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Urodynamic standardization in a large-scale, multicenter clinical trial examining the effects of daily tadalafil in men with lower urinary tract symptoms with or without benign prostatic obstruction.

Author(s): Kraus SR, Dmochowski R, Albo ME, Xu L, Klise SR, Roehrborn CG

Affiliation(s): Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229-3900, USA. krauss@uthscsa.edu

Publication date & source: 2010-06, Neurourol Urodyn., 29(5):741-7.

AIMS: To present the methodology, standardization techniques, and results from post hoc test-retest reproducibility analyses for a large, placebo-controlled, multicenter trial, employing urodynamic studies (UDS) to assess the impact of daily tadalafil on men with lower urinary tract symptoms (LUTS) with or without benign prostatic obstruction (BPO). METHODS: UDS implemented International Continence Society (ICS) Good Urodynamic Practice guidelines and standardized urodynamic and LUTS terminology. Further standardization procedures included: equipment calibration; a detailed procedure manual and centralized training; and implementation of a central reader. Measures included: monitoring of invalid studies, comparison of actual versus expected standard deviation (SD) for primary outcome (detrusor pressure at maximum urinary flow rate [p(detQmax)]), and test-retest reproducibility of the placebo arm at baseline and endpoint. RESULTS: Two hundred men with moderate to severe LUTS (baseline IPSS >or=13) at 20 sites were randomized to receive either tadalafil 20 mg or placebo. All men underwent non-invasive uroflow and pressure-flow studies. Numbers of invalid studies at baseline and endpoint were 9.3% and 0.6%, respectively. Variability of p(detQmax) was lower than anticipated based on actual versus expected SD of 15 and 30, respectively. Correlation coefficients were very good for pressure-flow parameters including p(detQmax) (r = .83). CONCLUSIONS: Multicenter clinical trials using urodynamic outcomes require additional standardized procedures to limit inter-site variability. By implementing centralized training with a detailed procedure manual and use of a central reader, we were able to limit common difficulties arising in multicenter clinical trials, as well as demonstrate good test-retest reproducibility of pressure flow measures. (c) 2010 Wiley-Liss, Inc.

Page last updated: 2010-10-05

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