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.

INTERVENTION: Trade Name: Neurobloc Pharmaceutical Form: Solution for injection INN or Proposed INN: Botulinum toxin B Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 5000‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intramuscular use CONDITION: Idiopathic detrusor overactivity PRIMARY OUTCOME: 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? 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 Secondary Objective: Does injection of Botulinum toxin B into the trigone relieve other symptoms associated with detrusor overactivity?; Is there any associated morbidity? 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