Status:
RECRUITING
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Lead Sponsor:
Mayo Clinic
Conditions:
Peyronie Disease
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- • 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
- 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.
Exclusion
Key Trial Info
Start Date :
January 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06065436
Start Date
January 19 2024
End Date
January 1 2027
Last Update
January 7 2026
Active Locations (1)
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1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905