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.
Highlights
Published: 30 October 2021The International Society for Continence (ICS) and the International UrogynecologicalSociety (IUGA) define overactive bladder (OAB) as urgency with frequent urination and nocturia with or without urgent incontinence in the absence of a urinary tract infection or other disease [1]
Public Health 2021, 18, 11426 is recommended when OAB symptoms persist after the administration of alpha-blockers [4]
Using the International Prostate Symptom Score (IPSS), changes in incontinence quality of life using the Overactive Bladder Questionnaire (OAB-q), changes in the patient’s global impression of improvement, and the incidence of adverse events in the combined silodosin and pelvic floor muscle training compared to silodosin treatment alone over 12 weeks of treatment
Summary
The International Society for Continence (ICS) and the International Urogynecological. Society (IUGA) define overactive bladder (OAB) as urgency with frequent urination and nocturia with or without urgent incontinence in the absence of a urinary tract infection or other disease [1] All of these symptoms contribute significantly to the deterioration of quality of life for both sexes. According to the Cochrane Urology Group, the method of the first treatment for overactive bladder in men with BPH and LUTS is pelvic floor muscle training (PFMT). Not enough studies on the combination of silodosin and PFMT in men with BPH and OAB have been published in the literature. Silva [8] in a Cochrane system review of studies from various databases (CENTRAL, MEDLINE, Embase, Web of Science, LILACS, ClinicalTrials.gov, and WHO ICTRP), described information from studies on the effect of physical activity in men with BPH and LUTS. The authors of the study point to the need for other high-quality randomized studies
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