NCT06461234 Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction
| NCT ID | NCT06461234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mingfu Wu |
| Condition | Pelvic Floor Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,360 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,360 participants in total. It began in 2024-05-20 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. knowledge of the study, voluntary enrolment in the study, and signing of informed consent; 2. 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). Exclusion Criteria: 1. history of comorbid serious medical or surgical illness; 2. comorbid psychiatric disorders; 3. contraindications to electrical and magnetic stimulation such as implanted pacemakers; 4. pelvic malignancy, acute genitourinary infection or vaginal bleeding, and genital tract malformation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06461234 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Floor Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06461234 currently recruiting?
Yes, NCT06461234 is actively recruiting participants. Contact the research team at mingfuwutj@163.com for enrollment information.
Where is the NCT06461234 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06461234 clinical trial?
NCT06461234 is sponsored by Mingfu Wu. The trial plans to enroll 1,360 participants.