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AI may predict which pelvic floor therapy works best

NCT ID NCT06461234

Knowledge-focused Sponsor: Mingfu Wu Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study will follow 1,360 Chinese women with pelvic floor disorders, such as postpartum weakness or mild to moderate prolapse, as they receive one of three rehabilitation treatments: pelvic floor muscle training, biofeedback electrical stimulation, or magnetic stimulation. Researchers will collect data on symptoms, muscle strength, and electrical activity before, during, and up to a year after treatment. The goal is to build an AI model that can predict which therapy is most effective for each individual and identify early warning signs of pelvic floor dysfunction.

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, biofeedback electrical stimulation, and magnetic stimulation
What this could lead to
If successful, this could lead to personalized pelvic floor rehabilitation plans for Chinese women, improving treatment outcomes and quality of life.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The results may not apply to all populations, and the AI model needs validation before clinical use.

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.

Participants

About 1,360 people

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

Started

May 2024

Expected to finish

Nov 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.

Who is studied

This study is aimed at female patients with pelvic floor dysfunction. A large group of people are women who develop reduced pelvic floor muscle strength after childbirth; these women may not present with organic changes in the pelvic organs, but may present with symptoms such as unsatisfactory sexual behaviour and stress urinary incontinence as a result of weakened muscle strength. The other part of the population is patients with mild to moderate pelvic organ prolapse, where physical examination may reveal mild to moderate prolapse of the anterior vaginal wall, uterus, or posterior vaginal wall. If this group of patients had a combination of urinary and gastrointestinal symptoms, they could also be included in the study.

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. knowledge of the study, voluntary enrolment in the study, and signing of informed consent; 2. postpartum pelvic floor weakness (pelvic floor muscle strength less than grade 3), or mild to moderate pelvic organ prolapse (POP-Q staging less than stage III), or pelvic organ prolapse combined with dysfunction (bowel or bladder dysfunction). Exclusion Criteria: 1. history of comorbid serious medical or surgical illness; 2. comorbid psychiatric disorders; 3. contraindications to electrical and magnetic stimulation such as implanted pacemakers; 4. pelvic malignancy, acute genitourinary infection or vaginal bleeding, and genital tract malformation.

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Conditions

The condition(s) this trial relates to.

Pelvic Floor Disorders pelvic organ prolapse

As listed by the trial registrant

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

Pelvic floor disorders Pelvic organ prolapse

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

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Contacts and locations

Locations

  • Tongji hospital

    RECRUITING

    Wuhan, Hubei, 430030, China

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