Back to resultsProstate Stimulation for Sexual Dysfunction
Primary Purpose
Sexual Dysfunction, Erectile Dysfunction, Delayed Ejaculation
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostate stimulator
Sponsored by
About this trial
This is an interventional other trial for Sexual Dysfunction
Eligibility Criteria
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
Sites / Locations
- Stanford Healthcare, Stanford Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prostate stimulation device arm
Arm Description
Participants will be asked to use our prostate stimulation device.
Outcomes
Primary Outcome Measures
change in modified International Index of Erectile Dysfunction score
score 0 to 30 with higher score meaning better erectile function
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05468931
Brief Title
Prostate Stimulation for Sexual Dysfunction
Official Title
Prostate Stimulation for Sexual Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Erectile Dysfunction, Delayed Ejaculation, Anorgasmia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prostate stimulation device arm
Arm Type
Experimental
Arm Description
Participants will be asked to use our prostate stimulation device.
Intervention Type
Device
Intervention Name(s)
Prostate stimulator
Intervention Description
Prostate stimulation device for sexual dysfunction
Primary Outcome Measure Information:
Title
change in modified International Index of Erectile Dysfunction score
Description
score 0 to 30 with higher score meaning better erectile function
Time Frame
baseline and up to 1 month post-baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satvir Basran
Phone
650-723-0948
Email
sbasran@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Eisenberg, M.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Healthcare, Stanford Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satvir Basran
Phone
650-723-0948
Email
sbasran@stanford.edu
12. IPD Sharing Statement
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Prostate Stimulation for Sexual Dysfunction
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