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Shoes that train your pelvic floor without you knowing

NCT ID NCT03194789

Symptom relief Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether wearing shoes with small pods that disturb balance and gait can help reduce stress urinary incontinence in women. The shoes are designed to trigger pelvic muscle contractions automatically, similar to exercises that stabilize the lower back and pelvis. Sixty-four women will receive the shoes plus traditional pelvic floor therapy for six months. The study measures changes in symptom severity and quality of life.

What this could mean

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

Active substance
Shoes with pertupods (footwear that creates balance and gait perturbations) plus traditional pelvic floor therapy
What this could lead to
If it works, this could offer a low-effort way to reduce urine leakage by using specially designed shoes alongside standard pelvic floor exercises.
What could go wrong
This is a small, early study with no published results yet. The shoes may not improve symptoms more than pelvic floor therapy alone, and some women may find the footwear uncomfortable or inconvenient.

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

64 people

The number who actually took part.

Started

Nov 2017

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 years

Sex

Female 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: * Stress or Mixed Urinary Incontinence, based on UDI-6. * Females between the ages of 18-75 years. * Weight less than 350 lbs. * Ambulatory and active patients that can participate in a rehabilitation program that includes daily walking * Able to walk at least 50 meters and scored positive on the STEADI test * Able to understand, read and sign the informed consent form * English or Spanish speaking Exclusion Criteria: * Prior surgery for incontinence * Pelvic Floor Therapy within past 6 months. * Currently pregnant * Predominantly Urge Incontinence. * Patients with more than 3 falls in the last 52 weeks, OR any balance related fall with an injury in the last 52 weeks. * Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure. * Patients with a history of pathological osteoporotic fracture * Any major cardiovascular comorbidities prohibiting enrollment in an active exercise program * Active heart disease (ischemia or heart failure admissions within 24 weeks) and Active COPD (exacerbation within 24 weeks) * Active malignancies on ongoing treatment * Patient with neurological gait pattern. * Patient requiring assistive device during gait analysis.

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Conditions

The condition(s) this trial relates to.

female stress incontinence Pelvic Floor Disorders Urinary Incontinence, Stress

As listed by the trial registrant

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

Pelvic floor disorders Stress urinary incontinence

Contacts and locations

Locations

  • Montefiore Medical Center - Medical Park Campuses

    The Bronx, New York, 10461, United States

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