A Novel Biofeedback for Urinary Incontinence in Women

February 26, 2024 updated by: Dr. Priya Kannan, The Hong Kong Polytechnic University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • Kwong Wah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: New Biofeedback
Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.
Other Names:
  • Conventional Biofeedback
Active Comparator: Conventional Biofeedback
Women allocated to the conventional biofeedback group will undergo pelvic floor muscle training with the conventional biofeedback probe inserted in the vagina
Device: New Biofeedback
Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.
Other Names:
  • Conventional Biofeedback
Active Comparator: Control group
The control group will perform pelvic floor muscle training without any biofeedback device.
Device: New Biofeedback
Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.
Other Names:
  • Conventional Biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of recruitment period
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
Post-intervention at 6 months
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.
Post-treatment at 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Consultation on Incontinence Questionnaire-short form
Time Frame: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
Measures amount of urine loss and intensity. Higher score indicates more sever urinary incontinence.
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
Measure amount of urine leakage. Larger the amount of urine lost in grams, greater is the severity of urinary incontinence.
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
To grade pelvic floor muscle strength. Lower the score, lower the strength of the pelvic floor muscles.
Baseline (pre-intervention), post-treatment at 1, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Kwong Wah Hospital

Investigators

  • Principal Investigator: Priya Kannan, PhD, The Hong Kong Polytechnic Unviersity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

September 29, 2021

Study Completion (Actual)

September 29, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0033900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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