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NCT Number: NCT01600716

Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)

This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.

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Key information

Conditions

Urinary Incontinence Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Multiple Sclerosis Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 3 episodes of urinary incontinence over a 3-day period
  • History of Multiple Sclerosis (MS)
  • Urinary incontinence not adequately controlled by anticholinergic medication

Exclusion criteria

  • Current use of intermittent catheter or indwelling catheter to manage urinary incontinence
  • Previous or current botulinum toxin therapy of any serotype for any urological condition
  • Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks
  • Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis

Treatment and study plan

onabotulinumtoxinA

Biological

OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.

Other names: BOTOX®, botulinum toxin Type A

Placebo (normal saline)

Drug

Placebo (normal saline) is administered into the detrusor at Day 1.

Primary outcomes

  1. Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes

    Time frame: Baseline, Week 6

    Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).

Secondary outcomes

  1. Change From Baseline in Maximum Cystometric Capacity (MCC)

    Time frame: Baseline, Week 6

    MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.

  2. Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)

    Time frame: Baseline, Week 6

    Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.

  3. Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

    Time frame: Baseline, Week 6

    The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.

Other outcomes

  1. Duration of Treatment Effect Through Week 52

    Time frame: Up to 52 Weeks

    The duration of treatment effect is the time to patient request for retreatment.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 17, 2012
Registry last updated
Apr 30, 2019

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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