Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction
NCT ID: NCT06461234
Last Updated: 2025-08-01
Study Results
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Basic Information
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RECRUITING
1360 participants
OBSERVATIONAL
2024-05-20
2026-11-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pelvic floor muscle training (PFMT)
Control group
Pelvic floor muscle training
A therapist will instruct the patient to contract the anus, perineum as well as the urethra, until the patient masters the correct method.
pelvic floor biofeedback electrical stimulation
Observation Group 1
Biofeedback electrical stimulation
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.
pelvic floor magnetic stimulation
Observation Group 2
Magnetic Stimulation
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
Observation Group 3
Magnetic stimulation combined with biofeedback electrical stimulation
Pelvic floor magnetic stimulation for 30 minutes followed by biofeedback electrical stimulation.
Interventions
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Pelvic floor muscle training
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
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
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
Pelvic floor magnetic stimulation for 30 minutes followed by biofeedback electrical stimulation.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Peking University Third Hospital
OTHER
The Second Hospital of Shandong University
OTHER
Changsha Hospital for Maternal and Child Health Care
OTHER
Southwest Hospital, China
OTHER
Hangzhou Women's Hospital
UNKNOWN
Mingfu Wu
OTHER
Responsible Party
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Mingfu Wu
Professor
Locations
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Tongji hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wang AC, Wang YY, Chen MC. Single-blind, randomized trial of pelvic floor muscle training, biofeedback-assisted pelvic floor muscle training, and electrical stimulation in the management of overactive bladder. Urology. 2004 Jan;63(1):61-6. doi: 10.1016/j.urology.2003.08.047.
Terlikowski R, Dobrzycka B, Kinalski M, Kuryliszyn-Moskal A, Terlikowski SJ. Transvaginal electrical stimulation with surface-EMG biofeedback in managing stress urinary incontinence in women of premenopausal age: a double-blind, placebo-controlled, randomized clinical trial. Int Urogynecol J. 2013 Oct;24(10):1631-8. doi: 10.1007/s00192-013-2071-5. Epub 2013 Feb 27.
Feng F, Ashton-Miller JA, DeLancey JOL, Luo J. Feasibility of a deep learning-based method for automated localization of pelvic floor landmarks using stress MR images. Int Urogynecol J. 2021 Nov;32(11):3069-3075. doi: 10.1007/s00192-020-04626-5. Epub 2021 Jan 21.
Zhang L, Wang F. Evaluation of Nursing Effects of Pelvic Floor Muscle Rehabilitation Exercise on Gastrointestinal Tract Rectal Cancer Patients Receiving Anus-preserving Operation by Intelligent Algorithm-based Magnetic Resonance Imaging. Contrast Media Mol Imaging. 2022 May 19;2022:1613632. doi: 10.1155/2022/1613632. eCollection 2022.
Wang X, He D, Feng F, Ashton-Miller JA, DeLancey JOL, Luo J. Multi-label classification of pelvic organ prolapse using stress magnetic resonance imaging with deep learning. Int Urogynecol J. 2022 Oct;33(10):2869-2877. doi: 10.1007/s00192-021-05064-7. Epub 2022 Jan 27.
Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
Erekson EA, Fried TR, Martin DK, Rutherford TJ, Strohbehn K, Bynum JP. Frailty, cognitive impairment, and functional disability in older women with female pelvic floor dysfunction. Int Urogynecol J. 2015 Jun;26(6):823-30. doi: 10.1007/s00192-014-2596-2. Epub 2014 Dec 17.
Hong MK, Ding DC. Current Treatments for Female Pelvic Floor Dysfunctions. Gynecol Minim Invasive Ther. 2019 Oct 24;8(4):143-148. doi: 10.4103/GMIT.GMIT_7_19. eCollection 2019 Oct-Dec.
Other Identifiers
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2024-S097
Identifier Type: -
Identifier Source: org_study_id
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