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NCT05468931 Clinical Trial

Prostate Stimulation for Sexual Dysfunction

Erectile Dysfunction Clinical Trial

Official title:
Prostate Stimulation for Sexual Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05468931
Other study ID # 65918
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2024
Est. completion date June 1, 2025

Study information
Verified date March 2024
Source Stanford University
Contact Satvir Basran
Phone 650-723-0948
Email sbasran@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to use a device to stimulate the prostate with a goal of helping improve symptoms in men with sexual dysfunction.

Description:

The purpose of the study is to use a device to stimulate the prostate. The goal of this is to help men with sexual dysfunction. Sexual dysfunction can include conditions like delayed ejaculation (e.g.takes more than 21 minutes to climax) and can hopefully assist them in achieving faster time to ejaculation (e.g. closer to the median of 5.4 minutes in a "normal" individual) along with erectile dysfunction (e.g. the inability to achieve and sustain an erection).

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males >18 years of age suffering from sexual dysfunction Exclusion Criteria: - Individuals who have had a prostatectomy - removal of prostate - Inability to operate the device for any reason - Females - Males <18 years of age

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Prostate stimulator
Prostate stimulation device for sexual dysfunction

Locations
Country Name City State
United States Stanford Healthcare, Stanford Hospital Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in modified International Index of Erectile Dysfunction score score 0 to 30 with higher score meaning better erectile function baseline and up to 1 month post-baseline
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