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

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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

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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