Comparing outcome of silodosin vs silodosin plus mirabegron for nocturia in patients of BEP/LUTS; a double blinded, randomized controlled trial

Benign Enlargement of prostate (BEP) is a common condition affecting most elderly men, and patients with BEP present with various lower urinary tract symptoms (LUTS). LUTS are commonly divided into three types: Storage symptoms (urinary daytime frequency, nocturia, urgency, incontinence), voiding symptoms (urinary hesitancy, slow stream, straining, splitting or spraying, intermittent stream, terminal dribbling) and post micturition symptoms (feeling of incomplete emptying, post micturition dribbling). Nocturia, defined as waking because of the desire to void during intended sleep, is a storage symptom. Treating bladder outlet obstruction (BOO) is thought to improve nocturia by lowering postvoid residual (PVR) volume, increasing functional bladder capacity, and reducing global urinary frequency. Alpha blockers are medications which act by reducing the BOO. Studies have shown that uro-selective alpha blockers like tamsulosin and silodosin have a significant effect in decreasing nocturia by the above mechanisms. Mirabegron, a selective beta-3 agonist approved for the treatment of OAB symptoms by the US Food and Drug Administration in 2012, acts on the detrusor muscle and relaxes it. Studies have shown that mirabegron helps in reducing nocturia. There have been various studies showing the effectiveness of alpha blockers on treating nocturia. Studies have also shown that mirabegron helps in reducing nocturia. However, there are no randomized studies comparing alpha blocker monotherapy with alpha blocker and beta 3 agonist combination therapy in management of nocturia. This study aims to compare these two groups in the treatment of nocturia. The study is a prospective RCT study, to be done in the Department of Urology and Department of Pharmacology at PGIMER, Chandigarh. The patients will be called back after 4 weeks. The IPSS and the ICIQ-NQoL questionnaires will be repeated at this time along with a 3 day FVC, uroflometry and a USG KUB with PVRU. The patients will then be given medications for 4 more weeks and will be followed up at the end of 8 weeks with IPSS, ICIC-NQoL, FVC, Uroflometry and USG KUB with PVRU. The data collected will be then analyzed.