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

Allergan356 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

356

Conditions

Overactive Bladder Urinary Incontinence

Interventions

BOTOX®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.

solifenacinDRUG

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)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Newport Beach, California, United States

Unnamed facility

Leuven, Belgium

Unnamed facility

Vancouver, British Columbia, Canada

Unnamed facility

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: Study Baseline, Week 12

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.

Time frame: Study Baseline, Week 12

Secondary Outcomes

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.'

Time frame: Week 12

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.

Time frame: Study Baseline, Week 12

Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1

Data from ClinicalTrials.gov

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