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 their quality of life 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 carried out at 2 centers, including the Stroke Registry Center of Imam Reza Hospital of Tabriz Medical University and Athens Greece Hospital Rehabilitation Center. 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 with LUTS. Exclusion criteria: Evidence of brain stem or bilateral lesions, psychopathy, 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.

Intervention group 1- approved antimuscarinic in the treatment of OAB, solifenacin 10 mg, intervention group 2- antimuscarinic approved in the treatment of OAB trospium chloride 20 mg and 3-placebo control group, one oral tablet daily for one Month in all groups.

NBSS score; ICIQ-SF score; I-QOL score;

1- Changing the sampling time: Study started later than we expected in scheduled because we had delay in preparing drugs. 2- Reduction in treatment duration from 3months to one month: Most of patients had low compliance in taking drugs for three months, we reduced treatment duration to 1 month. 3- We omitted 3day urinary diary form because most of patients were old with associated disabilities to fill that form accuratly. 4- We also changed content of placebo from vitamin E to uniform tablets and without active ingredient. 5- We also omitted sonographic evaluation as we couldn't have a fulltime radiologist in our clinic.

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.

The first group will receive one 10 mg tablet solifenacin daily, the second group will receive a 20 mg trospium chloride, and the third group will receive a placebo tablet that will be the same shape, color, and weight. Participants, the principal investigator, those evaluating the outcome, the Data Safety and Monitoring Committee, and those drafting the article will be blinded.