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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peyronie Disease, Erectile Dysfunction

Intervention / Treatment
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* Drug: Collagenase Clostridium Histolyticum
* Device: Storz Duolith LiSWT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy<br>Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT). | Drug: Collagenase Clostridium Histolyticum<br>* 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.<br>* Other names: Xiaflex;Device: Storz Duolith LiSWT<br>* 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.<br>|
| Active Comparator: Collagenase Clostridium Histolyticum<br>Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care. | Drug: Collagenase Clostridium Histolyticum<br>* 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.<br>* Other names: Xiaflex;|

What is the study measuring?
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Primary Outcome Measures

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