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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06065436
Status
Recruiting
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Conditions

  • Erectile Dysfunction
  • Peyronie Disease

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 19, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy
    Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).
  • Active Comparator: Collagenase Clostridium Histolyticum
    Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.

Primary Outcome Measure

Change in symptom bother [ Time Frame: Baseline, 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905
Wyatt H Anians, CCRP
[email protected]
507-538-6151

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By research site
Mayo Clinic Minnesota· Rochester, MN

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