Multicenter study on the effectiveness of entomological extract-based therapy in men with lower urinary symptoms associated with benign prostatic hyperplasia and chronic prostatitis

Abstract

Introduction and objectives:

Benign prostatic hyperplasia (BPH) and chronic prostatitis (CP) are common causes of lower urinary tract symptoms (LUTS) in men. This multicenter study evaluated the efficacy of an entomological extract-based treatment (EEBT) as monotherapy and in combination with standard drugs.

Materials and methods:

A total of 6375 men with LUTS (IPSS ⩾ 10, Qmax 5–15 mL/s) were included; 1498 had BPH, 3060 had CP, and 1817 had both. Group I received EEBT monotherapy, while Group II underwent combination therapy with α1-adrenergic blockers, NSAIDs, antibiotics, and other agents. Outcomes were assessed after 30 days using NIH-CPSI, IPSS, IIEF-5, QoL, Qmax, prostate volume, and residual urine.

Results:

Both regimens significantly improved LUTS. In BPH patients, monotherapy reduced prostate and residual urine volumes and improved IIEF-5, whereas combination therapy provided greater symptom relief. In CP patients, both regimens improved NIH-CPSI, IPSS, and urinary flow, with monotherapy showing superior QoL benefits. In men with BPH + CP, monotherapy favored erectile function, while combination therapy improved IPSS. All subgroups demonstrated significant gains in Qmax. Treatment was well tolerated; only mild Clavien–Dindo grade I and II adverse events were reported, with no serious complications.

Conclusion:

EEBT is effective as both monotherapy and in combination therapy for LUTS associated with BPH and CP, supporting its role in personalized treatment strategies.