Prostate Stimulation for Sexual Dysfunction | NCT05468931

Studies
Prostate Stimulation for Sexual Dysfunction

NCT05468931

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Jun 3, 2025Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Sexual Dysfunction
Erectile Dysfunction
Delayed Ejaculation
Anorgasmia

Interventions

Prostate stimulator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2024Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Jul 18, 2022

First Submission Date that Met QC Criteria

Jul 18, 2022

First Posted Date

Jul 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2025

Last Update Posted Date

Jun 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prostate stimulation device arm	Experimental	Participants will be asked to use our prostate stimulation device.	Device: Prostate stimulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prostate stimulator	Device	Prostate stimulation device for sexual dysfunction	Prostate stimulation device arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Satvir Basran	Contact	650-723-0948		sbasran@stanford.edu

Overall Officials

Name	Affiliation	Role
Michael Eisenberg, M.D.	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Healthcare, Stanford Hospital	Recruiting	Stanford	California	94304	United States

Condition Browse Module

MeSH Terms

ID	Term
D012735	Sexual Dysfunction, Physiological
D007172	Erectile Dysfunction
D000097910	Ejaculatory Dysfunction

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D005832	Genital Diseases, Male
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided