Early intradetrusor injection of Onabotulinumtoxin A in patients with subacute spinal cord injury: The SCIBOT study

OBJECTIVES: The aim of this study was to examine if early intradetrusor injections of onabotulinumtoxin A (BTX) permanently prevent the development of neurogenic detrusor overactivity (NDO) in patients with spinal cord injury (SCI). MATERIALS AND METHODS: Double-blinded randomised controlled trial. Patients with a sensorimotor complete subacute traumatic suprasacral SCI received intradetrusor injection of BTX or placebo at baseline (within 12 weeks after injury) and 3 months later. Urodynamic and clinical evaluation was performed at baseline, at 3 months, at 12 months and at long-term follow-up after >24 months. The primary endpoint was occurrence of NDO with contractions above 40 cmH2O. The secondary endpoints included comparisons of urodynamic parameters, as well as clean intermittent catheterisation (CIC) frequency, occurrence of urinary incontinence, and quality of life (QOL) evaluated by questionnaires. RESULTS: Nine patients were included, with four in the placebo group and five patients in the BTX group. Two patients in the placebo group but none in the BTX group developed NDO with contractions above 40 cmH2O. Regarding the secondary outcome variables, there were lower maximum detrusor pressure, less frequent CIC, less incontinence, and better QOL in the BTX group at >24 months follow up. Although there was a trend toward better outcome measures, none of the differences were statistically significant. No adverse events were related to BTX in either group. CONCLUSION: Intradetrusor injection of BTX in patients with SCI during the subacute phase seems to be safe and may be beneficial, but further studies are needed.