Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction
NCT Number: NCT06461234
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pelvic Floor Disorders|Pelvic Organ Prolapse
Interventions: BEHAVIORAL: Pelvic floor muscle training|OTHER: Biofeedback electrical stimulation|OTHER: Magnetic Stimulation|OTHER: Magnetic stimulation combined with biofeedback electrical stimulation
Sponsor: Mingfu Wu
Collaborators: Peking Union Medical College Hospital|Peking University Third Hospital|The Second Hospital of Shandong University|Changsha Hospital for Maternal and Child Health Care|Southwest Hospital, China|Hangzhou maternity and child health care hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1360
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-20
Completion Date: 2026-11-30
Locations: Tongji hospital, Wuhan, Hubei, 430030, China

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.

Primary Outcome Measures: pelvic floor muscle strength, Pelvic floor muscle strength was assessed with reference to the Modified Oxford Muscle Strength Classification Method. Pelvic floor muscle strength was graded on a scale of 0-5: 0 for no contraction; 1 for tremor; 2 for slight contraction, with increased muscle strength but no lifting sensation; 3 for moderate contraction, with a sense of lifting of the posterior vaginal wall; 4 for good contraction, with a sense of lifting of the posterior vaginal wall against resistance; and 5 for strong contraction, with a sense of strong wrapping. The higher the grade, the better the pelvic floor strength., Baseline, 0 month and 3 months after pelvic floor rehabilitation treatment|pelvic floor electromyography, Pelvic floor electromyography is assessed by the pelvic floor surface electromyography analysis and biofeedback training system. EMG values and parameters regarding muscle contraction and relaxation will be recorded., Baseline, 0 month and 3 months after pelvic floor rehabilitation.
Secondary Outcome Measures: POP-Q, The patient empties the bladder in a quiet state and is examined in the truncated position, the maximum degree of prolapse that can be achieved with a forceful downward breath-hold in the Valsalva manoeuvre., Baseline, 0 month and 3 months after pelvic floor rehabilitation.|PFDI-20, Clinical symptoms are collected using the validated Chinese version of the international standardised questionnaire: PFDI-20, and patients are asked to select the answers that apply to their situation., Baseline, , 0 month, 3 months and 1 year after pelvic floor rehabilitation.