Status:
COMPLETED
Sham-Controlled Prospective Study Characterizing Erectile Tissue Ultrasound Changes Resulting From Penile LiSWT
Lead Sponsor:
San Diego Sexual Medicine
Conditions:
Erectile Dysfunctions
Eligibility:
MALE
21-80 years
Phase:
NA
Brief 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 ...
Detailed Description
This is a single site sham-controlled clinical trial to be conducted at San Diego Sexual Medicine in San Diego, California. Subjects meeting inclusion and exclusion criteria will be randomized to one ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06600893
Start Date
August 5 2019
End Date
April 7 2023
Last Update
September 19 2024
Active Locations (1)
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1
San Diego Sexual Medicine
San Diego, California, United States, 92120