Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00222248




Registration number
NCT00222248
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
3/05/2021

Titles & IDs
Public title
Pelvic Floor Muscle Training for Incontinence in Older Women.
Scientific title
The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.
Secondary ID [1] 0 0
251632
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress Urinary Incontinence 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
Experimental: Pelvic floor muscle training - Weekly group session of education and exercise to music incorporating pelvic floor muscle training incorporating motor control, strength, endurance, power and functional training in a variety of different positions.

Active comparator: Bladder training - Weekly group session of education regarding deferral techniques, timed voiding parameters and gentle exercise to music.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quantity of urine lost over a 7-day period measured by self-report.
Timepoint [1] 0 0
1, 3, 5 (end of intervention) and 12 months
Primary outcome [2] 0 0
Urine lost on stress test measured by pad weigh test.
Timepoint [2] 0 0
1, 3, 5 (end of intervention) and 12 months
Secondary outcome [1] 0 0
King's Health Questionnaire.
Timepoint [1] 0 0
1, 3, 5 (end of intervention) and 12 months
Secondary outcome [2] 0 0
Degree of bother
Timepoint [2] 0 0
1, 3, 5 (end of intervention) and 12 months
Secondary outcome [3] 0 0
Severity of stress incontinence
Timepoint [3] 0 0
1, 3, 5 (end of intervention) and 12 months
Secondary outcome [4] 0 0
Displacement of pelvic floor during muscle contraction
Timepoint [4] 0 0
1, 3, 5 (end of intervention) and 12 months

Eligibility
Key inclusion criteria
* Community-dwelling women aged over 65 years
* urodynamically proven stress incontinence
* Medically stable
Minimum age
65 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Already receiving physiotherapy intervention
* Neurogenic incontinence
* Cannot comply with training program

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
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
3/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2006
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mary P Galea, PhD
Address 0 0
University of Melbourne
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

TypeCitations or Other Details
Journal Sherburn M, Bird M, Carey M, Bo K, Galea MP. Incon... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00222248