Early urodynamic effects of the lipido-sterolic extract of Serenoa repens (Permixon®) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia

Abstract

This prospective, controlled study was undertaken to evaluate the early urodynamic and symptomatic impact of the lipido-sterolic extract of Serenoa repens (Permixon® ) in the treatment of patients with benign prostatic hyperplasia (BPH).

A total of 75 patients, aged 52–78 y with lower urinary tract symptoms due to mild/moderate BPH (mean International Prostate Symptom Score (I-PSS) 8.2) were included in the study, of which 57 received Permixon® 160 mg twice daily for 9 weeks. Urodynamic evaluation, including maximum urinary flow rate (Q_max) and detrusor pressure (DP), was performed at baseline and endpoint. Prostate volume and post-void residual urine volume were assessed by transrectal and transabdominal ultrasound respectively. In addition, the I-PSS and its associated quality of life (QoL) score were determined and adverse events were recorded.

Baseline parameters were comparable between the active treatment and control groups. After 9 weeks of Permixon® treatment Q_max increased (6.0%, P<0.001), and there were reductions in DP at maximum flow (12.8%, P<0.001), opening DP (12.6%, P<0.001), and residual urine volume (12.6%, P<0.05). In addition, the I-PSS and QoL score both decreased significantly from baseline in the active treatment group (26.8% and 18.2% respectively, P<0.001). None of these parameters improved significantly in control patients. There were also improvements in prostate volume (2.7%) and maximum DP (5.2%) in the Permixon® group which did not reach significance. Three patients receiving Permixon® experienced gastrointestinal disturbances but these did not lead to withdrawal or require additional therapy.

In patients with mild/moderate BPH, Permixon® treatment reduced infravesical obstruction and produced a rapid improvement in urodynamic parameters and symptoms. The drug was well tolerated. These data support the use of Permixon® as first-line therapy in patients with uncomplicated symptomatic BPH.