Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction
- Conditions
- Pelvic Floor DisordersPelvic Organ Prolapse
- Interventions
- Other: Magnetic stimulation combined with biofeedback electrical stimulationOther: Biofeedback electrical stimulationOther: Magnetic StimulationBehavioral: Pelvic floor muscle training
- Registration Number
- NCT06461234
- Lead Sponsor
- Mingfu Wu
- Brief 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.
- Detailed Description
This multicentre, prospective cohort study will be conducted at seven hospital-based pelvic floor health centres nationwide in China. Patients with pelvic floor dysfunctional disorders who are scheduled to undergo pelvic floor rehabilitation are included, including 1) postpartum pelvic floor muscle weakness, 2) mild-to-moderate pelvic organ prolapse (POP), and 3) POP in combination with dysfunction (bowel or bladder dysfunction) or POP in combination with lower urinary tract symptoms (overactive bladder syndrome, constipation, faecal incontinence).
Pelvic floor rehabilitation was performed in accordance with the clinical pathway based on patients' disease characteristics and individual conditions, during which baseline data were collected from patients who met the inclusion and exclusion criteria, as well as follow-up surveys at the end of the treatment, 3 months after the end of the treatment, and 12 months after the end of the treatment. The clinical data collected were used to determine the effectiveness of treatment and to summarise the effects of different rehabilitation programmes on the prognosis of postpartum and middle-aged and elderly PFD patients. The data were matched and compared with the patients' clinical symptoms, signs and auxiliary examinations, so as to optimise and determine the individualised and precise pelvic floor rehabilitation treatment plan.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1360
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Magnetic stimulation combined with biofeedback electrical stimulation Magnetic stimulation combined with biofeedback electrical stimulation Observation Group 3 pelvic floor biofeedback electrical stimulation Biofeedback electrical stimulation Observation Group 1 pelvic floor magnetic stimulation Magnetic Stimulation Observation Group 2 pelvic floor muscle training (PFMT) Pelvic floor muscle training Control group
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method POP-Q Baseline, 0 month and 3 months after pelvic floor rehabilitation. 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.
PFDI-20 Baseline, , 0 month, 3 months and 1 year after pelvic floor rehabilitation. 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.
Trial Locations
- Locations (1)
Tongji hospital
🇨🇳Wuhan, Hubei, China