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Can a shorter workout with a pelvic trainer stop leaks just as well?

NCT ID NCT06152224

Symptom relief Sponsor: University of Wisconsin, Madison 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether using the Leva Pelvic Health System for 8 weeks is as good as using it for 16 weeks to help women with fecal incontinence. About 38 women will use the device and fill out surveys. The goal is to find the shortest effective treatment time.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

38 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

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 years and older

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: * Adult, age ≥ 18years, assigned female at birth * Fecal incontinence, defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment * Able to stand to perform daily training for at least 3 minutes * Able to speak and read English due to Leva smartphone application availability in only English at this time * Have an email address, owns a smartphone, and can download an app Exclusion Criteria: * Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum) * Current diagnosis of colorectal or anal malignancy * Diagnosis of uncontrolled inflammatory bowel disease * Current rectovaginal fistula or cloacal defect * Rectal prolapse (mucosal or full thickness) * Inability to utilize smart phone technology ("app" use) * Chronic Stool Types 6 or 7 * Fecal impaction by exam * Stage 4 pelvic organ prolapse * Concurrent supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback * Presence of sacral neuromodulator * Pelvic floor surgery (including anal sphincteroplasty) within the past 3 months * Currently pregnant

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Conditions

The condition(s) this trial relates to.

Encopresis Fecal Incontinence

As listed by the trial registrant

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

Fecal incontinence

Contacts and locations

Locations

  • University of Wisconsin

    Madison, Wisconsin, 53705, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.