Evaluation of tolerability and cognitive safety of trospium chloride in the treatment of overactive bladder: a systematic review and meta-analysis

Kuzmin I.V., Slesarevskaya M.N., Al-Shukri S.Kh.

Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia, St. Petersburg, Russia

Introduction. Overactive bladder (OAB) is one of the most common lower urinary tract dysfunctions, significantly impairing the quality of life of patients. Pharmacotherapy is the leading treatment for OAB; however, poor tolerability of antimuscarinic drugs prescribed for this condition hinders clinical efficacy in a significant number of patients.
Objective. To evaluate the tolerability and cognitive safety of the anticholinergic drug trospium chloride (TCh) in the treatment of OAB in adults and children.
Materials and Methods. The study was conducted in accordance with the PRISMA criteria. A search of eLibrary, PubMed, EMBASE, Web of Science, and the Cochrane Library was performed for the period 1991–2025. Randomized and non-randomized controlled trials, as well as prospective observational studies, were included in the analysis. A control group was required in adult studies. A total of 23 studies (15 in adults, 8 in children) were included in the analysis. A total of 2,244 patients (1,934 adults, 310 children) received TCh.
Results. Most adverse events (AEs) with TCh were due to the drug’s systemic antimuscarinic effect. The most common AEs were dry mouth (OR 3.75; 95% CI 2.83–4.97; NNH = 6.0) and constipation (OR 2.69; 95% CI 1.72–4.19; NNH = 17.1). The incidence of peripheral AEs with TCh is comparable to that with other antimuscarinic agents used to treat OAB, with the exception of oxybutynin, which is significantly less well-tolerated. Unlike other anticholinergic drugs, TCh does not affect the central nervous system or cause cognitive impairment. TCh was well tolerated in children at age-appropriate doses.
Conclusion. The results of the study demonstrate good tolerability of TCh in adults and children. A significant advantage of TCh is its cognitive safety. Along with its clinical efficacy, this allows TCh to be considered as a first-line anticholinergic therapy in adults with OAB, particularly in elderly patients and those at high risk of cognitive impairment. Further studies of the long-term safety of TCh in patients of different age groups are warranted.

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About the Authors

Corresponding author: I.V. Kuzmin – Ph.D., MD, Professor, Department of Urology, Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia, St. Petersburg, Russia, e-mail: kuzminigor@mail.ru

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