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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
Trial website
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

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