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A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency

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Author(s)
Ji-Yeon HanKyu-Sung LeeWon Hee ParkChoal Hee ParkJeong Gu LeeJeong Zoo LeeDuk Yoon KimYong Gil NaDong Deuk KwonMyung-Soo Choo
Keimyung Author(s)
Park, Choal Hee
Department
Dept. of Urology (비뇨의학)
Journal Title
PLoS One
Issued Date
2014
Volume
9
Issue
11
Abstract
Objectives
Patients with overactive bladder (OAB) often have trouble perceiving urgency because of difficulties in distinguishing between urgency and desire to void. Empirical antimuscarinic treatment of patients with frequency only may be reasonable if conservative management has failed. We compared the efficacy of solifenacin in patients with frequency with or without urgency.

Materials and Methods
This multicenter, 12-week, open-label, comparative, non-inferiority clinical trial assessed whether the solifenacin efficacy for frequency without urgency is non-inferior to its efficacy for frequency with urgency. All patients had micturition frequency ≥8 voids/day with or without urgency. Primary efficacy variable: daily frequency change at 12 weeks relative to baseline. Secondary efficacy variables: change at 12 weeks relative to baseline in Patients' Perception of Bladder Condition (PPBC), OAB Symptom Score (OABSS), and Benefit, Satisfaction, Willingness to continue (BSW) questionnaire.

Results
Of the 286 enrolled patients, 240 (83.9%) completed the study (without urgency n = 115; with urgency n = 125). Full dataset analysis revealed that the groups without and with urgency exhibited significant reductions in daily micturition frequency of −2.49±0.35 (mean ± standard error) and −2.63±0.37, respectively. The lower limit of the 95% two-sided CI of the comparison of the two group means was −1.14, which is smaller than the −0.8 margin of clinical equivalence. The two groups did not differ in improvement in PPBC, OABSS, or BSW scores. Both tolerated the treatment well.

Conclusions
It was not possible to verify that the solifenacin efficacy for frequency alone was non-inferior to its efficacy for OAB. Nevertheless, solifenacin tended to be effective for frequency regardless of urgency.
Keimyung Author(s)(Kor)
박철희
Publisher
School of Medicine
Citation
Ji-Yeon Han et al. (2014). A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency. PLoS One, 9(11), e112063–e112063. doi: 10.1371/journal.pone.0112063
Type
Article
ISSN
1932-6203
DOI
10.1371/journal.pone.0112063
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/33681
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Urology (비뇨의학)
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