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
This trial does not accept healthy volunteersQualifiers
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 population
This study is aimed at female patients with pelvic floor dysfunction. A large group of people are women who develop reduced pelvic floor muscle strength after childbirth; these women may not present with organic changes in the pelvic organs, but may present with symptoms such as unsatisfactory sexual behaviour and stress urinary incontinence as a result of weakened muscle strength. The other part of the population is patients with mild to moderate pelvic organ prolapse, where physical examination may reveal mild to moderate prolapse of the anterior vaginal wall, uterus, or posterior vaginal wall. If this group of patients had a combination of urinary and gastrointestinal symptoms, they could also be included in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pelvic floor muscle training
BehavioralA 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 interventionThe 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 interventionThe 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 interventionPelvic floor magnetic stimulation for 30 minutes followed by biofeedback electrical stimulation.
Treatment groups
1,360 Participants
are divided into 4 treatment groupsGroup A: pelvic floor muscle training (PFMT)1 intervention
Group B: pelvic floor biofeedback electrical stimulation1 intervention
Group C: pelvic floor magnetic stimulation1 intervention
Group D: Magnetic stimulation combined with biofeedback electrical stimulation1 intervention
Trial outcomes
Primary outcomes
1
pelvic floor muscle strength
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.
Time frame
Baseline, 0 month and 3 months after pelvic floor rehabilitation treatment2
pelvic floor electromyography
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.
Time frame
Baseline, 0 month and 3 months after pelvic floor rehabilitation.Secondary outcomes
1
POP-Q
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.
Time frame
Baseline, 0 month and 3 months after pelvic floor rehabilitation.2
PFDI-20
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.
Time frame
Baseline, , 0 month, 3 months and 1 year after pelvic floor rehabilitation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov