Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease

Not Applicable

Recruiting

• Conditions: Peyronie Disease; Erectile Dysfunction
• Interventions: Drug: Collagenase Clostridium Histolyticum; Device: Storz Duolith LiSWT

• Registration Number: NCT06065436
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-04
• Study Start: 2024-01-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• Prior intralesional injections or surgery for PD.
• Severe baseline penile pain.
• Moderate or severe baseline ED based on IIEF-EF domain.
• History of low intensity shockwave therapy for sexual dysfunction (ED or PD).
• Ventral (downward) or ventrolateral penile curvature.
• Moderate or severe (grade 2/3) plaque calcification as determined by PDDU.
• Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy	Storz Duolith LiSWT	Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).
Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy	Collagenase Clostridium Histolyticum	Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).
Collagenase Clostridium Histolyticum	Collagenase Clostridium Histolyticum	Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.

Primary Outcome Measures

Name	Time	Method
Change in symptom bother	Baseline, 6 weeks	Measured using the validated Peyronie's Disease Questionnaire (PDQ) subdomain symptom bother. Four questions to evaluate pain or discomfort during vaginal intercourse: responses include "not at all bothered", "a little bit bothered" , "moderately bothered", "very bothered", "extremely bothered"
Change in Erectile Function Domain (IIEF-EF)	Baseline, 6 weeks
Change in erectile function	Baseline, 6 weeks	Measured using the International Index of erectile Function
Change in penetrative sexual intercourse	Baseline, 6 weeks	Measured using self-reported question: "Over the past 4 weeks: When you attempted intercourse, how often were you able to penetrate (enter) your partner?" Responses include "no sexual activity", "almost never or never" , "a few times (less than half the time)", "sometimes (about half the time)", "Most times (more than half the time)", "almost always or always.
Surgical straightening intervention	6 weeks	Number of subjects to require surgical straightening

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States