Randomised trial of detrusor botulinum toxin injection (BOTOX®) compared to placebo in women with idiopathic detrusor overactivity
- Conditions
- Detrusor overactivity which is a disease of bladder function where unprovoked contractions of the detrusor muscle are generated during the storage phase of micturition. Symptoms include frequency, urgency, urge incontinence, nocturia. The first line treatment for this condition is with oral anticholinergic medication, which in many patients is ineffective.
- Registration Number
- EUCTR2004-002981-39-GB
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 240
Age over 18
Women with urodynamically proven detrusor overactivity unresponsive to oral medication defined as:
•8 weeks of continued treatment with any licensed anticholinergic drug, with a screening Patient Global Impression of Improvement (PGI-I) scale score of a little better” or worse.
•8 weeks of continued treatment, with a verbal response that the treatment has not provided acceptable improvement
•Treatment stopped because of side effects within 8 weeks
•Previous treatments stopped because of lack of efficacy, and currently receiving no treatment
·At least 8 voids per 24 hours
·At least 2 urgency episodes per 24 hours
·Patients who have given fully informed written consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patients with known multiple sclerosis, stroke, spinal injury, or other neurological disease
•Patients with pre-existing voiding dysfunction (flow rate less than 5th centile, or post void residual volume greater than 100ml)
•Patients fulfilling the exclusion criteria for the licensed indications of botulinum toxin (myasthenia gravis and Eaton Lambert syndrome, or allergy to constituents of BOTOX® injection)
•Patients with co-existing urodynamic stress incontinence
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of detrusor muscle injection of purified botulinum toxin A (BOTOX®) in relieving symptoms of detrusor overactivity.;Secondary Objective: •To examine the side effects and complications of detrusor muscle botulinum toxin A injection.<br>•To collect basic cost effectiveness data including EuroQol 5D data to allow simple cost effectiveness calculations to be done.<br>•To obtain data on longer term duration of action and the need for re-injection of patients recruited to both arms of the trial<br>;Primary end point(s): Diary recorded urinary voiding frequency per 24 hours measured at 6 months<br>
- Secondary Outcome Measures
Name Time Method