Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence

Apogepha

Status and phase: Completed; Phase 3

Conditions: Children; Urinary Incontinence; Overactive Bladder

Treatments: Drug: Mictonetten 5 mg, coated tablet; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00603343

EudraCT-Number 200400124330

Details and patient eligibility

About

The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.

Full description

This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.

Enrollment: 303 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• voiding frequency 8 or above per day
• at least one incontinence episode per day
• age between 5-10 years
• body weight between 17 and 45 kg

Exclusion criteria

• normal age expected bladder capacity
• PVR more than 10 ml
• dysfunctional voiding
• neurogenic disorders
• UTI, constipation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

303 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Mictonetten 5 mg, coated tablet

2

Placebo Comparator group

Treatment:

Drug: placebo