A prospective open study evaluating the use of botulinum toxin in patients with overactive bladder as an alternative to other conservative treatments.
- Conditions
- Overactive bladder syndrome is characterized by a combination of urinary frequency, urgency and urge incontinence.
- Registration Number
- EUCTR2005-004011-30-GB
- Lead Sponsor
- Gwent Healthcare NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion criteria.
Patients with urodynamically proven detrusor overactivity. This must be on conventional CMG or VCMG - not ambulatory monitoring
This may be of congenital, neuropathic or idiopathic aetiology.
Previous failed treatment with conservative and standard medical therapy.
Patients who might otherwise be considered for neuromodulation, augmentation or diversion surgery.
A subgroup of patients with known neurogenic detrusor overactivity who already have indwelling suprapubic catheters may also be studied.
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
Exclusions.
Patients < 18 years of age.
Patients with proven bladder outflow obstruction on urodynamics.
Any patients with generalised disorder of muscle activity eg; Myaesthenia Gravis.
Serious concomitant illness.
Patients with bleeding disorders.
Pregnant or breast feeding patients.
Patients who would not tolerate intermittent self catheterisation (this excludes the subgroup who already have indwelling suprapubic catheters).
Patients in whom stress incontinence is the primary symptom.
Previous failure of Botulinum toxin therapy.
Acute urinary infection.
Any other bladder pathology demonstrated at the time of cystoscopy (includes trauma, stones, tumour).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method