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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05527639




Registration number
NCT05527639
Ethics application status
Date submitted
26/08/2022
Date registered
2/09/2022
Date last updated
7/08/2023

Titles & IDs
Public title
Kegel Exercises Prior to Strength Training to Improvestress Urinary Incontinence
Scientific title
Does a Kegel Exercise Program Prior to Resistance Training Reduce the Risk of Stress Urinary Incontinence?
Secondary ID [1] 0 0
CharlesDarwinU
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
Behaviour - strength training program

Other: intervention group during study - all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats. They had all completed a program of Kegel exercise prior.

Other: control group during study - all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats


Behaviour: strength training program
12-weeks of strength training consisting of warm ups, dead-lifts, squats and cool down exercises
Intervention code [1] 0 0
Behaviour
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 index (ISI) tool
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
pelvic floor muscle strength
Timepoint [3] 0 0
week 0
Primary outcome [4] 0 0
pelvic floor muscle strength
Timepoint [4] 0 0
week 12

Eligibility
Key inclusion criteria
- being female

- over eighteen years of age

- suffer from stress urinary incontinence

- did not perform Kegel exercises

- had no experience in regular resistance/strength training

- completed a physical activity readiness questionnaire (PAR-Q) form.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- pregnancy, 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
Single group
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
18/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/12/2019
Sample size
Target
Accrual to date
Final
24
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
This comparative pre-post intervention study investigates the feasibility and benefits of
Kegel exercises amongst incontinent women, prior to commencing resistance training, to reduce
the risk of stress urinary incontinence compared to a group of women without prior Kegel
exercises.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05527639
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