Pelvic Floor Rehabilitation of 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.
Mingfu Wu
1,360 participants
May 20, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria4
- 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.
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Interventions
A therapist will instruct the patient to contract the anus, perineum as well as the urethra, until the patient masters the correct method.
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.
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.
Pelvic floor magnetic stimulation for 30 minutes followed by biofeedback electrical stimulation.
Locations(1)
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NCT06461234