Urinary IncontinenceNCT00239824
Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy
A study testing Strength training of the pelvic floor muscles and strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist in people with Urinary Incontinence, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Strength training of the pelvic floor muscles and strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2005to Jan 2008
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer prostata operated (radical prostatectomy)
- Incontinence after separation of catheter
- Understands Norwegian language
Who cannot join
- Drug/alcohol abuse
Trial locations and contacts
1 site in 1 country.
Norway1 site
Clinical Services, St.Olavs Hospital, Trondheim University Hospital, Trondheim University Hospital
Trondheim
About this study
Official title: Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial
The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.
Read the detailed description
Urinary incontinence is a well known side effect of radical prostatectomy. The prevalence differs according to time period after the operation and the definition of incontinence used. However, a prevalence of 10-20% have been reported one year after the operation. Pelvic floor muscle training has been suggested as a treatment of urinary incontinence. The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.We conduct a randomized clinical trial, comparing one group(n=40) following a pelvic floor muscle training program after prostatectomy and one group (n=40) receiving only standard information.Primary outcome variable is self registration of urinary incontinence.
- Conditions
- Urinary Incontinence
- Being tested
- Strength training of the pelvic floor muscles, strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist
- Keywords
- urinary incontinence, pelvic floor muscle training, radical prostatectomy, physiotherapy
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training of the pelvic floor musclesBehavioural
Also called Physiotherapy, pelvic floor muscle training
Group A followed a pelvic floor muscle exercise course consisting of intensive pelvic floor muscle training with follow up instructions (training group or DVD instructions)by a physiotherapist;3 x 10 contractions daily.
Group B were instructed to train the pelvic floor muscles 3 x 10 contractions daily without follow up instructions by a physiotherapist.
strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapistBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Strength training of the pelvic floor muscles with follow up instructions by a physiotherapist Receives: Behavioral: Strength training of the pelvic floor muscles; Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist |
| 2 | Active comparator | Strength training of the pelvic floor muscles without follow up instructions Receives: Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
self reported continence (no need for wearing a pad)at 3 months
Measured: One year
Secondary outcomes (6)
Self reported time period from operation to continence.
Measured: One year
24 hours home pad test registering grams of urine
Measured: One year
Pelvic floor muscle strength
Measured: one year
Erectile dysfunction
Measured: one year
Quality of life
Measured: one year
Perceived problems with urinary function
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2007
- Study completionJan 2008
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 Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy, Fund for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Siv Mørkved, PhD, Study chair, Clinical Services, St Olavs Hospital/ Dept.of Community Medicine and General Practice, Norwegian University of Science and Technology, Trondheim, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239824
- Sponsor's protocol ID
- REK4.2005.211
- Other IDs
- T-97450/001
- Status last verified
- Jul 2016
- First submitted
- 14 Oct 2005
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Overgard M, Angelsen A, Lydersen S, Morkved S. Does physiotherapist-guided pelvic floor muscle training reduce urinary incontinence after radical prostatectomy? A randomised controlled trial. Eur Urol. 2008 Aug;54(2):438-48. doi: 10.1016/j.eururo.2008.04.021. Epub 2008 Apr 18.
PubMed 18448233
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00239824
- Acronym / sponsor ID
- REK4.2005.211
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, pelvic floor muscle training, radical prostatectomy, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy, Fund for Cancer Research
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 17 Oct 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.
The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.
Detailed description
Urinary incontinence is a well known side effect of radical prostatectomy. The prevalence differs according to time period after the operation and the definition of incontinence used. However, a prevalence of 10-20% have been reported one year after the operation. Pelvic floor muscle training has been suggested as a treatment of urinary incontinence. The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.We conduct a randomized clinical trial, comparing one group(n=40) following a pelvic floor muscle training program after prostatectomy and one group (n=40) receiving only standard information.Primary outcome variable is self registration of urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Strength training of the pelvic floor muscles, Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapistStrength training of the pelvic floor muscles with follow up instructions by a physiotherapist |
| 2 | Active comparator | Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapistStrength training of the pelvic floor muscles without follow up instructions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cancer prostata operated (radical prostatectomy)
- Incontinence after separation of catheter
- Understands Norwegian language
Key exclusion criteria (1 listed)
- Drug/alcohol abuse
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 |
|---|---|---|
| Strength training of the pelvic floor musclesAlso: Physiotherapy, pelvic floor muscle trainingGroup A followed a pelvic floor muscle exercise course consisting of intensive pelvic floor muscle training with follow up instructions (training group or DVD instructions)by a physiotherapist;3 x 10 contractions daily. Group B were instructed to train the pelvic floor muscles 3 x 10 contractions daily without follow up instructions by a physiotherapist. | Behavioural | 1 |
| strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist | Behavioural | 1, 2 |
Primary outcome
self reported continence (no need for wearing a pad)at 3 months
Time frame: One year
6 secondary outcomes
Self reported time period from operation to continence.
Time frame: One year
24 hours home pad test registering grams of urine
Time frame: One year
Pelvic floor muscle strength
Time frame: one year
Erectile dysfunction
Time frame: one year
Quality of life
Time frame: one year
Perceived problems with urinary function
Time frame: One year
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 18 Jul 2016.
- Results publication: PubMed 18448233Overgard M, Angelsen A, Lydersen S, Morkved S. Does physiotherapist-guided pelvic floor muscle training reduce urinary incontinence after radical prostatectomy? A randomised controlled trial. Eur Urol. 2008 Aug;54(2):438-48. doi: 10.1016/j.eururo.2008.04.021. Epub 2008 Apr 18.
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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.
Siv Mørkved, PhD study chair
Clinical Services, St Olavs Hospital/ Dept.of Community Medicine and General Practice, Norwegian University of Science and Technology, Trondheim, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training of the pelvic floor muscles and strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist in people with Urinary Incontinence, run by Norwegian University of Science and Technology at 1 site in Norway.
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 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 18 Jul 2016. 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 Norway. 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?
self reported continence (no need for wearing a pad)at 3 months (time frame: One year). 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 NCT00239824, 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 18 Jul 2016.