Collagenase clostridium histolyticum for the treatment of Peyronie's disease: a prospective Italian multicentric study

Capece, Marco; Cocci, Andrea; Russo, Giorgio Ivan; Cito, G.; Giubilei, Gianluca; Cacciamani, Giovanni; Garaffa, Giulio; Falcone, Marco; Timpano, M.; Tasso, Giovanni; Sessa, Francesco; Campi, Riccardo; Maida, Fabrizio Di; Cai, Tommaso; Morelli, Girolamo; Giammusso, Bruno; Verze, Paolo; Palmieri, Alessandro; Ralph, David; Mirone, Vincenzo; Mondaini, Nicola

doi:10.1111/andr.12497

Cited by 39 publications

(27 citation statements)

References 7 publications

(12 reference statements)

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“…In addition, the authors highlighted the reduction of costs and duration of treatment (Abdel Raheem, Capece, et al, ; Abdel Raheem, Johnson, Abdel Raheem, Capece, & Ralph, ). These results were subsequently confirmed in a recent prospective Italian multicentric study (Capece et al, ). The authors who proposed this protocol have published data regarding the first cycle of three injections, but none of them has evaluated how effective and safe a second cycle could be.…”

Section: Introductionsupporting

confidence: 58%

“…Its safety and efficacy have already been demonstrated in two large RCTs, various retrospective studies, and some authors have also tried to identify predictors of treatment success (Cocci, Russo, Briganti, et al, ; Cocci, Russo, Salonia, et al, ; Gelbard et al, ; Lipshultz et al, ). A standardised protocol of injections has not been established yet, considering that the modified shortened protocol (three injections) has given comparable results to the initial IMPRESS protocol (eight injections; Abdel Raheem, Capece, et al, ; Abdel Raheem, Johnson, et al, ; Capece et al, ). However, there is a minority of patients who may not be completely satisfied after three injections and may want to receive a second cycle of three injections.…”

Section: Discussionmentioning

confidence: 99%

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Second cycle of intralesional Collagenase Clostridium histolyticum for Peyronie's disease using the modified shortened protocol: Results from a retrospective analysis

et al. 2020

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The purpose of this study was to evaluate the effectiveness and safety of the second cycle of Collagenase Clostridium histolyticum injections using the modified shortened protocol. We performed a retrospective analysis on patients who had already undergone the first cycle of injections using the modified shortened protocol and requested more injections to improve the remaining curvature. The International Index of Erectile Function, the Peyronie's Disease Questionnaire and the Global Assessment of Peyronie's Disease questionnaire were self‐administered to all patients. All the parameters were recorded at baseline, after the first cycle and after the second cycle of injections. All adverse events were recorded. Seventeen patients completed two cycles of injections. All patients had a reduction of the initial curvature after the first cycle, with a mean improvement of 17.4° (27.4%). After the second cycle, the reduction of the curvature was 7.9° (17.1%), and 29.4% of patients had no further improvement. No severe side effect was recorded. The results of the present study confirm the effectiveness and safety of the modified shortened protocol of Collagenase C. histolyticum injections for Peyronie's disease. However, the second cycle of three injections may be less effective, and patients may not be completely satisfied.

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Section: Introductionsupporting

confidence: 58%

Section: Discussionmentioning

confidence: 99%

Second cycle of intralesional Collagenase Clostridium histolyticum for Peyronie's disease using the modified shortened protocol: Results from a retrospective analysis

et al. 2020

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“…Although surgery remains the gold standard treatment option for patients with stable PD, it is not recommended for men in the active phase. On the other hand, collagenase clostridium histolyticum (CCH) represents the only licensed drug for the minimally invasive treatment of PD [14,15], however the acute phase of PD is not currently an indication for CCH therapy [3,16,17]. Four studies [18][19][20][21] demonstrated significant improvements in penile curvature after 10 or 15 mg intralesional verapamil, although the protocols varied widely, ranging from 6 to 12 injections.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Intralesional Hyaluronic Acid vs. Verapamil for the Treatment of Acute Phase Peyronie's Disease: A Prospective, Open-Label Non-Randomized Clinical Study

Cocci

Maida

Cito

et al. 2021

World J Mens Health

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Purpose: To compare the efficacy and safety of intralesional hyaluronic acid (HA) as compared with verapamil injection in patients with Peyronie's disease (PD). Materials and Methods: Between January 2015 and December 2018, men in PD acute phase were prospectively recruited. This open-label, prospective study included 2 different protocols. Group A: 8-week cycle of weekly intraplaque injections with HA; Group B: 8-week cycle of weekly intraplaque injections with verapamil. Penile curvature, plaque size, International Index of Erectile Function (IIEF)-15 score and visual analogue scale (VAS) were assessed at baseline and after 3 months. Results: Two-hundred forty-four patients were enrolled. Of these, 125 received intralesional HA (Group A), 119 received intralesional verapamil (Group B). At enrollment, median age was 56.0 years (interquartile range [IQR]=47.0-63.0 years), median curvature 35.0° (IQR=25.0°-45.0°), median IIEF-15 score 19.0 (IQR=16.0-23.0), median VAS 4.0 (IQR=4.0-5.0). Median difference for IIEF-15 was 1.0 (95% confidence interval [CI]=1.12-1.94) in Group A and 0.0 (95% CI=-0.04-0.14) in Group B (p<0.05) and median difference for VAS score was-4.0 (95% CI=-4.11-3.65) in Group A and-1.0 (95% CI=-0.50-2.01) in Group B (p<0.05). Plaque size decreased by-1.50 mm (IQR=1.60-2.10 mm) in Group A and-1.20 in Group B (p=0.10), while penile curvature decreased by-9.50° (IQR=4.50°-13.00°) in group A and-4.50 (IQR=2.50-7.50) in Group B (p<0.01). Conclusions: Intralesional HA injections could represent a reliable treatment option for the conservative management of patients with acute phase of PD.

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“…The only other mechanical therapy that has been reported in conjunction with CCH is the use of vacuum erection devices (VEDs). 21,22 However, because these series did not include a non-VED comparison arm, whether VED resulted in greater improvements over CCH alone is unclear. Thus, the present study is the first to report benefits of adjunctive mechanical therapy on improving CCH outcomes and demonstrates the greatest overall curvature and length improvements of any adjunctive therapy reported to date.…”

Section: Discussionmentioning

confidence: 99%

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

Alom¹,

Sharma²,

Toussi³

et al. 2019

The Journal of Sexual Medicine

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Background: Previous studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie's disease (PD). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with PD. Aim: To assess the safety and efficacy of treatment with the RestoreX device plus collagenase Clostridium histolyticum (CCH) compared with CCH alone and CCH with other PTT devices. Methods: A prospective registry has been maintained of all men undergoing CCH injections for PD between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX). Outcomes: Changes in penile length, curvature, and subjective perception and the occurrence of adverse events. Results: Of 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous PD medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3 /31% for group 1, 19.2 /30% for group 2, and 33.8 / 49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and þ1.9 cm/þ17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience 20 , 20%, and 50% curvature improvements, 1 cm length gain, and 20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of 3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve 20 curvature improvement, and 3.5 times more likely to achieve 50% curvature improvement, and 10.7 times more likely to experience 20% length improvement. Adverse events were similar among the 3 groups. Clinical Implications: Use of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with PD receiving CCH therapy. Strengths & Limitations: Study strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting. Conclusion: The combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices. Alom M, Sharma KL, Toussi A, et al. Efficacy of Combined Collagenase Clostridium histolyticum and R...

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Collagenase clostridium histolyticum for the treatment of Peyronie's disease: a prospective Italian multicentric study

Cited by 39 publications

References 7 publications

Second cycle of intralesional Collagenase Clostridium histolyticum for Peyronie's disease using the modified shortened protocol: Results from a retrospective analysis

Second cycle of intralesional Collagenase Clostridium histolyticum for Peyronie's disease using the modified shortened protocol: Results from a retrospective analysis

Comparison of Intralesional Hyaluronic Acid vs. Verapamil for the Treatment of Acute Phase Peyronie's Disease: A Prospective, Open-Label Non-Randomized Clinical Study

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

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