{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T04:28:59Z","timestamp":1697603339435},"reference-count":16,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2011,9,8]],"date-time":"2011-09-08T00:00:00Z","timestamp":1315440000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2012,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>To evaluate a urodynamic platform designed to identify treatment effects in small numbers of patients after a short duration of treatment using a medication with known efficacy in overactive bladder (OAB).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Twenty women with OAB were randomized in a crossover study with 7\u2010day treatment periods with either tolterodine 4\u2009mg long\u2010acting (LA) or placebo and 7\u2010day washout. Patients underwent urodynamic study (UDS) at baseline, 4\u2010hr post\u2010dose on Day 1 (PD1) and 4\u2009hr post\u2010dose on Day 7 (PD7) in each treatment period. The primary endpoint was the change from baseline in volume at maximum cystometric capacity (MCC) at PD7. As a result of dosing errors, some patients allocated to tolterodine in Period 1 mistakenly received placebo on Day 7. The data from the time points at which patients were dosed incorrectly were excluded from the per protocol (PP) analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The PP and intent to treat (ITT) mean increase in volume at MCC on PD7 for tolterodine compared with placebo was 28.9% (<jats:italic>P<\/jats:italic>\u2009=\u20090.038, one\u2010sided) and 23.2% (<jats:italic>P<\/jats:italic>\u2009=\u20090.008, one\u2010sided), respectively. The PD7 mean increase in volume at first desire to void was 36.5% (<jats:italic>P<\/jats:italic>\u2009=\u20090.054, PP) and 40.3% (<jats:italic>P<\/jats:italic>\u2009=\u20090.008, ITT). No volume endpoint at PD1 was statistically significant. Of all the endpoints, MCC was the least variable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This crossover design was able to detect a clinically meaningful and statistically significant treatment effect consistent with the previous reports of tolterodine. Despite multiple urodynamics per patient, the study was able to recruit quickly. This model is valuable for evaluating therapeutic effects for existing and novel treatments for OAB. Neurourol. 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