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

NCT06065436 | Recruiting FDA Device

• 1 other identifier: 23-002478
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peyronie Disease; Erectile Dysfunction

Outcome Measures

Primary Outcomes (5)

• Change in symptom bother

  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"

  Baseline, 6 weeks

• Change in penetrative sexual intercourse

  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.

  Baseline, 6 weeks

• Surgical straightening intervention

  Number of subjects to require surgical straightening

  6 weeks

• Change in erectile function

  Measured using the International Index of erectile Function

  Baseline, 6 weeks

• Change in Erectile Function Domain (IIEF-EF)

  Baseline, 6 weeks

Study Arms (2)

Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy

EXPERIMENTAL

Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).

Drug: Collagenase Clostridium Histolyticum; Device: Storz Duolith LiSWT

Collagenase Clostridium Histolyticum

ACTIVE COMPARATOR

Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.

Drug: Collagenase Clostridium Histolyticum

Interventions

Collagenase Clostridium Histolyticum DRUG

Total of 8 Intralesional injection (0.90 mg), administered as four separate injection series. Within each series, subjects will receive two injections, administered approximately 1-7 days apart.

Also known as: Xiaflex

Collagenase Clostridium Histolyticum; Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy

Storz Duolith LiSWT DEVICE

Single low intensity shockwave therapy consistent of 1,500 shocks at a rate of 120 shocks/minute and using a power setting of 0.09 mJ/mm2. These treatments will occur four separate times, before each of the four separate CCH injection series.

Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with PD
• Palpable penile plaque
• Dorsal, lateral, or dorsolateral penile curvature
• Penile curvature \> 30 degrees and \< 90 degrees as measured using goniometer during objective curvature assessment
• Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)
• "Stable PD symptoms' defined as PD symptom duration \> 6-months or stable symptoms \> 3-months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Penile Induration; Erectile Dysfunction

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Tobias Kohler, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wyatt H Anians, CCRP

CONTACT

507-538-6151; Anians.Wyatt@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 4, 2023
• Study Start: January 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)