NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder

Phase 2TerminatedNCT00213577

University Hospital, Rouen80 enrolled

Overview

The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Overactive Bladder

Interventions

type A botulinum toxinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic Exclusion Criteria: * Pregnancy * Bladder cancer * Symptomatic urinary infection

Locations (1)

CHU-Rouen

Rouen, France

Outcomes

Primary Outcomes

complete urinary continence at baseline, and days 30, 90, 180, and 360

Secondary Outcomes

number of mictions or self catheterizations a day

number of leakages, urgency adverse events

guarding times

urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure

Data from ClinicalTrials.gov

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