Study Evaluating the Efficacy and Safety of Botox and Solifenacin
Research type
Research Study
Full title
A Study Evaluating the Efficacy and Safety of BOTOX® and Solifenacin in Patients with Overactive Bladder and Urinary Incontinence
IRAS ID
116957
Contact name
Paraskeve Granitsiotis
Sponsor organisation
Allergan Ltd.
Eudract number
2012-003255-11
Clinicaltrials.gov Identifier
Research summary
This study will compare the effectiveness and safety of either Botox or Solifenacin (study medication) to placebo (dummy medication) for the treatment of overactive bladder. Participants with overactive bladder whose symptoms have not been adequately managed with anticholinergic therapy (a medication used to treat over active bladder symptoms) will be invited to participate. This study will enroll about 345 participants in approximately 70 study sites in Europe, United States, and Canada.In the UK , the study will be conducted by doctors in urology and urogynaecology departments of NHS hospitals.Eligible participants will be randomly assigned by chance (randomisation) in a 2:2:1 ratio into one of the three treatment groups 1) BOTOX and oral placebo, or; 2) Placebo (saline) and oral solifenacin, or 3) Placebo (saline) and oral placebo.All participants will receive an intradetrusor (injection to a muscle that expels urine from the bladder) study treatment (BOTOX 100 U or placebo) after randomisation on day 1 following fulfillment of all ??day of intradetrusor treatment 1 criteria??. An additional intradetrusor treatment (BOTOX 100 U) may also be administered following fulfillment of pre-specified qualification for intradetrusor treatment 2 criteria and ??day of intradetrusor treatment 2 criteria??. All participants will also receive daily oral study treatment (solifenacin 5 mg or placebo) after randomisation on day 1; participants will have an option to dose escalate at week 6 (i.e. will receive either 10 mg solifenacin or placebo). Oral medication will be continued until ??qualification for intradetrusor treatment 2?? has been fulfilled, or for the duration of the study if the participant does not request and subsequently qualify for intradetrusor retreatment.Duration of the study will be a minimum of 24 weeks and a maximum duration of 40 weeks (i.e., if a patient qualifies for intradetrusor treatment 2 at week 24 and received an intradetrusor injection at week 28).
REC name
East of Scotland Research Ethics Service REC 2
REC reference
13/ES/0009
Date of REC Opinion
27 Feb 2013
REC opinion
Further Information Favourable Opinion