Evaluation of Silodosin and Pelvic Floor Muscle Training in Men with Benign Prostatic Hyperplasia and Overactive Bladder (Silodosing) Study Protocol (Spirit Compliant)

Magdalena Hagovska and Jan Svihra
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Magdalena Hagovska: Department of Physiatry, Balneology, and Medical Rehabilitation, Faculty of Medicine, PJ Safarik University, 040 01 Kosice, Slovakia
Jan Svihra: Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University, 814 99 Bratislava, Slovakia

IJERPH, 2021, vol. 18, issue 21, 1-9

Abstract: The aim of our study will be to evaluate the effect of combining pelvic floor muscle training (PFMT) with the urgency-suppression technique and silodosin in comparison with silodosin alone in men with Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB) after 12 weeks of treatment. The primary outcome will be a change in the number of voidings and intensity of urgencies over 24 h using a micturition diary, and the secondary outcomes will be a change in lower urinary tract symptoms, a change in incontinence quality of life, a change in patients’ global impression of improvement, and a lower incidence of adverse events. A randomized intervention parallel multicenter study will be conducted in collaboration with 45 urological clinics at the national level. Patients will be assigned at a 1:1 ratio to the experimental and control groups using simple randomization according to odd and even patient sequence numbers in each ambulatory clinic. The experimental group will receive oral silodosin at a daily dose of 8 mg once daily and pelvic floor muscle training (PFMT) 5 times a week for 20–30 min a day, for 12 weeks. The control group will receive oral treatment with silodosin at a daily dose of 8 mg once daily for 12 weeks. The study protocol presents the starting points and design of a randomized, interventional, parallel, multicenter study looking at the effect of a combination of silodosin and PFMT versus silodosin treatment in men with BPH and OAB.

Keywords: silodosin; pelvic floor exercise; overactive bladder (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
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