Back to resultsA Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
Primary Purpose
Overactive Bladder, Urinary Incontinence
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BOTOX®
solifenacin
Botox placebo (normal saline)
solifenacin placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
BOTOX®
solifenacin
placebo
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1
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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01767519
Brief Title
A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
September 30, 2014 (Actual)
Study Completion Date
March 18, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
356 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOTOX®
Arm Type
Experimental
Arm Description
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.
Arm Title
solifenacin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
BOTOX®
Other Intervention Name(s)
onabotulinumtoxinA, botulinum toxin Type A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
Vesicare
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Botox placebo (normal saline)
Intervention Description
Botox placebo (normal saline) intradetrusor injection at Day 1.
Intervention Type
Drug
Intervention Name(s)
solifenacin placebo
Intervention Description
Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.
Primary Outcome Measure Information:
Title
Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1
Description
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.
Time Frame
Study Baseline, Week 12
Title
Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1
Description
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.
Time Frame
Study Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1
Description
A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'
Time Frame
Week 12
Title
Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1
Description
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.
Time Frame
Study Baseline, Week 12
Title
Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1
Description
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.
Time Frame
Study Baseline, Week 12
Title
Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Description
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.
Time Frame
Study Baseline, Week 12
Title
Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Description
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.
Time Frame
Study Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States
City
Leuven
Country
Belgium
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Prague 6
Country
Czechia
City
Berlin
Country
Germany
City
Warsaw
Country
Poland
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28161352
Citation
Herschorn S, Kohan A, Aliotta P, McCammon K, Sriram R, Abrams S, Lam W, Everaert K. The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naive Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial. J Urol. 2017 Jul;198(1):167-175. doi: 10.1016/j.juro.2017.01.069. Epub 2017 Feb 1.
Results Reference
background
Learn more about this trial
A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
We'll reach out to this number within 24 hrs