Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction

NCT06461234 | Recruiting

• 1 other identifier: 2024-S097
• Study Type: observational
• Target: 1,360
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.Which pelvic floor rehabilitation therapy is most suitable for Chinese patients with female pelvic floor dysfunction?
4. 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.

Conditions

Pelvic Floor Disorders; Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse; pelvic floor rehabilitation; pelvic floor muscle training; biofeedback electrical stimulation; magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 0 month and 3 months after pelvic floor rehabilitation treatment

• 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.

  Baseline, 0 month and 3 months after pelvic floor rehabilitation.

Secondary Outcomes (2)

• POP-Q

  Baseline, 0 month and 3 months after pelvic floor rehabilitation.

• PFDI-20

  Baseline, , 0 month, 3 months and 1 year after pelvic floor rehabilitation.

Study Arms (4)

pelvic floor muscle training (PFMT)

Control group

Behavioral: Pelvic floor muscle training

pelvic floor biofeedback electrical stimulation

Observation Group 1

Other: Biofeedback electrical stimulation

pelvic floor magnetic stimulation

Observation Group 2

Other: Magnetic Stimulation

Magnetic stimulation combined with biofeedback electrical stimulation

Observation Group 3

Other: Magnetic stimulation combined with biofeedback electrical stimulation

Interventions

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.

pelvic floor muscle training (PFMT)

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.

pelvic floor biofeedback electrical stimulation

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.

pelvic floor magnetic stimulation

Magnetic stimulation combined with biofeedback electrical stimulation OTHER

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

Magnetic stimulation combined with biofeedback electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mingfu Wu: lead
• 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

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 14751349 BACKGROUND

• 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.

  PMID: 23443345 BACKGROUND

• 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.

  PMID: 33475815 BACKGROUND

• 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.

  PMID: 35655733 BACKGROUND

• 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.

  PMID: 35083500 BACKGROUND

• 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.

  PMID: 18799443 BACKGROUND

• 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.

  PMID: 25516232 BACKGROUND

• 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.

  PMID: 31741838 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mingfu Wu, professor

CONTACT

86 + 13720172196; mingfuwutj@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 14, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)