Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
NCT ID: NCT06065436
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-01-19
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).
Collagenase Clostridium Histolyticum
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
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
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.
Collagenase Clostridium Histolyticum
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.
Interventions
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Collagenase Clostridium Histolyticum
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Tobias S. Kohler, MD, MPH
Principal Investigator
Principal Investigators
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Tobias Kohler, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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23-002478
Identifier Type: -
Identifier Source: org_study_id
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