BackgroundIt is currently unclear if men with Peyronie's Disease (PD) who achieve minimal benefits with the first 2 series of Collagenase Clostridium Histolyticum (CCH) injections should continue with additional injections.AimTo analyze curvature improvements from the final two series of CCH injections based on amount of improvement during the first 2 series.MethodsA prospective registry was analyzed of all men undergoing CCH injections for PD at a single institution. Men were included if they had completed a full 4 series (8 injections) of CCH and had baseline, interval (after 2 series), and/or final (after 4 series) curvature assessments available. Men were stratified into cohorts using baseline-to-interval assessments of ≤10° (or ≤20%) and >10° (or >20%), and improvements were compared using interval-to-final assessments.OutcomesThe primary outcome was interval-to-final curvature improvements stratified by ≤10°/>10° or ≤20%/>20% improvements achieved during the baseline-to-interval period. Secondary outcomes included analyses of demographic and pathophysiologic variables to determine associations with significant improvements during the final 2 CCH series.ResultsA total of 296 PD men were identified as receiving at least one CCH injection, of whom 175 had baseline-to-interval, 84 interval-to-final, and 115 with baseline-to-final measurements. Mean age was 56.6, PD duration 28.6 months, baseline curvature 63.4°, hourglass deformity 36.2%, and calcification 20%. Mean overall curve improvement was ?21.5° (33.1%). Among men who experienced ≤20% improvements after 2 series, the mean subsequent curvature change was -24.6% during the final two series (vs +4.3% of those with >20% initial improvement, P< .001), and they were 2.7x more likely to experience >20% subsequent curve improvements. Thirty-one percent of those who achieved >10° during the first 2 series experienced benefits during the final 2 series compared to 70% of men who had ≤10° improvement initially. No demographic or pathophysiological variables predicted likelihood for improvements during the final 2 series of injections.Clinical ImplicationsMen who fail to achieve significant benefits with 2 series of CCH injections may benefit from completing the final 2 series.Strengths and LimitationsStrengths including a relatively large, prospective series. Limitations include a single center, nonrandomization, nonblinded assessments, and restriction to men who completed eight injections.ConclusionsIn the current series, approximately 2/3 of men who fail to achieve >10° or 20% curve improvements with an initial 2 series of CCH injections achieved >10° or 20% improvements with the subsequent 2 series.Alom M, Burgon H, Ziegelmann M, et al. Continuing Collagenase Clostridium Histolyticum Injections Among Initial Nonresponders Results in Significant Curvature Improvements in the Majority of Peyronie's Disease Men. J Sex Med 2021;18:1092–1098.     

Surgical Correction of Persistent Peyronie's Disease Following Collagenase Clostridium Histolyticum Treatment

IntroductionCollagenase clostridium histolyticum (CCH) is an Food and Drug Administration‐approved intralesional injection for treatment of Peyronie's disease (PD) that has been shown to reduce penile curvature deformity and PD symptom bother in phase 2b and phase 3 placebo‐controlled clinical trials. For some patients, nonsurgical treatment with CCH may not sufficiently improve penile curvature, and surgical correction may be pursued following CCH therapy.AimThis study aims to examine intraoperative and postsurgical outcomes of surgical correction of persistent penile curvature in patients with PD who had previously received CCH.MethodsRetrospective chart review was used to identify patients with PD who had received CCH intralesional injection within either the phase 2b or phase 3 CCH clinical trials and then underwent surgical correction due to remaining penile curvature. Surgical techniques used were partial plaque excision and grafting (PEG) and/or tunica albuginea plication (TAP).Main Outcome MeasuresPrimary assessments included pre‐ and postsurgery penile curvature, erectile rigidity, stretched penile length, intraoperative time, and occurrence of adverse events.ResultsSeven men were identified who underwent surgical straightening with TAP or PEG following CCH treatment. Mean number of days from the final CCH injection to surgery was 182 (standard deviation 118; median 127 days). Average penile curvature prior to surgical straightening was 58°. No anatomical difficulties or complications secondary to the effects of prior CCH treatment occurred during surgery. Intraoperative time was representative of standard TAP and PEG surgeries (range 88–146 minutes). All men reported penile curvature <20° postsurgery. One patient experienced a postsurgery subgraft hematoma that required aspiration. There were no postsurgery reports of decreased penile sexual sensation and no occurrence of vascular compromise or decreased penile rigidity.ConclusionThis initial case series supports the hypothesis that prior CCH treatment is not a contraindication to PEG or TAP surgery in the treatment of penile curvature in patients with PD. Levine LA and Larsen SM. Surgical correction of persistent Peyronie's disease following collagenase clostridium histolyticum treatment. J Sex Med 2015;12:259–264.     

Baseline Characteristics from an Ongoing Phase 3 Study of Collagenase Clostridium Histolyticum in Patients with Peyronie's Disease

IntroductionPeyronie's disease (PD) is a localized penile collagen disorder of the tunica albuginea associated with significant physical deformity and psychological impairment. Current understanding of pretreatment characteristics in patients with chronic PD is limited by small samples, varied quality of assessments, and the lack of a PD‐specific, validated measure of the psychosexual impact of PD.AimsReporting baseline demographic and disease characteristics of the large multinational cohort of subjects with chronic PD who participated in the collagenase clostridium histolyticum (CCH, an investigational intralesional injection and minimally invasive intervention) phase 3 clinical study program. Findings from well‐defined assessments, including the Peyronie's Disease Questionnaire (PDQ), the first validated PD‐specific patient‐reported measure of psychosexual impact, are reported.MethodsSubjects included men ≥18 years old with PD symptoms ≥12 months and penile deformity between 30° and 90°. Analysis data included demographics, disease history, and psychosexual impact.Main Outcome MeasuresPenile deformity, disease symptoms, the International Index of Erectile Function, and the PDQ were assessed.ResultsEight hundred thirty‐two subjects were enrolled from 64 sites across the United States and Australia. The mean age was 57.7 years; mean PD duration was 4.1 years. The majority of subjects had penile deformity ≤60° (77.3%); mean penile deformity was 50.5°. Subjects reported having intercourse a mean of 10.2 times in the previous 3 months, 70.8% reported difficulty in performing vaginal intercourse, and 80.4% reported less frequent vaginal intercourse. Approximately 71.5% of subjects with severe (>60°) and 58.1% of subjects with mild/moderate (≤60°) penile deformity were “very bothered” or “extremely bothered” upon last look at their erect penis (P = 0.0041), as measured by the PDQ.ConclusionsThese data add to the body of knowledge regarding the clinical impact of chronic phase PD, including the PD-specific patient-reported psychosexual symptoms, using a large multinational chronic PD cohort in the CCH phase 3 clinical program. Gelbard M, Hellstrom WJG, McMahon CG, Levine LA, Smith T, Tursi J, Kaufman G, and Goldstein I. Baseline characteristics from an ongoing phase 3 study of collagenase clostridium histolyticum in patients with Peyronie's disease. J Sex Med 2013;10:2822–2831.     

Predictors of Depression in Men With Peyronie's Disease Seeking Evaluation

BackgroundPeyronie's disease (PD) has negative impacts on the psychosocial status of men including depression warranting clinical evaluation in up to 50% of men.AimTo examine predictors of depression in patients with early PD seeking evaluation.MethodsAll PD patients at a high-volume PD practice underwent screening and curvature assessment after intracavernosal injection. Complex deformity was defined as any degree of multiplanar curvature, curvature >60 degrees, or presence of hourglass deformity. Men completed the PD questionnaire (PDQ), a validated depression questionnaire (CES-D) as well as the Self-Esteem and Relationship (SEAR) questionnaire. Scores of ≥16 on CES-D were considered indicative of moderate/severe depression. Predictors of the presence of depression were defined using univariable and multivariable logistic regression.OutcomesDemographic, bother and curve related predictors of depression in men with PD.Results408 men completed all questionnaires. Mean age was similar between depressed and nondepressed groups (57 ± 10 years overall, P = .60 between groups). Proportions of erectile dysfunction were similar between groups (P = .96). Mean PD duration was similar between groups (19 ± 35 months overall, P = .46 between groups). Mean degree of curvature was 38 ± 2 degrees in the depressed vs 33 ± 1 degrees in the nondepressed groups (P = .03). A complex deformity was seen in 64.5% in the depressed vs 61.5% in the nondepressed (P = .56). A total of 110 (27%) patients had CESD scores ≥16. 74% depressed men were in relationships compared to 84% nondepressed men (P < .01). Other characteristics including bother, pain, duration of disease, curve complexity and instability were similar between the two groups. On univariable analysis, factors protective against depression included being partnered (OR 0.42, 95%CI 0.24–0.75, P < .01) and higher total SEAR scores (OR 0.95, 95%CI 0.94–0.97, P < .01). Elevated PDQ domain scores were associated with depression (Psychologic Symptoms 1.05, 95%CI 1.02–1.10, P < .01; Pain 1.08, 95%CI 1.03–1.12, P < .01; Bother 1.11, 95% CI 1.05–1.68, P < .01) as well as baseline history of depression (OR 2.93, 95%CI 1.67–5.14, P < .001). On multivariable analysis, only total SEAR score remained protective against depression (OR 0.96, 95%CI 0.94–0.97, P < .001).Clinical ImplicationsProviders must recognize that men with PD seeking evaluation have meaningful rates of depression for which early recognition is necessary.Strengths and LimitationsRetrospective review of a large prospectively collected dataset from a single center of men with PD utilizing a validated screening tool for depression.ConclusionWhile no significant demographic, bother or curve related factors predicted depression in early PD men seeking evaluation, it remains a significant problem warranting further prospective evaluation.P. Nahid, N. Bruno, S. Carolyn, et al. Predictors of Depression in Men With Peyronie's Disease Seeking Evaluation. J Sex Med 2021;18:783–788.     

Predictors of Pursuing Intralesional Xiaflex in Peyronie's Disease Patients

BackgroundIntralesional collagenase such as Xiaflex (ILX) has become a standard treatment for Peyronie's disease (PD). Many robust studies have demonstrated its clear efficacy in the treatment algorithm.AimTo examine predictors of the patient decision to pursue ILX in PD patients.MethodsThe study included PD patients (i) with stable disease (ii) who had doppler duplex ultrasonography (DUS) at least 6 months prior to analysis date and (iii) did not choose an operation. All patients received a standard discussion regarding treatment options, specifically, observation, ILX and penile reconstructive surgery (plication, plaque incision and grafting, implant surgery). Patients who opted to use ILX were compared to those who opted against it. Comorbidity, demographic and PD characteristics were recorded at the initial PD visit. All patients completed three validated questionnaires including the PD questionnaire (PDQ), Self-Esteem and Relationship (SEAR) questionnaire and a depression questionnaire (CES-D). Logistic regression was used to determine predictors of ILX use.OutcomesPredictors of ILX utilization.ResultsFour hundred and fifty stable PD men had DUS completed 6 months before to allow sufficient time for treatment decision. Of these, 111 (24.7%) patients had ILX treatment and 339 (75.3%) did not. Mean age, relationship status and pain occurrence were similar between groups, but ILX patients had less bother defined as PDQ ≥ 9 (46.8% vs 53.7%, P = .02). ILX patients had more complex curves (79.3% vs 47.8%, P < .01) and more severe instability (32.4% vs 15.3%, P = .01). ILX patients also had higher PDQ domain scores (Psychological 11.5 ± 6.4 vs 7.5 ± 6.2, P < .01; Pain 6.2 ± 6.0 vs 4.3 ± 5.6, P = .02; and Bother 9.8 ± 4.7 vs 6.6 ± 4.8, P < .01). On univariable statistics, significant bother (OR 2.41, 95% CI 1.36–4.28, P<0.01), complex curvature (OR 4.18, 95%CI 2.52–6.93, P < .01), moderate and/or severe instability (OR 1.98, 95%CI 1.18–3.30, P < .01) and PDQ-Bother scores (OR 1.15, 95%CI 1.08–1.22 P < .01) predicted ILX use. On multivariable analysis, instability (OR 2.58, 95%CI 1.02–6.57, P = .05) and significant bother (OR 1.23, 95%CI 1.04–1.45, P = .01) predicted ILX use.Clinical ImplicationsEducates providers as to which patients are more likely to choose ILX.Strengths & LimitationsOur study has a large sample size and all patients received the same standardized treatment discussion. Our study is limited by the absence of insurance data on all patients, and its retrospective single center design.ConclusionILX was chosen by the minority of stable PD patients. While moderate to severe instability and significant bother is predictive of ILX use, other demographic factors including relationship status, sexual orientation or pain were not.Punjani N, Nascimento B, Salter C, et al. Predictors of Pursuing Intralesional Xiaflex in Peyronie's Disease Patients. J Sex Med 2021;18:1258–1264.     

Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized,Open-Label Pilot Study

BackgroundCollagenase Clostridium histolyticum (CCH) is indicated for the treatment of penile curvature in adult men with Peyronie's disease (PD) with palpable plaque and curvature deformity of at least 30° at the start of therapy.AimTo evaluate the efficacy and safety of CCH plus vacuum-pump therapy with and without penile modeling for the management of PD.MethodsAdult men with PD and penile curvature of at least 30° were randomly assigned to receive CCH 0.58 mg plus vacuum therapy alone (n = 15) or with penile plaque modeling (n = 15). Patients received no more than four treatment cycles (cycle = ∼6-week duration), each consisting of two intralesional injections of CCH administered 24 to 72 hours apart. Vacuum therapy was applied twice daily from 14 days after the second injection of each cycle until the following cycle. Modeling was performed 24 to 72 hours after the second injection of each cycle.OutcomesThe primary end point was change in penile curvature from baseline to week 36; additional end points included changes in Peyronie's Disease Questionnaire (PDQ) domain scores, composite response (≥20% decrease in penile curvature and decrease in PDQ bother score ≥ 1 point), and global response (small but important, moderate, or much improvement in the Global Assessment of PD).ResultsAt week 36, improvement in penile curvature from baseline was similar in the two groups (mean change from baseline = −23.7° [SD = 10.9] for CCH + vacuum + modeling and −23.3° [SD = 7.2] for CCH + vacuum; between-group difference = −0.3°, 95% CI = −7.3 to 6.6). Improvements in most PDQ domains, including bother, were observed from baseline to week 36 in the two groups. Most patients were composite (66.7% and 84.6% with CCH + vacuum + modeling and CCH + vacuum, respectively) and global (86.7% and 92.3%, respectively) responders. The most common adverse events were penile contusion, penile swelling, and penile pain.Clinical ImplicationsVacuum-pump therapy administered alone or in combination with modeling after CCH treatment could improve PD symptoms.Strengths and LimitationsThis was a pilot study with a small sample and limited follow-up duration.ConclusionCCH and vacuum-pump therapy (alone or combined with modeling) could be an appropriate consideration for men with PD and warrants further investigation.Ralph DJ, Abdel Raheem A, Liu G. Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study. J Sex Med 2017;14:1430–1437.     

Collagenase Clostridium histolyticum for the Treatment of Peyronie's Disease: The Development of This Novel Pharmacologic Approach

IntroductionThe conception of collagenase Clostridium histolyticum (CCH) as treatment for Peyronie's disease (PD) was a vital first step in providing a nonsurgical, minimally invasive FDA-approved treatment for men with PD.AimTo review the origins, clinical research history, and ultimately FDA approval of collagenase as PD treatment.MethodsA PubMed search using (Peyronie's or Peyronie) AND collagenase, and limited to clinical research studies, returned nine papers that were examined in the current review.ResultsCollagenase as a PD treatment arose in response to a lack of effective nonsurgical treatments and the incomplete understanding of underlying PD etiology. Awareness of dense collagen in PD scarring and parallel initial exploration of collagenase to treat herniated lumbar discs coincided with and inspired laboratory-based investigation of collagenase effects on excised PD plaque tissue. The foundational conceptual work and the critical development of purified injectable collagenase allowed the pursuit of clinical studies. Progression of clinical studies into large-scale robust trials culminated in two important outcomes: development of the first validated, PD-specific measure of psychosexual function, the Peyronie's Disease Questionnaire, and the first FDA-approved treatment for PD.ConclusionsCollagenase therapy began as an attempt to modify the structure of PD-related tunica albuginea scarring, despite the lack of a fundamental understanding of the scar's origin. If we wish to advance PD treatment beyond this first effective step, the future needs to bring us full circle to the starting point: We need a greater understanding of the control of collagen deposition and wound healing in men with PD. Gelbard MK, Chagan L, and Tursi JP. Collagenase Clostridium histolyticum for the treatment of Peyronie's disease: The development of this novel pharmacologic approach. J Sex Med 2015;12:1481–1489.     

Predictors of Erectile Function Normalization in Men With Erectile Dysfunction Treated With Placebo

Background

Clinical study and practice data have shown sildenafil improves sexual function in men with erectile dysfunction (ED). However, some men treated with placebo in double-blind, placebo-controlled sildenafil studies also report improved erectile function as measured by International Index of Erectile Function (IIEF)–Erectile Function Domain (EFD) scores.

Correlation of Degree of Penile Curvature between Patient Estimates and Objective Measures among Men with Peyronie's Disease

IntroductionAmong men with Peyronie's disease (PD), the degree of penile curvature has significant implications on psychological well-being, sexual function, treatment planning, and posttherapy evaluations.AimThe primary objective of the current study was to correlate patients' estimates of penile angulation with objective measures.Main Outcome Measures(i) Proportion of patients over- or underestimating their actual degree of curvature; and (ii) degree differences between patient estimates and objective measures of penile curvature.MethodsAt baseline, patients with established PD were asked to provide a “best estimate” of their degree of penile curvature. Objective measures of penile angulation were then performed using standardized photographs and protractor-based measurement of penile curvature during full erection. Correlations were performed between patient estimates of penile curvature and objective measures of penile angulation.ResultsEighty-one men with established PD and a mean age of 52 years (range: 20–72 years) were prospectively evaluated. Mean duration of disease was 33 months (range: 6–276 months), and mean plaque size was 1.4 cm ± 0.1 standardized error (SE). The proportion of patients with dorsal, lateral, and ventral curvatures was 39%, 57%, and 4%, respectively. Patient estimates of baseline penile curvature (mean 51 degrees ± 3.1 SE) differed significantly from objective measurements (mean 40 degrees ± 2.4, P = 0.001). A significantly higher proportion of patients overestimate their actual degree of penile curvature (54% overestimate, 26% underestimate, and 20% are accurate within 5 degrees, P = 0.002). Compared with objective measures, patients' estimates of degree of penile curvature differed by an average of 20 degrees ± 2.2 SE.ConclusionsPatients with PD tend to overestimate their degree of penile curvature. Objective measurement of penile angulation is necessary to accurately counsel patients regarding disease severity, recommend appropriate treatment strategies, and objectively evaluate outcomes following therapy. Bacal V, Rumohr J, Sturm R, Lipshultz LI, Schumacher M, and Grober ED. Correlation of degree of penile curvature between patient estimates and objective measures among men with Peyronie's disease. J Sex Med 2009;6:862–865.     

Predictive Factors of Patients' and Their Partners' Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study

Background

Collagenase Clostridium histolyticum (CCH; Xiapex) injections represent the only licensed medical treatment for Peyronie's disease (PD).

Comparative Analysis of Tunical Plication vs. Intralesional Injection Therapy for Ventral Peyronie's Disease

IntroductionApproximately 10% of Peyronie's disease (PD) patients present with ventral curvatures and, as such, there is a paucity of data describing the optimal approach for treatment.AimThis study aims to compare the outcomes of surgery (tunical plication [TP]) and intralesional injection (ILI) therapy (interferon‐α2b) in men with ventral PD.Materials and MethodsRetrospective data were collected from two centers: Tulane University (ILI) and Technical University of Munich (TP). Collected variables included patient demographics, pre‐ and post‐treatment sexual function, rigorous penile measurements (curvature, length, and penile vascular findings), and post‐treatment outcomes.ResultsA total of 35 patients with ventral PD (21 ILI and 14 TP) were included in the study. There were no significant differences between the two groups prior to the interventions. There was a significantly better improvement in mean curvature with TP (46.4 degrees) as compared with ILI (9.3), P < 0.0001. TP was also associated with a significantly higher rate of ≥20% improvement in curvature as compared with ILI (100% vs. 67%, P = 0.027). Although there was no significant difference in post‐treatment change in Sexual Health Inventory for Men (SHIM) scores between the groups, 36% of the ILI patients noted an improved SHIM score as compared with none in the TP group. Erect penile length was preserved or improved in 67% of the ILI group vs. 14% of the TP group, P = 0.005.ConclusionsTP confers a better overall improvement in penile curvature as compared with ILI in patients with ventral PD. Preserved or improved erect penile length and SHIM scores may be observed in patients undergoing ILI. Yafi FA, Hatzichristodoulou G, Knoedler CJ, Trost LW, Sikka SC, and Hellstrom WJG. Comparative analysis of tunical plication vs. intralesional injection therapy for ventral Peyronie's disease. J Sex Med 2015;12:2492–2498.     

Evaluating the Impact of Penile Girth Discrepancy on Patient Bother in Men With Peyronie's Disease: An Observational Study

BackgroundMen with Peyronie's disease (PD) may experience penile narrowing. Little data on penile girth changes and their psychosocial impact exist.AimTo assess girth discrepancy in men with PD and its association with patient bother.MethodsThis was a retrospective observational study. All patients with PD at our institution who were seen in the sexual medicine clinic and who completed 3 validated instruments the PD questionnaire (PDQ), Self-Esteem and Relationship (SEAR) questionnaire, and a depression questionnaire, the Center for Epidemiologic Studies Depression Scale (CES-D), and a curvature assessment were included. Patient and PD characteristics are described. Associations of instability and bother to girth differences are assessed. 2 outcomes for girth differences are classified as (i) girth difference of ≥ 1 cm vs less and (ii) girth differences of ≥10% vs less. Unadjusted and adjusted effects of PD and patient characteristics are assessed on the outcome of high bother using logistic regression models.OutcomesThe main outcomes of this study were penile girth changes, instability, and questionnaire scores. High bother was defined as a PDQ bother score of ≥9.ResultsA total of131 men had midshaft curvature and were the focus of the study. Their mean age was 59 ± 9 (range 31–78) years. PD duration was 16 ± 25 (range 1–180) months, with a mean degree of primary curvature of 37 ± 20^o. Mean girth difference between base and point of maximum curvature was 0.78 ± 0.53 cm equating to a mean girth difference at point of maximum curvature of 6 ± 4%. Instability was present in 53% of men. There were 54 men with a girth difference of ≥ 1 cm and 23 men with a ≥10% change in girth. There was no difference in CES-D, SEAR, or PDQ domain scores or high bother in men with significant girth changes. Univariable analysis of predictors of high bother included the degree of curvature (odds ratio [OR]: 1.06; P < .001), instability (OR 6.62; P < .001), CES-D sum (OR 1.09; P = .002), and SEAR score (OR 0.96; P = .001). On multivariate analysis, only the degree of primary curvature was predictive of high bother (OR 1.06; P < .001).Clinical ImplicationsPenile girth changes have little impact on overall psychosocial well-being. The degree of penile curvature is the primary predictor of patient bother.Strengths and LimitationsStrengths include a large patient population and use of validated questionnaires. Limitations include single-center, retrospective study and subjective instability grading.ConclusionsPenile girth discrepancy in men with PD has limited psychosocial impact. Clinically significant bother was associated with the degree of primary curvature.Salter CA, Nascimento B, Terrier, JE, et al. Evaluating the Impact of Penile Girth Discrepancy on Patient Bother in Men With Peyronie's Disease: An Observational Study. J Sex Med 2020;17:1560–1565.     

Concordance Between Patient and Physician Assessment of the Magnitude of Peyronie's Disease Curvature

IntroductionThe magnitude of penile deformity is a critically important factor in Peyronie's disease, as it is associated with increased difficulty in penetrative sexual intercourse and in turn with negative psychosocial consequences. Deformity magnitude also influences treatment choice when surgical correction is indicated.AimTo determine the concordance between patient and physician assessment of magnitude of penile curvature in men with Peyronie's disease.MethodsPatient assessment of curvature was obtained at initial interview. Physician assessment was performed using intracavernosal injection-assisted erection using a goniometer applied during excellent penile rigidity.Main Outcome MeasuresPatient and physician assessments of penile curvature.ResultsThe sample consisted of 192 men with a mean age of 54 ± 12 years old. Mean curvature on patient and physician assessment was 33 ± 17 and 36 ± 18 degrees, respectively. Only 49% of patients (94) correctly assessed their curvature, whereas 35% underestimated and 16% overestimated it.ConclusionsOnly half of PD patients accurately assess their penile curvature, with more than twice as many patients underestimating it than overestimating it. These data suggest that patient self-reporting of penile curvature should not be used as a clinical marker or end point in Peyronie's disease trials. Matsushita K, Stember DS, Nelson CJ, and Mulhall JP. Concordance between patient and physician assessment of the magnitude of Peyronie's disease curvature. J Sex Med 2014;11:205–210.     

Multicenter Prospective Study of Grafting With Collagen Fleece TachoSil in Patients With Peyronie's Disease

BackgroundA xenograft consisting of equine collagen coated with human fibrinogen and thrombin (TachoSil; Baxter, CA) has recently been introduced in grafting procedures for Peyronie’s disease (PD).AimTo describe the results of a multicenter prospective registry on patients with PD undergoing plaque incision or and grafting (PIG) or plaque excision and grafting (PEG) with collagen fleece TachoSil, to evaluate the efficacy and safety of this procedure.MethodsA prospective non-controlled multicenter study of patients with PD was performed between May 2016 and March 2018. Patients from 10 centers with stable PD for at least 3 months, difficulties in sexual intercourse, normal erectile function with or without pharmacological treatment, curvature >45°, and/or penile shortening and/or complex deformities were included. All patients underwent PIG/PEG with collagen fleece TachoSil.OutcomesThe main outcome measure of this study were penile curvature correction (intraoperative), penile shortening (intraoperative), erectile function with the 5-item version of the International Index of Erectile Function (IIEF-5) and the Erection Hardness Score, subjective patient outcomes with non-validated questionnaires, and complications.ResultsA total of 52 patients were enrolled in the study. The mean (SD) preoperative penile curvature was 72.8° (17.0). PIG was the preferred technique (80.8%). Intraoperatively, complete curvature correction was achieved in 92.3%, and no significant penile shortening was recorded in 80.8% of subjects. Subjective penile shortening was reported in 83.3% of patients at 6 months. No objective measurement of penile curvature and length was recorded during follow-up. No statistically significant difference from the baseline was found in IIEF-5 and Erection Hardness Score at 3 or at 6 months, although 16.7% of men experienced a worsening of IIEF-5 scores and 14.3% required de novo phosphodiesterase type 5 inhibitor use. 6 months after surgery, 78.5% of men were satisfied with intervention. Swelling and ecchymosis/hematoma were the most common perioperative complications (40.4%). 2 cases (3.8%) of wound infection were recorded. At 6 months, 35.7% of patients reported mild penile hypesthesia.Clinical implicationsOur results confirm the high success rate of grafting with TachoSil, and the surgeon perceived low percentage of penile shortening.Strength & LimitationsThis is the first multicentre study on patients with PD undergoing grafting with TachoSil without concomitant placement of penile prosthesis. The main limitations are the short follow-up and the relatively small sample size.ConclusionGrafting with TachoSil after PIG/PEG in patients with PD is an effective and safe procedure. Among the main advantages of this technique, there are ease of use of the graft and reduced operative time.Fernández-Pascual E, Manfredi C, Torremadé J, et al. Multicenter Prospective Study of Grafting With Collagen Fleece TachoSil in Patients With Peyronie's Disease. J Sex Med 2020;17:2279–2286.     

Multicenter Experience Using Collagen Fleece for Plaque Incision With Grafting to Correct Residual Curvature at the Time of Inflatable Penile Prosthesis Placement in Patients With Peyronie's Disease

BackgroundAdjuvant maneuvers are often necessary to correct residual curvature during inflatable penile prosthesis (IPP) placement in patients with Peyronie's disease (PD).AimWe present our multicenter experience using collagen fleece as graft material for plaque incision and grafting (PIG) during IPP placement in patients with moderate to severe PD.MethodsWe retrospectively reviewed 51 patients with IPP from 3 sites who underwent PIG with Tachosil (Baxter, IL) collagen fleece. Coloplast (Minneapolis, MN) IPP devices were used. Factors associated with residual curvature, revision, and patient satisfaction were performed using chi-squared analysis.OutcomesWe evaluated postoperative outcomes including factors associated with residual curvature, revision, and patient satisfaction.ResultsThe mean compound curvature was 69.6°. The mean follow-up was 10.6 (range 1–38) months. All patients reported erections sufficient for penetrative intercourse at the last follow-up. Residual curvature <15° was noted in 6 of 51 (12%) patients. 3 patients required device revision. 2 patients experienced temporary glanular paresthesia, and no patients experienced device infection.Clinical ImplicationsIn our multicenter study, patients experienced substantial curve correction with minimal complications, and in the few patients who had persistent mild curvature, severe preoperative curvature (>60°) was found to be the only risk factor.Strengths & LimitationsOur study represents the largest series of patients coming from multiple centers undergoing surgical correction of PD with IPP and collagen fleece grafting. Limitations of this study include the retrospective study design, lack of a comparison group, and modest follow-up.ConclusionPIG using collagen fleece is a safe and effective means of correcting residual curvature after IPP placement in patients with moderate to severe PD.Hatzichristodoulou G, Yang DY, Ring JD, et al. Multicenter Experience Using Collagen Fleece for Plaque Incision With Grafting to Correct Residual Curvature at the Time of Inflatable Penile Prosthesis Placement in Patients With Peyronie's Disease. J Sex Med 2020;17:1168–1174.     

Luteinizing Hormone Suppression Profiles in Men Treated With Exogenous Testosterone

BackgroundDue to the negative feedback mechanism involved in the hypothalamic-pituitary-gonadal axis, testosterone therapy (TTh) may result in suppression of luteinizing hormone (LH) secretion, but clinical experience demonstrates the level of LH suppression is variable.AimWe sought to define the relationship between TTh and LH levels, specifically predictors of LH suppression in men on TTh.MethodsWe performed a retrospective analysis of a prospectively maintained database of patients with testosterone deficiency (TD) treated with TTh. Patient demographic and clinical data including vascular risk factor (VRF) status were collected. Serum total T and LH levels before TTh and after ≥3 months (m) were recorded. LH suppression was defined as serum LH level <1.0 IU/ml.Main Outcome MeasuresPredictors of LH suppression were searched though a series of logistic regression models assessing suppression status at the final observation, and then a series of Cox proportional hazards models assessing time to first suppression were performed.ResultsA total of 227 patients with mean age of 58±14 years at time of TTh initiation were included in our analysis. Just under half of subjects received transdermal T as the only modality (n = 101, 44%), while one third (n = 77, 34%) received intramuscular only, and the remainder (n = 49, 22%) received both modalities during follow-up. The mean baseline LH level was 10 ± 12 IU/ml. The percent of men who had baseline LH level above 1 IU/ml and at any given point of TTh was 84% and 78%, respectively, thus 22% of men had suppressed LH levels on TTh considering the definition of LH <1 IU/ml. Most men (73%) had a suppressed LH level of <1 IU/ml at least once during follow-up. In the final adjusted model for LH suppression, intramuscular route (OR = 2.44), baseline LH (OR = 0.94), estradiol (OR = 1.05) remained significant.Clinical ImplicationsLH suppression profiles may be relevant for dose titration during TTh and perhaps to minimize testicular atrophy.Strengths & LimitationsA strict definition for TD was applied using LCMS for T measurements and patients had long-term follow-up.ConclusionWhile 73% of patients had at least one LH <1 IU/ml during TTh, only 22% maintained suppressed throughout the treatment.Miranda EP, Schofield E, Matsushita K, et al. Luteinizing Hormone Suppression Profiles in Men Treated With Exogenous Testosterone. J Sex Med 2022;19:1359–1365.     

Surgical Reconstruction of Penile Curvature due to Peyronie's Disease by Plaque Incision and Buccal Mucosa Graft

Background/aimWe aimed to evaluate the effectiveness and safety of penile plaque incision and buccal mucosa grafting in patients with stable-phase Peyronie's disease (PD).MethodsThis was a prospective evaluation of patients with stable-phase PD who were treated by plaque incision and buccal mucosa grafting. Preoperative evaluation included International Index of Erectile Function Questionnaire (IIEF-5), measurement of erect penile length, and penile Doppler ultrasound during prostaglandin-induced erection. At 3- and 24-month follow-up visits, penile length and residual curvature were measured along with penile Doppler ultrasound and IIEF5 questionnaires. Patient and sexual partner satisfaction were also assessed at 24-month-visit.ResultsThe study was completed with 20 patients (mean age 46.5 ± 9.9 years). Dorsal curvature was the most frequent site of curvature (45%). The median curvature at preoperative evaluation was 45°(range 40-90°). The postoperative median curvatures were 5°(5-10, IQR) and 7°(5-10, IQR) at 3- and 24-month postoperatively, respectively. Success rate was 95% at 3-month and 90% at 24-month. There was no significant penile shortening. The mean IIEF-5 score was 17.5 ± 2.2 at preoperative evaluation. The median IIEF-5 scores were calculated as 20.1 ± 2.2 and 21.3 ± 2.2 at 3-month and 24-month visits, respectively (p<0.0001). Compared with baseline IIEF-5 score, both postoperative IIEF-5 scores were significantly higher. There was no de novo erectile dysfunction. There were no serious complications during and after the surgery. Ten percent of patients were poorly satisfied with the results of the surgery.ConclusionCorporoplasty with buccal mucosa graft led to excellent structural and functional results and patient satisfaction.Ainayev Y, Zhanbyrbekuly U, Gaipov A, et al. Surgical Reconstruction of Penile Curvature due to Peyronie's Disease by Plaque Incision and Buccal Mucosa Graft. J Sex Med 2021;18:1308–1316.