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NCT Number: NCT06461234

Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction

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.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Pregnancy Complications Prolapse Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Tongji hospital

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Mingfu Wu, professor

CONTACT

[email protected]

13720172196

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Pelvic floor muscle training

Behavioral

A therapist will instruct the patient to contract the anus, perineum as well as the urethra, until the patient masters the correct method.

Biofeedback electrical stimulation

Other

The therapist will place the electrodes of the instrument into the vagina, adjust the current value until the woman feels obvious contraction of the pelvic floor muscles but no pain, and instructs the patient to refer to the biofeedback mode for vaginal and anal contraction and relaxation.

Magnetic stimulation

Other

The therapist will use the magnetic stimulator to intermittently stimulate the and adjust the stimulation intensity at any time according to the patient's condition, adjusting it until there is a clear sense of contraction and feel comfortable.

Magnetic stimulation combined with biofeedback electrical stimulation

Other

Pelvic floor magnetic stimulation for 30 minutes followed by biofeedback electrical stimulation.

Primary outcomes

  1. pelvic floor muscle strength

    Time frame: 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.

  2. pelvic floor electromyography

    Time frame: 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.

Secondary outcomes

  1. POP-Q

    Time frame: 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.

  2. PFDI-20

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingfu Wu, professor

CONTACT

[email protected]

86 + 13720172196

Sponsors and collaborators

Lead sponsor

Mingfu Wu

Other

Collaborators

  • Changsha Hospital for Maternal and Child Health Care
  • Hangzhou Women's Hospital
  • Peking Union Medical College Hospital
  • Peking University Third Hospital
  • Southwest Hospital, China
  • The Second Hospital of Shandong University

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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