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

NCT05646602 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-10-10

No results posted yet for this study

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

Interventions

DRUG

Collagenase Clostridium Histolyticum

Intralesional injection

DEVICE

Duolith SD1 T-TOP

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

Sponsors & Collaborators

Principal Investigators

  • Tobias Kohler, MD, MPH · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646602 on ClinicalTrials.gov