Observational study of BOTOX in Idiopathic Overactive Bladder Patients
Research type
Research Study
Full title
A prospective observational study of real world use of BOTOX® for the management of urinary incontinence in patients with Idiopathic overactive bladder (iOAB) ‘GRACE - expansion’
IRAS ID
169115
Contact name
Rizwan Hamid
Contact email
Sponsor organisation
Allergan Pharmaceutical Ireland
Duration of Study in the UK
1 years, 11 months, 13 days
Research summary
This is a prospective, non-interventional, observational, open label study of idiopathic overactive bladder (iOAB) patients with urinary incontinence who have been prescribed BOTOX®. The objective of the study is to evaluate the real world pattern of use of BOTOX® in actual clinical practice for adult idiopathic overactive bladder (iOAB) patients with urinary incontinence whose symptoms have not been adequately managed by – or who are intolerant to – oral anticholinergic therapy.
This study will be measuring the:
• Proportion of patients who have a positive treatment response at week 12 post-injection on the Benefit Scale (TBS) (score of either 1 or 2, representing ‘greatly improved’ or ‘improved’) as documented in the patient diary
• Reduction in the number of episodes of urinary incontinence from baseline to week 12
• Time to re-injection
• Number of nocturia episodes (voids that interrupt night sleep since treatment)
- Incontinence support management (liner / pants / pad use)
- Proportion of patients who have = 50% and 100% reduction in urinary incontinence and urinary urgency incontinence. (incontinence–free/dry days) from study baseline (i.e. visit 1)All adverse drug reactions observed will be recorded. All procedures are performed at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care. It is planned to recruit approximately 500 patients into the study and Patients’ involvement in the study will last up to 12 months. The total study duration is approximately 36 months.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0024
Date of REC Opinion
23 Jan 2015
REC opinion
Unfavourable Opinion