Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, single blind, non-inferiority clinical study was performed evaluating the
      efficacy and safety of AbobotulinumtoxinA vs. IncobotulinumtoxinA intradetrusor injections in
      women with overactive bladder and urge urinary incontinence. Also the effect of local
      anesthesia on pain level of the procedure was assessed.
    

Detailed description: 
      In the described prospective, clinical trial, approved by the National Medical Ethics
      Committee (protocol number: 0120-44/2018/5; date of approval: 22/02/2018), female patients
      were enrolled, followed by signed informed consent.

      Before treatment patients underwent history and physical examination. Before botulinum toxin
      injection each patient completed three questionnaires, UDI-6 (Urogenital Distress Inventory),
      IIQ-7 (Incontinence Impact Questionnaire), I-QOL (Incontinence Quality of Life). The total
      score of each questionnaire was considered. Before botulinum toxin injection, urinalysis was
      performed to check for a urinary tract infection (UTI). For those presenting with UTI,
      treatment was postponed until the UTI was treated and a repeat urinalysis was performed.
      Nitrofurantoin 100 mg twice daily per os was given prophylactically on the day of the
      procedure. Patients were randomised to receive either 300 units of AbobotulinumtoxinA
      (Dysport®) or 100 units of IncobotulinumtoxinA (Xeomin®). They were further randomised to
      receive local anesthesia or placebo. 30 minutes before the procedure the bladder was
      instilled with either 40 ml 1% lidocaine solution using a 16Fr urethral Foley catheter or
      with 40 ml 0.9% NaCl solution. All patients received urethral lubrication gel. Using rigid
      cystoscopy, normal saline was used to dilute the vial to 20 ml. A total of 20 evenly
      distributed intradetrusor injections, 1 ml per site, were performed, 2 of them included the
      trigone area. During the procedure the patients graded the pain level of every injection on a
      Visual Analog Scale (VAS). All patients were treated in an outpatient clinic and by one
      experienced surgeon.

      After 1 to 2 weeks patients were seen for evaluation of systemic side effects, physical
      examination, measurement of residual urine and urinalysis to eventually diagnose and treat a
      urinary tract infection. After 4 months patients were seen to evaluate the treatment result
      and complete the questionnaires, IIQ-7, UDI-6, patient satisfaction survey and I-QOL. Side
      effects were monitored for 5 months after the procedure.
    

Intervention name(s): AbobotulinumtoxinA 300 UNT; IncobotulinumtoxinA 100 UNT; Lidocain; placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 20 evenly distributed intradetrusor injections, 1 ml per site, were performed; 20 evenly distributed intradetrusor injections, 1 ml per site, were performed; 30 minutes before the procedure the bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter; 30 minutes before the procedure the bladder was instilled with 40 ml of 0.9% NaCl solution
Intervention MeSH terms: Lidocaine; abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized to receive 20 intradetrusor injections of either 300 U AbobotulinumtoxinA or 100 U IncobotulinumtoxinA. They were further randomized to receive either local anesthesia (40 ml of 1% lidocaine solution) or placebo before botulinum toxin injection.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: botulinum toxin; overactive bladder; abobotulinumtoxinA; incobotulinumtoxinA; local anesthesia