A Study Evaluating the Efficacy and Safety of Botulinum Toxin Type A and Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01767519
First received: January 11, 2013
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

A study to evaluate the efficacy and safety of botulinum toxin type A (BOTOX®) in patients with overactive bladder (OAB) and urinary incontinence.


Condition Intervention Phase
Overactive Bladder
Urinary Incontinence
Biological: botulinum toxin type A
Drug: solifenacin
Drug: placebo (normal saline)
Drug: solifenacin placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Episodes of Urinary Incontinence [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percentage of participants who are 100% incontinence-free/dry [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants with positive response on the single-item Treatment Benefit Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of micturition episodes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Nocturia Episodes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • King's Health Questionnaire Role and Social Limitation Domain Scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 356
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botulinum toxin type A
Botulinum toxin type A injected at Day 1, followed by another treatment after a minimum of 12 weeks has elapsed from previous treatment (if applicable). Beginning on Day 1, one solifenacin placebo capsule taken orally once daily for up to 27 weeks with dose modifications as per protocol (if applicable).
Biological: botulinum toxin type A
Botulinum toxin type A injected at Day 1, followed by another treatment after a minimum of 12 weeks has elapsed from previous treatment (if applicable).
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Drug: solifenacin placebo
Beginning on Day 1, one capsule taken orally once daily for up to 27 weeks with dose modifications as per protocol (if applicable).
Active Comparator: solifenacin
Placebo (normal saline) injected at Day 1, followed by another treatment after a minimum of 12 weeks has elapsed from previous treatment (if applicable). Beginning on Day 1, one solifenacin capsule taken orally once daily for up to 27 weeks with dose modifications as per protocol (if applicable).
Drug: solifenacin
Beginning on Day 1, one capsule taken orally once daily for up to 27 weeks with dose modifications as per protocol (if applicable).
Drug: placebo (normal saline)
Placebo (normal saline) injected at Day 1, followed by another treatment after a minimum of 12 weeks has elapsed from previous treatment (if applicable).
Placebo Comparator: placebo
Placebo (normal saline) injected at Day 1, followed by another treatment after a minimum of 12 weeks has elapsed from previous treatment (if applicable). Beginning on Day 1, one solifenacin placebo capsule taken orally once daily for up to 27 weeks with dose modifications as per protocol (if applicable).
Drug: placebo (normal saline)
Placebo (normal saline) injected at Day 1, followed by another treatment after a minimum of 12 weeks has elapsed from previous treatment (if applicable).
Drug: solifenacin placebo
Beginning on Day 1, one capsule taken orally once daily for up to 27 weeks with dose modifications as per protocol (if applicable).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
  • Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

  • Overactive Bladder caused by neurological condition
  • Patient has predominance of stress incontinence
  • Use of anticholinergics or other medications to treat OAB symptoms in the 7 days prior to screening
  • Previous use of solifenacin
  • History or evidence of pelvic or urological abnormality
  • Previous use of any botulinum toxin of any serotype for any urological condition
  • Previous use of any botulinum toxin of any serotype for any non-urological condition within 12 weeks of randomization
  • Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
  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: NCT01767519

Locations
United States, California
Newport Beach, California, United States
Belgium
Leuven, Belgium
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Czech Republic
Prague 6, Czech Republic
Germany
Berlin, Germany
Poland
Warsaw, Poland
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01767519     History of Changes
Other Study ID Numbers: 191622-125
Study First Received: January 11, 2013
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Solifenacin
Botulinum Toxins
Botulinum Toxins, Type A
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014