Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2020-02-01
2021-09-29
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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New Biofeedback
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.
New Biofeedback
Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.
Conventional Biofeedback
Women allocated to the conventional biofeedback group will undergo pelvic floor muscle training with the conventional biofeedback probe inserted in the vagina
New Biofeedback
Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.
Control group
The control group will perform pelvic floor muscle training without any biofeedback device.
New Biofeedback
Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.
Interventions
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New Biofeedback
Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
35 Years
60 Years
FEMALE
No
Sponsors
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Kwong Wah Hospital
OTHER
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Dr. Priya Kannan
Assistant Professor
Principal Investigators
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Priya Kannan, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic Unviersity
Locations
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Kwong Wah Hospital
Kowloon, , Hong Kong
Countries
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References
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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.
Other Identifiers
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P0033900
Identifier Type: -
Identifier Source: org_study_id
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