Comparison Between Home-based Wearable Device and Supervised PFMT on SUI/MUI

Study Overview
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Brief Summary
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Objective The study is designed to compare the benefit of self-assessment of a home-based wearable device assisted pelvic floor muscle training (PFMT) to standard supervised PMFT program for women with SUI/MUI (stress urinary incontinence/mixed urinary incontinence). Background National and international clinical practice guidelines recommend supervised pelvic floor muscle training of at least 3 months' duration as a first-line treatment to women (including the elderly and post-natal) with stress or mixed urinary incontinence (Level of evidence A). However, it remains unknown that which component could bring extra benefit when assisted with surprised PFMT. Patients selection and study design The study protocol was approved by the Peking union medical college hospital ethics committee (JS-3192D, 26/10/2021). Women who had their 6-week to 3-month postpartum clinical visits in the member hospitals between Dec 01, 2021 and May 01, 2022 were invited to participate in the study. The women who reported SUI/MUI symptoms within 3 months postpartum were recruited. The exclusion criteria were 1）urgency urinary incontinence alone; 2）a prolapse greater than stage II on examination (>1cm below the hymen on straining); 3）third and fourth degree perineal tear; 4）suffering diastasis recti abdominis and chronic pelvic pain as the primary problem need treatment; 5）a history of stress urinary incontinence(SUI) before pregnancy; 6）had previous pelvic surgery; 7）malignant pelvic cancer; 8）Genurological infection; 9）had received formal instruction on PFMT in the past 5 years; 10）unsuitable to participate because of significant diseases; 11）others:were unable to contract pelvic floor muscles on digital examination when requested;Inability to use the device in vagina. Once each participate was recruited, they were arranged randomly to either an intervention group or a control group (1:1). The intervention group used a wireless wearable vaginal device to record the pressure and practice time and the grade of type I and II pelvic floor muscle fiber strength were assessed by the device once three weeks. The control group accepted the supervised PFMT. Both groups followed the same program three months. During three months, the investigators phoned both groups once three weeks to guide their training. Both groups were assessed by questionnaire and PFM measurements at baseline(pre-test), 3-month, 6-month and 12-month. The primary outcome is ICIQ-UI SF; The secondary outcomes include POP-SS; POP-Q; Oxford Classification; Pelvic floor muscle surface electromyography; I-QOL; PISQ-12; BPMSES. The hypothesis is that the wearable device with self-assessment function providing PFMT is superior to the supervised PFMT program alone for the treatment of both SUI and MUI of postpartum women.

Official Title
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The Role of Self-assessment Combined With Home-based Wearable Device Over Supervised Pelvic Floor Muscle Training for Stress or Mixed Urinary Incontinence in Postpartum Women: a Multi-center Randomized Controlled Trial

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: PFMT with device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 weeks<After delivery<3 mo postpartum Clinically diagnosed stress or mixed urinary incontinence as the primary problem Women aged 18 years or older Exclusion Criteria: Urgency urinary incontinence alone A prolapse greater than stage II on examination (>1cm below the hymen on straining) Third and fourth degree perineal tear; Suffering diastasis recti abdominis and chronic pelvic pain as the primary problem need treatment A history of stress urinary incontinence (SUI) before pregnancy Had previous pelvic surgery Malignant pelvic cancer Genitourinary system infection Had received formal instruction on PFMT in the past 5 years Unsuitable to participate because of significant diseases Others: were unable to contract pelvic floor muscles on digital examination when requested; Inability to use the device in vagina

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PFMT with device (intervention) group<br>The patients in PFMT with device (intervention) group followed the practice program three months. During three months, the intervention group is commanded to complete the PFMT program with the vaginal device and assess the grade of type I and II pelvic floor muscle fiber strength once three weeks. | Device: PFMT with device<br>* The wearable PFMT device (XFT-0010CK) is made by two parts. One part is the screen device which is able to show the real-time vaginal resting pressure and voluntary contraction pressure in units of mmHg. The other part is a vaginal air-filled probe. The two parts are combined with a thin air tube. The whole device is connected to a smartphone app by Bluetooth to record the progress of PFMT. There are two modes of the device, one is assessment mode, when it comes to the assessment mode that the device is able to assess the grade of type I and II pelvic floor muscle fiber strength by the patients themselves, the other mode is practice mode by displaying real-time visual pressure value according to the completeness of the PFMT program.<br>|
| No Intervention: PFMT alone （control） group<br>The patients in PFMT alone (control) group are commanded to follow the same practice program three months without using the device. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Consultation on Incontinence Questionnaire [ICIQ-UI SF] | The ICIQ-UI SF score ranges from 0 to 21 and is the weighted sum of three items addressing urinary incontinence frequency (how often do you leak urine? 0=never to 5=all the time), leakage quantity (how much urine do you usually leak? 0=none to 6=a large amount), and interference with everyday life (0=not at all to 10=a great deal). Higher scores reflect greater severity. | Baseline (pre-test) | 
| Change from Baseline ICIQ-UI SF at 3 months | The change on the severity of SUI | at 3 months | 
| Change from Baseline ICIQ-UI SF at 6 months | The change on the severity of SUI | at 6 months | 
| Change from Baseline ICIQ-UI SF at 12 months | The change on the severity of SUI | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality-of-life outcomes: Incontinence Quality of Life Instrument [I-QOL] | The instrument has 3 subscales: (1) avoidance and limiting behavior, (2) psychosocial impacts, and (3) social embarrassment. All items are evaluated using a 5-point Likert-type scale. The 22 items in the I-QOL were summed and transformed to a 0 to 100 scale for greater interpretability, with the higher scores representing better quality of life. | at baseline(pre-test), 3-month, 6-month and 12-month | 
| Pelvic floor-related outcomes: Pelvic Organ Prolapse Symptom Score [POP-SS] | POP-SS contains seven items relating to frequency of prolapse symptoms. Each item is scored from 0 (never) to 4 (all the time), with a possible total score ranging from 0 to 28. Higher scores reflect greater severity. | at baseline(pre-test), 3-month, 6-month and 12-month | 
| Sex function outcome: the short-form Prolapse Incontinence Sexual Questionnaire [PISQ-12] | Ranging from 0 to 48, with higher scores indicating greater sexual dysfunction | at baseline(pre-test), 3-month, 6-month and 12-month | 
| Self-efficacy outcomes:Chinese version of the broome pelvic muscle self-efficacy scale: reliability and validity[BPMSES] | It is a 23-item rating scale consisting of two domains: efficacy expectations and outcome expectations. In efficacy expectations domain, participants demonstrate how confident they are in performing pelvic floor muscle training. In outcome expectations domain, participants show the confidence that the training will prevent unwanted urine leakage. The score ranges are from 0 to 100. The higher the score, the greater self-efficacy perceived by the participant. | at baseline(pre-test), 3-month, 6-month and 12-month | 
| The Pelvic Organ Prolapse Quantification (POP-Q) | The Pelvic Organ Prolapse Quantification (POP-Q) approach was used to measure the positions of vaginal structures relative to the hymenal ring. Stage of POP was diagnosed using the reliable and valid Pelvic Organ Prolapse-Quantification examination (POP-Q) in which the maximal point of vaginal descent is measured relative to the hymen during strain with the woman in the 45-degree lithotomy position. | at baseline(pre-test), 3-month, 6-month and 12-month | 
| Oxford grading scale | It consists of a six-point scale ranging from 0 to 5, 0 indicating no muscle activity, 1 minor muscle flicker, 2 weak muscle activity, 3 moderate muscle contraction, 4 good muscle contraction and 5 a strong muscle contraction | at baseline(pre-test), 3-month, 6-month and 12-month | 
| PFM strength assessed by manometry | The outcomes included vaginal resting pressure (VRP), maximum vaginal pressure (MVP), maximum voluntary contraction pressure (MVCP), the grade of type I and II pelvic floor muscle fiber strength. | at baseline(pre-test), 3-month, 6-month and 12-month | 
| Patient adherence to treatment | In our study, patients' adherence to treatment will be determined as the frequency of exercises anticipated for 3 months of supervised treatment, which will be subjectively self-reported and objectively device-recorded. Patients' overall adherence will be categorized as follows: 50%≤= low adherence; 50%-75%= medium adherence; and ≥75%= high adherence. | During the 3-month supervised treatment | 
| Patient Global Impression of Improvement (PGI-I) | Answers to the question which best describes your urinary symptoms now, compared with how they were before this study are evaluated on a seven-point scale ranging from 1 = Very much better to 7 = Very much worse. Only answers affirming a score of 1 (very much better) or 2 (much better) will be considered to indicate improvement. | at 3, 6, 9, and 12 weeks during 3-month intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor muscle training, stress urinary incontinence, wearable device