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Completed

NCT Number: NCT03042052

Toxin Retrospective Study

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.

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Key information

Conditions

Neurogenic Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Raymond Poincare

Garches, 92380, France

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

detrusor infection of Botulinum toxin

Drug

detrusor injection

Primary outcomes

  1. failure ratio

    Time frame: 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.

  2. Failure ratio

    Time frame: 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.

  3. Failure ratio

    Time frame: 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.

  4. withdrawal ratio

    Time frame: 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.

  5. withdrawal ratio

    Time frame: 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.

  6. Withdrawal ratio

    Time frame: 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 outcomes

  1. Risk factors for failures based on and clinical, radiological and urodynamic parameters

    Time frame: 3 years

    univariate analysis and multivariate analysis using Cox model

  2. Risk factors for failures based on and clinical, radiological and urodynamic parameters

    Time frame: 5 years

    univariate analysis and multivariate analysis using Cox model

  3. Risk factors for failures based on and clinical, radiological and urodynamic parameters

    Time frame: 7 years

    univariate analysis and multivariate analysis using Cox model

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Official study title

Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity

Acronym: NDOTOX

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2017
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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