NCT06065436NARecruiting
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Mayo Clinic
Start Date
1/19/2024
Completion Date
1/1/2027
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
Age Range: 18 years to No maximum
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.
Interventions
DRUG
Collagenase Clostridium Histolyticum
DEVICE
Storz Duolith LiSWT
Conditions
Peyronie DiseaseErectile Dysfunction
Locations
Mayo Clinic Minnesota
Rochester, Minnesota 55905
United States