Female pelvic medicine & reconstructive surgery · 2022
Urgent PC Versus a Generic Posterior Tibial Neurostimulator for Overactive Bladder: A Retrospective Noninferiority Study.
Equivalence TrialСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Handler Stephanie Jillian, Yang Su-Jau T, Nguyen John N
Аннотация
OBJECTIVE: The aim of the study was to determine whether a generic posterior tibial neurostimulator was noninferior to Urgent PC in the treatment of nonneurogenic OAB, urgency urinary incontinence, and mixed urinary incontinence. Secondary outcomes include rates of starting and completing 3 months of maintenance therapy, treatment success after 3 months, and adverse events.
METHODS: We performed a retrospective cohort analysis of women whose nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence was treated with either Urgent PC or a generic posterior tibial neurostimulator. Previous research shows a 55% treatment success rate for posterior tibial nerve stimulation (PTNS). To demonstrate noninferiority with a limit of 14% and 80% power, our analysis required 157 patients per group.
RESULTS: We included 267 Urgent PC and 234 generic patients and excluded 51 patients from analysis. A per-protocol analysis demonstrated treatment success in 55.3% (121 of 219) of the Urgent PC and 48.6% (85 of 175) of the generic cohort (P = 0.187). An intention-to-treat analysis showed treatment success in 45.3% (121 of 267) of the Urgent PC and 36.3% (85 of 234) of the generic cohort (P = 0.690). There were no significant differences in rates of starting (82.2% vs 78.2%, P = 0.409) or completing (79.9% vs 70.9%, P = 0.129) 3 months of maintenance therapy, treatment success after 3 months (78.5% vs 73.8%, P = 0.485), and adverse events (0.37% vs 0.85%, P = 1.000) in the Urgent PC versus generic group, respectively.
CONCLUSIONS: In this cohort of women undergoing PTNS for nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence, the generic neurostimulator demonstrated noninferior rates of treatment success compared with Urgent PC.
METHODS: We performed a retrospective cohort analysis of women whose nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence was treated with either Urgent PC or a generic posterior tibial neurostimulator. Previous research shows a 55% treatment success rate for posterior tibial nerve stimulation (PTNS). To demonstrate noninferiority with a limit of 14% and 80% power, our analysis required 157 patients per group.
RESULTS: We included 267 Urgent PC and 234 generic patients and excluded 51 patients from analysis. A per-protocol analysis demonstrated treatment success in 55.3% (121 of 219) of the Urgent PC and 48.6% (85 of 175) of the generic cohort (P = 0.187). An intention-to-treat analysis showed treatment success in 45.3% (121 of 267) of the Urgent PC and 36.3% (85 of 234) of the generic cohort (P = 0.690). There were no significant differences in rates of starting (82.2% vs 78.2%, P = 0.409) or completing (79.9% vs 70.9%, P = 0.129) 3 months of maintenance therapy, treatment success after 3 months (78.5% vs 73.8%, P = 0.485), and adverse events (0.37% vs 0.85%, P = 1.000) in the Urgent PC versus generic group, respectively.
CONCLUSIONS: In this cohort of women undergoing PTNS for nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence, the generic neurostimulator demonstrated noninferior rates of treatment success compared with Urgent PC.