Erin T Bird1, Brian D Parker, Hyun Sun Kim, K Scott Coffield. 1. Department of Urology, Scott & White Memorial Hospital and Clinic, Scott, Sherwood and Brindley Foundation, The Texas A&M University System Health, Science Center College of Medicine, Temple, Texas, USA. ebird@swmail.sw.org
Abstract
AIMS: To assess lower urinary tract symptoms (LUTS) after caffeine ingestion in healthy volunteers. MATERIALS AND METHODS: We conducted a randomized, double-blind, placebo-controlled trial utilizing healthy adult volunteers without urinary tract disease. Caffeine dosage was based on patient weight (equivalent to a 70 kg person taking 200 mg of caffeine twice a day). After a 24-hr washout period, subjects ingested tablets (placebo and drug were identical in appearance) twice a day for 3 days. All participants completed volume-frequency diaries and a post-study symptom questionnaire. Statistical analysis was performed using SAS (version 8.2). Differences voiding frequency and volume were assessed by Wilcoxon rank sum test. The designated level of statistical significance was P < 0.05. RESULTS: During the first day on study medications, patients taking caffeine versus placebo voided a mean of 7.8 versus 6.4 times in a 24-hr period, respectively, P = 0.05. The mean total urine production was 2,004 ml (caffeine) versus 1,643 ml (placebo), P = 0.06, while total fluid ingested was similar (2,246 ml-caffeine, 2,102 ml-placebo, P = 0.46). For the remaining 2 days there was no significant difference between the two arms. The post-study questionnaire revealed no differences in symptom perception between the two groups. CONCLUSIONS: In healthy volunteerscaffeine appears to produce an initial diuresis, but does not appear to have other significant or sustaining effects on lower urinary symptoms in this 4-day model. (c) 2005 Wiley-Liss, Inc.
RCT Entities:
AIMS: To assess lower urinary tract symptoms (LUTS) after caffeine ingestion in healthy volunteers. MATERIALS AND METHODS: We conducted a randomized, double-blind, placebo-controlled trial utilizing healthy adult volunteers without urinary tract disease. Caffeine dosage was based on patient weight (equivalent to a 70 kg person taking 200 mg of caffeine twice a day). After a 24-hr washout period, subjects ingested tablets (placebo and drug were identical in appearance) twice a day for 3 days. All participants completed volume-frequency diaries and a post-study symptom questionnaire. Statistical analysis was performed using SAS (version 8.2). Differences voiding frequency and volume were assessed by Wilcoxon rank sum test. The designated level of statistical significance was P < 0.05. RESULTS: During the first day on study medications, patients taking caffeine versus placebo voided a mean of 7.8 versus 6.4 times in a 24-hr period, respectively, P = 0.05. The mean total urine production was 2,004 ml (caffeine) versus 1,643 ml (placebo), P = 0.06, while total fluid ingested was similar (2,246 ml-caffeine, 2,102 ml-placebo, P = 0.46). For the remaining 2 days there was no significant difference between the two arms. The post-study questionnaire revealed no differences in symptom perception between the two groups. CONCLUSIONS: In healthy volunteers caffeine appears to produce an initial diuresis, but does not appear to have other significant or sustaining effects on lower urinary symptoms in this 4-day model. (c) 2005 Wiley-Liss, Inc.
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