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A Novel Biofeedback for Urinary Incontinence in Women

NCT04638348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-02-28

No results posted yet for this study

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 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.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

New Biofeedback

Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.

Sponsors & Collaborators

  • Kwong Wah Hospital

    collaborator OTHER

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Priya Kannan, PhD · The Hong Kong Polytechnic Unviersity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-09-29
Completion
2021-09-29

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638348 on ClinicalTrials.gov