Stress Urinary IncontinenceNCT05115864
Comparison Between Home-based Wearable Device and Supervised PFMT on SUI/MUI
A study testing PFMT with device in people with Stress Urinary Incontinence, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- PFMT with device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2022to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6 weeks<After delivery<3 mo postpartum
- Clinically diagnosed stress or mixed urinary incontinence as the primary problem
- Women aged 18 years or older
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
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
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.
Read more
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
- Being tested
- PFMT with device
- Keywords
- pelvic floor muscle training, stress urinary incontinence, wearable device
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMT with deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-test)
Change from Baseline ICIQ-UI SF at 3 months
The change on the severity of SUI
Measured: at 3 months
Change from Baseline ICIQ-UI SF at 6 months
The change on the severity of SUI
Measured: at 6 months
Change from Baseline ICIQ-UI SF at 12 months
The change on the severity of SUI
Measured: at 12 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 3, 6, 9, and 12 weeks during 3-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start30 Mar 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiuqi Wang, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115864
- Sponsor's protocol ID
- PFMT-PUMCH
- Status last verified
- Mar 2023
- First submitted
- 2 Nov 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication including both primary and secondary outcomes
Publications
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.
PubMed 39499517Wang 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.
PubMed 37185188
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05115864
- Acronym / sponsor ID
- PFMT-PUMCH
- Conditions
- Stress Urinary Incontinence
- Keywords
- pelvic floor muscle training, stress urinary incontinence, wearable device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFMT with device (intervention) group | Experimental | Device: PFMT with deviceThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 6 weeks<After delivery<3 mo postpartum
- Clinically diagnosed stress or mixed urinary incontinence as the primary problem
- Women aged 18 years or older
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFMT with deviceThe 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. | Device | PFMT with device (intervention) group |
Primary outcome
International Consultation on Incontinence Questionnaire [ICIQ-UI SF]
Time frame: Baseline (pre-test)
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.
Change from Baseline ICIQ-UI SF at 3 months
Time frame: at 3 months
The change on the severity of SUI
Change from Baseline ICIQ-UI SF at 6 months
Time frame: at 6 months
The change on the severity of SUI
Change from Baseline ICIQ-UI SF at 12 months
Time frame: at 12 months
The change on the severity of SUI
9 secondary outcomes
Quality-of-life outcomes: Incontinence Quality of Life Instrument [I-QOL]
Time frame: at baseline(pre-test), 3-month, 6-month and 12-month
Pelvic floor-related outcomes: Pelvic Organ Prolapse Symptom Score [POP-SS]
Time frame: at baseline(pre-test), 3-month, 6-month and 12-month
Sex function outcome: the short-form Prolapse Incontinence Sexual Questionnaire [PISQ-12]
Time frame: 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]
Time frame: at baseline(pre-test), 3-month, 6-month and 12-month
The Pelvic Organ Prolapse Quantification (POP-Q)
Time frame: at baseline(pre-test), 3-month, 6-month and 12-month
Oxford grading scale
Time frame: at baseline(pre-test), 3-month, 6-month and 12-month
PFM strength assessed by manometry
Time frame: at baseline(pre-test), 3-month, 6-month and 12-month
Patient adherence to treatment
Time frame: During the 3-month supervised treatment
Patient Global Impression of Improvement (PGI-I)
Time frame: at 3, 6, 9, and 12 weeks during 3-month intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 39499517Wang 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.
- Derived from this study: PubMed 37185188Wang 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication including both primary and secondary outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuqi Wang principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFMT with device in people with Stress Urinary Incontinence, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire [ICIQ-UI SF] (time frame: Baseline (pre-test)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05115864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.