The study Peptide-ALPHA: a role of bladder regulatory peptides and alpha-blockers in combination therapy for LUTS
Abstract
INTRODUCTION
The pathogenesis of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) is quite complex and may be associated with overactive bladder (OAB). Alpha-1-blockers are not effective enough to resolve irritative LUTS caused by OAB. According to recent studies, regulatory polypeptides of the bovine urinary bladder (Vesusten) have shown their efficiency in patients with OAB.
AIM
To evaluate the efficiency and safety of combination therapy of LUTS caused by BPH with alpha-1-blockers and Vesusten in comparison with standard monotherapy with alpha-1-blockers.
MATERIALS AND METHODS
An open, prospective, randomized, single-center study was carried out. In the main group, patients received Vesusten intramuscularly 3 times a week (a total of 10 doses) and an alpha-1-adrenoblocker daily, while in the control group patients received alpha-blockers as monotherapy. Uroflowmetry and ultrasound parameters, IPSS and OAB-q questionnaires, as well as adverse events (AE) were assessed.
RESULTS
A total of 100 patients were included in the study, 93 of whom completed the protocol. The baseline characteristics of the groups were comparable, all patients received selective alpha-adrenoblockers (silodosin or tamsulosin) before inclusion in the study. The IPSS change in the main group was -2.43, compared to -0.38 in the control group (p<0.001). OAB-q parameters also significantly improved in the main group (-2.89 vs. -0.12; p<0.001). There was a significant…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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