Overactive BladderNCT00282490
Surface Nerve Stimulation Treatment for OAB in Children
A study testing Nerve stimulator 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 perform a randomized controlled investigation of the effect of surface nerve stimulation on functional daytime incontinence in children with OAB. 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?
- Nerve stimulator
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Mar 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 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
- Incontinence refractory to treatment
- Informed consent
Who cannot join
- Severe diseases of the kidneys or urinary tract besides OAB
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of pediatrics,Skejby Sygehus, University hospital of Aarhus
Aarhus, Aarhus N, 8200
About this study
Official title: Sacral Transcutaneous Nerve Stimulation Treatment for Functional Daytime Incontinence in Children With Over Active Bladder Syndrome
The purpose of this study is to perform a randomized controlled investigation of the effect of surface nerve stimulation on functional daytime incontinence in children with OAB.
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 of OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. In the non-responding cases behavioural modifying regimes can be coupled with anticholinergic medication. However, poor compliance of the child or parents, or dose limiting side effects often influences the efficacy of this intervention. Also a considerable number of children experience no or only limited effect from the treatment even though all instructions are complied with. This has let to research into new treatment modalities and the use of low frequency electrical current to inhibit detrusor overactivity in adults has become common. Pilot studies have indicated a significant effect of TENS on urinary incontinence in children with OAB.
Hypothesis:
- Sacral TENS is an effective treatment of urinary incontinence in children with OAB refractory to anticholinergic medication coupled with bladder training and voiding reeducation.
- The acute effect of sacral TENS can be identified by urodynamics
- It is possible to predict the outcome of sacral TENS treatment in these children. 30 children (age 5-14 years) with functional daytime incontinence refractory to anticholinergic medication coupled with bladder training. The study protocol consists of 1 week of basic home registrations and a 4 day in-patient phase succeeded by a 4 week home training period. The participants will be randomized to treatment with either active or inactive TENS.
- Conditions
- Overactive Bladder, Urinary Incontinence
- Being tested
- Nerve stimulator
- Keywords
- Overactive bladder, Children, Nerve stimulation, TENS
- 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.
Nerve stimulatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effects evaluated by home registrations of degree of incontinence, VAS score of degree of urgency and frequency volume charts at specified intervals. Acute effect evaluated by urodynamics.
Secondary outcomes (1)
Bladder capacity, voiding frequency and subjective impression of incontinence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2008
- Study completionMar 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
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
- NCT00282490
- Sponsor's protocol ID
- SHTENS2006
- Other IDs
- 2006-41-6085,, 20050180
- Status last verified
- Jun 2008
- First submitted
- 25 Jan 2006
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- 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
- Sacral Transcutaneous Nerve Stimulation Treatment for Functional Daytime Incontinence in Children With Over Active Bladder Syndrome
- ClinicalTrials.gov ID
- NCT00282490
- Acronym / sponsor ID
- SHTENS2006
- Conditions
- Overactive Bladder, Urinary Incontinence
- Keywords
- Overactive bladder, Children, Nerve stimulation, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 26 Jan 2006 (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 perform a randomized controlled investigation of the effect of surface nerve stimulation on functional daytime incontinence in children with OAB.
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 of OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. In the non-responding cases behavioural modifying regimes can be coupled with anticholinergic medication. However, poor compliance of the child or parents, or dose limiting side effects often influences the efficacy of this intervention. Also a considerable number of children experience no or only limited effect from the treatment even though all instructions are complied with. This has let to research into new treatment modalities and the use of low frequency electrical current to inhibit detrusor overactivity in adults has become common. Pilot studies have indicated a significant effect of TENS on urinary incontinence in children with OAB.
Hypothesis:
- Sacral TENS is an effective treatment of urinary incontinence in children with OAB refractory to anticholinergic medication coupled with bladder training and voiding reeducation.
- The acute effect of sacral TENS can be identified by urodynamics
- It is possible to predict the outcome of sacral TENS treatment in these children. 30 children (age 5-14 years) with functional daytime incontinence refractory to anticholinergic medication coupled with bladder training. The study protocol consists of 1 week of basic home registrations and a 4 day in-patient phase succeeded by a 4 week home training period. The participants will be randomized to treatment with either active or inactive TENS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
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
- Incontinence refractory to treatment
- Informed consent
Key exclusion criteria (1 listed)
- Severe diseases of the kidneys or urinary tract besides OAB
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 |
|---|---|---|
| Nerve stimulator | Device | – |
Primary outcome
Clinical effects evaluated by home registrations of degree of incontinence, VAS score of degree of urgency and frequency volume charts at specified intervals. Acute effect evaluated by urodynamics.
1 secondary outcome
Bladder capacity, voiding frequency and subjective impression of incontinence.
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 Nerve stimulator 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 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 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 degree of incontinence, VAS score of degree of urgency and frequency volume charts at specified intervals. Acute effect evaluated by urodynamics.. 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.