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.     

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.     

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.     

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.     

Safety of Collagenase Clostridium histolyticum Injection Therapy for Peyronie Disease in Patients Continuing Antiplatelet or Anticoagulant Therapy

IntroductionThe initial clinical trials for intralesional collagenase Clostridium histolyticum (CCh) injection therapy for Peyronie disease (PD) excluded men on antiplatelet or anticoagulant medications except those on low-dose aspirin. Men with PD who take such medications present a challenging clinical scenario because of a lack of evidence regarding the safety of CCh while on these drugs.AimTo evaluate safety outcomes among patients continuing anticoagulant and antiplatelet therapy during ongoing intralesional CCh injection treatment for PD.MethodsAn institutional review board approved a database of 187 patients treated with CCh at an academic men's health practice from January 2016 through April 2019 was reviewed. Men on antiplatelet/anticoagulant medications were not instructed to stop these agents. Data on patient demographics, comorbidities, CCh injection details, use or nonuse of antiplatelet/anticoagulant medications, and adverse events were extracted from the electronic medical record. Rates of hematoma formation, bruising, swelling, and corporal rupture were determined. Univariate statistical analysis compared clinical data and adverse events between men on or off antiplatelet/anticoagulant medications.Main Outcome MeasureStatistical comparison of adverse events in those taking or not taking antiplatelet or anticoagulant medications while undergoing intralesional CCh injection therapy for PD.ResultsOf 187 men undergoing CCh treatment, 33 (17.6%) were on concomitant antiplatelet or anticoagulant therapy. Aspirin 81 mg alone was the most common pharmacologic agent (58% of men on antiplatelet/anticoagulants); medications also included other antiplatelet drugs, warfarin, and novel oral anticoagulants (NOACs). Men taking blood thinners during intralesional CCh injection therapy experienced no statistical difference in rates of bruising, swelling, or hematoma formation compared with men not on antiplatelet/anticoagulants. No corporal ruptures were observed in either group. Men on antiplatelet or anticoagulant therapy were more likely to be older (64 vs 58 years old, P = 0.005), have hypertension (P = 0.025), and have hyperlipidemia (0.009).Clinical ImplicationsIntralesional CCh injection therapy may be offered to men on antiplatelet/anticoagulant medications without increased risk of adverse events.Strength & LimitationsThis study evaluated the experience of a single surgeon, with a systematic evaluation of adverse events captured in a robust electronic medical record. The retrospective nature of this study limits conclusions but builds upon work performed in the initial clinical trials for CCh.ConclusionOur findings suggest that antiplatelet and anticoagulant medications do not increase the risk of adverse events during intralesional CCh injection therapy for PD.Amighi A, Regets KV, Nork JJ, et al. Safety of Collagenase Clostridium histolyticum Injection Therapy for Peyronie Disease in Patients Continuing Antiplatelet or Anticoagulant Therapy. J Sex Med 2020;17:353–356.     

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.     

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).

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.     

ORIGINAL RESEARCH—PEYRONIE'S DISEASE: Penile Sonographic and Clinical Characteristics in Men with Peyronie's Disease

IntroductionUltrasonography of the penis is readily available to the urologist and gives good anatomic detail of soft tissue structures. It has not been widely utilized in the assessment of Peyronie's disease (PD).AimsTo describe the sonographic characteristics of the penis in PD and the relationship between clinical and sonographic features.MethodsThis cross-sectional study enrolled patients from a single clinical practice. A PD-specific questionnaire was administered and sonographic evaluations were performed.Main Outcome MeasuresSonographic characteristics of men with PD.ResultsTunical thickening, calcifications, septal fibrosis, and intracavernosal fibrosis, were observed at initial clinical evaluation in 50%, 31%, 20%, and 15% of men, respectively. Men aged 40–49 (OR 2.4, P = 0.02) and men aged 50–59 (OR 2.4, P = 0.004) were more likely to have sub-tunical calcifications relative to men under age 40. Men with septal fibrosis had fewer chronic medical conditions such as diabetes (OR 0.3, P = 0.04), hypertension (OR 0.5, P = 0.03), and coronary artery disease (OR 0.2, P = 0.05), and presented within 1 year of disease onset (OR 2.1, P = 0.001). Men with septal fibrosis were less likely to have lost penile length (OR 0.5, P = 0.04) and more likely to be able to have intercourse (OR 1.9, P = 0.05). Men with intracavernosal fibrosis were less likely to have penile pain (OR 0.5, P = 0.05), but more likely to have penetration difficulty during intercourse (OR 1.9, P = 0.008), an additional penile deformity (OR 1.8, P = 0.02), or rapid onset of disease (OR 1.7, P = 0.04). Tunical thickening was associated with a decreased ability to have intercourse (OR 2.3, P < 0.001).ConclusionPD is a clinically and sonographically heterogeneous condition. Sonography is a safe, low-cost, and rapid means of objectively characterizing lesions in this condition. This may help track the evolution of the condition in individual patients and in the future may be useful for tailoring treatment strategies. Smith JF, Brant WO, Fradet V, Shindel AW, Vittinghoff E, Chi T, Huang YC, Davis CB, Conti S, and Lue TF. Penile sonographic and clinical characteristics in men with Peyronie's disease. J Sex Med 2009;6:2858–2867.     

子宫腺肌病发生血栓性病变的风险及临床特点

子宫腺肌病（adenomyosis）是育龄期女性常见的良性疾病之一,主要临床表现为痛经、月经过多及不孕,严重影响患者的生活质量。近年来,国内外学者相继报道了30多例子宫腺肌病发生血栓性病变的病例,包括脑梗死、弥散性血管内凝血和静脉血栓栓塞症,这些病例多发生于月经期。分析这些患者的病变特点后发现,子宫腺肌病患者发生血栓性病变的危险因素包括炎症、组织因子表达增加、血糖类抗原125（CA125）水平升高、月经过多和子宫体积增大等。子宫腺肌病患者一旦发生血栓性病变,将增加临床上诊断和治疗的难度。了解子宫腺肌病患者凝血功能的变化和警惕其发生血栓性疾病的风险将有助于提高子宫腺肌病的诊疗准确率和安全性。     

Inflatable Penile Prosthesis Placement in Men with Peyronie's Disease and Drug-resistant Erectile Dysfunction: A Single-Center Study

IntroductionErectile dysfunction (ED) frequently accompanies Peyronie's disease (PD) and changes the therapeutic approach.AimTo evaluate a single-center experience with inflatable penile prostheses (IPP) in men with medication refractory ED and PD.MethodsNinety men underwent placement of an IPP with straightening maneuvers as necessary to address their deformity and ED.Main Outcome MeasuresPreoperative assessment included International Index of Erectile Function-erectile function domain (IIEF-EF) and duplex ultrasound to confirm ED and measure erect deformity. Postoperative assessment included a modified Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire, as well as office visits at 1, 6, and every 12 months thereafter.ResultsComplete chart review was performed with mean follow-up of 49 months. Mean preoperative IIEF-EF score was 11. Full rigidity was not obtained in any patient during duplex ultrasound. Mean curvature at maximum erection was 53°. There were seven mechanical failures requiring device replacement, two revision surgeries for pump or reservoir malposition, one infected device, and two corporoplasties for distal tunica erosion. Postoperative office assessment revealed a functionally straight (i.e., <20°) erect penis and a properly positioned as well as operational device in all patients. The modified EDITS questionnaire was returned by 56 (62%). Overall, 84% of patients were satisfied with their outcome, yet only 73% were satisfied with their straightness. Patient perceived postoperative curvature correction stabilized quickly and was complete by 3 months in 84% of patients. Satisfaction with ease of inflation, deflation, and concealability was 84%, 71%, and 91%, respectively. Coital activity was reported by 91% of men in this group.ConclusionIn men with PD and ED, IPP placement allowed reliable and satisfactory coitus for the great majority of men. Mechanical failure was 7%. Men with PD undergoing IPP placement should be counseled regarding potential penile length loss and residual curvature, neither of which appeared to interfere with coitus but may reduce satisfaction. Levine LA, Benson J, and Hoover C. Inflatable penile prosthesis placement in men with Peyronie's disease and drug-resistant erectile dysfunction: A single-center study.     

The Use of Penile Computed Tomography Cavernosogram in the Evaluation of Peyronie's Disease: A Pilot Study

BackgroundClinical assessment of Peyronie disease (PD) is unreliable and difficult to reproduce.AimTo assess the utility of the computed tomography cavernosography (CTC) in evaluating the penile functional abnormalities of PD.MethodsMen were placed in the Philips IQon Spectral CT scanner (Phillips, Cambridge, MA, USA) in the supine position. The penis was injected with trimix (papaverine 30 mg/cc, phentolamine 2 mg/cc, and prostaglandin 20 mcg/cc) in the left proximal base using a 27-gauge syringe. Clinical effect was assessed after 5 minutes. If penile erection was less rigid than adequate for penetration, the dose was repeated until a satisfactory result was achieved. A subcutaneous injection of 1% lidocaine for local analgesia was then injected into the left subcoronal corpora. After the maximum erection was obtained, a 20-gauge angiocatheter was inserted into the anesthetized area. The angiocatheter was connected via intravenous tubing to a 60-cc luer lock syringe of 50% mixture of iodinated contrast in normal saline. The penis was manually inflated until maximum erection was achieved as per the patient's report. The patient then underwent computed tomography scan. Upon completion, a reversal dose of phenylephrine was administered through the angiocatheter. The angiocatheter was then removed, and a penile compression dressing was applied.OutcomesImages were assessed for degree of curvature, presence of corporal involvement, and location of corporal involvement.Results63 men underwent CTC. The average age was 57 years (95% confidence interval [CI]: 54, 60). Duration of PD was 5.2 years (95% CI: 3, 7). Diabetes and hypogonadism were found in 15% and 50% of men, respectively. The primary angulation was 52° (95% CI: 40, 60). Multiple angulations were found in 80% of men with 3 or more degrees of angulation in 14%. Bilateral corporal involvement was found in 87%, and proximal involvement was found in 64%. Dorsal/dorsolateral, ventral/ventrolateral, lateral, and hourglass/corkscrew deformities were seen in 58%, 23%, 12%, and 7%, respectively. Average dose of trimix (mg-papaverine + mg-phentolamine + mcg-PGE-1), contrast dose, and radiation dose per scan were 26 (22, 31), 55 cc (47, 63), and 770 mGy1cm (902, 638), respectively.Clinical ImplicationsCTC may reveal additional information regarding the anatomy of the penis in men with PD which is not readily available by existing methods of evaluation.Strengths & LimitationsWe evaluated a small cohort of men with CTC which allowed for detailed visualization and assessment of their PD. This study is limited by the small sample of patients, retrospective nature, and absence of clinical outcomes which will require further study in the future.ConclusionThe CTC may be useful in clearly defining the corporal abnormalities in men with PD.McCullough AR, Trussler J, Alnammi M, et al. The Use of Penile Computed Tomography Cavernosogram in the Evaluation of Peyronie's Disease: A Pilot Study. J Sex Med 2020;17:1041–1043.     

Baseline Characteristics and Treatment Outcomes for Men with Acquired or Lifelong Premature Ejaculation with Mild or No Erectile Dysfunction: Integrated Analyses of Two Phase 3 Dapoxetine Trials

IntroductionPremature ejaculation (PE) is classified as an acquired or lifelong condition but data on baseline characteristics and response to treatment of men with acquired or lifelong PE and mild erectile dysfunction (ED) or normal erectile function (EF) is limited.AimTo present integrated analyses of baseline characteristics and treatment outcomes from phase 3 dapoxetine trials in men with acquired or lifelong PE and mild or no ED.MethodsData were analyzed from two randomized, double-blind, placebo-controlled, phase 3 clinical trials (International and Asia-Pacific) that evaluated efficacy and safety of dapoxetine (30 mg or 60 mg as needed [PRN]) in patients with PE. Men were ≥18 years, in a stable monogamous relationship for ≥6 months, met DSM-IV-TR criteria for PE for ≥6 months, had an International Index of Erectile Function EF domain score ≥21, and had an intravaginal ejaculatory latency time (IELT) ≤2 minutes in ≥75% of intercourse episodes.Main Outcome MeasuresDemographics, sexual history, and PE symptomatology at baseline, and mean IELT and patient-reported outcomes (PROs) at study end (week 12), were analyzed for men with acquired or lifelong PE and mild or no ED (EF score 21–25 vs. ≥26).ResultsBaseline characteristics except duration of PE were similar in men with acquired and lifelong PE, with no other differentiating features by ED status. Dapoxetine treatment improved significantly mean IELT (arithmetic and geometric) and PRO responses (perceived control over ejaculation, satisfaction with sexual intercourse, ejaculation-related personal distress, and interpersonal difficulty) for acquired and lifelong subtypes, but presence of mild ED diminished PRO responsiveness in both subtypes, particularly those with lifelong PE.ConclusionsBaseline characteristics and treatment outcomes were generally similar in men with acquired and lifelong PE. The presence of mild ED appears to be associated with a more modest treatment response, irrespective of lifelong or acquired PE subtype. Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, and Rivas DA. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: Integrated analyses of two phase 3 dapoxetine trials.     

The Prevalence of Peyronie's Disease in Japan: A Study in Men Undergoing Maintenance Hemodialysis and Routine Health Checks

IntroductionThe incidence of Peyronie's disease (PD) in the general population is believed to be as high as 20%. However, most of the data concerning the prevalence of PD have been obtained from Caucasian populations.AimThe aim of this study was to examine the prevalence of PD in Asia and among men undergoing hemodialysis and discuss the pathophysiology of PD.MethodsA total of 1,090 men who received a routine health check at our hospital (control group) as well as 130 male patients undergoing maintenance hemodialysis were enrolled. The diagnosis of PD was based on a palpable penile plaque.Main Outcome MeasuresHemodialysis patients were asked about their sexual activity and completed the International Index of Erectile Function‐5 questionnaires. The differences between patients' and hemodialysis‐associated factors, comorbidities, and medications were statistically assessed for patients with and without PD.ResultsThe prevalence of PD was significantly increased among hemodialysis patients (12 patients: 9.2%) relative the control group (six men: 0.6%) (P < 0.0001, odds ratio: 18.4). In both groups, the plaques were primarily allocated dorsally. In the hemodialysis patients with PD, the frequency of masturbation (P < 0.05) and the incidence of moderate or severe erectile dysfunction (P < 0.01) were significantly higher than those among hemodialysis patients without PD. In comparison with patients without PD, the number of acetate dialysate users was significantly higher among patients with PD (P < 0.05), and none of the PD patients used angiotensin‐related antihypertensive drugs (P < 0.05).ConclusionsThe prevalence of PD in healthy Japanese men is low (0.6%), which suggests the existence of racial differences in the prevalence of PD. Moreover, these results indicate that hemodialysis increases the incidence of PD. The differences in the characteristics between male hemodialysis patients with and without PD provide new insights into the pathophysiology and therapeutic window of PD. Shiraishi K, Shimabukuro T, and Matsuyama H. The prevalence of Peyronie's disease in Japan: A study in men undergoing maintenance hemodialysis and routine health checks. J Sex Med **;**:**–**.