Efficacy and Safety of Initial 10 mg Solifenacin Treatment in Female Patients with Overactive Bladder in elderly patients: a Randomized Controlled Trial
IUGA Academy. Yoon H. Jun 30, 2018; 212966; 309 Topic: Overactive Bladder
Hana Yoon
Hana Yoon

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Efficacy and safety of initial 10 mg Solifenacin treatment in female patients with overactive bladder in elderly patients: A randomized controlled trial

Yoon, H1; Lee, HN2; Oh, MM3; Cho, ST4; Yoon, HS1

1: Ewha Womans University College of Medicine; 2: Seoul Seonam Hospital; 3: Korea University College of Medicine; 4: Hallym University College of Medicine

Introduction: Solifenacin is a well-known antimuscarinic with proven efficacy and safety in the treatment of OAB,4-7 and its dose flexibility has provided an opportunity for optimal treatment in other studies. The prevalence of OAB increases with age and the aging process significantly affects pharmacokinetics and pharmacodynamics. With the current diversity in oral pharmaceutical treatment, including not only antimuscarinics but also beta-3 agonists, proper selection of treatments with greater efficacy and safety for the elderly patient seems challenging.

Objectives: To evaluate the efficacy and safety of initial solifenacin doses of 5mg and 10mg. Additionally, to evaluate differences in drug efficacy and safety, and patient satisfaction between elderly and younger female patients.

Methods: Women aged 20-80 years with overactive bladder symptoms were randomized into two groups (A and B) depending on the initial starting dose of solifenacin (10mg and 5mg, respectively).The dose was modified 4weeks after the initial dose according to patient and physician preference and continued for 12 weeks from the start date. A 3-day frequency-volume chart noting incontinence and urgency episodes, changes in Overactive Bladder Symptom Score (OABSS), and adverse effects was evaluated and analyzed. The Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire was completed at week 12. The primary endpoint was symptom improvement and secondary endpoints were patient satisfaction and adverse effect occurrence.

Results: Seventy-five subjects were enrolled and 59 patients completed the study. In both groups, decreased daytime frequency, nocturia, urgency, and incontinence were shown in the micturition diary. Total and individual voiding symptom scores in OABSS decreased. The BSW questionnaire showed satisfactory response. Dry mouth and constipation were the most frequent side effects. In all parameters, there was no significant difference between both groups. A sub-analysis regarding age was conducted. In the elderly, after the 4-week administration, mean decrease of daytime frequency was 4.2 in group A and 1.5 in group B. The difference was statistically significant (mean difference2.7, Wilcoxon’s rank test, p=0.024). However, the difference was unmaintained at study completion (p=0.086). No significant difference was observed regarding other parameters and no side effect caused treatment cessation.

Conclusions : Compared to the younger female patients, the elderly showed a substantial improvement in OAB symptoms after a 4-week treatment with 10 mg solifenacin, without an increase in adverse events.


Work supported by industry: yes, by Astellas pharmaceuticals.

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