Rehabilitation for female pelvic floor dysfunction

Establishment of an Artificial Intelligence Multidimensional Early Warning Diagnostic and Prognostic Model of Pelvic Floor Rehabilitation Therapy in the Chinese Population: a Prospective Cohort Study.

This study is testing different rehabilitation treatments for pelvic floor issues in Chinese women to see which ones work best for those with postpartum weakness and mild to moderate pelvic organ prolapse.

Quick facts

• Study type: Observational
• Enrollment: 1360 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06461234 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the therapeutic effects of various pelvic floor rehabilitation treatments, including muscle training, biofeedback electrical stimulation, and magnetic stimulation, on Chinese women with pelvic floor dysfunction. The study will assess the effectiveness of these treatments in patients with postpartum pelvic floor weakness and mild to moderate pelvic organ prolapse. It will involve a multicenter approach across seven hospitals in China, collecting baseline data and follow-up surveys to determine the most suitable rehabilitation plans for individual patients.

Who should consider this trial

Good fit: Ideal candidates include postpartum women with pelvic floor muscle weakness or those with mild to moderate pelvic organ prolapse.

Not a fit: Patients with serious comorbid conditions, psychiatric disorders, or contraindications to electrical and magnetic stimulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide tailored rehabilitation strategies that significantly improve the quality of life for women suffering from pelvic floor disorders.

How similar studies have performed: Other studies have shown promising results with similar rehabilitation approaches, indicating potential for success in this study.

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.

Where this trial is running

Wuhan, Hubei

• Tongji hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Mingfu Wu, professor

Conditions Pelvic Floor Disorders; Pelvic Organ Prolapse; pelvic floor rehabilitation; pelvic floor muscle training; biofeedback electrical stimulation; magnetic stimulation