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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: PFMT with device

Study type: Interventional

Funder types: Other

Identifiers

NCT05115864

PFMT-PUMCH

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

PFMT with device (intervention) group

Experimental group

Description:

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.

Treatment:

Device: PFMT with device

PFMT alone （control） group

No Intervention group

Description:

The patients in PFMT alone (control) group are commanded to follow the same practice program three months without using the device.