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

Evaluation of the Efficacy and Tolerance of 2 Dosages of Type A Botulinic Toxin in Neurogenic Areactive Bladder Resistant to Oral Medical Treatment

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00213577

Enrollment

Registered

2005-09-21

Start date

2003-12-31

Completion date

2007-10-31

Last updated

2015-03-24

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

Conditions

Overactive Bladder

Keywords

overactive neurogenic bladder

Brief summary

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.

Interventions

DRUGtype A botulinum toxin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic

Exclusion criteria

* Pregnancy * Bladder cancer * Symptomatic urinary infection

Design outcomes

Primary

Measure	Time frame
complete urinary continence at baseline, and days 30, 90, 180, and 360	—

Secondary

Measure	Time frame
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	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026