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OpenTrials
Completed

NCT Number: NCT05529238

Kegel Exercises for Stress Urinary Incontinence

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biofeedback training

Behavioral

participants received biofeedback training for kegel exercises in the supervised group. the unsupervised group practised their Kegel exercises at home

Primary outcomes

  1. 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.

  2. 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.

  3. Pelvic floor assessment from physiotherapist

    Time frame: week 0

    pelvic floor muscle strength

  4. Pelvic floor assessment from physiotherapist

    Time frame: week 12

    pelvic floor muscle strength

Sponsors and collaborators

Lead sponsor

Charles Darwin University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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