Efficacy of Solifenacin and trospium chloride on neurogenic bladder after stroke: a multicentric three arms placebo-controlled trial

Patients with stroke who have bladder dysfunction caused by neurogenic bladder with detrusor overactivity and urinary incontinence can improve the quality of life in these patients and reduce the financial burden of renal failure.

3 arm parallel group randomised trial with blinded out come assessment placebo, sulfinacine and trospium chloride

Sampling will be carried out at three centers, including the Stroke Registry Center of Imam Reza Hospital of Tabriz Medical University, Athens Greece Hospital Rehabilitation Center, and the Urology Department of Maastricht Hospital, The Netherlands.This study is a three-blind randomized controlled clinical trial that the researcher, data collector and analyzer will not know type of the intervention received by the groups.To hide the intervention type allocation based on random allocation sequences written by the non-researcher, the paper will be written in opaque envelopes and in the same package.

Inclusion criteria: Stroke diagnosis patients older than 18 years old, Normal cognitive function, LUTS. Exclusion criteria: Evidence of brain stem or bilateral signs on examination, Mental disorders according to the patient's own statement, Having history of LUTS surgery, pelvic surgery, or trauma, Having previous urologic surgery, More than two strokes (diagnosed at a hospital), Other severe neurological disease including dementia, Severe psychiatric disease, Prostate cancer, Patients who refuse consent, Abnormal liver function, closed anterior chamber glaucoma and history of hypersensitive reaction to anticholinergic drugs.

Individuals with a 1: 1: 1 allocation ratio will be divided into three groups receiving solifenacin, trosporium chloride and placebo.

NBSS score; ICIQ-SF score; Post voiding residue; I-QOL score; 3-day voiding diary

researchers will be randomized patients in these healthing care units, and using wwww.randomiser.org to simple randomise and the patients IDs will be saved.

To hide the intervention type allocation based on random allocation sequences written by the non-researcher, the paper will be written in opaque envelopes and in the same package, numbered 1 to 201, respectively.The first envelope will be given to the first person who meets the inclusion criteria and will continue until the samples are completed. The sample, researcher and analyst will not be aware of the contents of the envelope.Identified envelopes of identical, opaque and sequential numbered envelopes will be used in order of concealment in the order of the sequences in which either the solifenacin or tropezium or placebo tablets are poured.Envelopes will be prepared by a person involved in sampling and collecting data and analyzing them on the basis of the allocation sequence.The first person is eligible for Envelope No. 1 and will continue to complete the sampling. In all three groups, stratification will be done equally based on months spent in stroke.