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Bok, Lim, Cho, Choi, Kim, Lee, and Park: Efficacy and Safety of Solifenacin Succinate for Urinary Difficulty in Brain Lesion -Multicenter Prospective Study-
Original Article
Brain & Neurorehabilitation

Brain & Neurorehabilitation 2012; 5(2): 75-81.

Published online: 26 September 2012

DOI: https://doi.org/10.12786/bn.2012.5.2.75

Efficacy and Safety of Solifenacin Succinate for Urinary Difficulty in Brain Lesion -Multicenter Prospective Study-

Soo-Kyung Bok, M.D., Jun Ho Lim, M.D., Kang Hee Cho, M.D., Eun Seok Choi, M.D.1, Sang Soo Kim, M.D.1, Young Jin Lee, M.D.2, Noh Kyung Park, M.D.3

Department of Rehabilitation Medicine, School of Medicine, Chungnam National University, Korea.

1Department of Rehabilitation Medicine, The Catholic University of Korea College of Medicine, Korea.

2Department of Rehabilitation Medicine, Konyang University College of Medicine, Korea.

3Department of Rehabilitation Medicine, Sun General Hospital, Korea.

Corresponding author (ljh2434@cnuh.co.kr)

Received 22 February 2012       Accepted 18 July 2012

Copyright © 2012 Korea Society for Neurorehabilitation

Abstract

Objective

We studied the efficacy and safety of solifenacin for urinary difficulty in brain lesion from multicenter prospective study.

Method

Eighty patients with brain lesion who visited from 5 multicenter department of rehabilitation medicine from May 2009 to June 2010 were included. Patients were treated with solifenacin 5 mg to 10 mg for 12 weeks. The outcome measure was mean change in daily micturation frequency, daily frequency of incontinence, urgency episodes, and nocturia episodes from baseline to week 12. Patient's attitude to drug was assessed using the BSW Questionnaire (Benefit, Satisfaction and Willingness to Continue Questions).

Results

Sixty-one of 80 were evaluated for effect. All voiding parameters showed significant improvement after 12 weeks of treatment (p<0.05). There was no significant difference in efficacy of solifenacin between ischemic and hemorrhagic stroke. A twenty-two patients experienced 27 adverse events (AE). The most frequent AE were dry mouth (12.5%) and constipation (6.3%). Treatment related adverse events with solifenacin were mainly mild in severity, and only led to discontinuation in 6.3% of patients.

Conclusion

Solifenacin succinate improve urinary difficulty symptoms with acceptable efficacy and safety in patient with brain lesion.

Keywords: brain injuries, solifenacin succinat, urinary dysfunction

Figures and Tables

Fig. 1
Changes of of urination after solifenacin (*p<0.001).
bn-5-75-g001
Fig. 2
Comparison of changes of urination according to stroke subtype.
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Table 1
Demographic and Clinical Features at Baseline
bn-5-75-i001

TBI: Traumatic brain injury, ACEI: Angiotensin converting enzyme inhibitor, ARB: Angiotensin receptor blocker, CCB: Calcium channel blocker, SSRI: Selective serotonin reuptake inhibitors, TCA: Tricyclic antidepressant.

Table 2
Changes of Urination after Solifenacin
bn-5-75-i002

Values are mean ± standard deviation. *p<0.01 for the comparison of the value at the follow up time with the baseline value by post Hoc test of Bonferroni F. †p<0.01 for the comparison of the value at the follow up time with the week 4 value by post Hoc test of Bonferroni F. ‡p<0.01 for the comparison of the value at the follow up time with the week 8 value by post Hoc test of Bonferroni F.

Table 3
Results of BSW Questionnaire
bn-5-75-i003

BSW: benefit, satisfaction, willingness to continue.

Table 4
Incidence Rates of Adverse Events after Solifenacin
bn-5-75-i004

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