title: Prospective randomised controlled trial comparing trigone-sparing versus trigone-including intradetrusor injection of abobotulinumtoxinA for refractory idiopathic detrusor overactivity.
abstract: BACKGROUND
  Botulinum toxin A is effective for treatment of idiopathic detrusor overactivity (IDO). The trigone is generally spared because of the theoretical risk of vesicoureteric reflux (VUR), although studies assessing injection sites are lacking.
  
  
  OBJECTIVE
  Evaluate efficacy and safety of trigone-including versus trigone-sparing intradetrusor injections of abobotulinumtoxinA in patients with IDO.
  
  
  METHODS
  Twenty-two patients from one centre were randomised to trigone-including or trigone-sparing injections.
  
  
  METHODS
  Injection of 500 U abobotulinumtoxinA diluted to 20ml into 20 trigone-including or trigone-sparing sites.
  
  
  METHODS
  The primary outcome measure was total overactive bladder symptom score (OABSS) at 6 wk. The OABSS questionnaire was completed at 0, 6, 12, and 26 wk. Baseline and postinjection urodynamic studies and micturating cystourethrograms were performed. Baseline values and subsequent time points were compared by t test. A mixed-effect model was used for repeated measures in time.
  
  
  CONCLUSIONS
  For symptom scores at baseline compared with scores at 6 wk postinjection, the mean total OABSS improved from 22.4 to 8.7 (p<0.001) in the trigone-including group compared with 22.7 to 13.4 (p<0.03) in the trigone-sparing group. The difference in mean change from baseline was 4.4 points in favour of the trigone-including group (p=0.03). The total OABSS at 12 and 26 wk and the urgency subscale scores at 6, 12, and 26 wk showed significant improvement in favour of the trigone-including group. Mean postvoid residual volumes and clean intermittent self-catheterisation rates between the two groups were similar. No patients developed VUR. Performing injections under general anaesthetic was a limitation, as tolerability under local anaesthetic was not assessed. A further limitation is the lack of a trigone-only arm.
  
  
  CONCLUSIONS
  Trigone-including injections are superior to trigone-sparing injections for the treatment of refractory IDO and did not cause VUR in this study.
authors.affiliation: Department of Urology, Adelaide & Meath Hospital, Dublin, Ireland. rustom.manecksha@gmail.com
authors.forename: Rustom P
authors.initials: RP
authors.lastname: Manecksha
authors.forename: Ivor M
authors.initials: IM
authors.lastname: Cullen
authors.forename: Sarfraz
authors.initials: S
authors.lastname: Ahmad
authors.forename: Graeme
authors.initials: G
authors.lastname: McNeill
authors.forename: Robert
authors.initials: R
authors.lastname: Flynn
authors.forename: Thomas E D
authors.initials: TE
authors.lastname: McDermott
authors.forename: Ronald
authors.initials: R
authors.lastname: Grainger
authors.forename: John A
authors.initials: JA
authors.lastname: Thornhill
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D019274:Botulinum Toxins, Type A; C542869:abobotulinumtoxinA