Fragility of overactive bladder medication clinical trials: A systematic review.

Kevin Danis LiNikit VenishettyAdrian M FernandezNizar HakamUmar GhaffarShiv GuptaHiren V PatelBenjamin N Breyer

Published in: Neurourology and urodynamics (2024)

A change in outcome for a median of five participants, or 3.5% of the total sample size, could reverse the direction of statistical significance in OAB trials. Studies with larger sample sizes and efficacy outcomes from blinded trials were less fragile.

Keyphrases

clinical trial
healthcare
emergency department
randomized controlled trial
adverse drug
phase ii
placebo controlled
open label
phase iii
electronic health record
drug induced