Propiverine hydrochloride in children suffering from overactive bladder and urinary incontinence. A randomised, double-blind, placebo-controlled, parallel grouped multicentre clinical trial

Phase 3

Conditions: detrusorinstability
Overactive bladder
urgency
10004994

Registration Number: NL-OMON30181

Lead Sponsor: APOGEPHA Arzneimittel GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

Male or female, caucasian children: 5 to 10.
Signed ICD
Body weight of 17-45 kg
Micturation frequency >= 8/day at least in 1 of 3 bladder diary days.
Incontinence episodes (at least 1 within 7 days)

Exclusion Criteria

Bladder capacity [ml] >= ((age +1) x 30) [ml]
Post void residual > 10 ml
Treatment of overactive bladder symptoms in the last 28 days
Urinary tract infection at the time of study inclusion and other acute and parasitic infections of the genitourinary tract
Enuresis nocturna
Dysfunctional voiding and detrusor-sphincter-dyssynergy
Constipation
Forbidden concomitant medication (see chapter 9.4.7 of the protocol)
Clinical relevant disease of the kidney, liver, gastro-intestinal tract, cardiovascular system metabolism disorder (e.g. juvenile diabetes mellitus, diabetes insipidus

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary efficacy criteria:<br /><br>Micturition frequency/24 hours determined per diary documented by parents and<br /><br>child before and at the end of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy criteria:<br /><br>- Occurrence of incontinence episodes/ 7 days determined by questioning<br /><br>- Number of incontinence episodes / 3 days determined by bladder diary<br /><br>(parents-child-diary)<br /><br>- Average voided volume/micturition determined per diary documented by parents<br /><br>and child before and at the end of treatment<br /><br>- Course of maximum voiding capacity determined per weekly micturition protocol<br /><br>documented by child<br /><br>Evaluation of efficacy by patient, parents and investigator</p><br>