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.
RCT Entities:
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.
Authors: Dale E Bjorling; Zunyi Wang; Chad M Vezina; William A Ricke; Kimberly P Keil; Weiqun Yu; Lianyu Guo; Mark L Zeidel; Warren G Hill Journal: Am J Physiol Renal Physiol Date: 2015-04-22
Authors: Smita Pattanaik; Ravimohan S Mavuduru; Arabind Panda; Joseph L Mathew; Mayank M Agarwal; Eu Chang Hwang; Jennifer A Lyon; Shrawan K Singh; Arup K Mandal Journal: Cochrane Database Syst Rev Date: 2018-11-16