A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01767519
First received: January 11, 2013
Last updated: June 2, 2016
Last verified: June 2016
  Purpose
A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.

Condition Intervention Phase
Overactive Bladder
Urinary Incontinence
Biological: BOTOX®
Drug: solifenacin
Drug: Botox 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:
  • Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

  • Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.


Secondary Outcome Measures:
  • Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'

  • Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]
    The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

  • Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]
    Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

  • Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]
    The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

  • Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]
    The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.


Enrollment: 356
Study Start Date: March 2013
Study Completion Date: March 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOTOX®
Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
Biological: BOTOX®
BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.
Other Names:
  • onabotulinumtoxinA
  • botulinum toxin Type A
Drug: solifenacin placebo
Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.
Active Comparator: solifenacin
Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Biological: BOTOX®
BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.
Other Names:
  • onabotulinumtoxinA
  • botulinum toxin Type A
Drug: solifenacin
Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks.
Other Name: Vesicare
Drug: Botox placebo (normal saline)
Botox placebo (normal saline) intradetrusor injection at Day 1.
Placebo Comparator: placebo
Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Biological: BOTOX®
BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.
Other Names:
  • onabotulinumtoxinA
  • botulinum toxin Type A
Drug: Botox placebo (normal saline)
Botox placebo (normal saline) intradetrusor injection at Day 1.
Drug: solifenacin placebo
Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01767519     History of Changes
Other Study ID Numbers: 191622-125 
Study First Received: January 11, 2013
Results First Received: October 21, 2015
Last Updated: June 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
OnabotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
AbobotulinumtoxinA
IncobotulinumtoxinA
Solifenacin Succinate
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Urological Agents
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 27, 2016