Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction

Recruiting now

Conditions studied: Pelvic Floor Disorders, Pelvic Organ Prolapse

In brief

The goal of this observational study is to learn about the therapeutic effects of different pelvic floor rehabilitation treatments, including pelvic floor muscle training , pelvic floor biofeedback electrical stimulation, and magnetic stimulation, in a population of Chinese patients with female pelvic floor dysfunction disorders. The study aims to find out the individualised pelvic floor rehabilitation treatment plan suitable for the Chinese population. The main question it aims to answer is: 1. Do patients with reduced pelvic floor muscle strength after childbirth, or patients with mild to moderate pelvic organ prolapse and symptomatic pelvic organ prolapse benefit from pelvic floor rehabilitation? 2. Is the combination of biofeedback electrical stimulation plus pelvic floor magnetic stimulation superior to single electrical stimulation, magnetic stimulation or pelvic floor muscle training? 3. Which pelvic floor rehabilitation therapy is most suitable for Chinese patients with female pelvic floor dysfunction? 4. What factors are early predictors of developing female pelvic floor dysfunction? And what factors can predict the prognostic status of patients treated with pelvic floor rehabilitation? Participants in the multicenter will be treated with different rehabilitation therapies, during which the researchers will collect clinical symptoms using the PFDI20 questionnaire, and POP-Q scores, pelvic floor muscle strength, and electromyography results from participants before, at the end of, and 3 months and 1 year after the end of treatment.

Key facts

Study ID

NCT06461234

Run by

Mingfu Wu

People needed

1360

Starts

2024-05-20

Expected to finish

2026-11-30

Last updated by the study team

2025-08-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• knowledge of the study, voluntary enrolment in the study, and signing of informed consent;
• 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).

You may not qualify if…

• history of comorbid serious medical or surgical illness;
• comorbid psychiatric disorders;
• contraindications to electrical and magnetic stimulation such as implanted pacemakers;
• pelvic malignancy, acute genitourinary infection or vaginal bleeding, and genital tract malformation.

Where it is running

• Tongji hospital — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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