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

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06065436
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Collagenase Clostridium Histolyticum
  • Device: Storz Duolith LiSWT
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy

Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).

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.
Other Names:
  • Xiaflex

    • 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.
    Active Comparator: Collagenase Clostridium Histolyticum

    Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.

    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.
    Other Names:
  • Xiaflex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in symptom bother [Baseline, 6 weeks]

      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"

    2. Change in penetrative sexual intercourse [Baseline, 6 weeks]

      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.

    3. Surgical straightening intervention [6 weeks]

      Number of subjects to require surgical straightening

    4. Change in erectile function [Baseline, 6 weeks]

      Measured using the International Index of erectile Function

    5. Change in Erectile Function Domain (IIEF-EF) [Baseline, 6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Minnesota Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Tobias Kohler, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Tobias S. Kohler, MD, MPH, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT06065436
    Other Study ID Numbers:
    • 23-002478
    First Posted:
    Oct 4, 2023
    Last Update Posted:
    Oct 4, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Penile Induration

    Study Results

    No Results Posted as of Oct 4, 2023