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