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

This study has been terminated.
(The study was terminated early due to enrollment challenges.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00575016
First received: December 13, 2007
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.


Condition Intervention Phase
Overactive Bladder
Biological: Normal saline (Placebo); botulinum toxin Type A (200U)
Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)
Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)
Biological: botulinum toxin Type A (200U)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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 Number of Weekly Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).


Secondary Outcome Measures:
  • Change From Baseline in Maximum Cystometric Capacity (MCC) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.

  • Change From Baseline in Maximum Detrusor Pressure (MDP) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.


Enrollment: 74
Study Start Date: December 2007
Study Completion Date: July 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
botulinum toxin Type A (50U); botulinum toxin Type A (200U)
Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)
botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
Other Name: BOTOX®
Experimental: 2
botulinum toxin Type A (100U); botulinum toxin Type A (200U)
Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)
botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
Other Name: BOTOX®
Experimental: 3
botulinum toxin Type A (200U)
Biological: botulinum toxin Type A (200U)
botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
Other Name: BOTOX®
4
placebo; botulinum toxin Type A (200U)
Biological: Normal saline (Placebo); botulinum toxin Type A (200U)
Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor
Other Name: BOTOX®

  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
  • Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria:

  • History or evidence of pelvic or urologic abnormality
  • Previous or current diagnosis of bladder or prostate cancer
  • Urinary tract infection at time of enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575016

Locations
Egypt
Cairo, Egypt
Greece
Thessaloniki, Greece
India
Ahmadabad, India
Lebanon
Beirut, Lebanon
Serbia
Belgrade, Serbia
Turkey
Ankara, Turkey
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00575016     History of Changes
Other Study ID Numbers: 191622-518
Study First Received: December 13, 2007
Results First Received: September 9, 2011
Last Updated: September 9, 2011
Health Authority: India: Drugs Controller General, India, Directorate General of Health Services
Greece: National Drug Organization
Turkey: Turkish Republic Ministry of Health
Egypt: Ministry of Health and Population

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 July 26, 2014