David J Ralph1, Amr Abdel Raheem2, Genzhou Liu3. 1. Institute of Urology, University College London Hospitals, London, UK. Electronic address: dralph@andrology.co.uk. 2. Institute of Urology, University College London Hospitals, London, UK; Andrology Department, Cairo University Hospital, Cairo, Egypt. 3. Endo Pharmaceuticals, Inc, Malvern, PA, USA.
Abstract
BACKGROUND:Collagenase 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. AIM: To evaluate the efficacy and safety of CCH plus vacuum-pump therapy with and without penile modeling for the management of PD. METHODS:Adult 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. OUTCOMES: The 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). RESULTS: At 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 IMPLICATIONS: Vacuum-pump therapy administered alone or in combination with modeling after CCH treatment could improve PD symptoms. STRENGTHS AND LIMITATIONS: This was a pilot study with a small sample and limited follow-up duration. CONCLUSION:CCH 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. Crown
RCT Entities:
BACKGROUND: Collagenase 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. AIM: To evaluate the efficacy and safety of CCH plus vacuum-pump therapy with and without penile modeling for the management of PD. METHODS: Adult 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. OUTCOMES: The 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). RESULTS: At 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 IMPLICATIONS: Vacuum-pump therapy administered alone or in combination with modeling after CCH treatment could improve PD symptoms. STRENGTHS AND LIMITATIONS: This was a pilot study with a small sample and limited follow-up duration. CONCLUSION: CCH 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. Crown
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