MaleNCT01042249
Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
A study testing Pelvic Floor Muscle training in people with Male and Stroke, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on Lower Urinary Tract Symptoms (LUTS) in men after stroke. 120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment group or a control group. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male, Stroke, Urinary Incontinence
- What is being tested?
- Pelvic Floor Muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to 26 Apr 2017
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan
- Onset of last stroke ≥ 1 month
- Normal cognitive function (minimal mental examination score > 25 ) (Folstein, Folstein et al. 1976).
- LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke
- Independent walking abilities indoor > 100 m with/without aids
- Independence in toilet visits
- Age > 18 years
Who cannot join
- Prior history of LUTS surgery, pelvic surgery or trauma
- More than 2 hospital diagnosed stroke
- Other severe neurological diseases including dementia
- Severe dysphasia
- Severe psychiatric disease
- Prostate cancer
- Do not speak Danish or English
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of physiotherapy and occupational therapy, Glostrup University Hospital, Copenhagen
Glostrup Municipality, DK-2600
About this study
Official title: The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on Lower Urinary Tract Symptoms (LUTS) in men after stroke.
120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment group or a control group. The subjects in the treatment group follows a 12 week standard PFMT program, while the control group is not given specific treatment of their LUTS but like the treatment group follows the standard rehabilitation program for stroke patient. Outcome are measured by
- 5 questionnaires
- Voiding diary
- 24-hour pad test
- pelvic floor muscle assessment test
- Conditions
- Male, Stroke, Urinary Incontinence
- Being tested
- Pelvic Floor Muscle training
- Keywords
- PFMT, Stroke, LUTS, Men
- Medical subject headings
- Stroke, Urinary Incontinence, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle trainingOther
12 week training program including home exercises
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treated with Pelvic Floor Muscle Training in 12 weeks Receives: Other: Pelvic Floor Muscle training |
| Control | No intervention | Receives standard rehabilitation after stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAN-PSS-1 questionnaire
Measured: 2010-2012
Secondary outcomes (1)
Pelvic Floor Muscle Assessment test
Measured: 2010-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completion26 Apr 2017
- Study completion26 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MaleStudies 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
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation of 18.12.1981
- Responsible party
- Principal investigator, Sigrid Tibaek, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042249
- Sponsor's protocol ID
- H-B-2009-069
- Status last verified
- Jul 2018
- First submitted
- 4 Jan 2010
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
- ClinicalTrials.gov ID
- NCT01042249
- Acronym / sponsor ID
- H-B-2009-069
- Conditions
- Male, Stroke, Urinary Incontinence
- Keywords
- PFMT, Stroke, LUTS, Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Fondation of 18.12.1981
- Study start
- Feb 2010
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 5 Jan 2010 (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.
The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on Lower Urinary Tract Symptoms (LUTS) in men after stroke.
120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment group or a control group. The subjects in the treatment group follows a 12 week standard PFMT program, while the control group is not given specific treatment of their LUTS but like the treatment group follows the standard rehabilitation program for stroke patient. Outcome are measured by
- 5 questionnaires
- Voiding diary
- 24-hour pad test
- pelvic floor muscle assessment test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Pelvic Floor Muscle trainingTreated with Pelvic Floor Muscle Training in 12 weeks |
| Control | No intervention | –Receives standard rehabilitation after stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan
- Onset of last stroke ≥ 1 month
- Normal cognitive function (minimal mental examination score > 25 ) (Folstein, Folstein et al. 1976).
- LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke
- Independent walking abilities indoor > 100 m with/without aids
Key exclusion criteria (7 listed)
- Prior history of LUTS surgery, pelvic surgery or trauma
- More than 2 hospital diagnosed stroke
- Other severe neurological diseases including dementia
- Severe dysphasia
- Severe psychiatric disease
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 training12 week training program including home exercises | Other | Treatment |
Primary outcome
DAN-PSS-1 questionnaire
Time frame: 2010-2012
1 secondary outcome
Pelvic Floor Muscle Assessment test
Time frame: 2010-2012
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 1 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Male and Stroke, 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 7 inclusion and 7 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 1 Aug 2018. 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.
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?
DAN-PSS-1 questionnaire (time frame: 2010-2012). 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 1 Aug 2018.