Urinary IncontinenceNCT00323245
Regaining Bladder Control in Postmenopausal Women With Osteoporosis
A study testing Physiotherapy for urinary incontinence in people with Urinary Incontinence, run by University of British Columbia at 1 site in Canada.
Trial summary
Conservative management for urinary incontinence has been shown to improve bladder control. We are conducting a study of the effectiveness of conservative management for urinary incontinence in women who also have osteoporosis. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Physiotherapy for urinary incontinence
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2006to Apr 2011
- 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 55 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women osteopenia or osteoporosis and stress urinary incontinence
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regaining Urinary Continence in Postmenopausal Women With Osteoporosis: A Randomized Controlled Trial.
Conservative management for urinary incontinence has been shown to improve bladder control. We are conducting a study of the effectiveness of conservative management for urinary incontinence in women who also have osteoporosis. We hope to find that treatment for incontinence improves bladder control and thereby allows women to be more active and reduces their risk of falling and breaking bones.
- Conditions
- Urinary Incontinence
- Being tested
- Physiotherapy for urinary incontinence
- Keywords
- Randomized clinical trial, osteoporosis, urinary incontinence, physiotherapy, education
- Medical subject headings
- Urinary Incontinence, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy for urinary incontinenceBehavioural
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Incontinent Episodes (baseline and end of treatment (12 weeks)
Secondary outcomes (9)
Urinary Distress Inventory
Pelvic Floor Muscle Strength
Quality of life: Each participant will complete the Incontinence Impact Questionnaire and the SF-36 at the initial and follow up measurement sessions
Physical Activity (PASE)
24 Hour Pad Test
Voiding Frequency using the bladder diary
Spinal Curvature with a flexicurve ruler
Self-Perceived Efficacy
All at initial and follow up (end) measurement sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startMar 2006
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Meena Sran, PT, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323245
- Sponsor's protocol ID
- C05-0608
- Other IDs
- W05-0259
- Status last verified
- Apr 2011
- First submitted
- 8 May 2006
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regaining Urinary Continence in Postmenopausal Women With Osteoporosis: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00323245
- Acronym / sponsor ID
- C05-0608
- Conditions
- Urinary Incontinence
- Keywords
- Randomized clinical trial, osteoporosis, urinary incontinence, physiotherapy, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 May 2006 (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.
Conservative management for urinary incontinence has been shown to improve bladder control. We are conducting a study of the effectiveness of conservative management for urinary incontinence in women who also have osteoporosis. We hope to find that treatment for incontinence improves bladder control and thereby allows women to be more active and reduces their risk of falling and breaking bones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women osteopenia or osteoporosis and stress urinary incontinence
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Physiotherapy for urinary incontinenceSee Detailed Description. | Behavioural | – |
Primary outcome
Number of Incontinent Episodes (baseline and end of treatment (12 weeks)
9 secondary outcomes
Urinary Distress Inventory
Pelvic Floor Muscle Strength
Quality of life: Each participant will complete the Incontinence Impact Questionnaire and the SF-36 at the initial and follow up measurement sessions
Physical Activity (PASE)
24 Hour Pad Test
Voiding Frequency using the bladder diary
Spinal Curvature with a flexicurve ruler
Self-Perceived Efficacy
All at initial and follow up (end) measurement sessions
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 14 Apr 2011.
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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.
Meena Sran, PT, PhD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy for urinary incontinence in people with Urinary Incontinence, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 1 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 14 Apr 2011. 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 Canada. 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?
Number of Incontinent Episodes (baseline and end of treatment (12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2011.