Back to resultsConcurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Primary Purpose
Peyronie Disease, Erectile Dysfunction
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collagenase Clostridium Histolyticum
Storz Duolith LiSWT
Sponsored by
About this trial
This is an interventional treatment trial for Peyronie Disease
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy
Collagenase Clostridium Histolyticum
Arm Description
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.
Outcomes
Primary Outcome Measures
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"
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.
Surgical straightening intervention
Number of subjects to require surgical straightening
Change in erectile function
Measured using the International Index of erectile Function
Change in Erectile Function Domain (IIEF-EF)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06065436
Brief Title
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Official Title
Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie Disease, Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy
Arm Type
Experimental
Arm Description
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).
Arm Title
Collagenase Clostridium Histolyticum
Arm Type
Active Comparator
Arm Description
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.
Intervention Type
Drug
Intervention Name(s)
Collagenase Clostridium Histolyticum
Other Intervention Name(s)
Xiaflex
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Storz Duolith LiSWT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in symptom bother
Description
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"
Time Frame
Baseline, 6 weeks
Title
Change in penetrative sexual intercourse
Description
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.
Time Frame
Baseline, 6 weeks
Title
Surgical straightening intervention
Description
Number of subjects to require surgical straightening
Time Frame
6 weeks
Title
Change in erectile function
Description
Measured using the International Index of erectile Function
Time Frame
Baseline, 6 weeks
Title
Change in Erectile Function Domain (IIEF-EF)
Time Frame
Baseline, 6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wyatt H Anians, CCRP
Phone
507-538-6151
Email
Anians.Wyatt@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kohler, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
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