Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease

Summary

Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH. The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data. Participants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2. The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.

Timeline

Start

2024-10-11

Primary completion

2029-10

Completion

2029-10

Publications

• Background Nguyen HMT, Anaissie J, DeLay KJ, Yafi FA, Sikka SC, Hellstrom WJG. Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute-Phase Peyronie's Disease. J Sex Med. 2017 Oct;14(10):1220-1225. doi: 10.1016/j.jsxm.2017.08.008. Epub 2017 Sep 2.
• Background Larson H, Warner J, Savage J, Kohler T, Ziegelmann M, Trost L. Changes in Point of Maximal Curvature During Collagenase Clostridium Histolyticum Injections for Peyronie's Disease. Urology. 2024 Feb;184:122-127. doi: 10.1016/j.urology.2023.11.024. Epub 2023 Dec 6.
• Background Gelbard M, Lipshultz LI, Tursi J, Smith T, Kaufman G, Levine LA. Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in patients with Peyronie disease. J Urol. 2012 Jun;187(6):2268-74. doi: 10.1016/j.juro.2012.01.032. Epub 2012 Apr 13.
• Background Alom M, Sharma KL, Toussi A, Kohler T, Trost L. Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease. J Sex Med. 2019 Jun;16(6):891-900. doi: 10.1016/j.jsxm.2019.03.007. Epub 2019 Apr 5.
• Background Ziegelmann MJ, Viers BR, Montgomery BD, Westerman ME, Savage JB, Trost LW. Self-reported Clinical Meaningfulness Early in the Treatment Course Predicts Objective Outcomes in Men Undergoing Collagenase Clostridium histolyticum Injections for Peyronie Disease. Urology. 2017 Aug;106:107-112. doi: 10.1016/j.urology.2017.04.045. Epub 2017 May 5.
• Background Ziegelmann MJ, Viers BR, McAlvany KL, Bailey GC, Savage JB, Trost LW. Restoration of Penile Function and Patient Satisfaction with Intralesional Collagenase Clostridium Histolyticum Injection for Peyronie's Disease. J Urol. 2016 Apr;195(4 Pt 1):1051-6. doi: 10.1016/j.juro.2015.10.065. Epub 2015 Oct 23.
• Background Alom M, Meng Y, Sharma KL, Savage J, Kohler T, Trost L. Safety and Efficacy of Collagenase Clostridium Histolyticum in Peyronie's Disease Men With Ventral Curvatures. Urology. 2019 Jul;129:119-125. doi: 10.1016/j.urology.2019.01.055. Epub 2019 Mar 22.

Drugs

Indications