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

Официальное название

Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease

Обзор

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.

Подробное описание

The current study would prospectively follow 40 men through the following treatment protocol:

* Men would receive 4 series of CCH injections according to the protocol below, which represents a modified version of our most recently published technique.13

* Medication administered on back-to-back days * Total of 0.9 mg administered with each series, diluted to 0.8 mL * Mild in-office modeling performed on treatment day 2 of each series * Wraps performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising * Sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series. * Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final series. * Note that men may stop sooner if they are satisfied before completing the 4 series. * If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol.

* This would be performed 9-12 months after the 4th series of injections. * The technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial. * The men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total.

At the time of initial enrollment, partners of study participants will be invited to enroll in the study and will be administered non-validated questionnaires designed to assess the partner's overall support for the ongoing treatment protocol.

Assessments and study questionnaires will be administered at baseline, with the 1st injection of each series, 6 weeks after completing the 4th series of CCH injections, and 1 year after completion of the final series of CCH injections.

Вмешательства

• Препарат Collagenase Clostridium Histolyticum
  4 Series given to each participant, 6 weeks apart. Medication administered on back-to-back days. If failing to achieve an adequate response, men may receive up to 2 additional series 9-12 months after the 4th series. Total of 0.9 mg administered with each series, diluted to 0.8 mL
• Устройство RestoreX
  Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final CCH series.
• Препарат Sildenafil
  Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.

Первичные конечные точки

• Penile Curvature [Срок оценки: 1 year]
• Penile Length [Срок оценки: 1 year]

Вторичные конечные точки (9)

• Penile curvature compared to more aggressive technique [Срок оценки: 1 year]
• Penile curvature compared to our current salvage approach for CCH [Срок оценки: 1 year]
• Adverse Events [Срок оценки: 1 year]
• Partner Support [Срок оценки: 1 year]
• Compliance with Therapy - Penile Curvature [Срок оценки: 1 year]
• Satisfaction with therapy [Срок оценки: 1 year]
• Penile length compared to more aggressive technique [Срок оценки: 1 year]
• Penile length compared to our current salvage approach for CCH [Срок оценки: 1 year]
• Compliance with Therapy - Penile Length [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Men with Peyronie's Disease
• Older than 18 years old
• Curvature ≥30 degrees
• Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors
• The patient exhibits a palpable plaque consistent with Peyronie's Disease
• For partners, the only inclusion criteria is being willing to complete a questionnaire

Критерии исключения

• Prior surgical treatment on the penis (other than circumcision)
• Prior treatment with CCH injections
• Any contraindications to CCH - as determined by the PI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Male Fertility and Peyronie's Clinic — Orem

Публикации

• 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. PMID 28874331
• 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. PMID 38061610
• 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. PMID 22503048
• 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. PMID 30956106
• 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. PMID 28483591
• 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. PMID 26476353
• 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. PMID 30910455

Идентификаторы

NCT: NCT06649539 · CUREPD120

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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