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

Erectile Dysfunction Clinical Trial

Official title:

Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065436
• Other study ID #: 23-002478
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Wyatt H Anians, CCRP
• Phone: 507-538-6151
• Email: Anians.Wyatt[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Penile Induration
• Peyronie Disease

Intervention

Drug:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Surgical straightening intervention	Number of subjects to require surgical straightening	6 weeks
Primary	Change in erectile function	Measured using the International Index of erectile Function	Baseline, 6 weeks
Primary	Change in Erectile Function Domain (IIEF-EF)		Baseline, 6 weeks