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

Phase 3

Completed

• Conditions: Overactive Bladder; Urinary Incontinence
• Interventions: Biological: BOTOX®; Drug: solifenacin placebo; Drug: solifenacin; Drug: Botox placebo (normal saline)

• Registration Number: NCT01767519
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-14
• Study Start: 2013-03-01
• Primary Completion: 2014-09-30
• Study Completion: 2015-03-18
• Results First Submitted: 2015-10-21
• Results First Submitted QC: 2015-12-08
• Results First Posted: 2016-01-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
solifenacin	BOTOX®	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.
BOTOX®	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.
BOTOX®	solifenacin placebo	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.
solifenacin	Botox placebo (normal saline)	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.
placebo	BOTOX®	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.
placebo	solifenacin 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.
placebo	Botox placebo (normal saline)	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.
solifenacin	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.

Primary Outcome Measures

Name	Time	Method
Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1	Study Baseline, Week 12	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	Study Baseline, Week 12	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

Name	Time	Method
Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1	Study Baseline, Week 12	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.
Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1	Week 12	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	Study Baseline, Week 12	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 Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1	Study Baseline, Week 12	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.
Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1	Study Baseline, Week 12	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.