To compare the efficacy of incobotulinumtoxinA to onabotulinumtoxinA for treatment of idiopathic overactive bladder syndrome.
This study is a single-blinded, randomized, non-inferiority trial. Participants received intradetrusor injections of either 100 units of incobotulinumtoxinA or 100 units of onabotulinumtoxinA. The primary outcome was measured as a change in the mean number of urgency urinary incontinence episodes from baseline to 2-6 weeks post-procedure.
Data from 59 participants was analyzed (29 incobotulinumtoxinA, 30 onabotulinumtoxinA). Most participants were between 40 and 59 years of age and postmenopausal. There were significantly more postmenopausal participants in the onabotulinumtoxinA group (51.72% incobotulinumtoxinA, 80% onabotulinumtoxinA, p<0.05). Comparing incobotulinumtoxinA to onabotulinumtoxinA, the difference in mean reduction of urgency urinary incontinence episodes from baseline to 2-6 weeks post-treatment was 0.41 (90% confidence interval -0.88 to 1.71), meeting the predetermined non-inferiority margin of -1. The mean daytime voids decreased by 0.97±2.54 from baseline of 7.28±2.77 in the incobotulinumtoxinA group, and by 2.97±4.74 from baseline of 9.57±5.61 in the onabotulinumtoxinA group (p<0.05). The Patient Global Impression of Improvement scores were significantly different between the two groups (2.57±1.34 IncobotulinumtoxinA, 1.93±0.83 OnabotulinumtoxinA (p<0.05)). However, the number of participants answering "very much better" and "much better" was similar between the groups (64% IncobotulinumtoxinA, 71% OnabotulinumtoxinA). There was no statistically significant difference in other secondary outcomes or with adverse events between the two groups.
Intradetrusor incobotulinumtoxinA was found to be non-inferior to onabotulinumtoxinA in treatment of idiopathic overactive bladder syndrome and offers a more pure, cost-effective, and logistically convenient alternative.
Urology. 2026 Mar 31 [Epub ahead of print]
Anna S Trikhacheva, Sara J Hamade, Jordan D Gisseman, Cara Olsen, Christine M Vaccaro, Katherine L Dengler
Department of Urology, Naval Medical Center Portsmouth, Portsmouth, VA. Electronic address: ., Department of Gynecologic Surgery and Obstetrics, Walter Reed National Military Medical Center, Bethesda, MD., Department of Gynecologic Surgery and Obstetrics, Tripler Army Medical Center, Honolulu, HI., Department of Preventive Medicine and Biostatistics, Uniformed Services University, Bethesda, MD., Gynecologic Surgery and Obstetrics, Uniformed Services University of the Health Sciences, Bethesda, MD.