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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05529238
Other study ID # Interventional
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 18, 2019
Est. completion date August 18, 2019

Study information

Verified date February 2023
Source Charles Darwin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date August 18, 2019
Est. primary completion date August 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Australia Charles Darwin University Darwin Northern Territory

Sponsors (1)

Lead Sponsor Collaborator
Charles Darwin University

Country where clinical trial is conducted

Australia, 

Outcome

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