AbobotulinumtoxinA cuts incontinence episodes in patients with NDOI
20 Aug 2021
In individuals with neurogenic detrusor overactivity incontinence (NDOI) who were regularly undergoing clean intermittent catheterization, significant reductions of urinary incontinence episodes were seen following treatment with abobotulinumtoxinA (aboBoNT-A), according to a pooled analysis of two CONTENT studies presented at EAU 2021.
NDOI frequently occurs in individuals with multiple sclerosis (MS) or spinal cord injury (SCI). [Neurol Urodyn 2018;37:1152-1161; Neurol Urodyn 2014;33:S2-S5] “Patients with NDOI experience substantial impairment of their quality of life (QoL), social stigma, and embarrassment associated with urinary incontinence,” said Dr Antonella Giannantoni from the University of Siena, Italy, during her presentation.
Although not currently approved for this indication, evidence suggests that aboBoNT-A is effective for NDOI management. [Eur Urol 2010;58:759-766]
The CONTENT studies evaluated SCI (70 percent) or clinically stable MS patients with NDOI* inadequately managed even after ≥4 weeks of oral therapy. A total of 485 participants (mean age 43.6 years, 61 percent male) were randomized 1:1:1 to receive aboBoNT-A 600 or 800 U or placebo injections to the detrusor muscle (0.5 mL in each of the 30 injection points) under cystoscopic control for 12 weeks. Mean baseline weekly incontinence episodes were similar across study arms. [EAU 2021, abstract P0024]
At 6 weeks, a significant reduction in weekly incontinence episodes was observed in both aboBoNT-A arms vs placebo (least squares mean [LSM], –22.7 [600 U] and –23.6 [800 U] vs –12.7 [placebo]; p<0.0001 for both). Up to 36 percent of aboBoNT-A recipients had no incontinence episodes as opposed to only 3 percent of participants receiving placebo.
These improvements subsequently contributed to QoL improvements, as reflected by the greater changes from baseline incontinence-related-QoL (I-QoL) total summary score with both aboBoNT-A doses relative to placebo (LSM, 22.1 [600 U] and 22.2 [800 U] vs 7.1). Two-thirds of aboBoNT-A recipients (65 percent [600 U] and 63 percent [800 U]) had ≥11-point improvement in I-QoL total summary score from baseline to week 6 compared with only a third of those on placebo.
Other endpoints that saw improvements from baseline to week 6 with both aboBoNT-A doses vs placebo are maximum cystometric capacity (LSM, 164.6 [600 U] and 175.8 [800 U] vs –4.0 mL) and maximum detrusor filling pressure (–33.1 and –35.4 vs –4.9 cmH20), translating to significant increases in volume per void and urodynamic parameters, explained Giannantoni.
Importantly, approximately half of participants on aboBoNT-A had no involuntary detrusor contractions (44 percent and 55 percent for the respective 600 and 800 U doses) compared with <7 percent for placebo.
AboBoNT-A injections were well-tolerated with no new safety signals seen. Across the full treatment cycle, the most frequent treatment emergent adverse event was urinary tract infection (ranging between 20 and 27 percent).
“[Overall, there were] significant improvements in patients receiving aboBoNT-A compared with placebo at all timepoints, [with] little difference observed between aboBoNT-A doses,” said Giannantoni.