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Savage, Joshua S.

0000-0003-0599-0245

Mayo Clinic

MFPC

Citations 26

(091) RATE OF RETURN OF SPERM AMONG MEN WITH AZOOSPERMIA POST VASECTOMY REVERSAL
Hans, ReproductionD, Brearton, K, Warner, R, Trost, L., Savage, Joshua S. , Brearton, K, Helo, Sevann

The Journal of Sexual Medicine | December 10, 2024 | Volume: 21 | Issue: Supplement_7 | Pages: No page available

10.1093/jsxmed/qdae167.089 Get It

Abstract Introduction Limited data exist on semen parameters post vasectomy reversal. Specifically, no studies have rigorously evaluated the likelihood of sperm return following discovery of azoospermia at some time point post vasectomy reversal. Objective To evaluate the rate of return of sperm among men who experience an azoospermia result post vasectomy-reversal. Methods A large, prospective dataset has been maintained of men undergoing vasectomy reversals at a single center from 2019 to the present. Men who had at least two post-operative semen analyses were included for review. The data were then analyzed in a manner to identify those who experienced a 0 count at varying time points and then either went on to continue to have 0’s beyond that point or who experienced a return of sperm. Results A total of 3414 men underwent a vasectomy reversal since 2019, with 2703 having semen analysis data available for review. Overall demographics demonstrated a mean age of 41, partner age 33, median time since vasectomy of 7 years, 92% first-time cases, and distribution of repair as noted: VV/VV (79%), VV/EV (12%), EV/EV (6%), VV/x (1%), EV/x (<1%), x/x (0%). Of men who had 0 sperm at varying time points, the percentages of those who experienced a return of sperm are noted as follows: 0 sperm at <2 months (52% experienced a return at some point, n = 349 used in calculation), 0 at 2-4 months (38% return, n = 210), 0 at 5-7 months (17% return, n = 206), 0 at 8-10 months (20% return, n = 133), 0 at 11-18 months (9% return, n = 107). The data are limited by the fact that relatively few men continued to send in semen analysis samples beyond 12 months (n = 403 with at least one result >12 months and n = 101 with results >24 months). Conclusions Men who experience azoospermia post-vasectomy reversal may experience a return of sperm over time, with the likelihood for return declining based on the duration of persistence of 0 sperm. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: PathRight Medical.
(395) Safety and Efficacy of Collagenase Clostridium Histolyticum in Peyronie's Disease Men with Ventral Curvatures
Larson, Henry, Brearton, K, Warner, R, Ziegelmann, Matthew , Köhler, Tobias , Trost, Landon , Savage, Joshua S. , Helo, Sevann

The Journal of Sexual Medicine | February 6, 2024 | Volume: 21 | Issue: Supplement_1 | Pages: No page available

10.1093/jsxmed/qdae001.380 Get It

Abstract Introduction Limited data are available on the efficacy of collagenase clostridium histolyticum (CCH) on Peyronie’s disease (PD) in men with ventral curvatures. Our team previously published a limited series of outcomes of 25 men with ventral curvatures who underwent CCH. Given the paucity of data available, we sought to provide an updated series of outcomes in this important cohort. Objective To report outcomes of men undergoing CCH injections for PD based on initial direction of curvature, including absolute and percent improvement in curvature, adverse events (AE), and other subjective outcomes. Methods A prospective registry has been maintained of all men undergoing CCH injections since 2014. All men underwent curvature assessments and subjective questioning at the time of initial evaluation and prior to each subsequent series of injections. The method of injection and subsequent protocol have changed in a stepwise fashion since 2014 and currently include injecting 0.9 mg (diluted to 0.8 mL) on back-to-back days, injecting into the point of max curve with an erection on day 1, performing in-office modeling on day 2, utilizing Restorex traction beginning on day 2, and wrapping for 4-8 days depending on results. To review outcomes, clinicopathologic data were abstracted from the registry including relevant history, exam, and data obtained at the time of penile ultrasound and curvature assessment. Outcomes are reported using a “Most Recent” definition (most recent data point used, regardless if the patient continues or finished treatment) and “Completed 8 or Satisfied” (only included if the patient indicated that they were done with treatment or had finished the full 8 injections). Results A total of 560 patients (mean age 57 years) were identified from March 2014 through Feb 2023 and comprise our study cohort. Overall, 85 men had a ventral component to their curvature and 475 non-ventral. Baseline demographics and clinical factors were similar between groups, with the exception of penile length (ventral 14.0 cm, non-ventral 12.0 cm, p<0.0001), Psych and Physical subdomain of the Peyronie’s Disease Questionnaire (10 vs 12, p=0.03), and prior treatment with CCH (3% vs 16%, p=0.03). Following treatment, men in the ventral cohort exhibited possibly greater improvements in curvature (Most Recent Definition: -25 degrees vs -24, p=0.08; 45% vs 34%, p=0.03; Completed 8 or Satisfied Definition: -35 vs -25, p<0.05, 48% vs 38%, p=0.11). However, all other outcomes were similar between cohorts, including differences in subdomains of the IIEF and PDQ, use of traction therapy, and adverse events including ecchymoses, hematomas, and popping sensations. Importantly, no urethral complications were experienced in the ventral group. Conclusions Men with ventral PD may be effectively treated with CCH with similar AEs compared to other directions. Ventral curvatures are likely associated with greater overall curvature improvements compared to other directions. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo - Matt Ziegelmann.
(371) Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie’s Disease: A Randomized Trial – 1 Year Outcomes
Larson, Henry, Brearton, K, Warner, R, Ziegelmann, M., Köhler, Tobias , Trost, Landon , Savage, Joshua S. , Helo, Sevann

The Journal of Sexual Medicine | February 6, 2024 | Volume: 21 | Issue: Supplement_1 | Pages: No page available

10.1093/jsxmed/qdae001.356 Get It

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. We have previously published results comparing the two therapies at 3-months post-treatment. Objective To compare various objective and subjective outcome measures at 12-months post-treatment between men undergoing CCH or surgery for PD. Methods A randomized, controlled trial (NCT04786106) is ongoing. Participants were randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD. Objective, standardized (International Index of Erectile Function [IIEF] and Peyronie’s Disease Questionnaire [PDQ]), and non-standardized assessments were obtained at baseline, and post-treatment at 3, 6, 12, 24, 36, 48, and 60 months. Key outcomes included differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Curvature was measured in two planes and summed to provide a composite curvature. Penile length was measured from pubic symphysis to corona. All adjunctive therapies were stopped at 3-months post treatment completion (i.e., traction and sildenafil). Results A total of 40 men were randomized, with 38 completing treatment and 12-month data available on 28 men (CCH=12, surgery=16). Mean age at enrollment was 54.7 years, PD duration 37.4 months (mo), composite curvature 73.1 degrees (deg), and penile length 12.7 cm. All baseline variables were statistically similar between cohorts. Regarding primary outcomes, at 12-months post-treatment, CCH men reported being very satisfied 36%, satisfied 27%, and neutral 36% with none dissatisfied. Men in the Surgery cohort reported 14% very satisfied, 64% satisfied, 0% neutral, and 21% dissatisfied (p<0.01). For secondary outcomes, the median differences between CCH and Surgery were: IIEF-EFD (+2.0 vs +2.0, p=0.82), PDQ-physical (-5 vs -5, p=0.77, note, lower is better for PDQ scales), PDQ-pain (-1 vs 0, p=0.92), PDQ-bother (-7 vs -3, p=0.12), length change (+1.0 vs -0.13 cm, p<0.05), curvature absolute change (-37.5 vs -53.8 degrees, p=0.17), and curvature % improvement (55% vs 82%, p=0.15). Compared to 3-month data, Surgery men experienced greater curve recurrence (objective: Surgery +5 degrees vs -5 degrees CCH, p<0.05), decreased subjective penile length 62% vs 9% CCH (p<0.01) and decreased sensitivity (54% vs 27% CCH, p<0.05). Both groups reported similar rates of improved sexual function (CCH 82% vs 64%, p=0.30) and change in erectile function (CCH 55% improved, 9% worsened; Surgery 62% improved, 8% worsened, p=0.53). Both groups were also equally satisfied with their curvature (CCH 55% vs Surgery 54%, p=0.97), despite greater overall curve improvements in the Surgery arm. 75% of CCH men reported improved indentation/hourglass vs 56% Surgery, p<0.05. Both groups reported similar rates of being willing to do their treatment again (CCH 73% vs 77%, p=0.64), while 91% of CCH men would recommend it to a friend vs 77% Surgery (p=0.35). Conclusions Preliminary data suggests that when compared to surgery at 12-months, CCH men were more likely to be very satisfied, experience penile length increases, and less likely to experience dissatisfaction, curvature recurrence, and decreased penile sensation. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Matthew Ziegelmann - Endo Pharmaceuticals.
(134) Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie’s Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
Palmer, Bruce, Brearton, K, Warner, R, Ziegelmann, M., Köhler, Tobias , Trost, Landon , Palmer, B, Savage, Joshua S. , Helo, Sevann

The Journal of Sexual Medicine | February 6, 2024 | Volume: 21 | Issue: Supplement_1 | Pages: No page available

10.1093/jsxmed/qdae001.128 Get It

Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We have previously published outcomes of men undergoing a novel protocol for CCH injections and which demonstrated significant improvements compared to original IMPRESS I and II techniques. We therefore sought to evaluate results of men who had previously failed CCH injections to determine if they would respond to a repeat course using a more aggressive protocol. Objective To evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants had previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 22/40 men have been randomized to date, with 11 having fully completed treatment. Mean age was 64 years, with a median PD duration of 24 months. Mean composite baseline curvature was 80 degrees, with 55% having hourglass or indentation deformities, 10% calcification, median baseline IIEF-EFD 15, and 60% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 19.4), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (60% vs 30% satisfied, 10% neutral). Of the 11 men who had completed the study protocol, 64% required 1 series, 9% 2 series, 18% 3 series, and 9% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (mean 78 degree vs 15, p=0.01). IIEF-EFD was also improved more in treated men (+4.3 vs -5.7, p<0.05). 100% of men reported a subjective major improvement in curvature, with the average subjectively estimated improvement 91%. 67% reported improved sensitivity (33% no change), while 60% reported improved or no change in erectile function, with 20% unsure, and 20% somewhat worse. Post-treatment, 83% of men were very satisfied with CCH as a treatment and 17% somewhat satisfied. Conclusions Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Matthew Ziegelmann - Endo Pharmaceuticals.
(074) Safety and Efficacy Varying Doses of Prednisone Post Vasectomy Reversal: Results from a Randomized, Controlled Trials
Tyler, A, Brearton, K, Warner, R, Trost, Landon , Savage, Joshua S. , Brearton, K, Helo, Sevann

The Journal of Sexual Medicine | February 6, 2024 | Volume: 21 | Issue: Supplement_1 | Pages: No page available

10.1093/jsxmed/qdae001.070 Get It

Abstract Introduction There has been significant ongoing debate on the role and utility of prednisone post-vasectomy reversal to improve sperm counts and long-term patency. However, there are relatively limited data available on the efficacy, with essentially no data available on pregnancy outcomes. Objective To report outcomes of randomized, clinical trial evaluating varying protocols for prednisone administration post vasectomy reversal. Methods A randomized, controlled trial was performed (NCT04788823) with an anticipated 100 men randomized to one of four prednisone protocols post vasectomy reversal: no treatment (Control), prednisone 20 mg taper over 1 month beginning the first month post-op and then every other month x 6 months (High Dose), prednisone 20 mg taper over 1 month if declining sperm counts or a 0 count were identified (PRN), and prednisone 5 mg daily x 1 week, followed by no treatment x 1 week, continued for 6 months (Low Dose). Randomization tables were created a priori to ensure an equal representation of differing durations of time since the original vasectomy as well as an equal distribution of VV/VV vs VV/EV vs EV/EV procedures. All men had semen analyses obtained monthly for a first 12 months. Surveys were sent periodically to follow-up on subsequent pregnancies. Inclusion criteria included having a female partner <36 years of age with no known fertility factors. Results A total of 75 men were ultimately enrolled due to interim findings suggesting inferiority of the High Dose and PRN treatment arms and decision to close those arms before completing full enrollment. Final enrollment included: Control (n=25), High Dose (n=14), PRN (n=11), and Low Dose (n=25). The mean patient age was 38.5 years, mean partner age 29.6, and mean time since vasectomy 6.3 years (SD 5.0). 82% of men underwent VV/VV, while 15% VV/EV, and 3% EV/EV. All men underwent successful anastomosis bilaterally with no cases of one-sided or no anastomosis performed. At a mean follow-up of 16.5 months (range 7.6 to 25.1), an overall patency (sperm observed on sample) rate of 93% was noted (Control 96%, High Dose 93%, PRN 100%, Low Dose 88%, p=0.41). The mean sperm concentration post-op was 34.4 million/ml (Control 24.0, High Dose 38.4, PRN 21.0, Low Dose 49.8, p=0.33). Patency rates at 6- and 12-months were: 6-months (Control 88%, High Dose 80%, PRN 83%, Low Dose 94%, p=0.75); 12-months (Control 75%, High Dose 71%, PRN 75%, Low Dose 91%). Mean sperm concentrations at 6- and 12-months were: 6-months (Control 15.7, High Dose 21.5, PRN 6.9, Low Dose 25.7, p=0.50); 12-months (Control 12.6 million/ml, High Dose 17.1, PRN 36.1, Low Dose 50.4, p=0.64) At the 6-month post-op time point, the overall rate of pregnancy was 47%, with notable differences between cohorts: Control 57%, High Dose 10%, PRN 38%, and Low Dose 67%, p=0.02. No patients discontinued prednisone due to side effects. Conclusions Prednisone taper protocols appear to reduce the likelihood for pregnancy following vasectomy reversal. Use of low-dose prednisone results in non-statistically higher rates of patency at 6- and 12-months, mean sperm concentration at 6- and 12-months, and pregnancy at 6-months. Overall results suggest superiority of either no prednisone post-vasectomy reversal or a low dose protocol but argue against the use of higher dosages at any time due to its negative impacts on pregnancy rates despite maintained sperm counts. Disclosure No.
Outcomes of collagenase Clostridium histolyticum in men with ventral curvatures: an updated series
Larson, Henry, Brearton, Klint, Warner, R, Ziegelmann, Matthew , Köhler, Tobias , Trost, Landon , Savage, Joshua S.

The Journal of Sexual Medicine | December 23, 2023 | Volume: 21 | Issue: 2 | Pages: 169-174

10.1093/jsxmed/qdad167 Get It

Abstract Background The efficacy and safety of collagenase Clostridium histolyticum (CCH) have been demonstrated in the treatment of men with Peyronie’s disease (PD); however, the pivotal clinical trials excluded men with ventral penile curvature. Aim The study sought to evaluate outcomes of CCH treatment in men with ventral curvatures secondary to PD. Methods Men with PD treated with CCH were identified from a prospective database. Patients received up to 4 series of CCH injections using a progressively modified protocol over time. Results were compared between those with baseline ventral vs nonventral penile curvatures. Outcomes Changes in penile curvature, Peyronie’s Disease Questionnaire scores, International Index of Erectile Function scores, nonstandardized assessments, and adverse events. Results A total of 560 men with PD (85 ventral curvature, 475 nonventral curvature) were included in the analysis. Baseline median curvature was 60.0° (interquartile range, 48.8°-75.0°) in the ventral cohort and 65.0° (interquartile range, 45.0°-80.0°) in the nonventral cohort. Median change from baseline penile curvature was −25.0° in the ventral cohort vs −24.0° in the nonventral cohort (P = .08, between-group comparison), which corresponded to curvature reductions of 44.7% and 33.6%, respectively (P = .03). In the subset of patients who completed CCH treatment (ie, received 8 injections or discontinued early because of patient satisfaction with curvature reduction), median change from baseline was −35.0° in the ventral cohort vs −25.0° in the nonventral cohort (P < .05); median percent improvement was 48.3% and 37.5%, respectively (P = .11). Median change from baseline in Peyronie’s Disease Questionnaire and International Index of Erectile Function domain scores and adverse events were similar between cohorts, with the exception of possibly higher hematoma rates in the nonventral group (50% vs 37%; P = .05). No urethral injuries were sustained in either cohort. Clinical Implications Data support the use of CCH for the treatment of ventral as well as nonventral penile curvatures in men with PD. Strengths and Limitations Study strengths are the inclusion of a general clinical population of men with PD, the prospective design, and the relatively large series of men with ventral curvature. Limitations include the single-center and observational nature of the study. Conclusion CCH was safe and effective in the treatment of both ventral and nonventral penile curvatures in men with PD.
(262) Grumpy Young Men? Factors Associated with Bother in Men with Peyronie’s Disease
Tyler, A, Green, B, Brearton, K, Ziegelmann, M., Helo, S, Kohler, T, Trost, Landon , Savage, Joshua S. , Helo, S

The Journal of Sexual Medicine | May 22, 2023 | Volume: 20 | Issue: Supplement_1 | Pages: No page available

10.1093/jsxmed/qdad060.247 Get It

Abstract Introduction Age is often correlated with various medical conditions, including bother with the condition itself. Peyronie’s disease (PD) is a condition which is most often associated with men in their 50-60’s, however, it does affect younger men as well. Anecdotally, younger men with PD appear to be more bothered by their condition compared to older men. We therefore sought to evaluate whether there is a difference among older vs younger men as to the degree of bother linked to PD. Objective To evaluate age as a potential predictor of bother associated with PD. Methods A prospective database has been maintained of men seeking treatment for PD. Beginning in Feb 2020, we began implementing men routinely completed standardized intake questionnaires relating to PD, including the Peyronie’s Disease Questionnaire (PDQ). The PDQ consists of 15 questions broken down into three key subdomains: psychological and physical, penile pain, and symptom bother. Men who had completed the PDQ questionnaire were evaluated to determine the correlation between various clinicopathologic variables and the PDQ-bother domain. Results A total of 645 men were seen for symptoms of PD and had PDQ questionnaire data available for review. Baseline demographics included a mean age was 51.8 years (SD 17.6), mean PD symptom duration 31.3 months (SD 65.3), estimated curve of 40.9 degrees (SD 26.8), and mean PDQ-Bother score 8.9 (SD 3.1 – Note: lower is better). Several clinicopathology variables were found to be associated with increased PDQ-bother scores, including age (younger = less bothered, parameter estimate -.0.03, p=0.03), the presence of indentation or hourglass (yes 9.4, no 8.4, p<0.05), pain (yes 9.3, no 8.5, p=0.16), PD preventing penetrative intercourse (yes 9.5, no 8.7, p=0.07), penile shortening (yes 9.3, no 8.7, p=0.10), subjective erectile dysfunction (yes 9.6, no 8.5, p<0.01), and subjective premature ejaculation (yes 9.8, no 8.4, p<0.01). Interestingly, several variables did not correlate, including the duration of relationship, frequency of intercourse, duration of symptoms, direction of curve, degree of curvature, partner pain with intercourse, or libido. Conclusions Several notable factors are associated with PD bother (as assessed by the PDQ-bother domain), and equally importantly, several factors are surprisingly not associated (e.g. curvature degree and direction). These factors provide useful information to the practicing clinician to help better identify men who may be at greater risk for bother associated with the condition. Disclosure No
(156) CLINiC Score - A Novel Prediction Model of Collagenase Clostridium Histolyticum Outcomes in Men with Peyronie’s Disease
Anderson, Norman B. , Green, B, Brearton, K, Ziegelmann, M., Köhler, Tobias , Trost, Landon , Savage, Joshua S. , Brearton, K, Helo, Sevann

The Journal of Sexual Medicine | May 22, 2023 | Volume: 20 | Issue: Supplement_1 | Pages: No page available

10.1093/jsxmed/qdad060.151 Get It

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH), few studies have been able to identify variables which predict curve improvements, with baseline extent of curvature most highly correlated. In addition to extent of baseline curvature, our team has previously identified curve direction and plaque calcification as additional predictive variables. We therefore sought to create an integrated predictive model which incorporated several factors to better estimate anticipated outcomes. Objective To report outcomes of a novel scoring system designed to better predict outcomes of men undergoing CCH injections for Peyronie’s disease (PD). Methods A prospective database has been maintained of men undergoing CCH injections for PD. Data were reviewed to identify variables predictive of curve improvements in men with isolated curvature as well as among those with key characteristics, including indentations, hourglass deformities, penile tapering, and calcification. A predictive model was subsequently developed to improve correlations between disease factors and subsequent CCH outcomes. The final model (CLINiC Score) assigned points as follows: +1 point for every 10 degrees of curvature (C for Curvature), +5 points for penile narrowing >25% (IN for INdent), +3 points for narrowing 0-25%, -4 points for pure lateral curvatures (L for Lateral), and -2 points for plaque calcification (C for Calcification). Patients were assigned scores based on the CLINiC model, and results were correlated with final curve outcomes. Results A total of 476 PD men were included in the current analysis. Baseline variables for the cohort included a mean age of 55.6 yrs (SD 10.9), PD duration 31.9 months (SD 61.4), composite curvature 64.6 degrees (SD 23.9), 47% with indentations, 42% with hourglass deformity, and 17% with calcification. The mean CLINiC score for the cohort was 6.9 (SD 3.4). For the overall cohort, the use of the CLINiC score increased the correlation coefficient from 0.35 to 0.46 (r-squared 0.13 vs 0.21), with a predictive linear formula of 2.1 - 3.2 * CLINiC score. The difference was more pronounced among a subset cohort of men who had pure lateral curvatures, plaque calcification, or narrowing deformity. In comparing the CLINiC predictive model to baseline curve alone, the correlation coefficient increased to 0.54 (r-squared 0.29, p<0.0001) compared to 0.38 (r-squared 0.15, p<0.001). The linear equation to predict curve improvement outcomes using the CLINiC score was 2.2 - 3.5 * total CLINiC score. Conclusions Use of a novel scoring system (CLINiC) improves upon baseline curvature alone to predict post-CCH curve improvements, with the difference more pronounced among men with pure lateral curvatures, plaque calcification, and/or narrowing deformities. External validation is warranted. Disclosure No
(150) Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie’s Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
Palmer, Bruce, Anderson, Norman B. , Green, B, Brearton, K, Ziegelmann, M., Köhler, Tobias , Trost, Landon , Palmer, B, Savage, Joshua S. , Helo, Sevann

The Journal of Sexual Medicine | May 22, 2023 | Volume: 20 | Issue: Supplement_1 | Pages: No page available

10.1093/jsxmed/qdad060.145 Get It

Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We have previously reported outcomes of men undergoing a more aggressive protocol for CCH injections. We therefore sought to evaluate results of men who had previously failed CCH injections to determine if they would respond to a repeat course using a more aggressive protocol. Objective To evaluate outcomes of a novel, aggressive protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants had previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men are randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes are subsequently compared between treatment and control groups. Key measures include objective curve improvements, and standardized / non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 11/40 men have been randomized to date, with one having completed four series of CCH injections, three completing one series, and three completing two series. The average age of the cohort is 64.4 years, with a mean PD duration of 28.1 months. Mean baseline curvature was 82.9 degrees (composite curve). The average estimated improvement with prior CCH injections (before enrollment in the current study) was 10%. Preliminary outcomes of men who had completed one series and had a follow-up curve assessment available (n=3) demonstrated an absolute improvement of 28.3 degrees (42%). Of the one patient who completed four full series, the absolute curve improvement was 55 degrees (65%). The overall range of improvement among the four men was 20 to 55 degrees or 31 to 65%, with no patients failing to experience improvements thus far. Conclusions Preliminary data suggests that a repeat course of CCH using a previously described more aggressive administration protocol is effective at improving penile curvature in the majority of men. It is unclear if the improvements are due to the difference in administration protocol, or due to the repeat course of CCH alone. Given the very preliminary nature of the current results, additional data, including external validation, are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceutical Clarification Industry funding only - investigator initiated and executed study
(148) Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie’s Disease: A Randomized Trial
Warner, J, Green, B, Brearton, K, Ziegelmann, M., Köhler, Tobias , Trost, Landon , Green, B, Anderson, Neil J. , Savage, Joshua S. , Brearton, K, Helo, Sevann

The Journal of Sexual Medicine | May 22, 2023 | Volume: 20 | Issue: Supplement_1 | Pages: No page available

10.1093/jsxmed/qdad060.143 Get It

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. Specifically, investigators have compared relative utilization, costs, and outcomes with varying conclusions. Objective To compare various objective and subjective outcome measures between men undergoing CCH or surgery for PD. Methods A randomized, controlled trial (NCT04786106) is ongoing. Participants are randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD. Objective, standardized (International Index of Erectile Function [IIEF] and Peyronie’s Disease Questionnaire [PDQ]), and non-standardized assessments are obtained at baseline, and post-treatment at 3, 6, 12, 24, 36, 48, and 60 months. Key outcomes include differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Curvature is measured in two planes and summed to provide a composite curvature. Penile length is measured from pubic symphysis to corona. All therapies were stopped prior to the 3-month time point (i.e. traction and sildenafil). Results A total of 40 men have been randomized, with 3-month data available on 27 men (CCH=14, surgery=13) and 12-month data on 15 men (CCH=5, surgery=10). Mean age at enrollment was 54.9 years, PD duration 36.6 months (mo), composite curvature 72.3 degrees (deg), and penile length 12.7 cm. All baseline variables were statistically similar between cohorts. Regarding the primary outcome, post-treatment, CCH men reported higher overall satisfaction (3-months: 100% vs 88% surgery, p=0.16; 12-months 80% vs 70%, p=0.52). For secondary outcomes at 3 months, the median differences between CCH and surgery respectively were: IIEF-EFD (+3.5 vs +7, p=0.64), PDQ-physical (-10 vs -7, p=0.47, note: lower is better for PDQ scales), PDQ-pain (-2 vs -0.5, p=0.21), PDQ-bother (-4.5 vs -8.5, p=0.60), length change (+1.0 vs -0.5 cm, p<0.01), curvature absolute change (-26 vs -65 degrees, p=0.01), and curvature percentage improvement (46% vs 84%, p<0.01). More CCH men felt that treatment improved sexual function (86% vs 79%, p=0.45), erectile function (64% vs 56%, p=0.04), penile length (36% vs 6%, p<0.0001), and had less impact on sensation (14% less sensation vs 56%, p<0.01), while surgery men were more likely to report satisfaction with curvature (75% vs 64%, p=0.52). 100% of men in both groups would recommend treatment to a friend at 3 months, whereas 100% of CCH vs 70% of surgery men would recommend their therapy at 12 months. When asked which treatment they would pick if they could start again, at 3 months 100% of CCH men reported CCH and/or traction, while 79% of surgery men indicated surgery. Conclusions Preliminary data suggests that, when compared to surgery, CCH results in higher overall satisfaction (not statistically significant), decreased curve improvement, improved penile length, and fewer impacts on erectile function and sensation. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceutical Clarification Industry funding only - investigator initiated and executed study