EUCTR2013-000711-24-DK
Active, not recruiting
Phase 1
The effect of combining anticholinergic treatment and transcutaneous electrical nerve stimulation in children suffering from daytime urinary incontinence and an overactive bladder.
Søren Rittig0 sites90 target enrollmentSeptember 3, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Daytime urinary incontinence and overactive bladder
- Sponsor
- Søren Rittig
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age 5\-14 years
- •\- Patients must have completed a frequency\-volume chart
- •\- A minimum of urinating 4 times per day according to the frequency\-volume chart
- •\- Daytime urinary incontinence and overactive bladder (urgency) with wetting accidents at least two days a week
- •\- No effect of minimum 3 months of urotherapy including information and guidance by an urotherapist and the child must have been compliant with timed voiding.
- •\- Normal clinical examination
- •\- Oral and written consent from the child and parents
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •F.1\.2 Adults (18\-64 years) no
Exclusion Criteria
- •\- Neurological and/or anatomical abnormalities in the bladder and/or urinary tract system
- •\- The child suffers from any type of disease that can affect the child’s ability to participate in the study or can affect the parameters that is being examined in the study
- •\- Ongoing faecal problems such as constipation and/or faecal incontinence that are not well treated
- •\- Former surgery in the urinary tract system
- •\- Former or actual treatment with TENS and/or anticholinergics
- •\- Ongoing urinary infection
- •\- Treatment with any medicine that could have an effect of the parameters being examined in the study
- •\- Incomplete emptying of the bladder, equal to a urinary volume of \>20 ml after voiding. As examined by ultrasound
Outcomes
Primary Outcomes
Not specified
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