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

Summary

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.

Conditions

• Stress Urinary Incontinence

Interventions

DEVICE

PFMT with device

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.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Xiuqi Wang · Peking Union Medical College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-30

Primary Completion

2023-11-01

Completion

2024-11-01

Countries

• China

Study Locations