Idiopathic detrusor overactivity
Conditions
Interventions
Trade Name: Neurobloc
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Botulinum toxin B
Concentration unit: IU international unit(s)
Sponsors
Swansea NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Reduction of incontinence episodes global QoL score median daily frequency median urgency episodes median leakage episodes median number of daily catheterisations ;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?; Secondary Objective: Does injection of Botulinum toxin B into the trigone relieve other symptoms associated with detrusor overactivity? Is there any associated morbidity? | — |
Countries
United Kingdom
Outcome results
None listed