Abstract | OBJECTIVE: MATERIALS AND METHODS: A stratified analysis was conducted on data from a phase III randomized, double-blind, controlled trial of imidafenacin performed at 158 centers in Japan. The subjects received imidafenacin (0.1 mg) twice daily (group I) or placebo twice daily (group P). The 24-hour urine volume, daytime and nighttime voiding frequency, and volume voided/micturition were evaluated from 3-day voiding diaries recorded every 4 weeks during the 12-week study period. Longitudinal data analysis was performed, with all values expressed as the least squares mean ± standard error. RESULTS: A total of 46 patients (mean age 66.54 ± 9.38 years, 9 men and 37 women) with nocturia and nocturnal polyuria (>33% of urine production at night) were enrolled. Group I (n = 35) and group P (n = 11) showed no baseline differences in the daily voided volume, concomitant diseases, age, or body weight. However, the average daily number of micturitions differed (11.22 ± 2.17 vs 14.45 ± 2.85). Therefore, longitudinal data analysis was performed for each micturition pattern. After 12 weeks of treatment, nighttime micturition was significantly less frequent in group I than in group P (P = .0292), and the nocturnal percentage of 24-hour production was significantly smaller (P = .0053). The interval to the first nighttime void was significantly longer in group I than in group P, but no difference was found in the first nighttime voided volume. CONCLUSION:
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Authors | Osamu Yokoyama, Yukio Homma, Osamu Yamaguchi |
Journal | Urology
(Urology)
Vol. 82
Issue 3
Pg. 515-20
(Sep 2013)
ISSN: 1527-9995 [Electronic] United States |
PMID | 23876590
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Crown Copyright © 2013. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Imidazoles
- Muscarinic Antagonists
- imidafenacin
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Topics |
- Aged
- Double-Blind Method
- Female
- Humans
- Imidazoles
(pharmacology, therapeutic use)
- Male
- Middle Aged
- Muscarinic Antagonists
(pharmacology, therapeutic use)
- Nocturia
(drug therapy)
- Polyuria
(drug therapy)
- Time Factors
- Urination
(drug effects)
- Urine
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