A double blind, randomised, placebo controlled crossover study of intra-trigonal injections of Botulinum toxin type B for treating patients with idiopathic detrusor overactivity refractory to other conservative treatments. - Neurobloc crossover
- Conditions
- Idiopathic detrusor overactivity
- Registration Number
- EUCTR2005-004716-75-GB
- Lead Sponsor
- Swansea NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Patients with urodynamically proven detrusor overactivity of idiopathic aetiology.
Previous failed treatment with anticholinergic therapy or if anticholinergic therapy was contra-indicated.
Patient might otherwise be considered for neuromodulation or for augmentation or diversion surgery.
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 < 18 years of age
Patients with proven bladder outflow obstruction
Any patient with neurological disease that may affect bladder function.
Any patients with generalised disorder of muscle activity
Serious concomitant illness
Patients with bleeding disorders
Pregnant or breast feeding patients
Patients who are unable to perform intermittent self-catheterisation
Patients in whom stress incontinence is the primary symptom
Acute urinary infection
Any other bladder pathology at the time of cystoscopy (includes trauma, stones, tumour)
Vesicoureteric reflux demonstrated on VCMG
Previous botulinum toxin B injections to the bladder
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Primary end point(s): Reduction of incontinence episodes<br> global QoL score<br> median daily frequency<br> median urgency episodes<br> median leakage episodes<br> median number of daily catheterisations<br> ;Main Objective: Does injection of Botulinum toxin B (Neurobloc) into the base (trigone) of the baldder relieve urge incontinence in patients suffering from detruspor overactivity?;<br> Secondary Objective: Does injection of Botulinum toxin B into the trigone relieve other symptoms associated with detrusor overactivity?<br> Is there any associated morbidity?<br>
- Secondary Outcome Measures
Name Time Method