Effect and safety of trigone-including intradetrusor injection of botulinum toxin A in patients with neurogenic detrusor overactivity and incontinence: a prospective, multicenter, single-blind and randomized controlled trial

Abstract

Objective To evaluate the effect and safety of trigone-including intradetrusor injection of botulinum toxin A (BTX-A) for patients with neurogenic detrusor overactivity (NDO) and incontinence. Methods A prospective, multicenter, single-blind and randomized controlled trial was conducted between June 2011 and June 2014. Patients with NDO and incontinence who suffered from spinal cord injury were recruited. At a 1∶1 ratio patients randomly received 200 U BTX-A intradetrusor injections excluding the trigone (control group) or 160 U intradetrusor plus 40 U intratrigonal injections (experimental group). Patients were evaluated at baseline, 4 and 12 weeks after injection. The primary outcomes included incontinence specific quality of life (I-QOL), mean voiding volume, mean incontinence episodes, complete dryness, maximum detrusor pressure (Pdetmax) during filling, volume at first involuntary detrusor contraction (VFIDC). Vesicoureteral reflux (VUR) and other adverse events were recorded. Results Ninety-six patients were recruited and 91 of them completed the trial. Among the 91 patients, 47 were randomized to experimental group, 44 to control group. There were no significant differences in baseline evaluation items between the 2 groups. All outcomes after treatment improved significantly as compared to the baseline in each group (P<0.05). Twelve weeks after treatment, the improvement percentage of I-QOL (65.84%), mean incontinence episodes (71.95%), complete dryness (29.79%), mean voiding volume (79.47%), Pdetmax (48.76%), VFIDC (64.56%) in experimental group had significant difference as compared to those in control group (55.81%, 65.80%, 11.36%, 69.76%, 40.68%, 57.23%) (P=0.01, 0.02, 0.03, 0.02, 0.04, 0.02), respectively. In both groups, no patients developed VUR. Three cases (1 in experimental group, 2 in control group) developed urinary tract infection. Conclusions Trigone-including intradetrusor injection of BTX-A is more effective than intradetrusor injection excluding the trigone for patients with NDO and incontinence. Intratrigonal injection does not induce VUR. Key words: Urinary bladder, overactive; Urinary bladder, neurogenic; Botulinum toxin type A; Bladder trigone; Treatment outcome