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.
Conditions
Interventions
Trade Name: BOTOX
Product Name: BOTOX®
Product Code: N/A
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administr
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. •To collect basic cost effectiveness data including EuroQol 5D data to allow simple cost effectiveness calculations to be done. •To obtain data on longer term duration of action and the need for re-injection of patients recruited to both arms of the trial ;Primary end point(s): Diary recorded urinary voiding frequency per 24 hours measured at 6 months | — |
Countries
United Kingdom
Outcome results
None listed