NCT01767519 - A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence | Biotech Hunter

Enrollment

356

Participants

Timeline

Start Date

March 1, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

March 18, 2015

Conditions

Overactive BladderUrinary Incontinence

Interventions

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.

Trial Locations (8)

Unknown

Newport Beach

Leuven

Vancouver

Toronto

Prague

Berlin

Warsaw

London