Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

This study has been terminated.
(In agreement with FDA the study was terminated based on data available.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00439140
First received: February 21, 2007
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.


Condition Intervention Phase
Overactive Bladder
Biological: botulinum toxin Type A
Drug: Normal Saline (Placebo)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: Yes ]
    Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.

  • Change From Baseline in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: Yes ]
    Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.

  • Change From Baseline in FEV1/FVC Ratio [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: Yes ]
    The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.


Secondary Outcome Measures:
  • Change From Baseline in the Number of Urinary Incontinence Episodes [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).

  • Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).

  • Change From Baseline in Maximum Cystometric Capacity (MCC) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).


Other Outcome Measures:
  • Number of Participants With at Least a 15% Decrease From Baseline in FVC [ Time Frame: Baseline, Weeks 2, 6 and 12 ] [ Designated as safety issue: Yes ]
    Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.

  • Number of Participants With at Least a 20% Decrease From Baseline in FVC [ Time Frame: Baseline, Weeks 2, 6 and 12 ] [ Designated as safety issue: Yes ]
    Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.


Enrollment: 41
Study Start Date: June 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botulinum toxin Type A 200U
Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
Biological: botulinum toxin Type A
Botulinum toxin Type A injection into the detrusor.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Experimental: botulinum toxin Type A 300U
Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
Biological: botulinum toxin Type A
Botulinum toxin Type A injection into the detrusor.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Placebo/botulinum toxin Type A 200U
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
Biological: botulinum toxin Type A
Botulinum toxin Type A injection into the detrusor.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Drug: Normal Saline (Placebo)
Placebo (Normal Saline) injection into the detrusor.
Placebo/botulinum toxin Type A 300U
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable).
Biological: botulinum toxin Type A
Botulinum toxin Type A injection into the detrusor.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Drug: Normal Saline (Placebo)
Placebo (Normal Saline) injection into the detrusor.

Detailed Description:

Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
  • Inadequate response to anticholinergic medication used to treat overactive bladder.
  • Neurological respiratory impairment and abnormal pulmonary function test results

Exclusion Criteria:

  • History or evidence of pelvic or urologic abnormality
  • Previous or current diagnosis of bladder or prostate cancer
  • Symptomatic or untreated urinary tract infection at time of enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439140

Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Australia, Queensland
Herston, Queensland, Australia
Canada, British Columbia
Victoria, British Columbia, Canada
India
Chennai, India
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00439140     History of Changes
Other Study ID Numbers: 191622-082
Study First Received: February 21, 2007
Results First Received: December 9, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014