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Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain

NCT05868668 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-01-21

No results posted yet for this study

Summary

The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.

Conditions

  • Erectile Dysfunction Due to Arterial Insufficiency
  • Erectile Dysfunction
  • Erectile Dysfunction Due to Arterial Disease
  • Chronic Pelvic Pain Syndrome
  • Chronic Prostatitis
  • Erectile Dysfunction Following Radical Prostatectomy
  • Erectile Dysfunction Following Radiation Therapy

Interventions

DEVICE

Focused shockwave

Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)

DEVICE

Radial wave

Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)

DEVICE

Sham treatment

Handheld sham probe

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Petar Bajic, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05868668 on ClinicalTrials.gov