NCT01767519

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Overactive Bladder
• Urinary Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	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.
DRUG	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.
DRUG	Botox placebo (normal saline)	Botox placebo (normal saline) intradetrusor injection at Day 1.
DRUG	solifenacin placebo	Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-09-30
• Completion: 2015-03-18
• First posted: 2013-01-14
• Last updated: 2019-04-23
• Results posted: 2016-01-12

Locations

8 sites across 7 countries: United States, Belgium, Canada, Czechia, Germany, Poland, United Kingdom