Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - 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


BEHAVIORAL: strength training program
12-weeks of strength training consisting of warm ups, dead-lifts, squats and cool down exercises
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 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/study/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05527639