Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMingfu Wu

About this trial

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

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Pelvic floor muscle training
  • Biofeedback electrical stimulation
  • Magnetic Stimulation
  • Magnetic stimulation combined with biofeedback electrical stimulation

Treatment groups

1,360 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Mingfu Wu

Lead sponsor

Tongji Hospital

Sponsor institution

Peking Union Medical College Hospital

Collaborator

Peking University Third Hospital

Collaborator

The Second Hospital of Shandong University

Collaborator

Changsha Hospital for Maternal and Child Health Care

Collaborator

Southwest Hospital, China

Collaborator

Hangzhou Women's Hospital

Collaborator