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European Urology

European Urology

Volume 61, issue 5, pages e41-e52, May 2012

Female Urology - Incontinence

Prospective Randomised Controlled Trial Comparing Trigone-Sparing versus Trigone-Including Intradetrusor Injection of AbobotulinumtoxinA for Refractory Idiopathic Detrusor Overactivity

Rustom P. Manecksha, Ivor M. Cullen, Sarfraz Ahmad, Graeme McNeill, Robert Flynn, Thomas E.D. McDermott, Ronald Grainger and John A. Thornhill

Accepted 27 October 2011, Published online 22 November 2011, pages 928 - 935


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.

Design, setting, and participants

Twenty-two patients from one centre were randomised to trigone-including or trigone-sparing injections.

Intervention

Injection of 500 U abobotulinumtoxinA diluted to 20 ml into 20 trigone-including or trigone-sparing sites.

Measurements

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.

Results and limitations

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.

Take Home Message

For patients with refractory idiopathic detrusor overactivity, including the trigone, rather than sparing it, during intradetrusor injection with abobotulinumtoxinA (Dysport, Ipsen Biopharm Ltd., Wrexham, UK) produced greater improvement in the total overactive bladder symptom score and the urgency subscale score.

Keywords: Botulinum toxin, AbobotulinumtoxinA, Dysport, Idiopathic detrusor overactivity, Overactive bladder syndrome, OAB, Trigone.


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