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

Completed · Not applicable · Has a placebo group

Conditions studied: Erectile Dysfunctions

In brief

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?

Key facts

Study ID: NCT06600893
Run by: San Diego Sexual Medicine
People needed: 35
Starts: 2019-08-05
Expected to finish: 2023-04-07
Last updated by the study team: 2024-09-19

Who can join

Age: 21 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
Subject is male;
Subject is aged 21-80 years;
Subject is in a relationship with a female partner for at least 3 months;
Subject has a body mass index (BMI) \< 37 kg/m2;
Subject has erectile dysfunction;
Subject has testosterone ≥ 300;
Subject has a prostate specific antigen (PSA) \< 4.0;
Subject is willing to attempt sexual activity at least 4 times during the screening period and 4 weeks before each follow-up visit;
Subject is willing to stop all erectile function aids (e.g. prescription and non-prescription medications, injections, vacuum erection devices, constriction ring) during the screening period and 4 weeks before each follow-up visit;
Subject agrees to comply with the study procedures and visits.

You may not qualify if…

Subject has been treated with acoustic wave previously;
Subject has a pacemaker or implanted defibrillator;
Subject has clinically significant findings on physical examination;
Subject has sciatica or severe back pain;
Subject has uncontrolled hypertension;
Subject has uncontrolled hypogonadism;
Subject is unwilling to maintain testosterone replacement therapy if currently using testosterone to treat hypogonadism;
Subject scores ≥ 26 on the IIEF;
Subject has homogenous corpora cavernosa on grey scale ultrasound;
Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes him ineligible for the study;
Subject has lesions or active infections on the penis or perineum;
Subject is unwilling to remove piercings from the genital region;
Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week;
Subject has received an investigational drug within 30 days prior to signing consent;
Subject has received platelet rich plasma (PRP) within 3 months of signing consent;
Subject has received stem cell within 6 months of signing consent;
Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.

Where it is running

San Diego Sexual Medicine — San Diego, California, United States

Full record on ClinicalTrials.gov

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