Stress Urinary IncontinenceNCT04638348
A Novel Biofeedback for Urinary Incontinence in Women
A study testing New Biofeedback in people with Stress Urinary Incontinence, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
A three-armed randomized pilot trial will be conducted with 51 women having stress urinary incontinence, to evaluate the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with… Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- New Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2020to 29 Sep 2021
- 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women in the age group of 35 to 60 years of age;
- non-pregnant;
- having stress urinary incontinence;
- experiencing mild to moderate urinary incontinence (obtaining a score of ≤ 12 on the short-form of the International Consultation on Incontinence Questionnaire (ICIQ-sf); and
- obtaining a mini-mental state examination (MMSE) score of ≥ 24.
Who cannot join
- being in the postpartum stage of < 6 months;
- having severe pelvic organ prolapse (stages 3 and 4 on the Baden and Walker grading tool);
- women taking any medications that might cause urine retention;
- women having complicated UI due to radiation to pelvic region;
- obesity with a body mass index ≥ 30;
- women with incontinence secondary to other medical conditions or previous surgeries;
- women with severe psychological problems impairing participation in the study; and
- women having mixed or urge UI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Biofeedback Device to Improve Adherence to Pelvic Floor Muscle Training in Women With Urinary Incontinence: A Randomized Controlled Pilot Trial
A three-armed randomized pilot trial will be conducted with 51 women having stress urinary incontinence, to evaluate the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with Bluetooth. Women will be randomly allocated to one of two intervention groups (new biofeedback or conventional biofeedback) or the control group (PFMT alone). Women in the intervention groups will perform PFMT either with the new biofeedback or the conventional biofeedback, based on their group allocation. The control group will perform PFMT without a biofeedback device. Study outcome measures include, feasibility measures, International Consultation on Incontinence Questionnaire, and 1-hour pad test.
Read the detailed description
Objectives: (1) to compare the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with Bluetooth; (2) to investigate the effects of conventional biofeedback, the new biofeedback, and pelvic floor muscle training (PFMT) alone on urinary incontinence and adherence to PFMT.
Hypotheses: (1) The new biofeedback will be easier to use and women will more readily accept it than the conventional biofeedback. (2) Women assigned to the new biofeedback group will report better adherence to PFMT and greater improvements in urinary incontinence than women assigned to participate in the conventional biofeedback group.
Design and subjects: A three-armed randomized pilot trial will be conducted with 51 women who have stress urinary incontinence.
Interventions: Women will be randomly allocated to one of two intervention groups (new biofeedback or conventional biofeedback) or the control group (PFMT alone). Women in the intervention groups will perform PFMT either with the new biofeedback or the conventional biofeedback, based on their group allocation. The control group will perform PFMT without a biofeedback device.
Outcome measures: Feasibility measures, International Consultation on Incontinence Questionnaire, and 1-hour pad test.
Data analysis and expected results: A one-way between-groups analysis of covariance will be conducted. Adherence to PFMT will be better in the new biofeedback group than in the conventional biofeedback group. New biofeedback will have greater beneficial effects on urinary incontinence than either the conventional biofeedback or PFMT alone.
- Conditions
- Stress Urinary Incontinence
- Being tested
- New Biofeedback
- Keywords
- Biofeedback
- 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.
New BiofeedbackDevice
Also called Conventional Biofeedback
Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.
| Study group | Role | What they receive |
|---|---|---|
| New Biofeedback | Experimental | Women allocated to the new biofeedback group will be instructed to attach the biofeedback device to their underpants and then perform pelvic floor muscle training. Receives: Device: New Biofeedback |
| Conventional Biofeedback | Active comparator | Women allocated to the conventional biofeedback group will undergo pelvic floor muscle training with the conventional biofeedback probe inserted in the vagina Receives: Device: New Biofeedback |
| Control group | Active comparator | The control group will perform pelvic floor muscle training without any biofeedback device. Receives: Device: New Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants recruited/screened in a week, the time taken for recruitment of participants, and reasons for declining to participate will be recorded.
Measured: At the end of recruitment period
Adherence
The 0-10-point scale of the reliable tool (Cronbach's α=0.7059) developed to monitor long-term adherence to PFMT in women with UI (that quantifies adherence to home exercise as "low," "moderate," or "high") will be used to evaluate adherence to PFMT with and without the biofeedback device
Measured: Post-intervention at 6 months
Retention rate
This will be calculated as the percentage of participants who completed assessments at 1, 3, and 6 months.
Measured: Post-treatment at 1, 3 and 6 months
Secondary outcomes (3)
International Consultation on Incontinence Questionnaire-short form
Measures amount of urine loss and intensity. Higher score indicates more sever urinary incontinence.
Measured: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
one-hour pad test with stress test
Measure amount of urine leakage. Larger the amount of urine lost in grams, greater is the severity of urinary incontinence.
Measured: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
Modified Oxford scale
To grade pelvic floor muscle strength. Lower the score, lower the strength of the pelvic floor muscles.
Measured: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Feb 2020
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 The Hong Kong Polytechnic UniversityThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Kwong Wah Hospital
- Responsible party
- Principal investigator, Dr. Priya Kannan, The Hong Kong Polytechnic University
- Investigators
- Priya Kannan, PhD, Principal investigator, The Hong Kong Polytechnic Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638348
- Sponsor's protocol ID
- P0033900
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kannan P, Cheing GLY, Fung BKY, Li J, Leung WC, Chung RCK, Cheung TW, Lam LF, Lee WY, Wong WC, Wong WH, Tang PYG, Chan PKL. Effectiveness of pelvic floor muscle training alone or combined with either a novel biofeedback device or conventional biofeedback for improving stress urinary incontinence: A randomized controlled pilot trial. Contemp Clin Trials. 2022 Dec;123:106991. doi: 10.1016/j.cct.2022.106991. Epub 2022 Nov 2.
PubMed 36332826
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Biofeedback Device to Improve Adherence to Pelvic Floor Muscle Training in Women With Urinary Incontinence: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT04638348
- Acronym / sponsor ID
- P0033900
- Conditions
- Stress Urinary Incontinence
- Keywords
- Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Kwong Wah Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 20 Nov 2020 (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.
A three-armed randomized pilot trial will be conducted with 51 women having stress urinary incontinence, to evaluate the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with Bluetooth. Women will be randomly allocated to one of two intervention groups (new biofeedback or conventional biofeedback) or the control group (PFMT alone). Women in the intervention groups will perform PFMT either with the new biofeedback or the conventional biofeedback, based on their group allocation. The control group will perform PFMT without a biofeedback device. Study outcome measures include, feasibility measures, International Consultation on Incontinence Questionnaire, and 1-hour pad test.
Detailed description
Objectives: (1) to compare the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with Bluetooth; (2) to investigate the effects of conventional biofeedback, the new biofeedback, and pelvic floor muscle training (PFMT) alone on urinary incontinence and adherence to PFMT.
Hypotheses: (1) The new biofeedback will be easier to use and women will more readily accept it than the conventional biofeedback. (2) Women assigned to the new biofeedback group will report better adherence to PFMT and greater improvements in urinary incontinence than women assigned to participate in the conventional biofeedback group.
Design and subjects: A three-armed randomized pilot trial will be conducted with 51 women who have stress urinary incontinence.
Interventions: Women will be randomly allocated to one of two intervention groups (new biofeedback or conventional biofeedback) or the control group (PFMT alone). Women in the intervention groups will perform PFMT either with the new biofeedback or the conventional biofeedback, based on their group allocation. The control group will perform PFMT without a biofeedback device.
Outcome measures: Feasibility measures, International Consultation on Incontinence Questionnaire, and 1-hour pad test.
Data analysis and expected results: A one-way between-groups analysis of covariance will be conducted. Adherence to PFMT will be better in the new biofeedback group than in the conventional biofeedback group. New biofeedback will have greater beneficial effects on urinary incontinence than either the conventional biofeedback or PFMT alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New Biofeedback | Experimental | Device: New BiofeedbackWomen allocated to the new biofeedback group will be instructed to attach the biofeedback device to their underpants and then perform pelvic floor muscle training. |
| Conventional Biofeedback | Active comparator | Device: New BiofeedbackWomen allocated to the conventional biofeedback group will undergo pelvic floor muscle training with the conventional biofeedback probe inserted in the vagina |
| Control group | Active comparator | Device: New BiofeedbackThe control group will perform pelvic floor muscle training without any biofeedback device. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women in the age group of 35 to 60 years of age;
- non-pregnant;
- having stress urinary incontinence;
- experiencing mild to moderate urinary incontinence (obtaining a score of ≤ 12 on the short-form of the International Consultation on Incontinence Questionnaire (ICIQ-sf); and
- obtaining a mini-mental state examination (MMSE) score of ≥ 24.
Key exclusion criteria (8 listed)
- being in the postpartum stage of < 6 months;
- having severe pelvic organ prolapse (stages 3 and 4 on the Baden and Walker grading tool);
- women taking any medications that might cause urine retention;
- women having complicated UI due to radiation to pelvic region;
- obesity with a body mass index ≥ 30;
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 |
|---|---|---|
| New BiofeedbackAlso: Conventional BiofeedbackConventional biofeedback consists of a electromyography biofeedback device with a vaginal probe. | Device | Control group, Conventional Biofeedback, New Biofeedback |
Primary outcome
Recruitment rate
Time frame: At the end of recruitment period
Number of participants recruited/screened in a week, the time taken for recruitment of participants, and reasons for declining to participate will be recorded.
Adherence
Time frame: Post-intervention at 6 months
The 0-10-point scale of the reliable tool (Cronbach's α=0.7059) developed to monitor long-term adherence to PFMT in women with UI (that quantifies adherence to home exercise as "low," "moderate," or "high") will be used to evaluate adherence to PFMT with and without the biofeedback device
Retention rate
Time frame: Post-treatment at 1, 3 and 6 months
This will be calculated as the percentage of participants who completed assessments at 1, 3, and 6 months.
3 secondary outcomes
International Consultation on Incontinence Questionnaire-short form
Time frame: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
one-hour pad test with stress test
Time frame: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
Modified Oxford scale
Time frame: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
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 28 Feb 2024.
- Derived from this study: PubMed 36332826Kannan P, Cheing GLY, Fung BKY, Li J, Leung WC, Chung RCK, Cheung TW, Lam LF, Lee WY, Wong WC, Wong WH, Tang PYG, Chan PKL. Effectiveness of pelvic floor muscle training alone or combined with either a novel biofeedback device or conventional biofeedback for improving stress urinary incontinence: A randomized controlled pilot trial. Contemp Clin Trials. 2022 Dec;123:106991. doi: 10.1016/j.cct.2022.106991. Epub 2022 Nov 2.
- Individual participant dataSharing planned: No
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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.
Priya Kannan, PhD principal investigator
The Hong Kong Polytechnic Unviersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Biofeedback in people with Stress Urinary Incontinence, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 inclusion and 8 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 28 Feb 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 Hong Kong. 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?
Recruitment rate (time frame: At the end of recruitment period). The study lists 3 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 NCT04638348, which also lists 1 linked publication.
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 28 Feb 2024.