Kegel Exercises for Stress Urinary Incontinence

February 3, 2023 updated by: Donelle Cross, Charles Darwin University

Effectiveness of Supervised Kegel Exercises Using Bio-feedback Versus Unsupervised Kegel Exercises on Stress Urinary Incontinence: A Quasi-experimental Study

Study about a targeted group of women suffering from self-reported stress urinary incontinence, attend a Kegel exercise training program. The group was divided into two; supervised and unsupervised. Whilst both groups benefited from initially seeing a women's health physiotherapist for a pelvic floor muscle assessment and a bespoke Kegel exercise program, only the supervised group continued to see the physiotherapist for monthly bio-feedback training. The unsupervised group relied on their own motivation to perform their Kegel exercises as prescribed. At the end of the twelve week program, both groups had a final pelvic floor muscle strength assessment by the physiotherapist to determine any changes and subsequent improvements in urinary incontinence.

Aim : Investigate and compare the efficacy of supervised Kegel exercises with biofeedback on Stress Urinary Incontinence (SUI) and Pelvic Floor Muscle Strength (PFMS) compared to unsupervised Kegel exercises.

The primary goal of this study was to determine the effectiveness of supervised Kegel exercises using BT versus unsupervised Kegel exercises without biofeedback training, on SUI. A secondary outcome was to establish whether an improvement was observed in PFMS and subsequently, the effect of this on SUI. It was hypothesized that regular support and visual motivation and direction of BT from the physiotherapist, would provide greater results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

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

  • Australia
    • Northern Territory
      • Darwin, Northern Territory, Australia, 0909
        • Charles Darwin University

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • being female
  • aged over 18 years
  • suffer from SUI (their subjective disclosure was based on a description provided for their reference)
  • did not perform Kegel exercises
  • be available for duration of 12-week program

Exclusion Criteria:

  • pregnancy and breastfeeding

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: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: supervised group during study
monthly physiotherapist appointment for half of the cohort including pelvic floor examination by physiotherapist including digital palpation and perineometry.
Behavioral: biofeedback training
participants received biofeedback training for kegel exercises in the supervised group. the unsupervised group practised their Kegel exercises at home
NO_INTERVENTION: unsupervised group during study
No intervention. Participants to practice kegel exercises at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence severity index (ISI) tool
Time Frame: Week 0
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Week 0
Incontinence severity (ISI) index tool
Time Frame: Week 12
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Week 12
Pelvic floor assessment from physiotherapist
Time Frame: week 0
pelvic floor muscle strength
week 0
Pelvic floor assessment from physiotherapist
Time Frame: week 12
pelvic floor muscle strength
week 12

Collaborators and Investigators

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

Sponsor

Charles Darwin University

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)

June 18, 2019

Primary Completion (ACTUAL)

August 18, 2019

Study Completion (ACTUAL)

August 18, 2019

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (ACTUAL)

September 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

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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