Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction

NCT05646602 | Withdrawn FDA Device

• 1 other identifier: 22-001663
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine the pure or additional effects of penile shockwave therapy with low intensity linear shock wave machine for penile curvature (and/or erectile dysfunction) vs patients' undergoing other treatments (including Xiaflex therapy, patients that have undergone older generations of SWT, or medical treatment).

Conditions

Peyronie Disease; Penile Curvature; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in penile curvature

  Measured with a goniometer after artificial erection reported in degree unit of measurements

  Baseline, 10 weeks

Secondary Outcomes (3)

• Change in Sexual function

  Baseline, 10 weeks

• Change in penile length

  Baseline, 10 weeks

• Li-SWL related pain at therapy sessions

  6 weeks

Study Arms (4)

Collagenase Clostridium Histolyticum with LiSWT for PD Group

EXPERIMENTAL

Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT).

Drug: Collagenase Clostridium Histolyticum; Device: Duolith SD1 T-TOP

Collagenase Clostridium Histolyticum for PD Group

ACTIVE COMPARATOR

Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection

Drug: Collagenase Clostridium Histolyticum

Radial Shockwave Therapy for ED Group

ACTIVE COMPARATOR

Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.

Device: Duolith SD1 T-TOP

Linear Shockwave Therapy for ED Group

EXPERIMENTAL

Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy

Device: Duolith SD1 T-TOP

Interventions

Collagenase Clostridium Histolyticum DRUG

Intralesional injection

Also known as: Xiaflex

Collagenase Clostridium Histolyticum for PD Group; Collagenase Clostridium Histolyticum with LiSWT for PD Group

Duolith SD1 T-TOP DEVICE

Delivers low-intensity shockwave therapy, six sessions (once/week) of 2000 shockwaves per session with a constant energy flux density of 0.29 mJ/mm2 and frequency of 3 Hz

Collagenase Clostridium Histolyticum with LiSWT for PD Group; Linear Shockwave Therapy for ED Group; Radial Shockwave Therapy for ED Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peyronie's Disease (PD) at any stage
• The presence of penile plaque or pain at erection or curvature
• PD therapy with or without simultaneous intralesional Xiaflex injection.

You may not qualify if:

• Prior penile surgery or LiSWT.
• Erective Dysfunction (ED) not responding to phosphodiesterase-type five inhibitors or intracavernosal injections.
• Unwillingness or inability to provide informed consent.
• Having active or life-threatening coagulopathies ore using anti-coagulation /anti-platelet medications

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Penile Induration; Erectile Dysfunction

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Tobias Kohler, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Following enrollment men will be randomized based on the severity of their penile curvature. Separate randomization tables will be established for men with penile curvature (i) 30 to \< 60 degrees and (ii) 60-90 degrees. Patients will be randomized in a 1:1 ratio to CCH + LiSWT versus CCH alone within each severity cohort, with the intention to enroll a similar number of patients within each severity group

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)