Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New study tests simple exercises and gadget to stop Post-Baby leaks

NCT ID NCT06411158

Symptom relief Sponsor: NICHD Pelvic Floor Disorders Network 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests two non-surgical approaches to reduce urinary leakage in new mothers. About 216 women who recently gave birth and have bothersome leakage will either do guided pelvic floor exercises, use a home biofeedback device called leva®, or receive standard education. The goal is to see which approach works best at 6 months after birth.

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 muscle training and home biofeedback device (leva®)
What this could lead to
If successful, this could provide effective, non-surgical options for new mothers to reduce bothersome urinary leakage after childbirth.
What could go wrong
This is a relatively small, early-stage trial comparing two active interventions to education alone. Results may not apply to all women, and the home devices may not work for everyone.

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 216 people

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

Started

Nov 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: 1. ≥18yo primiparous patient s/p singleton vaginal delivery (\>32 weeks), approximately 6wk postpartum 2. At increased risk of sustained pelvic floor disorders, as defined by 1. neonate ≥3.5kg, and/or 2. operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or 3. ≥2nd-degree perineal laceration 3. Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF. Exclusion Criteria: 1. Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up 2. Stillbirth or significant maternal or neonatal illness 3. Non-English or non-Spanish speaking 4. Perineal wound breakdown or cloaca observed on exam 5. Severe pain with assessments of PFM integrity and/or strength/function 6. Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor 7. Unwilling or unable to upload and use external smartphone app(s)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Delivery complication are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Encopresis Pelvic Floor Disorders Urinary Incontinence

As listed by the trial registrant

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

Delivery complication Urinary incontinence

How to take part

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

  1. The places running it

    7 sites. 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

  • Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

    RECRUITING

    Durham, North Carolina, 27707, United States

  • Kaiser Permanente -- San Diego

    RECRUITING

    San Diego, California, 92110, United States

  • University of California - San Diego

    RECRUITING

    San Diego, California, 92121, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

More trials for these conditions

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