Overactive BladderNCT01187082
Grouptraining for Overactive Bladder in Adults
A study testing bladdertraining in groups and bladdertraining individually in people with Overactive Bladder, run by University of Aarhus at 5 sites in Denmark.
Trial summary
Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder syndrome) equals the effect of bladdertraining individually for patients with overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- bladdertraining in groups and bladdertraining individually
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 5 sitesDenmark
- Study dates
- Dec 2009to Mar 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women at the age of 18 and more
- patients with overactive bladder
Who cannot join
- dominance of stress incontinence
- not able to attend sessions
- do not to understand danish
- do not want training in groups or individual
- hormonebalanced (if postmenopausal with added hormonetreatment for at least 2 months)
- no treatment for OAB up till 1 month before study and during study
Show all 13Show fewer
- no renal or neurological diseases, symptomatic cystitis or non regulated diabetes
- no pregnancy during study
- no normal gynecological examination
- no operation in pelvis up till 3 month before studystart
- no polyuria measured 2 times before studystart (> 40 ml/ kg/ day)
- no upstart of treatment with medication during studystart which according to the investigator can create symptoms of OAB
- no participation in other CT
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Århus Universitetshospital, Skejby, urogynaekology dep.
Aarhus, 8300
Glostrup Hospital
Glostrup Municipality, 2600
Kolding Sygehus, urogynecology department
Kolding, 6000
Sønderborg Sygehus, Gynækologiske Ambulatorium
Sønderborg, 6400
Regionshospitalet Viborg, Kontinensklinikken
Viborg, 8800
About this study
Official title: A Clinical, Randomized, Comparative, Non-blinded Study on the Effect of Bladdertraining in Groups Compared to Individual Bladdertraining for Female Patients With Overactive Bladder.
Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder syndrome) equals the effect of bladdertraining individually for patients with overactive bladder.
The effect of the training is measured in a 3 dimensional scope by the means of 3 primary outcome measures used in the statistical evaluation. Symptoms of OAB (either (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (VAS score).
Read the detailed description
Program consisting of 3 hourly sessions with bladdertraining and daily training with a pocket bladder schedule. patients are randomised either for groups or individual training with a continence nurse over a period of 2 months.
- Conditions
- Overactive Bladder
- Being tested
- bladdertraining in groups, bladdertraining individually
- Keywords
- overactive bladder, women, bladder training, groups
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladdertraining in groupsBehavioural
Cognitive training in groups of 4 patients at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule.
bladdertraining individuallyBehavioural
Cognitive training individually at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule.
| Study group | Role | What they receive |
|---|---|---|
| bladdertraining group | Experimental | Cognitive training in groups at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule. Receives: Behavioral: bladdertraining in groups |
| bladdertraining individually | Active comparator | Cognitive training individually at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule. Receives: Behavioral: bladdertraining individually |
What is being measured
The primary outcome is the main question the study is designed to answer.
urgencyepisodes
with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
Measured: after 2 month (end of study)
urgeincontinence
with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
Measured: after 2 month (studyend)
VAS score from ICI_OAB_Q
with the ICI_OAB_Q counted before studystart / after 3 sessions/ after 2 month (studyend)
Measured: after 2 month (studyend)
Secondary outcomes (3)
voiding frequency
counted from a bladder diary before studystart/ after 3 sessions of training/ after 2 month (studyend)
Measured: after 2 month (studyend)
Compliance in training
counted from a pocket bladder schedule at every training session (3 times)and after 2 month (studyend)
Measured: after 2 month (studyend)
Adverse events
asked at every training session (3 times)and after 2 month (studyend). Patients are supposed to report in if any AEs during study
Measured: after 2 month (studyend)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2013
- Study completionMar 2013
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 Overactive BladderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Kaysen, nurse, Principal investigator, Århus Universitetshospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187082
- Sponsor's protocol ID
- BLATRA 01
- Status last verified
- Feb 2011
- First submitted
- 10 Aug 2010
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
PubMed 37811598
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical, Randomized, Comparative, Non-blinded Study on the Effect of Bladdertraining in Groups Compared to Individual Bladdertraining for Female Patients With Overactive Bladder.
- ClinicalTrials.gov ID
- NCT01187082
- Acronym / sponsor ID
- BLATRA 01
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, women, bladder training, groups
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Aug 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.
Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder syndrome) equals the effect of bladdertraining individually for patients with overactive bladder.
The effect of the training is measured in a 3 dimensional scope by the means of 3 primary outcome measures used in the statistical evaluation. Symptoms of OAB (either (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (VAS score).
Detailed description
Program consisting of 3 hourly sessions with bladdertraining and daily training with a pocket bladder schedule. patients are randomised either for groups or individual training with a continence nurse over a period of 2 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bladdertraining group | Experimental | Behavioral: bladdertraining in groupsCognitive training in groups at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule. |
| bladdertraining individually | Active comparator | Behavioral: bladdertraining individuallyCognitive training individually at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women at the age of 18 and more
- patients with overactive bladder
Key exclusion criteria (13 listed)
- dominance of stress incontinence
- not able to attend sessions
- do not to understand danish
- do not want training in groups or individual
- hormonebalanced (if postmenopausal with added hormonetreatment for at least 2 months)
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 |
|---|---|---|
| bladdertraining in groupsCognitive training in groups of 4 patients at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule. | Behavioural | bladdertraining group |
| bladdertraining individuallyCognitive training individually at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule. | Behavioural | bladdertraining individually |
Primary outcome
urgencyepisodes
Time frame: after 2 month (end of study)
with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
urgeincontinence
Time frame: after 2 month (studyend)
with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
VAS score from ICI_OAB_Q
Time frame: after 2 month (studyend)
with the ICI_OAB_Q counted before studystart / after 3 sessions/ after 2 month (studyend)
3 secondary outcomes
voiding frequency
Time frame: after 2 month (studyend)
Compliance in training
Time frame: after 2 month (studyend)
Adverse events
Time frame: after 2 month (studyend)
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 10 Mar 2015.
- Derived from this study: PubMed 37811598Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
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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.
Kirsten Kaysen, nurse principal investigator
Århus Universitetshospital, Skejby
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bladdertraining in groups and bladdertraining individually in people with Overactive Bladder, run by University of Aarhus at 5 sites 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 2 inclusion and 13 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 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
urgencyepisodes (time frame: after 2 month (end of study)). The study lists 3 primary outcomes in all. 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 NCT01187082, 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 10 Mar 2015.