Predictors of treatment success after collagenase <i>Clostridium histolyticum</i> injection for Peyronie's disease: development of a nomogram from a multicentre single‐arm, non‐placebo controlled clinical study

Cocci, Andrea; Russo, Giorgio Ivan; Briganti, Alberto; Salonia, Andrea; Cacciamani, Giovanni; Capece, Marco; Falcone, Marco; Timpano, M.; Cito, G.; Verze, Paolo; Giammusso, Bruno; Morgia, Giuseppe; Mirone, Vincenzo; Minervini, Andrea; Gacci, Mauro; Cai, Tommaso; Serni, Sergio; Carini, Marco; Giubilei, Gianluca; Mondaini, Nicola

doi:10.1111/bju.14410

Cited by 39 publications

(19 citation statements)

References 25 publications

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“…This condition can lead to penile curvature, painful erections and erectile dysfunction (ED). PD is believed to affect 3% to 9% of the male population, with a higher prevalence among patients suffering from ED, diabetes and cardiovascular disease [1][2][3][4]. PD presents 2 different phases: active or acute and stable or chronic.…”

Section: Introductionmentioning

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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Section: Introductionmentioning

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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“…The CCH protocol used in the present study has already proven its usefulness as an alternative to the IMPRESS protocol in a first report of results [12]. That first study showed that the decrease in curvature per cycle (two injections of 0.9 mg) was 14 (11)(12)(13)(14)(15)(16)(17)(18)(19)°, which corresponds to a 26% decrease in curvature. The IMPRESS studies [7] showed an improvement after four cycles (eight injections) of 34% (17°).…”

Section: Discussionmentioning

confidence: 72%

“…It has been found to degrade type I and III collagen selectively, which are the predominant forms in Peyronie's plaque tissue . Since its approval, some modifications of the original protocol of drug use – adding vacuum therapy, shortening the protocol or increasing the dose of each injection – have been suggested to optimize treatment outcomes and reduce costs , and predictive factors have also been evaluated to provide better selection of patients for this therapy .…”

Section: Introductionmentioning

confidence: 99%

Optimizing collagenase Clostridium histolyticum therapy for Peyronie’s disease using a novel approach with percutaneous needle tunnelling

et al. 2019

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Objectives To compare the efficacy and safety of a combined treatment of percutaneous needle tunnelling (PNT) and a modified collagenase Clostridium histolyticum (CCH) protocol (PNT/CCH) vs the modified protocol alone (CCH) in the treatment of Peyronie's disease (PD). Patients and Methods A prospective registry of patients treated with a modified CCH protocol was maintained between June 2014 and February 2018. The last 50 patients received PNT as an adjuvant therapy (PNT/CCH), and their data were compared with those of the other 94 patients treated previously (CCH). PNT involves the creation of multiple holes made percutaneously in the plaque before each injection. The modified protocol consisted of two collagenase injections, at 1‐week intervals, followed by penile modelling. Patients used penile traction therapy, tadalafil and pentoxifylline for the next 2 months and were followed up for 6 months. The main outcome was improvement of curvature. Secondary outcomes were improvements in erectile function, PD symptoms, stretched penile length and satisfaction. Results Improvement in curvature was greater in patients in the PNT/CCH group than in the CCH group (mean ± sd 19.2 ± 6.1° vs 12.7 ± 5.0°; P < 0.001 [36.2 ± 12.5% vs 28.1 ± 14.5%; P = 0.001]). Compared with baseline, both interventions were associated with significant improvement in secondary outcomes. The main complications were ecchymosis, bruising and penile pain, with no significant differences between groups. Conclusions Treatment of PD with CCH using our modified protocol in combination with PNT is safe and more effective than the modified protocol alone, with the potential for improved cost‐effectiveness.

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“…CCH is one of the newest nonsurgical options that appeared on the market, and to date is the only licensed drug for this disease (European Medicines Agency, ). 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, ).…”

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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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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Predictors of treatment success after collagenase Clostridium histolyticum injection for Peyronie's disease: development of a nomogram from a multicentre single‐arm, non‐placebo controlled clinical study

Abstract: Patients with longer PD duration, greater baseline PC and basal plaque location had a greater chance of treatment success. These results could be applied to clinical practice before external validation of our nomogram.

Cited by 39 publications

References 25 publications

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

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

Optimizing collagenase Clostridium histolyticum therapy for Peyronie’s disease using a novel approach with percutaneous needle tunnelling

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

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