Stress Urinary IncontinenceNCT00222248
Pelvic Floor Muscle Training for Incontinence in Older Women.
A study testing Pelvic floor muscle training and bladder training in people with Stress Urinary Incontinence, run by University of Melbourne at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pelvic floor muscle training and bladder training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Mar 2003to 6 Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community-dwelling women aged over 65 years
- urodynamically proven stress incontinence
- Medically stable
Who cannot join
- Already receiving physiotherapy intervention
- Neurogenic incontinence
- Cannot comply with training program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.
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:
- 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.
- 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.
Read the detailed description
Urinary incontinence is associated with significant personal stress, shame and social stigma and affects around one-third of women over 60 years of age. It restricts the amount of physical activity and can lead to social isolation and poor health. Pelvic floor muscle re-education by physiotherapists is the most commonly recommended method of conservative management. Although a recent Cochrane review concluded that it was an effective treatment for women with stress and mixed incontinence, there is still no strong evidence for the effectiveness of this intervention in elderly women. It has also been suggested that bladder training alone is equally effective in patients with stress urinary incontinence, urge and mixed incontinence. This is contrary to current clinical experience. It is therefore important to distinguish the relative effectiveness of these interventions used in isolation in order to ensure that urinary incontinence is managed in the most effective and efficient way.
Comparisons: pelvic floor muscle training group and bladder training.
Assessments will be conducted at baseline, 1 month, 3 months and 5 months during the intervention period. Both groups will then continue with their home program for a further 7 months until their final assessment (Assessment 5).
Outcome measures will include: volume of urine lost during a stress test, completion of accident diaries, Degree of 'bother', quality of life using the Kings Health Questionnaire, and assessment of pelvic floor function using real time transabdominal diagnostic ultrasound.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Pelvic floor muscle training and bladder training
- Keywords
- Stress urinary incontinence, Pelvic floor muscle training, Bladder training, Older women
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training and bladder trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training | Experimental | 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. Receives: Behavioral: Pelvic floor muscle training and bladder training |
| Bladder training | Active comparator | Weekly group session of education regarding deferral techniques, timed voiding parameters and gentle exercise to music. Receives: Behavioral: Pelvic floor muscle training and bladder training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of urine lost over a 7-day period measured by self-report.
Self report of urine leakage
Measured: 1, 3, 5 (end of intervention) and 12 months
Urine lost on stress test measured by pad weigh test.
Pad weight following stress test
Measured: 1, 3, 5 (end of intervention) and 12 months
Secondary outcomes (4)
King's Health Questionnaire.
Quality of life questionnaire
Measured: 1, 3, 5 (end of intervention) and 12 months
Degree of bother
Visual Analogue Scale of degree of bother
Measured: 1, 3, 5 (end of intervention) and 12 months
Severity of stress incontinence
Severity of stress incontinence measured by the ICIQ-UI SF
Measured: 1, 3, 5 (end of intervention) and 12 months
Displacement of pelvic floor during muscle contraction
Displacement measured using transabdominal ultrasound imaging.
Measured: 1, 3, 5 (end of intervention) and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study start3 Mar 2003
- Primary completion6 Mar 2006
- Study completion6 Mar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Galea, University of Melbourne
- Investigators
- Mary P Galea, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222248
- Sponsor's protocol ID
- 251632
- Status last verified
- Apr 2021
- First submitted
- 13 Sep 2005
- Last updated
- 3 May 2021
- Results posted
- No
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.
PubMed 21284022
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT00222248
- Acronym / sponsor ID
- 251632
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, Pelvic floor muscle training, Bladder training, Older women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 3 Mar 2003 (actual)
- Primary completion
- 6 Mar 2006 (actual)
- Study completion
- 6 Mar 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
Urinary incontinence is associated with significant personal stress, shame and social stigma and affects around one-third of women over 60 years of age. It restricts the amount of physical activity and can lead to social isolation and poor health. Pelvic floor muscle re-education by physiotherapists is the most commonly recommended method of conservative management. Although a recent Cochrane review concluded that it was an effective treatment for women with stress and mixed incontinence, there is still no strong evidence for the effectiveness of this intervention in elderly women. It has also been suggested that bladder training alone is equally effective in patients with stress urinary incontinence, urge and mixed incontinence. This is contrary to current clinical experience. It is therefore important to distinguish the relative effectiveness of these interventions used in isolation in order to ensure that urinary incontinence is managed in the most effective and efficient way.
Comparisons: pelvic floor muscle training group and bladder training.
Assessments will be conducted at baseline, 1 month, 3 months and 5 months during the intervention period. Both groups will then continue with their home program for a further 7 months until their final assessment (Assessment 5).
Outcome measures will include: volume of urine lost during a stress test, completion of accident diaries, Degree of 'bother', quality of life using the Kings Health Questionnaire, and assessment of pelvic floor function using real time transabdominal diagnostic ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training | Experimental | Behavioral: Pelvic floor muscle training and bladder trainingWeekly 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. |
| Bladder training | Active comparator | Behavioral: Pelvic floor muscle training and bladder trainingWeekly group session of education regarding deferral techniques, timed voiding parameters and gentle exercise to music. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Community-dwelling women aged over 65 years
- urodynamically proven stress incontinence
- Medically stable
Key exclusion criteria (3 listed)
- Already receiving physiotherapy intervention
- Neurogenic incontinence
- Cannot comply with training program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training and bladder training | Behavioural | Bladder training, Pelvic floor muscle training |
Primary outcome
Quantity of urine lost over a 7-day period measured by self-report.
Time frame: 1, 3, 5 (end of intervention) and 12 months
Self report of urine leakage
Urine lost on stress test measured by pad weigh test.
Time frame: 1, 3, 5 (end of intervention) and 12 months
Pad weight following stress test
4 secondary outcomes
King's Health Questionnaire.
Time frame: 1, 3, 5 (end of intervention) and 12 months
Degree of bother
Time frame: 1, 3, 5 (end of intervention) and 12 months
Severity of stress incontinence
Time frame: 1, 3, 5 (end of intervention) and 12 months
Displacement of pelvic floor during muscle contraction
Time frame: 1, 3, 5 (end of intervention) and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Results publication: PubMed 21284022Sherburn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary P Galea, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training and bladder training in people with Stress Urinary Incontinence, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of urine lost over a 7-day period measured by self-report. (time frame: 1, 3, 5 (end of intervention) and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.