Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Magnetic stimulation combined with biofeedback electrical stimulation: Pelvic floor magnetic stimulation for 30 minutes followed by biofeedback electrical stimulation.

Study 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.

Eligibility

Primary outcome measure(s)

• pelvic floor muscle strength — Baseline, 0 month and 3 months after pelvic floor rehabilitation treatment
  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.
• pelvic floor electromyography — Baseline, 0 month and 3 months after pelvic floor rehabilitation.
  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.

Trial sites (1)

Other trials for the same condition