Overactive BladderNCT00238680
Programmable Timer in the Bladder Rehabilitation Treatment of OAB
A study testing Bladder rehabilitation and Bladder rehabilitation with programmable timer in people with Overactive Bladder and Urinary Incontinence, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the effect of bladder rehabilitation in a non-selected group of children with idiopathic overactive bladder and to clarify whether the effect of the treatment can be increased by addition of a programmable timer Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Overactive Bladder, Urinary Incontinence
- What is being tested?
- Bladder rehabilitation and Bladder rehabilitation with programmable timer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2005to Apr 2007
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Daytime urinary incontinence with at least 1 episode of at least 1 ml per week
- More than 6 voidings per day
- Informed consent
Who cannot join
- Known diseases of the kidneys or urinary tract besides OAB
- Receiving treatment with drugs that have an effect on the urine production or bladder function
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of pediatrics, University hospital of Aarhus, Skejby Sygehus
Aarhus, Aarhus N, 8200
About this study
Official title: The Effect of Programmable Timer in Bladder Rehabilitation Treatment of Idiopathic Overactive Bladder in Children
The purpose of this study is to evaluate the effect of bladder rehabilitation in a non-selected group of children with idiopathic overactive bladder and to clarify whether the effect of the treatment can be increased by addition of a programmable timer
Read the detailed description
Daytime urinary incontinence is common in children. At the age of 7 a prevalence of 2-9 % has been reported. Daytime urinary incontinence is a heterogenic multifactorial illness where the the symptoms has several degrees of severity and can be caused by different mechanisms. Daytime urinary incontinence can be etiologically classified in the rare neurogenic and structural forms and the common functional or idiopathic form (where no neurological or structural cause of the bladder dysfunction can be identified.
The symptom based diagnosis OAB (overactive bladder) is most often used to describe daytime urinary incontinence in children. OAB is defined as a symptom syndrome including urgency with or without urge incontinence in combination with frequency.
When urinary tract infection and neurogenic and structural causes has been excluded the nonpharmacological bladder rehabilitation is first line treatment in children with OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. The treatment consist of instruction in good micturition habits including toilet position, sufficient fluid intake and voidings at predefined intervals. The treatment effect is to a large degree dependent upon the ability of the children to void at fixed intervals. Children at the age of 5-10 yrs generally find this difficult and a programmable timer seems be an useful instrument in order to remind the child of voiding at fixed times. However there has not been published studies of the effect of programmable timer.
Hypothesis:
- Daytime urinary incontinence in children aged 5-15 with idiophatic OAB can in 50 % of cases be cured by bladder rehabilitation
- The compliance of the bladder rehabilitation treatment can for each individual be increased by adding a programmable timer to the treatment.
Material and methods:
100 children with idiopathic OAB will be recruited from the Center of Child Incontinence, Skejby University Hospital, Aarhus, Denmark.
After a run-in period of at least 4 weeks the children will be randomized to 12 weeks of bladder rehabilitation with or without programmable timer.
The effect of the treatment will be estimated based on home recordings.
- Conditions
- Overactive Bladder, Urinary Incontinence
- Being tested
- Bladder rehabilitation, Bladder rehabilitation with programmable timer
- Keywords
- Overactive bladder, Children, Bladder rehabilitation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder rehabilitationBehavioural
Bladder rehabilitation with programmable timerBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effects evaluated by home registrations of incontinence episodes and frequency volume charts at specified intervals.
Secondary outcomes (1)
Bladder capacity measure before and after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startMar 2005
- Primary completionSep 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Soeren Hagstroem, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238680
- Sponsor's protocol ID
- SHTIMER2005
- Other IDs
- 2005-41-4853, 20040192
- Status last verified
- Jun 2008
- First submitted
- 12 Oct 2005
- Last updated
- 17 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Programmable Timer in Bladder Rehabilitation Treatment of Idiopathic Overactive Bladder in Children
- ClinicalTrials.gov ID
- NCT00238680
- Acronym / sponsor ID
- SHTIMER2005
- Conditions
- Overactive Bladder, Urinary Incontinence
- Keywords
- Overactive bladder, Children, Bladder rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 13 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 purpose of this study is to evaluate the effect of bladder rehabilitation in a non-selected group of children with idiopathic overactive bladder and to clarify whether the effect of the treatment can be increased by addition of a programmable timer
Detailed description
Daytime urinary incontinence is common in children. At the age of 7 a prevalence of 2-9 % has been reported. Daytime urinary incontinence is a heterogenic multifactorial illness where the the symptoms has several degrees of severity and can be caused by different mechanisms. Daytime urinary incontinence can be etiologically classified in the rare neurogenic and structural forms and the common functional or idiopathic form (where no neurological or structural cause of the bladder dysfunction can be identified.
The symptom based diagnosis OAB (overactive bladder) is most often used to describe daytime urinary incontinence in children. OAB is defined as a symptom syndrome including urgency with or without urge incontinence in combination with frequency.
When urinary tract infection and neurogenic and structural causes has been excluded the nonpharmacological bladder rehabilitation is first line treatment in children with OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. The treatment consist of instruction in good micturition habits including toilet position, sufficient fluid intake and voidings at predefined intervals. The treatment effect is to a large degree dependent upon the ability of the children to void at fixed intervals. Children at the age of 5-10 yrs generally find this difficult and a programmable timer seems be an useful instrument in order to remind the child of voiding at fixed times. However there has not been published studies of the effect of programmable timer.
Hypothesis:
- Daytime urinary incontinence in children aged 5-15 with idiophatic OAB can in 50 % of cases be cured by bladder rehabilitation
- The compliance of the bladder rehabilitation treatment can for each individual be increased by adding a programmable timer to the treatment.
Material and methods:
100 children with idiopathic OAB will be recruited from the Center of Child Incontinence, Skejby University Hospital, Aarhus, Denmark.
After a run-in period of at least 4 weeks the children will be randomized to 12 weeks of bladder rehabilitation with or without programmable timer.
The effect of the treatment will be estimated based on home recordings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Daytime urinary incontinence with at least 1 episode of at least 1 ml per week
- More than 6 voidings per day
- Informed consent
Key exclusion criteria (2 listed)
- Known diseases of the kidneys or urinary tract besides OAB
- Receiving treatment with drugs that have an effect on the urine production or bladder function
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 |
|---|---|---|
| Bladder rehabilitation | Behavioural | – |
| Bladder rehabilitation with programmable timer | Behavioural | – |
Primary outcome
Clinical effects evaluated by home registrations of incontinence episodes and frequency volume charts at specified intervals.
1 secondary outcome
Bladder capacity measure before and after treatment.
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 17 Jun 2008.
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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.
Soeren Hagstroem, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder rehabilitation and Bladder rehabilitation with programmable timer in people with Overactive Bladder and Urinary Incontinence, run by University of Aarhus 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 3 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 17 Jun 2008. 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?
Clinical effects evaluated by home registrations of incontinence episodes and frequency volume charts at specified intervals.. 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 17 Jun 2008.