Sexual DysfunctionNCT05468931
Prostate Stimulation for Sexual Dysfunction
A study testing Prostate stimulator in people with Sexual Dysfunction and Erectile Dysfunction, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sexual Dysfunction, Erectile Dysfunction, Delayed Ejaculation
- What is being tested?
- Prostate stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males >18 years of age suffering from sexual dysfunction
Who cannot join
- Individuals who have had a prostatectomy - removal of prostate
- Inability to operate the device for any reason
- Females
- Males <18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Healthcare, Stanford Hospital
Stanford, California, 94304
Satvir Basran, 650-723-0948, sbasran@stanford.edu
About this study
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.
Read the 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).
- Being tested
- Prostate stimulator
- Medical subject headings
- Sexual Dysfunction, Physiological, Erectile Dysfunction, Ejaculatory Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate stimulatorDevice
Prostate stimulation device for sexual dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Prostate stimulation device arm | Experimental | Participants will be asked to use our prostate stimulation device. Receives: Device: Prostate stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in modified International Index of Erectile Dysfunction score
score 0 to 30 with higher score meaning better erectile function
Measured: baseline and up to 1 month post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start18 Apr 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Eisenberg, Stanford University
- Investigators
- Michael Eisenberg, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468931
- Sponsor's protocol ID
- 65918
- Status last verified
- May 2025
- First submitted
- 18 Jul 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Stimulation for Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT05468931
- Acronym / sponsor ID
- 65918
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate stimulation device arm | Experimental | Device: Prostate stimulatorParticipants will be asked to use our prostate stimulation device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males >18 years of age suffering from sexual dysfunction
Key exclusion criteria (4 listed)
- Individuals who have had a prostatectomy - removal of prostate
- Inability to operate the device for any reason
- Females
- Males <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate stimulatorProstate stimulation device for sexual dysfunction | Device | Prostate stimulation device arm |
Primary outcome
change in modified International Index of Erectile Dysfunction score
Time frame: baseline and up to 1 month post-baseline
score 0 to 30 with higher score meaning better erectile function
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Eisenberg, M.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate stimulator in people with Sexual Dysfunction and Erectile Dysfunction, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Satvir Basran (650-723-0948, sbasran@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in modified International Index of Erectile Dysfunction score (time frame: baseline and up to 1 month post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.