The Test–Retest Reliability of the Peyronie's Disease Questionnaire

IntroductionThe Peyronie's Disease Questionnaire (PDQ) is a disease-specific, patient-reported outcome instrument designed to measure the psychosexual consequences and treatment outcomes of Peyronie's disease (PD).AimThe aim of this study was to evaluate the test–retest reliability of the PDQ.MethodsAdult men with PD were recruited through eight clinical sites across the United States. Participants completed the PDQ during two study visits scheduled 7 (±3) days apart. At Visit 1, participants completed a sociodemographic questionnaire, the PDQ, and the International Index of Erectile Function (IIEF). At Visit 2, participants repeated the PDQ and completed an Overall Treatment Effect (OTE) scale. Test–retest reliability of the PDQ was assessed in a stable subsample (as determined by responses to the OTE). Intraclass correlation coefficients (ICCs) were calculated to evaluate the degree of association between the three PDQ subscale scores at Visits 1 and 2. Internal consistency of the subscales was also evaluated using Cronbach's alpha.Main Outcome MeasureThe main outcome measure was the PDQ.ResultsOf the 61 PD patients (mean age 59.3) who took part in the study, the majority were not receiving treatment for their PD (n = 35, 57.4%). The sample's mean score on the erectile function domain of IIEF was 19.7 (±8.2), indicating mild–moderate dysfunction. Nearly two-thirds reported penile pain at baseline (n = 37, 63.8%). Of the participants with baseline PDQ data and who had engaged in vaginal intercourse in the past 3 months, 57 completed both study visits. The PDQ demonstrated excellent test–retest reliability in 53 stable patients. The ICC was 0.85 for the Psychological and Physical Symptom subscale, 0.89 for the Peyronie's Symptom Bother subscale, and 0.88 for the Penile Pain subscale. The Cronbach's alpha estimates for all three subscales were acceptable at the >0.70 level.ConclusionsThe PDQ is a highly reproducible measure of PD and can be an effective end point in clinical trials evaluating treatments for PD. Coyne KS, Currie BM, Thompson CL, and Smith TM. The test–retest reliability of the Peyronie's Disease Questionnaire. J Sex Med 2015;12:543–548.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

Continuing Medical Education: Incision and Grafting for Severe Peyronie's Disease (CME)

BackgroundPeyronie's Disease is a wound healing disorder involving growth of fibrous plaques in the tunica albuginea, and often results in abnormal penile curvature and subsequent development of erectile dysfunction. A 59-year-old man with a history of untreated penile trauma who presented with a 6-year history of worsening penile curvature that interfered with sexual functioning and resulted in associated erectile dysfunction.MethodsThe patient's Peyronie's Disease was evaluated in clinic with a focused physical exam and a penile vasculature study using a color duplex Doppler ultrasound. Since the patient did not have proper insurance coverage for an inflatable penile prosthesis, but did have normal arterial flow with only boderline veno-occlusive disease, he instead underwent an incision and grafting procedure. After degloving the penis, a lateral approach parallel to the corpus spongiosum was used to enter Buck's fascia and isolate the neurovascular bundles. The fibrous plaque was incised with a residual tunical defect of 4 × 5 cm, and covered with a pericardial graft.ResultsPreoperatively, artificially induced erection during the patient's Doppler study demonstrated dorsal curvature greater than 80 degrees. Intraoperatively, after completing the incision and grafting procedure, artificial erection demonstrated minimal (less than 15 degrees) residual curvature. At his 1-week postoperative visit, he reported spontaneous erections and minimal pain. One month postoperatively, his incisions were well healed and an artificially induced erection continued to demonstrate minimal curvature.DiscussionManagement of severe Peyronie's Disease with significant penile curvature is a challenging clinical problem. In extreme cases, placement of an inflatable penile prosthesis with ancillary techniques usually gives the best clinical outcome. Although more difficult to execute in severe cases, incision and grafting represents an acceptable alternative in the appropriately selected patient. Richardson B, Pinsky MR, and Hellstrom WJG. Incision and grafting for severe peyronie's disease. J Sex Med 2009;6:2084–2087.     

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.     

Simultaneous penile lengthening and penile prosthesis implantation in patients with Peyronie's disease, refractory erectile dysfunction, and severe penile shortening

IntroductionDue to loss of length, patients who had penile prosthesis implantation for Peyronie's disease (PD) show a statistically significant reduction in their levels of satisfaction when compared with the general implant population.AimThe aim of this study is to report our experience of penile lengthening with circumferential graft during penile prosthesis implantation in patients with PD and severe penile shortening.MethodsBetween March 2006 and February 2008, 23 patients with PD, refractory erectile dysfunction, and severe penile shortening underwent penile lengthening with circumferential graft and concomitant implantation of an inflatable penile prosthesis.Main Outcome MeasuresSurgical outcome and complications have been recorded during postoperative follow‐up. Patients' satisfaction has been assessed 6 months postoperatively with the administration of the modified Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire.ResultsAfter an average follow‐up of 22 months (range 6–36), 20 patients attended all the postoperative follow‐up visits and returned the EDITS questionnaire. An average length gain of 2.8 cm (range 2.2–4.5) was recorded, and all patients were able to cycle the device and engage in penetrative sexual intercourse. Patient recorded complications included diminished glans sensitivity in four (20%) and persistent dorsal curvature of less than 15° in three (15%). Overall, 18 patients (90%) were satisfied with the cosmetic and functional result of surgery.ConclusionPenile lengthening with circumferential graft during penile prosthesis implantation in patients with PD represents a safe and reproducible technique that yields higher satisfaction rates than penile prosthesis implantation alone in patients with severe penile shortening. Sansalone S, Garaffa G, Djinovic R, Egydio P, Vespasiani G, Miano R, Loreto C, and Ralph DJ. Simultaneous penile lengthening and penile prosthesis implantation in patients with Peyronie's disease, refractory erectile dysfunction, and severe penile shortening. J Sex Med 2012;9:316–321.     

Extracorporeal Shockwave Therapy in Peyronie's Disease: Systematic Review and Meta-Analysis

BackgroundPeyronie's disease (PD) is associated with penile pain, deviation, and sexual dysfunction. Up till now, there is no conservative standard treatment for PD. However, the role of Extracorporeal Shock Wave Therapy (ESWT) is gaining increasing interest.AimTo evaluate the effect of ESWT on penile deviation, plaque size, erectile function, pain scale, and the rate of complications in PD patients.MethodsPubMed database was searched for articles published from January 2000 to November 2020, using related keywords and including randomized controlled trials (RCTs) only. Meta-analysis and forest plots were carried out using RevMan, and outcomes were reviewed by 2 authors independently. PRISMA guidelines were used in this article to achieve the quantitative and qualitative synthesis of data.OutcomesChanges in penile deviation, plaque size, erectile function, pain scale, and the rate of ESWT related complications.ResultsThe search yielded 73 articles. Three RCTs, including 117 patients in the ESWT group and 121 patients in the placebo group, were reviewed. ESWT is associated with reduction in plaque size (OR = 2.59, 95% CI (1.15–5.85), P= .02). No significant difference in reduction of penile deviation angle or rate of bruises were detected in post ESWT group when compared to placebo. No evidence was found to show an effect of ESWT on erectile function or pain scale.Clinical ImplicationsBased on the available RCTs, ESWT fails to improve penile curvature or pain in men with PD.  Although ESWT may reduce plaque size, this remains of questionable clinical significance.Strengths & LimitationsRCTs used different metrics to report the same outcome. Missed data were imputed to match the requirements of meta-analysis. However, there is still much data that cannot be estimated.ConclusionThe current data suggest that ESWT fails to improve penile curvature or pain in men with PD.  Although ESWT may reduce plaque size, this remains of questionable clinical significance, and further studies are required to confirm findings.Bakr AM, El-Sakka A. Extracorporeal Shockwave Therapy in Peyronie's Disease: Systematic Review and Meta-Analysis. J Sex Med 2021;18:1705–1714.     

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.     

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.