Clinical Safety and Effectiveness of Collagenase Clostridium Histolyticum Injection in Patients with Peyronie's Disease: A Phase 3 Open‐Label Study

IntroductionCollagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration‐approved, intralesional treatment for Peyronie's disease (PD).AimThe aim of this study was to assess the safety and effectiveness of CCH in the treatment of PD.MethodsThis phase 3, open‐label study enrolled subjects who were CCH‐naïve, were enrolled in a previous pharmacokinetic study, or had received placebo in an earlier phase 2 CCH study. Each treatment cycle included two intralesional injections of CCH 0.58 mg, approximately 24–72 hours apart, and plaque modeling 24–72 hours after the second injection of each cycle. The treatment cycle was repeated after 6 weeks for ≤4 treatment cycles.Main Outcome MeasuresThe co‐primary end points were the mean percent change in penile curvature deformity and the mean improvement in PD bother score (range 0–16) from baseline to week 36.ResultsOf the 347 subjects treated with ≥1 injection, 238 had both a penile curvature measurement and a Peyronie's Disease Questionnaire response at baseline and ≥1 subsequent time point. Mean baseline penile curvature deformity was 53.0° and mean PD symptom bother was 7.3. Statistically significant mean improvements from baseline to week 36 were observed in both penile curvature deformity (34.4% [95% confidence interval {CI}, 31.2%, 37.6%]) and PD symptom bother score (3.3 [95% CI, 2.8, 3.7]). Most adverse events (AEs) were mild or moderate in severity and local to the penis. There were three serious treatment‐related AEs, two penile hematomas and one corporal rupture; all resolved with treatment.ConclusionsPotentially clinically meaningful and statistically significant improvements in penile curvature deformity and PD symptom bother scores were observed with intralesional injection of CCH compared with baseline in men with PD. CCH was generally well tolerated, with AEs primarily transient and local to injection site. In conjunction with previous studies, the results of this open‐label study support the use of CCH in the treatment of PD. Levine LA, Cuzin B, Mark S, Gelbard MK, Jones NA, Liu G, Kaufman GJ, Tursi JP, and Ralph DJ. Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: A phase 3 open‐label study. J Sex Med 2015;12:248–258.     

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 Curvature Improvement in Men With Peyronie's Disease Treated With Intralesional Collagenase Clostridium Histolyticum

IntroductionPenile curvature is the most common abnormality that is observed by men with Peyronie's disease (PD). Collagenase Clostridium histolyticum (CCH) has become a standard treatment for PD patients.AimTo identify predictor factors associated with improvements of penile curvature outcomes in men with PD treated with CCH.MethodsWe retrospectively collected the data of patients with PD treated with CCH up to 8 injections divided into 4 cycles between January 2014 and July 2020. Per protocol, penile curvature was assessed at baseline, and after the second and ford CCH cycle. If after cycle 2, curvature demonstrated no improvement, or penile curvature was significantly improved and the patient was happy, no further treatment was recommended. However, if penile curvature was significantly improved and the patient remained dissatisfied, 4 cycles were completed. Three categories of response were evaluated: improvement (≥10 degrees or ≥20%, either 1 happens), unchanged (±10 degrees or ±20%) or worsened (≥10 degrees or ≥20%, either 1 happens). Logistic regression analyses were performed to evaluate predictive factors associated with penile curvature improvements.OutcomesDegrees of the curvature changes between the baseline and after the cycles of CCH.ResultsA total of 114 patients underwent CCH treatment. Median age was 57 years. Median PD duration was 11 months. At baseline, mean curvature was 47 degrees, 65% had dorsal curvature, 53% mid-shaft location, and 15% calcification. After CCH treatment, the mean final curvature was 40 degrees. A total of 44% improved the curvature, 39% had no change while 17% worsened after CCH treatment. Of men who had penile curvature improvement with CCH treatment, the mean curvature decreasing in degrees and percentage were 22 degrees and 41%, respectively. Men with baseline curvature ≤ 30, 31–59, and ≥ 60 degrees, the percentage curvature improvement were 29%, 43%, and 60%, respectively. Baseline curvature was the only significant predictor of penile curvature improvement after CCH (OR 1.33, 95% CI = 1.1, 1.7).Clinical ImplicationsWe confirmed baseline penile curvature is the most important predictive factor, and this is the first report describing proportions of penile curvature improvement with CCH treatment.Strengths and LimitationsThis study has several strengths, including the use of validated instruments. Nonetheless, there are limitations: the retrospective nature of the study, a single institution; and modelling device was not controlled.ConclusionPenile curvature improvement was significantly more common in patients with greater baseline curvature, reaching up to 60% for patients with ≥ 60 degrees.Flores JM, Nascimento B, Punjani N, et al. Predictors of Curvature Improvement in Men With Peyronie's Disease Treated With Intralesional Collagenase Clostridium Histolyticum. J Sex Med 2022;19:1680–1686.     

Examining Postoperative Outcomes after Employing a Surgical Algorithm for Management of Peyronie's Disease: A Single-Institution Retrospective Review

AimSurgery remains the gold standard treatment for men with stable Peyronie's disease (PD). In an attempt to guide operative selection, we report our series of penile-straightening procedures for PD, using a surgical algorithm that recommended tunica albuginea plication (TAP), partial plaque excision and grafting (PEG) or inflatable penile prosthesis (IPP) placement. With this study, we attempt to further refine surgical approach, define realistic surgical outcomes, and help establish reasonable postoperative expectations for treatment of PD.MethodsWe retrospectively reviewed all patients who underwent surgery for PD at our institution between 2007 and 2013. Work-up involved a history, physical exam, and a duplex ultrasound. Several questionnaires were employed to assess bother and distress associated with PD. Objective outcomes and patient satisfaction were assessed postoperatively. Primary outcomes include postoperative patient satisfaction with rigidity, curvature, and ability to engage in intercourse. Secondary outcomes include comparing emotional, relationship, and psychological distress to severity of disease.ResultsA total of 390 patients underwent penile-straightening procedures for correction of PD. Of these patients, 29%, (n = 114) underwent TAP, 41% (n = 159) PEG, and 30% (N = 114) IPP. Mean follow-up was 17 months. The three surgical modalities showed no significant difference in satisfaction with penile rigidity, presence of bothersome residual curve, or ability to engage in intercourse. Preoperatively, 80% of men reported a negative effect of PD on their emotional status. Postoperatively, 88.4% of men were able to engage in penetrative intercourse, while only 70% were satisfied with rigidity and 84.9% were satisfied with curvature correction.ConclusionPatient experience with postsurgical rigidity, ability to engage in intercourse, and residual bothersome curve was not statistically different across the three groups, supporting the use of this surgical algorithm. The majority of patients with PD experience some degree of emotional and psychological distress, which may compromise patient satisfaction. Papagiannopoulos D, Yura E, and Levine L. Examining postoperative outcomes after employing a surgical algorithm for management of Peyronie's disease: A single-institution retrospective review. J Sex Med 2015;12:1474–1480.     

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.     

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.     

A Retrospective Comparative Study of Traction Therapy vs. No Traction Following Tunica Albuginea Plication or Partial Excision and Grafting for Peyronie's Disease: Measured Lengths and Patient Perceptions

IntroductionLoss of penile length is a recognized and common consequence of Peyronie's disease (PD). Traction therapy (TT+) has been reported to decrease post‐op length loss as well as increase stretched penile length (SPL) prior to surgery.AimThe aim of this study was to study patient outcomes with penile length change and patient satisfaction after surgery following tunica albuginea plication (TAP) and partial plaque excision and grafting (PEG) with or without postoperative TT.MethodsRetrospective analysis was performed from our cohort of Peyronie's reconstructive surgery between 2007 and 2010. SPL was measured dorsally from pubis to corona and recorded at the initial office visit and then compared to most recent postoperative visit. Patients were then stratified by procedure and whether TT was used (TT+ and TT?; TAP N = 52 [27 TT+ and 25 TT?] and PEG N = 59 [36 TT+ and 23 TT?). Traction therapy was initiated for >2 hours a day for 3 months typically starting 3–4 weeks postoperatively. A non‐validated mailed questionnaire assessed patient perceptions.ResultsMean length change seen in TAP (TT+) was 0.85 cm (0.25–1.75) vs. ?0.53 cm (?1.75 to 0.5) in TAP (TT?) (P < 0.001). The mean length change seen in PEG (TT+) was 1.48 cm (0–6) vs. PEG (TT?) 0.24 cm (?1 to 2.5 cm) (P < 0.001). Sixty‐one percent of surveys were returned; 85% lost length prior to the initial office evaluation, with an average of ?2.5 cm lost. Importantly, in those who used traction, there was no perceived length loss, 58% reported a mean erect length gain of 1.1 cm. However, only 54% of all patients were satisfied with their current erect length.ConclusionsLoss of length in men with PD remains a serious concern. It appears that postoperative TT can result in length preservation, and in many, a measured and perceived length gain following correction of the curvature. Rybak J, Papagiannopoulos D, and Levine L. A retrospective comparative study of traction therapy vs. no traction following tunica albuginea plication or partial excision and grafting for Peyronie's disease: Measured lengths and patient perceptions. J Sex Med 2012;9:2396–2403.     

The Surgical Treatment of Peyronie’s Disease in the Older Man: Patient Characteristics and Surgical Outcomes in Men 65 and Older

IntroductionSurgery remains the gold standard for the correction of penile deformities secondary to Peyronie’s disease (PD). Nevertheless, there is no published data on the surgical treatment of PD in older men.AimConsidering the aging national and international population, we sought to evaluate the pre-operative characteristics and surgical outcomes of men aged 65 or older who underwent surgical treatment for PD at our tertiary care institution.MethodsWe retrospectively reviewed the charts of all men 65 years or older who underwent surgery for PD from January 2010 to September 2017. We compared men who underwent penile prosthesis implantation with straightening maneuvers (PP+SMs), tunica albuginea plication (TAP), and plaque partial excision with grafting (PEG).Main Outcome MeasureThe main objective of this study was to find the baseline pre-operative patient characteristics and postoperative patient-reported outcomes.ResultsA total of 86 men with a median age of 68 years underwent surgery during the study period. 39 men underwent PP+SM (45%), 25 men a TAP (29%), and 22 men a PEG (26%). The mean curvature for all men was 59.9 ± 22.0° (range 0?105°). Those who underwent a PEG had a mean ± SD degree of curvature of 78.6 ± 16.6°, significantly higher than those who underwent PP+SM or TAP (49.1 ± 20.2° and 61.4 ± 17.4°, respectively; P < .001). Moreover, men who underwent a PEG had significantly more complex penile deformities (eg, narrowing with hinge effect) and better reported baseline erectile function compared with men who underwent PP+SM or TAP. Overall, 95% of all men reported having a functionally straight penis postoperatively with 94% engaging in penetrative intercourse at last follow-up. Overall, patient-reported satisfaction was 85% with a median follow-up of 43.5 months.Clinical ImplicationsOur findings suggest that the surgical treatment of PD in older men is safe, effective, and associated with high patient satisfaction. Although this represents a surgical series susceptible to selection bias, it underscores the importance of patient selection and counseling in achieving good surgical outcomes.Strengths & LimitationsOur study is the first to report on outcomes of surgical treatment of PD in an elderly patient population with relatively long-term follow-up. Our limitations include a small sample size, single operating surgeon, and the lack of a younger comparison group.ConclusionDespite an aging global population, surgery remains a viable and reliable option for the properly selected and counseled older men with PD.Abdelsayed GA, Setia SA, Levine LA. The Surgical Treatment of Peyronie’s Disease in the Older Man: Patient Characteristics and Surgical Outcomes in Men 65 and Older. J Sex Med 2019;16:1820–1826.     

Surgical Outcomes of Plaque Excision and Grafting and Supplemental Tunica Albuginea Plication for Treatment of Peyronie's Disease With Severe Compound Curvature

Background

There are limited data in the literature that describe the management of Peyronie's disease (PD) with severe compound curvature, which often requires additional straightening procedures after plaque excision and grafting (PEG) to achieve functional penile straightening (<20 degrees).

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.     

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.     

Standard Operating Procedures for Peyronie's Disease

IntroductionPeyronie's disease (PD) refers to a penile deformity that is associated with sexual dysfunction.AimTo provide recommendations and Standard Operating Procedures (SOPs) based on best evidence for diagnosis and treatment of PD.MethodsMedical literature was reviewed and combined with expert opinion of the authors.Main Outcome MeasuresRecommendations and SOPs based on grading of evidence–based medical literature.ResultsPD is a fibrotic wound-healing disorder involving the tunica albuginea of the corpora cavernosa. The resulting scar is responsible for a variety of deformities, including curvature, shortening, narrowing with hinge effect, and is frequently associated in the early phase with pain. Patients frequently experience diminished quality erections. All of these conditions can compromise sexual function for the affected male. The etiopathophysiology of PD has yet to be clarified and as a result, effective, reliable, mechanistic directed non-surgical therapy is lacking.ConclusionsThe management of PD consists of proper diagnosis and treatment, ranging from non-surgical to surgical interventions. The main state of treatment for PD rests at this time on surgical correction that should be based on clear indications, involve surgical consent, and follow a surgical algorithm that includes tunica plication, plaque incision/partial excision and grafting, and penile prosthesis implantation. Levine LA and Burnett AL. Standard operating procedures for Peyronie's disease. J Sex Med 2013;10:230-244.     

Responsiveness of the Peyronie's Disease Questionnaire (PDQ)

IntroductionIn order to reliably assess treatment effectiveness, patient-reported outcome instruments must demonstrate adequate psychometric properties.AimTo assess the responsiveness of the Peyronie's Disease Questionnaire (PDQ) using data from two Phase 3 trials of collagenase clostridium histolyticum for Peyronie's disease (PD).MethodsBoth trials recruited adult males with PD who were in a stable relationship with a female partner for at least 3 months. Patients completed the PDQ, International Index of Erectile Function (IIEF), and a global assessment of PD (GAPD) questionnaire at baseline and Weeks 24 and 52. Anchor- and distribution-based methods were used to evaluate the responsiveness of the PDQ.Main Outcome MeasurePeyronie's Disease Questionnaire.ResultsThe number of men available with baseline and Week 52 data was 267 for Study 1 and 270 for Study 2. The mean age was 58.0 for Study 1 and 57.4 for Study 2; the majority were white (95.2% and 97.3%, respectively). Mean PDQ subscale change scores from baseline to Week 52 for both studies ranged from −1.5 to −4.6 (P < 0.0001). In Study 1, effect sizes were moderate to large on the Psychological and Physical Symptoms (−0.56) and Symptom Bother subscales (−0.84). For patients with penile pain at baseline, the effect size was large (−1.05) for the Penile Pain subscale. Similar effect sizes were seen in Study 2. The Psychological and Physical Symptoms and Symptom Bother subscales significantly discriminated patient improvement ratings of GAPD and degree of penile curvature at Weeks 24 and 52.ConclusionsThe PDQ is highly responsive to change in men with PD. Coyne KS, Currie BM, Thompson CL, and Smith TM. Responsiveness of the Peyronie's Disease Questionnaire (PDQ). J Sex Med 2015;12:1072–1079.     

High Patient Satisfaction of Inflatable Penile Prosthesis Insertion with Synchronous Penile Plication for Erectile Dysfunction and Peyronie's Disease

IntroductionTwenty to thirty percent of patients with Peyronie's disease (PD) have erectile dysfunction (ED) refractory to medical therapy and may benefit from a combined procedure addressing both conditions.AimThe aim of this study was to show the efficacy of inflatable penile prosthesis (IPP) insertion and synchronous penile plication for correcting penile curvature and ED in patients with PD.MethodsA retrospective review was performed of all patients who underwent IPP insertion with synchronous penile plication at our tertiary care center between 2010 and 2013. All patients received an intraoperative saline intracorporal injection to induce an artificial erection. After the tunica albuginea was exposed via a standard transverse scrotal incision over the proximal penile shaft, the incision was retracted distally and/or laterally as needed for plication suture placement. Plication sutures were placed in parallel opposite the angle of greatest curvature. The incision was returned proximally to the standard penoscrotal junction for IPP insertion. Demographic and surgical data were collected from the patients' medical records. Patient satisfaction was assessed postoperatively using a nonvalidated questionnaire.Main Outcome MeasuresThe focus of this study was surgical outcomes, both technical and patient-reported satisfaction.ResultsEighteen patients with a mean age of 63 years underwent IPP insertion with synchronous penile plication. Patients presented with dorsal (n = 11), lateral (n = 2), and biplanar curvature (n = 5). Mean preoperative curvature was 39 degrees (range 30–60) and was corrected on average to <5 degrees (range <5–12) using a median of four plication sutures (range 3–6). Among 15 patients completing a postoperative satisfaction survey at a mean of 11 months, all reported improvement in their overall condition and penile curvature; one with biplanar deformity reported minor residual curvature. None reported continued pain or required suture release.ConclusionsIPP insertion with synchronous penile plication for the correction of ED and PD is effective and results in high patient satisfaction. Chung PH, Scott JF, and Morey AF. High patient satisfaction of inflatable penile prosthesis insertion with synchronous penile plication for erectile dysfunction and Peyronie's disease. J Sex Med 2014;11:1593–1598.     

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

BackgroundPrevious studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie’s disease (PD). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with PD.AimTo assess the safety and efficacy of treatment with the RestoreX device plus collagenase Clostridium histolyticum (CCH) compared with CCH alone and CCH with other PTT devices.MethodsA prospective registry has been maintained of all men undergoing CCH injections for PD between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX).OutcomesChanges in penile length, curvature, and subjective perception and the occurrence of adverse events.ResultsOf 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous PD medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3°/31% for group 1, 19.2°/30% for group 2, and 33.8°/49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and +1.9 cm/+17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience ≥20°, ≥20%, and ≥50% curvature improvements, ≥1 cm length gain, and ≥20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of ≥3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve ≥20° curvature improvement, and 3.5 times more likely to achieve ≥50% curvature improvement, and 10.7 times more likely to experience ≥20% length improvement. Adverse events were similar among the 3 groups.Clinical ImplicationsUse of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with PD receiving CCH therapy.Strengths & LimitationsStudy strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting.ConclusionThe combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices.Alom M, Sharma KL, Toussi A, et al. Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease. J Sex Med 2019;16:891–900.     

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.     

Trans-corporal incision of Peyronie's plaques

IntroductionPatients presenting with Peyronie's disease (PD) curvature and erectile dysfunction (ED) can achieve straightening and rigidity through penile prosthesis implantation and manual modeling and, if necessary, a relaxing tunical incision with or without grafting. Unfortunately, this maneuver will not correct PD‐induced shortening. In addition, incision and grafting after the prosthesis has already been implanted adds to operative time and risk, and may indicate mobilization of the neurovascular bundle and, possibly, a secondary skin incision.AimThis work describes trans‐corporal incision (TCI), a minimally invasive endoscopic approach for plaque incision from within the corpora cavernosa, restoring straightness and length to the penis, before calibration of the corpora cavernosa, allowing implantation of a longer prosthesis in a straight penis, with neither mobilizing the neurovascular bundle nor a secondary incision.MethodsSixteen patients with PD deformity and refractory ED were operated upon. Intra‐operative artificial erection demonstrated the deformity. Through a penoscrotal incision, the corpora were dilated. TCI was performed to incise Peyronie's plaques at the point of maximum deformity. Artificial erection was re‐induced and correction of curvature evaluated. Length was measured before and after TCI. Implantation proceeded as usual.Main Outcome MeasuresPenile straightness and length.ResultsFollowing implantation, the penis was straight in all cases. Pre‐TCI length of the corpora was unequal on either side. Post‐TCI, both corpora were of equal length with an average increase of 2.5 cm (11.9%) on the right side and 1.9 (9.1%) on the left.ConclusionTCI; corporoscopic incision of Peyronie's plaques upon implantation of penile prosthesis is a minimally invasive approach that restores both straightness and length to patients with PD and ED, with neither mobilization of the neurovascular bundle nor plaque incision and grafting. Shaeer O. Trans‐corporal incision of Peyronie's Plaques. J Sex Med 2011;8:589–593.     

Predicting erectile dysfunction following surgical correction of Peyronie's disease without inflatable penile prosthesis placement: vascular assessment and preoperative risk factors

IntroductionSurgical therapy remains the gold standard treatment for Peyronie's Disease (PD). Surgical options include plication, grafting, and placement of inflatable penile prosthesis (IPP). Postoperative erectile dysfunction (ED) is a potential complication for PD surgery without IPP. We present our large series follow‐up to evaluate preoperative risk factors for postoperative ED.AimsThe aim of this study is to evaluate preoperative risk factors for the development of ED following surgical correction of PD taking into account the degree of curvature, graft size, surgical approach, hypertension, hyperlipidemia, diabetes, smoking history, preoperative use of phosphodiesterase 5 inhibitors (PDE5), and preoperative duplex ultrasound findings including peak systolic and end diastolic velocities and resistive index.MethodsWe identified 218 men undergoing either tunica albuginea plication (TAP) or partial plaque excision with pericardial grafting for PD following a previously published algorithm between November 1992 and April 2007. Preoperative and postoperative erectile function, curvature characteristics, presence of vascular risk factors, and duplex ultrasound findings were available on 109 patients.Main Outcome MeasuresOur primary outcome measure is the development of ED after surgery for PD.ResultsTen percent of TAP and 21% of plaque excision with grafting patients developed postoperative ED. Neither curve direction (P = 0.76), graft area (P = 0.78), surgical approach (P = 0.12), chronic hypertension (P = 0.51), hyperlipidemia (P = 0.87), diabetes (P = 0.69), nor smoking history (P = 0.99) were significant predictors of postoperative ED. No combination of risk factors was found to be predictive of postoperative ED. Preoperative use of PDE5 was not a significant predictor of postoperative ED (P = 0.33). Neither peak systolic, end diastolic, nor resistive index were significant predictors of ED (P = 0.28, 0.28, and 0.25, respectively).ConclusionThis long‐term follow‐up of a large published series suggests that neither preoperative risk factors nor preoperative duplex ultrasound findings are predictive of postoperative ED, thus reinforcing the use of previously published preoperative treatment algorithms. Taylor FL, Abern MR, and Levine LA. Predicting erectile dysfunction following surgical correction of peyronie's disease without inflatable penile prosthesis placement: Vascular assessment and preoperative risk factors. J Sex Med 2011;9:296–301.