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

  178306

• Contact name

  Rizwan Hamid

• Contact email

  rizwan.hamid@uclh.nhs.uk

• Sponsor organisation

  Allergan Pharmaceutical Ireland

• Duration of Study in the UK

  1 years, 8 months, 5 days

• Research summary

  This is a prospective, noninterventional, 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 reinjection
  • 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)

  The study will record the variation in the clinical use of botox (antibiotic use, injection technique, patient follow-up etc.) between countries.

  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/0204

• Date of REC Opinion

  1 Jun 2015

• REC opinion

  Favourable Opinion