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| Name | Class |
|---|---|
| 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 |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pelvic floor muscle training (PFMT) | Control group |
| |
| pelvic floor biofeedback electrical stimulation | Observation Group 1 |
| |
| pelvic floor magnetic stimulation | Observation Group 2 |
| |
| Magnetic stimulation combined with biofeedback electrical stimulation | Observation Group 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 0 month and 3 months after pelvic floor rehabilitation. |
| PFDI-20 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingfu Wu, professor | Contact | 86 + 13720172196 | mingfuwutj@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital | Recruiting | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14751349 | Result | 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. | |
| 23443345 | Result | 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. |
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| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
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| OTHER |
| Southwest Hospital, China | OTHER |
| Hangzhou Women's Hospital | UNKNOWN |
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| 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. |
|
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. |
| Baseline, , 0 month, 3 months and 1 year after pelvic floor rehabilitation. |
| 33475815 | Result | 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. |
| 35655733 | Result | 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. |
| 35083500 | Result | 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. |
| 18799443 | Result | 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. |
| 25516232 | Result | 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. |
| 31741838 | Result | 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. |
| D052801 | Male Urogenital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |