Influence of the Short-term Intake of High Doses of Solifenacin and Trospium on Cognitive Function and Health-Related Quality of Life in Older Women With Urinary Incontinence

Abstract

Purpose: The aim of this study was to investigate the safety and the effects of elevated doses of solifenacin and trospium on cognitive function and health-related quality of life (HRQoL) in elderly women receiving treatment for urinary incontinence.

Methods: The study included 312 women aged 60-83 years (mean age, 69.4 years). All participants had scored at least 24 points on the Mini-Mental State Examination (MMSE) scale, and all of them had been diagnosed with urge urinary incontinence (UUI) or mixed urinary incontinence (MUI). The women were randomly assigned to 3 groups: group A, individuals who were simultaneously administered solifenacin at a high dosage of 20 mg per day and trospium at a high dosage of 60 mg per day; group B, persons taking solifenacin and trospium at the usual dosage of 10 and 30 mg per day, respectively; and group C, persons who received a placebo. Participants' cognitive status was assessed by the MMSE, Controlled Oral Word Association Test, Wechsler Adult Intelligence Scale-Revised, Wechsler Memory Scale III, Colour Trails Test, and California Verbal Learning Test scales. The HRQoL assessment was performed using the Medical Outcomes Study 36-Item Health Survey.

Results: The cognitive function parameters did not differ at the start and end of the study across the groups (P>0.05). Additionally, the cognitive function parameters did not differ significantly within each group between the start and end of the study (P>0.05). The values of most HRQoL parameters regarding the functional state of the lower urinary tract (LUT) after the termination of treatment significantly improved in groups A and B (P<0.05). A significant correlation between cognitive status and HRQoL or LUT parameters was absent (r<0.3), while the correlations between HRQoL and LUT parameters were r=0.31-0.83, P<0.05.

Conclusions: The use of elevated doses of solifenacin and trospium did not increase the risk of cognitive impairment in women with UUI and MUI. The combination of solifenacin and trospium at a double dosage may be recommended to elderly women with treatment-resistant symptoms of UUI and MUI. However, the safety of combining antimuscarinic drugs in women with an increased volume of residual urine requires further study.

Keywords: Cognition disorders; Muscarinic antagonists; Quality of life; Urinary incontinence.

Fig. 1.

Algorithm of examination and treatment of patients with urge urinary incontinence (n=312). ICIQ-SF, International Consultation on Incontinence Questionnaire-Short Form (score point); MMSE, Mini-Mental State Examination; COWAT, Controlled Oral Word Association Test; WAIS-R, Wechsler Adult Intelligence Scale-Revised; WMS-III, Wechsler Memory Scale III; LM, logic memory; CVLT, California Verbal Learning Test; MOS-SF-36, Medical Outcomes Study 36-Item Short-Form.

Fig. 2.

The relationship between assessment of level of cognitive performance before and after of treatment (n=312). WAIS-R, Wechsler Adult Intelligence Scale-Revised; WAIS-RF, digit span forward; WAIS-RB, digit span backward; COWAT, Controlled Oral Word Association Test; LM 2R, logic memory 2 recognition (WMS-III); MMSE, Mini-Mental State Examination; CVLT TL, California Verbal Learning Test TL; CTT1, Color Trails Test 1. Group A, solifenacin 20 mg+trospium 60 mg per day; group B, solifenacin 10 mg+trospium 30 mg per day; group C, control (placebo).