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Sham-Controlled Prospective Study Characterizing Erectile Tissue Ultrasound Changes Resulting From Penile LiSWT

NCT06600893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-09-19

No results posted yet for this study

Summary

The primary goal of this single blind, prospective sham-controlled clinical trial is to assess safety and efficacy of low intensity shockwave therapy (LiSWT) to improve erectile function in men 21-80 years of age with erectile dysfunction naive to radial ballistic acoustic wave and LiSWT. The main questions it aims to answer are:

* Does homogeneity/inhomogeneity of corporal cavernosal tissue improve using Grayscale ultrasound (GUS) when comparing sham to active treatment groups?
* Do peak systolic velocity (PSV) and end diastolic velocity (EDV) improve using color duplex Doppler ultrasound when comparing sham to active treatment groups?
* Do the International Index of Erectile Function (IIEF), its erectile function domain (IIEF-EF) and question 3 of the Sexual Encounter Profile (SEP) improve comparing sham to active treatment groups?

Conditions

  • Erectile Dysfunctions

Interventions

DEVICE

Low intensity shockwave therapy (LiSWT)

The Urogold100™ uses electrohydraulic technology to generate low intensity shockwave energies in ranges of 0.1 - 0.18 mJ/mm2 (using 0.9 - 0.12 mJ/mm2 in this study) associated with biologic activities of stimulation of mechanosensors, activation of neo-angiogenesis processes, recruitment and activation of stem cell progenitor cells, improvement of microcirculation, nerve regeneration, remodeling of erectile tissue with increase in the muscle/collagen ratio and reducing inflammatory and cellular stress responses. The device uses the parabolic applicator OP 155 that generates a plasma-driven detonation resulting in a shockwave with a broad and widely-stretched 5 megapascal therapeutic volume. Due to the absence of a concentrated focus, a 14 mm wide shockwave is delivered to the erectile tissue with up to 30 mm penetration. LiSWT is delivered to Active Arms 1 and 2 per protocol. After unblinding at the first follow up visit, participants in Sham Arms 1 and 2 receive active LiSWT treatment

DEVICE

Sham

With the Urogold 100 turned on and with the participant wearing headphones and blinded by a pulled curtain the applicator is applied in a similar manner to when it is active treatment and the sound of shockwave playing in a blue tooth speaker the participant believes he is receiving active treatment but zero energy is delivered.

Sponsors & Collaborators

  • San Diego Sexual Medicine

    lead OTHER

Principal Investigators

  • Irwin Goldstein, MD · San Diego Sexual Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2022-06-22
Completion
2023-04-07
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06600893 on ClinicalTrials.gov