Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction

Mingfu Wu

Status: Enrolling

Conditions: Pelvic Floor Disorders; Pelvic Organ Prolapse

Treatments: Other: Magnetic stimulation combined with biofeedback electrical stimulation; Other: Biofeedback electrical stimulation; Other: Magnetic Stimulation; Behavioral: Pelvic floor muscle training

Study type: Observational

Funder types: Other

Identifiers

NCT06461234

2024-S097

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,360 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,360 participants in 4 patient groups

pelvic floor muscle training (PFMT)

Description:

Control group

Treatment:

Behavioral: Pelvic floor muscle training

pelvic floor biofeedback electrical stimulation

Description:

Observation Group 1

Treatment:

Other: Biofeedback electrical stimulation

pelvic floor magnetic stimulation

Description:

Observation Group 2

Treatment:

Other: Magnetic Stimulation

Magnetic stimulation combined with biofeedback electrical stimulation

Description:

Observation Group 3

Treatment:

Other: Magnetic stimulation combined with biofeedback electrical stimulation