OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women A Randomized Clinical Trial

OnabotulinumtoxinA 200 U produced a greater 6-month mean reduction in daily urgency incontinence episodes than sacral neuromodulation (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.1

Effect: improvement; mean difference, 0.63 episodes per day; CI: 95% CI, 0.13 to 1.14

OnabotulinumtoxinA showed greater improvement than sacral neuromodulation in OAB symptom bother (-46.7 vs -38.6, mean difference 8.1, p=.002), treatment satisfaction (67.7 vs 59.8, mean difference 7.8

Effect: improvement; mean difference, 8.1 on OAB-q SF symptom bother; CI: 95% CI, 3.0 to 13.3

Among participants completing at least 4 monthly diaries, 20% in the onabotulinumtoxinA group vs 4% in the sacral neuromodulation group had complete resolution of urgency incontinence (treatment diffe

Effect: improvement; 20% vs 4% complete resolution; 46% vs 26% >=75% reduction; CI: complete resolution: 95% CI for difference, -26% to -5%; >=75% reduction:

Urinary tract infections were significantly more frequent in the onabotulinumtoxinA group than in the sacral neuromodulation group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001),

Effect: adverse; 35% vs 11%; risk difference, -23%; CI: 95% CI, -33% to -13%

In the onabotulinumtoxinA group, 8% required intermittent self-catheterization at 1 month, 4% at 3 months, and 2% at 6 months, with a median catheterization duration of 37 days (range, 2-203).

Effect: adverse; 8% at 1 month, 4% at 3 months, 2% at 6 months

In the sacral neuromodulation group, 3% of women (6 of 189) had their device revised or removed during the 6-month period.

Effect: adverse; 3% (6 of 189 women)