Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction
NCT06461234 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1360
Last updated 2025-08-01
Summary
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.
Conditions
- Pelvic Floor Disorders
- Pelvic Organ Prolapse
Interventions
- BEHAVIORAL
-
Pelvic floor muscle training
A therapist will instruct the patient to contract the anus, perineum as well as the urethra, until the patient masters the correct method.
- OTHER
-
Biofeedback electrical stimulation
The therapist will place the electrodes of the instrument into the vagina, adjust the current value until the woman feels obvious contraction of the pelvic floor muscles but no pain, and instructs the patient to refer to the biofeedback mode for vaginal and anal contraction and relaxation.
- OTHER
-
Magnetic Stimulation
The therapist will use the magnetic stimulator to intermittently stimulate the and adjust the stimulation intensity at any time according to the patient\'s condition, adjusting it until there is a clear sense of contraction and feel comfortable.
- OTHER
-
Magnetic stimulation combined with biofeedback electrical stimulation
Pelvic floor magnetic stimulation for 30 minutes followed by biofeedback electrical stimulation.
Sponsors & Collaborators
-
Peking Union Medical College Hospital
collaborator OTHER -
Peking University Third Hospital
collaborator OTHER -
The Second Hospital of Shandong University
collaborator OTHER -
Changsha Hospital for Maternal and Child Health Care
collaborator OTHER -
Southwest Hospital, China
collaborator OTHER -
Hangzhou Women's Hospital
collaborator UNKNOWN -
Mingfu Wu
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-20
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
Countries
- China
Study Locations
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