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Introduction

Although several randomized studies have reported the efficacy of a combination therapy (CT) with an anticholinergic agent and an α1-blocker or β3-adrenoceptor agonist and an α1-blocker for patients with benign prostatic enlargement (BPE) complicated by overactive bladder (OAB), no study has compared the improvement of subjective and objective symptoms in patients with BPE/OAB, between the two drugs. We compared the efficacy of CT with an anticholinergic agent and an α1-blocker, and CT with β3-adrenoceptor agonist and an α1-blocker for patients with BPE/OAB, by conducting a urodynamic study (UDS).

Methods

This was a randomized prospective study involving 80 outpatients with untreated BPE (IPSS ≥8, IPSS- QOL ≥3, prostate volume ≥25 mL) associated with urinary urgency at least once per week, who had an OAB symptom score (OABSS) of ≥3. The patients were randomly assigned to receive CT with silodosin at 8 mg/day and fesoterodine 4 mg/day (Feso-CT group) or CT with silodosin and mirabegron 50 mg/day (Mira-CT group). Changes in parameters from baseline to 12 weeks after administration were assessed based on IPSS, IPSS-QOL, OABSS, and voiding and storage functions, as measured using a UDS.

Results

In the efficacy analysis, 33 patients from the Feso-CT group (mean age, 71.3 years; mean prostate volume, 47.2 mL) and 31 patients from the Mira-CT group (70.8 years, 45.9 mL) were included. Although the mean IPSS and OABSS significantly improved in both groups, the improvement in OABSS in the Feso-CT group was significantly greater than that in the Mira-CT group. With regard to the storage function assessed by UDS, the Feso-CT group demonstrated a significantly greater improvement in terms of the incidence of detrusor overactivity. Urodynamic voiding function significantly improved in both groups, without significant inter-group difference (Table).

Conclusions

CT with silodosin and fesoterodine or mirabegron significantly improved subjective and objective symptoms in patients with BPE and OAB. Thus, CT with fesoterodine was thought to be more effective than CT with mirabegron, with regard to storage symptoms and functions.

Funding

none