The effect of combining anticholinergic treatment and transcutaneous electrical nerve stimulation in children suffering from daytime urinary incontinence and an overactive bladder.

Phase 1

• Conditions: Daytime urinary incontinence and overactive bladder; MedDRA version: 17.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2013-000711-24-DK
• Lead Sponsor: Søren Rittig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-03
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of combining anticholinergics and trancutaneous electrical nerve stimulation to children who suffer from daytime urinary incontinence and an overactive bladder. Main objective is mesured by reduction in number of incontinence episodes per week compared with placebo.;Secondary Objective: not applicable;Primary end point(s): Number of incontinence episodes during daytime;Timepoint(s) of evaluation of this end point: at the end of the trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of incontinence episodes during daytime;Timepoint(s) of evaluation of this end point: at the end of the trial