NCT05468931

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Apr 2024Jun 2026

First Submitted

Initial submission to the registry

July 18, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 18, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

2.1 years

First QC Date

July 18, 2022

Last Update Submit

May 28, 2025

Conditions

Sexual DysfunctionErectile DysfunctionDelayed EjaculationAnorgasmia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Prostate stimulation device arm

EXPERIMENTAL

Participants will be asked to use our prostate stimulation device.

Device: Prostate stimulator

Interventions

Prostate stimulatorDEVICE

Prostate stimulation device for sexual dysfunction

Prostate stimulation device arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males \>18 years of age suffering from sexual dysfunction

You may not qualify if:

  • Individuals who have had a prostatectomy - removal of prostate
  • Inability to operate the device for any reason
  • Females
  • Males \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Healthcare, Stanford Hospital

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalErectile DysfunctionEjaculatory Dysfunction

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, MaleMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Michael Eisenberg, M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Satvir Basran

CONTACT

650-723-0948sbasran@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 21, 2022

Study Start

April 18, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

June 3, 2025

Record last verified: 2025-05

Locations

US(1)