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/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
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
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
To determine the effect of pelvic floor muscle training in women aged 70 years and over, who have proven stress urinary incontinence. The hypotheses to be tested are:

1. That pelvic floor muscle training is effective in relief of symptoms of stress urinary incontinence as measured by a greater reduction in the number of episodes of incontinence, quantity of urine lost and improvement of quality of life.
2. That women who undertake pelvic floor muscle training will show greater improvement of pelvic floor muscle function than women who have behavioural (bladder) training, as measured by real time transabdominal ultrasound.
Trial website
https://clinicaltrials.gov/study/NCT00222248
Trial related presentations / publications
Sherburn M, Bird M, Carey M, Bo K, Galea MP. Incontinence improves in older women after intensive pelvic floor muscle training: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2011 Mar;30(3):317-24. doi: 10.1002/nau.20968. Epub 2011 Jan 31.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00222248