Clinical trial NCT05115864: Comparison Between Home-based Wearable Device and Supervised PFMT on SUI/MUI
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: pelvic floor muscle training
stress urinary incontinence
wearable device
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire [ICIQ-UI SF]
timeFrame: Baseline (pre-test)
measure: Change from Baseline ICIQ-UI SF at 3 months
timeFrame: at 3 months
measure: Change from Baseline ICIQ-UI SF at 6 months
timeFrame: at 6 months
measure: Change from Baseline ICIQ-UI SF at 12 months
timeFrame: at 12 months
Secondary outcomes:
measure: Quality-of-life outcomes: Incontinence Quality of Life Instrument [I-QOL]
timeFrame: at baseline(pre-test), 3-month, 6-month and 12-month
measure: Pelvic floor-related outcomes: Pelvic Organ Prolapse Symptom Score [POP-SS]
timeFrame: at baseline(pre-test), 3-month, 6-month and 12-month
measure: Sex function outcome: the short-form Prolapse Incontinence Sexual Questionnaire [PISQ-12]
timeFrame: at baseline(pre-test), 3-month, 6-month and 12-month
measure: Self-efficacy outcomes:Chinese version of the broome pelvic muscle self-efficacy scale: reliability and validity[BPMSES]
timeFrame: at baseline(pre-test), 3-month, 6-month and 12-month
measure: The Pelvic Organ Prolapse Quantification (POP-Q)
timeFrame: at baseline(pre-test), 3-month, 6-month and 12-month
measure: Oxford grading scale
timeFrame: at baseline(pre-test), 3-month, 6-month and 12-month
measure: PFM strength assessed by manometry
timeFrame: at baseline(pre-test), 3-month, 6-month and 12-month
measure: Patient adherence to treatment
timeFrame: During the 3-month supervised treatment
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: at 3, 6, 9, and 12 weeks during 3-month intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiuqi Wang
role: PRINCIPAL_INVESTIGATOR
References: