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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05529238
Registration number
NCT05529238
Ethics application status
Date submitted
26/08/2022
Date registered
7/09/2022
Date last updated
8/02/2023
Titles & IDs
Public title
Kegel Exercises for Stress Urinary Incontinence
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Scientific title
Effectiveness of Supervised Kegel Exercises Using Bio-feedback Versus Unsupervised Kegel Exercises on Stress Urinary Incontinence: A Quasi-experimental Study
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Secondary ID [1]
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Interventional
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urinary Incontinence,Stress
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - biofeedback training
Other: supervised group during study - monthly physiotherapist appointment for half of the cohort including pelvic floor examination by physiotherapist including digital palpation and perineometry.
No intervention: unsupervised group during study - No intervention. Participants to practice kegel exercises at home.
BEHAVIORAL: biofeedback training
participants received biofeedback training for kegel exercises in the supervised group. the unsupervised group practised their Kegel exercises at home
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incontinence severity index (ISI) tool
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Assessment method [1]
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self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
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Timepoint [1]
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Week 0
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Primary outcome [2]
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Incontinence severity (ISI) index tool
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Assessment method [2]
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self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
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Timepoint [2]
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Week 12
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Primary outcome [3]
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Pelvic floor assessment from physiotherapist
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Assessment method [3]
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pelvic floor muscle strength
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Timepoint [3]
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week 0
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Primary outcome [4]
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Pelvic floor assessment from physiotherapist
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Assessment method [4]
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pelvic floor muscle strength
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Timepoint [4]
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week 12
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* pregnancy and breastfeeding
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/06/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/08/2019
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Sample size
Target
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Accrual to date
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Final
29
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Recruitment in Australia
Recruitment state(s)
NT
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Recruitment hospital [1]
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Charles Darwin University - Darwin
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Recruitment postcode(s) [1]
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0909 - Darwin
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Funding & Sponsors
Primary sponsor type
Other
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Name
Charles Darwin University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05529238
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05529238
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