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LiSWT for Men With Erectile Dysfunction

NCT06469775 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-04-11

No results posted yet for this study

Summary

The goal of this a clinical trial to investigate the effect of low-intensity shock wave therapy on patients with erectile function. The main questions it aims to answer are:

1. Can low-intensity shock wave therapy (LiSWT) to the penis improve male sexual health, particularly erectile function?
2. What is the optimal LiSWT protocol (number of shocks, energy delivered, timeline, etc) for initial and maintenance therapy?

Researchers will compare validated questionnaires on erectile function in men treated with LiSWT compared to men who receive standard of care to see if there is an improvement in erectile function with LiSWT.

Participants will be asked to complete questionnaires at each visit. Those who choose to undergo LiSWT will receive 6 sessions, once per week.

Conditions

Interventions

DEVICE

Low intensity shock wave

6 sessions of low intensity shock wave therapy, applied in 15 minute appointments once weekly.

COMBINATION_PRODUCT

Control

Standard of care treatment: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, and penile implant.

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Danielle Velez Leitner, MD · Rutgers Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2029-09-01
Completion
2031-09-01
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 NCT06469775 on ClinicalTrials.gov