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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
Scientific title
Effectiveness of Supervised Kegel Exercises Using Bio-feedback Versus Unsupervised Kegel Exercises on Stress Urinary Incontinence: A Quasi-experimental Study
Secondary ID [1] 0 0
Interventional
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Incontinence,Stress 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incontinence severity index (ISI) tool
Timepoint [1] 0 0
Week 0
Primary outcome [2] 0 0
Incontinence severity (ISI) index tool
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Pelvic floor assessment from physiotherapist
Timepoint [3] 0 0
week 0
Primary outcome [4] 0 0
Pelvic floor assessment from physiotherapist
Timepoint [4] 0 0
week 12

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* pregnancy and breastfeeding

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2019
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Charles Darwin University - Darwin
Recruitment postcode(s) [1] 0 0
0909 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Charles Darwin University
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05529238
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05529238