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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000711-24-DK

Enrollment

Registered

2013-09-03

Start date

2013-10-09

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Daytime urinary incontinence and overactive bladder MedDRA version: 17.0 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857

Interventions

Trade Name: Ditropan (Oxybutynin) Product Name: Ditropan Pharmaceutical Form: Tablet INN or Proposed INN: OXYBUTYNIN CAS Number: 5633-20-5 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion 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 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Denmark

Contacts

Public ContactLuise Borch

Aarhus University Hospital

luise.borch@ki.au.dk457845 15 23

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026