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

NCT05115864 | Completed

• 1 other identifier: PFMT-PUMCH
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pelvic floor muscle training; stress urinary incontinence; wearable device

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Quality-of-life outcomes: Incontinence Quality of Life Instrument [I-QOL]

  at baseline(pre-test), 3-month, 6-month and 12-month

• Pelvic floor-related outcomes: Pelvic Organ Prolapse Symptom Score [POP-SS]

  at baseline(pre-test), 3-month, 6-month and 12-month

• Sex function outcome: the short-form Prolapse Incontinence Sexual Questionnaire [PISQ-12]

  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]

  at baseline(pre-test), 3-month, 6-month and 12-month

• The Pelvic Organ Prolapse Quantification (POP-Q)

  at baseline(pre-test), 3-month, 6-month and 12-month

Study Arms (2)

PFMT with device (intervention) group

EXPERIMENTAL

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

PFMT alone （control） group

NO INTERVENTION

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

Interventions

PFMT with device 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.

PFMT with device (intervention) group

Eligibility Criteria

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

You may qualify if:

• weeks\<After delivery\<3 mo postpartum
• Clinically diagnosed stress or mixed urinary incontinence as the primary problem
• Women aged 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

• Wang X, Qiu J, Li D, Wang Z, Yang Y, Fan G, Mao X, Wang J, Gao S, Zhu X, Xu T, Sun Z. Pressure-Mediated Biofeedback With Pelvic Floor Muscle Training for Urinary Incontinence: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2442925. doi: 10.1001/jamanetworkopen.2024.42925.

  PMID: 39499517 DERIVED

• Wang X, Sun Z, Xu T, Fan G. Efficacy of supervised pelvic floor muscle training with a home-based biofeedback device for urinary incontinence in postpartum women: protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Apr 25;13(4):e069874. doi: 10.1136/bmjopen-2022-069874.

  PMID: 37185188 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiuqi Wang

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 10, 2021
• Study Start: March 30, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: November 21, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: starting 6 months after publication

Locations

CN (1)