Objective: To evaluate the effect and safety of trigonal injection of botulinum toxin A (BTX-A) for patients with neurological detrusor overactivity (NDO) with incontinence.
Methods: A prospective, multicenter, single-blind and randomized controlled trial (RCT) was conducted between June 2011 and June 2014. Spinal cord injury patients with urinary incontinence secondary to NDO 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 and 40 U intratrigonal injections (experimental group). Patients were evaluated at baseline, and 4, 12 weeks after injection. The efficacy and safety outcomes included I-QoL, voiding volume, urinary incontinence episodes, complete dryness, maximum detrusor pressure (Pdetmax), 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 and 44 to the control group. There were no significant differences in baseline evaluation items (gender, age, duration of spinal cord injury, level of neurological injury, AIS scores) between the two groups. At 12 weeks, the improvement was significantly better in the experimental group than in the control group for I-QoL (26.01 vs. 18.75, P=0.01), mean urinary incontinence episodes (−5.22/d vs. −4.68/d, P=0.01), complete dryness (13 vs. 5, P=0.03), mean voiding volume (159.72 vs. 139.07 mL, P=0.02), Pdetmax (−33.34 vs. −28.02 cmH2O, P=0.04), and VFIDC (106.81 vs. 97.86 mL, P=0.02), duration of first detrusor contraction (−41.54 vs. −18.65 s, P=0.03) and the number of patients with detrusor contraction (−20 vs. −9, P=0.02). In both of two groups, no patients developed VUR.
Conclusions: BTX-A intradetrusor and intratrigonal injections are more effective than those excluding the trigone for patients with NDO with incontinence. Intratrigonal injections do not induce VUR.
