StrokePhase 2NCT00258037
Effect of Pelvic Floor Muscle Training in Stroke
A Phase 2 study testing Pelvic Floor Muscle training in people with Stroke and Urinary Incontinence, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke measured by quality of life paramters. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stroke, Urinary Incontinence
- What is being tested?
- Pelvic Floor Muscle training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 1999to Sep 2001
- Phase
- Phase 2
- 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 40 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female stroke patients
- one month since stroke
- UI in close relation to the stroke
- normal cognitive level
- independent walking indoor ability > 100 m
- independence in toilet visit
Who cannot join
- urinary ineffections
- vaginal prolabs
- qronical lung disease
- psychiatric diseases
- other neurological diseases
- do not speak Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Glostrup
Glostrup Municipality, DK-2600
About this study
Official title: Six Months Follow-Up of Pelvic Floor Muscle Training in Women With Urinary Incontinence After Stroke
Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke measured by quality of life paramters.
- Conditions
- Stroke, Urinary Incontinence
- Being tested
- Pelvic Floor Muscle training
- Keywords
- Physiotherapy, Stroke, Urinary Incontinence, quality of Life
- Medical subject headings
- Stroke, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life parameters (SF-36, IIQ)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startJan 1999
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Sigrid G Tibaek, MSc., Pt, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258037
- Sponsor's protocol ID
- ST-KA98117
- Status last verified
- Mar 2000
- First submitted
- 23 Nov 2005
- Last updated
- 26 May 2010
- Results posted
- No
Publications
Tibaek S, Jensen R, Lindskov G, Jensen M. Can quality of life be improved by pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A randomised, controlled and blinded study. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):117-23; discussion 123. doi: 10.1007/s00192-004-1124-1. Epub 2004 Jan 31.
PubMed 15014939Tibaek S, Gard G, Jensen R. Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodyn. 2005;24(4):348-57. doi: 10.1002/nau.20134.
PubMed 15791633Tibaek S, Gard G, Jensen R. Is there a long-lasting effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A 6-month follow-up study. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):281-7. doi: 10.1007/s00192-006-0137-3. Epub 2006 Jun 28.
PubMed 16673051
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Months Follow-Up of Pelvic Floor Muscle Training in Women With Urinary Incontinence After Stroke
- ClinicalTrials.gov ID
- NCT00258037
- Acronym / sponsor ID
- ST-KA98117
- Conditions
- Stroke, Urinary Incontinence
- Keywords
- Physiotherapy, Stroke, Urinary Incontinence, quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Sep 2001
- First posted
- 24 Nov 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.
Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke measured by quality of life paramters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female stroke patients
- one month since stroke
- UI in close relation to the stroke
- normal cognitive level
- independent walking indoor ability > 100 m
Key exclusion criteria (6 listed)
- urinary ineffections
- vaginal prolabs
- qronical lung disease
- psychiatric diseases
- other neurological diseases
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 | Behavioural | – |
Primary outcome
Quality of Life parameters (SF-36, IIQ)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
- Results publication: PubMed 15014939Tibaek S, Jensen R, Lindskov G, Jensen M. Can quality of life be improved by pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A randomised, controlled and blinded study. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):117-23; discussion 123. doi: 10.1007/s00192-004-1124-1. Epub 2004 Jan 31.
- Results publication: PubMed 15791633Tibaek S, Gard G, Jensen R. Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodyn. 2005;24(4):348-57. doi: 10.1002/nau.20134.
- Results publication: PubMed 16673051Tibaek S, Gard G, Jensen R. Is there a long-lasting effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A 6-month follow-up study. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):281-7. doi: 10.1007/s00192-006-0137-3. Epub 2006 Jun 28.
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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.
Sigrid G Tibaek, MSc., Pt principal investigator
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pelvic Floor Muscle training in people with Stroke and Urinary Incontinence, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 May 2010. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Quality of Life parameters (SF-36, IIQ). 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 NCT00258037, which also lists 3 linked publications.
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 26 May 2010.