Onabotulinum toxin-A versus extended release tolterodine in the management of

INTERVENTION: Trade Name: Botox Product Name: Onabotulinum toxin A Pharmaceutical Form: Powder for injection INN or Proposed INN: Botulinum toxin type A (from Clostridium botulinum) Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 5‐150 Trade Name: Tolterodine XL Product Name: Tolterodine Product Code: Tolterodine XL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Tolterodine Other descriptive name: Tolterodine XL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐4 CONDITION: Idiopathic Overactive Bladder ; MedDRA version: 17.0 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857 Therapeutic area: Diseases [C] ‐ Symptoms and general pathology [C23] INCLUSION CRITERIA: 1. Children of both sexes between the age of 7 and 16 years inclusive, with clinical symptoms of IOAB. IOAB clinical symptoms are urgency, wetting episodes, increased frequency of micturition. 2. Symptoms must include episodes of daytime urinary incontinence. Symptomatic patients are defined as those who have symptoms of overactive bladder with at least two episodes of daytime wetting per week despite medication. 3. Incomplete resolution of symptoms after bladder training and at least six months of anticholinergic therapy (or at least four months duration of therapy at study registration). Anticholinergic therapy may comprise of Oxybutynin, Solifenacin or Tolterodine. Incomplete resolution is defined as per ICCS definition as no and partial response (less than 50% and 50 ‐ 90% improvement respectively). 4. Urodynamic studies demonstrating either detrusor over activity and/or reduced bladder compliance and/or reduced bladder capacity.

Epistemonikos ID: 3b00386ff1c914745ad6a8fcf874c9b575fd4684
First added on: Aug 23, 2024