Hypothesis / aims of study
Base on trigonal botulinum toxin A (BTX-A) injection has been proven effective in adults with neurological or non-neurological disorders. Especially one of our previous studies also found that BTX-A intradetrusor and intratrigonal injections were superior to those excluding the trigone with respect to neurological detrusor overactivity (NDO) in adults, and no patients developed systemic or significant adverse events after treatment. In this study, we aim to evaluate the efficacy and safety of trigonal injections for children with neurological NDO secondary to spinal cord injury (SCI).
Study design, materials and methods
Children with NDO secondary to SCI were enrolled. All patients received 200U BTX-A intradetrusor injections including the trigone. Videourodynamic study was performed at baseline and 12 weeks after injection. The primary outcome measures were the presence of vesicoureteral reflux and standardized urodynamic measures. Secondary outcomes included incontinence quality of life questionnaire (I-QoL), voiding volume, urinary incontinence episodes, and complete dryness.
Results
A total of 33 pediatric inpatients (28 male and 5 female) completed the study. No one developed VUR at week 0 or week 12. At the first instance of NDO, maximum detrusor pressure (PdetmaxFNDO) and NDO duration were reduced by 29.8% and 31.8%, respectively, whereas NDO volume (VFNDO) increased by 50.5%,12 weeks after injection. The PdetmaxFNDO was 45.83 cmH2O vs. 32.15 cmH2O (P = 0.002), VFNDO was163.44 ml vs. 246.01. ml( P < 0.001), and NDO duration was 60.20 s vs. 41.08 s, (P = 0.048) before and after treatment. Mean urinary incontinence episodes were reduced by 31.7% (4.01/d vs.2.76/d, P = 0.013), whereas voiding volume and I-QOL were increased by 52.9% (183.16 ml vs. 280.02 ml, P < 0.001) and 23.3% (40.68 vs. 50.13, P = 0.036). 3 patients reported mild transient hematuria during the first week after injection.
Interpretation of results
To our knowledge, this study is the first to evaluate efficacy and safety of trigone-including intradetrusor injections of BTX-A in children with NDO owing to SCI. . Consistent with previous findings in adults, our findings suggest that trigone-including injections do not induce VUR in children and is a safe and effective procedure for NDO.