Treatment Arms
Arm A · n = 190 ITT
OnabotulinumtoxinA 200 U
Cystoscopic intradetrusor injection
Arm B · n = 174 ITT
Sacral Neuromodulation
InterStim (Medtronic), staged implant
Population: Women with refractory UUI (failed behavioral therapy + ≥2 medications). Baseline UUI episodes/day: Botox 5.4 vs SNM 5.2.
Primary Outcome: Change in UUI Episodes/Day at 6 Months
−3.9
Botox
95% CI −4.26 to −3.52
−3.3
SNM
95% CI −3.64 to −2.87
0.63
Mean difference
95% CI 0.13–1.14 · P = .01
Key Secondary Outcomes
OAB-SF Symptom Bother Change
Adverse Events
Higher with Botox
UTI: 35% vs 11% (P < .001)
Self-catheterization at 1 mo: 8%
Self-catheterization at 6 mo: 2%
SNM Issues
Device revision/removal: 3%
Clinical responder rate: 84%
Failed test phase: 16%
Clinical Bottom Line
In women with refractory UUI, onabotulinumtoxinA 200 U produced a statistically significant but small additional reduction vs SNM (0.63 episodes/day) of uncertain clinical importance. Botox achieved far more complete resolution (20% vs 4%) but with substantially higher UTI rates (35% vs 11%). Treatment choice should be individualized.