Stress Urinary IncontinenceNCT01445834
Age-stratified Outcome of Pelvic Floor Muscle Exercise for Urinary Incontinence
An observational study of Stress Urinary Incontinence and Urge Urinary Incontinence, run by University of Zurich.
Trial summary
In this retrospective study the outcome of pelvic floor muscle training in 150 women will be tested regarding patients reported satisfaction and achievement of the incontinence improvement. Comparison of two age groups, controlled for BMI, parity and previous incontinence operations. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urge Urinary Incontinence
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Nov 2011
- Phase
- Observational
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women from a tertiary referral center with urodynamically proven incontinence willig to perform physiotherapy
Who may be able to join
- premenopausal women (<50 years) with urodynamically proven urinary incontinence
- postmenopausal women (>65 years) with urodynamically proven urinary incontinence
- 9 sessions of pelvic floor muscle exercise in a professional kinesiological setting inbetween 2003-2008
- follow up regarding need of incontinence operation up to June 2011
Who cannot join
- women aged 50-65 years with urodynamically proven urinary incontinence
- stool incontinence
About this study
Official title: Retrospective Study About the Age-stratified Outcome of Pelvic Floor Muscle Exercise for Stress (SUI), Mixed (MUI) and Urgency Urinary Incontinence (UUI) 2003-2008
In this retrospective study the outcome of pelvic floor muscle training in 150 women will be tested regarding patients reported satisfaction and achievement of the incontinence improvement.
Comparison of two age groups, controlled for BMI, parity and previous incontinence operations.
Read the detailed description
Pelvic floor muscle exercise is an established conservative treatment for female urinary incontinence. Up to now, the investigators don't know whether treatment outcome in elderly women is as good as in younger premenopausal women. The International Incontinence Society states 2009: "There is no good evidence to date to suggest that "healthy" older women with urinary incontinence do not benefit from pelvic floor muscle training as much as younger women".
In this retrospective study the investigators analyze patient charts from 2003-2008 regarding subjective patients and physiotherapists reported outcome after physiotherapy as well as for objective parameters like the need of an incontinence surgery in the follow-up of at least 2 years.
Eligibility criteria are age younger than 50 years (premenopausal) and age older than 65 years and a urodynamically proven urinary incontinence. As incontinence forms the investigators include in this study the following three form: stress urinary incontinence, mixed urinary incontinence and urgency urinary incontinence.
- Keywords
- outcome of pelvic floor muscle physiotherapy, female, stress urinary incontinence, urgency urinary incontinence, mixed urinary incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Incontinent women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients reported outcome regarding their urinary incontinence
Measured: 2003-2009 (up to 6 years)
Secondary outcomes (2)
Physiotherapists reported outcome after finishing the pelvic floor muscle training
Measured: 2003-2008 (up to 5 years)
need of incontinence surgery after conservative treatment in the follow up of at least 2 years
Measured: follow up of at least 2 years after physiotherapy that was performed between 2003-2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelia Betschart, University of Zurich
- Investigators
- Cornelia Betschart, MD, Principal investigator, University Hospital of Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445834
- Sponsor's protocol ID
- KEK-ZH2011/0299/0
- Status last verified
- Dec 2015
- First submitted
- 23 Sep 2011
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study About the Age-stratified Outcome of Pelvic Floor Muscle Exercise for Stress (SUI), Mixed (MUI) and Urgency Urinary Incontinence (UUI) 2003-2008
- ClinicalTrials.gov ID
- NCT01445834
- Acronym / sponsor ID
- KEK-ZH2011/0299/0
- Keywords
- outcome of pelvic floor muscle physiotherapy, female, stress urinary incontinence, urgency urinary incontinence, mixed urinary incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 4 Oct 2011 (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.
In this retrospective study the outcome of pelvic floor muscle training in 150 women will be tested regarding patients reported satisfaction and achievement of the incontinence improvement.
Comparison of two age groups, controlled for BMI, parity and previous incontinence operations.
Detailed description
Pelvic floor muscle exercise is an established conservative treatment for female urinary incontinence. Up to now, the investigators don't know whether treatment outcome in elderly women is as good as in younger premenopausal women. The International Incontinence Society states 2009: "There is no good evidence to date to suggest that "healthy" older women with urinary incontinence do not benefit from pelvic floor muscle training as much as younger women".
In this retrospective study the investigators analyze patient charts from 2003-2008 regarding subjective patients and physiotherapists reported outcome after physiotherapy as well as for objective parameters like the need of an incontinence surgery in the follow-up of at least 2 years.
Eligibility criteria are age younger than 50 years (premenopausal) and age older than 65 years and a urodynamically proven urinary incontinence. As incontinence forms the investigators include in this study the following three form: stress urinary incontinence, mixed urinary incontinence and urgency urinary incontinence.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incontinent women | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women from a tertiary referral center with urodynamically proven incontinence willig to perform physiotherapy
Key inclusion criteria (4 listed)
- premenopausal women (<50 years) with urodynamically proven urinary incontinence
- postmenopausal women (>65 years) with urodynamically proven urinary incontinence
- 9 sessions of pelvic floor muscle exercise in a professional kinesiological setting inbetween 2003-2008
- follow up regarding need of incontinence operation up to June 2011
Key exclusion criteria (2 listed)
- women aged 50-65 years with urodynamically proven urinary incontinence
- stool incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients reported outcome regarding their urinary incontinence
Time frame: 2003-2009 (up to 6 years)
2 secondary outcomes
Physiotherapists reported outcome after finishing the pelvic floor muscle training
Time frame: 2003-2008 (up to 5 years)
need of incontinence surgery after conservative treatment in the follow up of at least 2 years
Time frame: follow up of at least 2 years after physiotherapy that was performed between 2003-2008
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 Dec 2015.
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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.
Cornelia Betschart, MD principal investigator
University Hospital of Zürich
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence and Urge Urinary Incontinence, run by University of Zurich.
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 4 inclusion and 2 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Patients reported outcome regarding their urinary incontinence (time frame: 2003-2009 (up to 6 years)). 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 3 Dec 2015.