Toxin Retrospective Study

Completed

• Conditions: Neurogenic Bladder
• Interventions: Drug: detrusor infection of Botulinum toxin

• Registration Number: NCT03042052
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

Brief Summary

Aims of this study were to assess the long-term outcomes of detrusor injection of OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk factors for failure.

Detailed Description

Neurogenic detrusor overactivity (NDO) remains a major concern for patients with neurological diseases. Fifty to eighty percent of patients with multiple sclerosis (MS) or traumatic spinal cord injury (SCI) and more than 60% of patients with myelomeningocele suffer from urinary incontinence episodes (UI) due to NDO. NDO is characterized by involuntary detrusor contractions during the filling phase, leading to leakage and increase in bladder pressure, which can, precipitate renal failure. Detrusor injection of OnabotulinumtoxinA (Botox®), is licensed worldwide and recommended as a second line therapy for the treatment of urinary incontinence due to NDO after failure of anticholinergic drugs (Grade A).

These recommendations are based on the results of international multicentric, randomized controlled trials.

These studies established not only clinical benefits, with a significant decrease of urinary incontinence episodes, but also urodynamic benefits.

There are very few data about the real prevalence of failure of Botox® in the long term.

Thus, aims of this study were to assess the long-term outcomes of detrusor injections of Botox® associated with clean intermittent-catheterization (CIC) for the treatment of NDO and to identify risk factors for failure .

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-05-01
• Study Completion: 2016-06-01
• Study First Submitted: 2017-01-27
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Study First Posted: 2017-02-03
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

• NDO due to MS, SCI or spina-bifida.
• follow-up ≥3 years from the first Botox® injection.
• Performing clean intermittent catheterization

Exclusion Criteria

• bladder surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients suffering from NDO managed with Botox	detrusor infection of Botulinum toxin	Doses used were 300 units Botox® from January 2001 to January 2011 and 200 units after 2011 Frequency depended on patient's symptoms Duration was an outcome of the study

Primary Outcome Measures

Name	Time	Method
Failure ratio	Seven years of follow up	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
failure ratio	3 years of follow up	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
withdrawal ratio	5 years of follow up	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Withdrawal ratio	7 years of follow up	Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Risk factors for failures based on and clinical, radiological and urodynamic parameters	7 years	univariate analysis and multivariate analysis using Cox model

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France