Kegel Exercises for Stress Urinary Incontinence
Primary Purpose
Urinary Incontinence,Stress
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
biofeedback training
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence,Stress
Eligibility Criteria
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
Sites / Locations
- Charles Darwin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
supervised group during study
unsupervised group during study
Arm Description
monthly physiotherapist appointment for half of the cohort including pelvic floor examination by physiotherapist including digital palpation and perineometry.
No intervention. Participants to practice kegel exercises at home.
Outcomes
Primary Outcome Measures
Incontinence severity index (ISI) tool
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Incontinence severity (ISI) index tool
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Pelvic floor assessment from physiotherapist
pelvic floor muscle strength
Pelvic floor assessment from physiotherapist
pelvic floor muscle strength
Secondary Outcome Measures
Full Information
NCT ID
NCT05529238
First Posted
August 26, 2022
Last Updated
February 3, 2023
Sponsor
Charles Darwin University
1. Study Identification
Unique Protocol Identification Number
NCT05529238
Brief Title
Kegel Exercises for Stress Urinary Incontinence
Official Title
Effectiveness of Supervised Kegel Exercises Using Bio-feedback Versus Unsupervised Kegel Exercises on Stress Urinary Incontinence: A Quasi-experimental Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
August 18, 2019 (Actual)
Study Completion Date
August 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles Darwin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence,Stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
supervised group during study
Arm Type
Other
Arm Description
monthly physiotherapist appointment for half of the cohort including pelvic floor examination by physiotherapist including digital palpation and perineometry.
Arm Title
unsupervised group during study
Arm Type
No Intervention
Arm Description
No intervention. Participants to practice kegel exercises at home.
Intervention Type
Behavioral
Intervention Name(s)
biofeedback training
Intervention Description
participants received biofeedback training for kegel exercises in the supervised group. the unsupervised group practised their Kegel exercises at home
Primary Outcome Measure Information:
Title
Incontinence severity index (ISI) tool
Description
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Time Frame
Week 0
Title
Incontinence severity (ISI) index tool
Description
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Time Frame
Week 12
Title
Pelvic floor assessment from physiotherapist
Description
pelvic floor muscle strength
Time Frame
week 0
Title
Pelvic floor assessment from physiotherapist
Description
pelvic floor muscle strength
Time Frame
week 12
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
must be female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Charles Darwin University
City
Darwin
State/Province
Northern Territory
ZIP/Postal Code
0909
Country
Australia
12. IPD Sharing Statement
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Kegel Exercises for Stress Urinary Incontinence
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