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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-01

Study Completion Date

2015-03-18

Brief Summary

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

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Detailed Description

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Conditions

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Overactive Bladder Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

BOTOX®

Intervention Type BIOLOGICAL

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.

solifenacin placebo

Intervention Type DRUG

Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

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.

Group Type ACTIVE_COMPARATOR

BOTOX®

Intervention Type BIOLOGICAL

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.

solifenacin

Intervention Type DRUG

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.

Botox placebo (normal saline)

Intervention Type DRUG

Botox placebo (normal saline) intradetrusor injection at Day 1.

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.

Group Type PLACEBO_COMPARATOR

BOTOX®

Intervention Type BIOLOGICAL

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.

Botox placebo (normal saline)

Intervention Type DRUG

Botox placebo (normal saline) intradetrusor injection at Day 1.

solifenacin placebo

Intervention Type DRUG

Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

Botox placebo (normal saline)

Botox placebo (normal saline) intradetrusor injection at Day 1.

Intervention Type DRUG

solifenacin placebo

Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

Intervention Type DRUG

Other Intervention Names

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onabotulinumtoxinA botulinum toxin Type A Vesicare

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No