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Pelvic floor therapy tested as new fix for ED and premature ejaculation

NCT ID NCT06425211

Symptom relief Sponsor: Boston Medical Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether pelvic floor therapy—a mix of exercises, biofeedback, and mild electrical stimulation—can help men with erectile dysfunction and/or premature ejaculation. Sixty-six men will be split into three groups based on their condition and will receive the therapy over several sessions. Researchers will measure changes in ejaculation timing and erectile function right after treatment and again at 3 and 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pelvic floor therapy (therapeutic exercises, biofeedback, electrical stimulation)
What this could lead to
If it works, this could offer a non-drug, non-surgical option to help men with erectile dysfunction or premature ejaculation improve their symptoms.
What could go wrong
This is a small, early-stage trial with only 66 participants and no comparison group, so results may not apply to everyone. The therapy requires multiple sessions and may not work for all causes of these conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Overall: * Men over 18 years of age * Erectile dysfunction or premature ejaculation for at least 6 months * Sexual activity with a heterosexual partner at least once a week * Signing of informed consent before the start of the study For the premature ejaculation group: * Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria * Premature Ejaculation Diagnosis Tool (PEDT) questionnaire score greater than 11 For the erectile dysfunction group: * Clinical diagnosis of primary erectile dysfunction * International Index Erectile Function - Erectile Function domain (IIEF-EF) score less than 26 Exclusion Criteria: * Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months * Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction * History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction * History of pelvic radiotherapy * Pacemaker or cardiac arrhythmia, epilepsy * History of spinal cord trauma or spinal surgeries. * Inability to attend therapies or controls * Illiteracy or cognitive disability that prevents you from completing the questionnaires * Psychiatric, psychological disorders, or cognitive deficiencies * Injuries in the area of application of the therapy * Active pelvic organ cancer

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Conditions

The condition(s) this trial relates to.

Asthenia erectile dysfunction Premature Birth premature ejaculation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction Pelvic floor; weak Premature (early) ejaculation Premature ejaculation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Medical Group Colombia

    RECRUITING

    Bogotá, Cundinamarca, 11022, Colombia

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