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

Allergan

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence; Overactive Bladder

Treatments: Drug: solifenacin placebo; Drug: solifenacin; Drug: Botox placebo (normal saline); Biological: BOTOX®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01767519

191622-125

Details and patient eligibility

About

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

Enrollment: 356 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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356 participants in 3 patient groups, including a placebo group

BOTOX®

Experimental group

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:

Biological: BOTOX®

Drug: solifenacin placebo

solifenacin

Active Comparator group

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.

Treatment:

Biological: BOTOX®

Drug: Botox placebo (normal saline)

Drug: solifenacin

placebo

Placebo Comparator group

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.

Treatment:

Biological: BOTOX®

Drug: Botox placebo (normal saline)

Drug: solifenacin placebo