Randomised trial of detrusor botulinum toxin injection (BOTOX®) compared to placebo in women with idiopathic detrusor overactivity

niversity Hospitals of Leicester NHS Trust0 sites240 target enrollmentFebruary 15, 2005

Overview

Phase: Phase 1
Intervention: Not specified
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.
Sponsor: niversity Hospitals of Leicester NHS Trust
Enrollment: 240
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

February 15, 2005

End Date

February 18, 2015

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

niversity Hospitals of Leicester NHS Trust

•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

•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