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

作者：Kraus Stephen R^*; Dmochowski Roger; Albo Michael E; Xu Lei; Klise Suzanne R; Roehrborn Claus G

来源：Neurourology and Urodynamics, 2010, 29(5): 741-747.

DOI：10.1002/nau.20825

• benign prostatic obstruction
• lower urinary tract symptoms
• multicenter trials
• standardization
• tadalafil
• urodynamic study

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 >= 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. Neurourol. Uroclynam. 29:741-747, 2010.

• 出版日期2010