RESUMO
This prospective, controlled study was undertaken to evaluate the early urodynamic and symptomatic impact of the lipido-sterolic extract of Serenoa repens (Permixon(R) ) 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(R) 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(R) 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(R) group which did not reach significance. Three patients receiving Permixon(R) experienced gastrointestinal disturbances but these did not lead to withdrawal or require additional therapy. In patients with mild/moderate BPH, Permixon(R) 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(R) as first-line therapy in patients with uncomplicated symptomatic BPH. Prostate Cancer and Prostatic Diseases (2000) 3, 195-199
RESUMO
OBJECTIVE: Benign prostatic hyperplasia (BPH) and its treatment can impair the quality of life (QoL) of patients with the condition. Among the BPH-specific instruments available for assessing QoL, no consensus has emerged on the concepts that should be measured, particularly for aspects of sexual life. The objective of this study was to determine which aspects of QoL were most affected by prostatic symptoms and which patients considered the most important. METHOD: After an extensive literature review, we drew up a self-administered questionnaire composed of an exhaustive list of concepts found in the available QoL/BPH measures. In a cross-sectional study, 73 French and 44 English patients with an International Prostate Score (I-PSS) > 7 were asked to fill in this 89-item questionnaire. The level of interference of the symptoms with each aspect of QoL and the importance of the problem were reported by the patients. RESULTS: The aspects reported to be most affected and to be the most important were sleep, anxiety and worry about the disease, mobility, leisure, daily activities, sexual activities and satisfaction with sexual relationships. French patients considered all sexual aspects of life more important than English patients. CONCLUSION: This study confirms that QoL is an important outcome in BPH. The major concepts identified by the patients to be important include sexual ones. These results suggest the importance of including the assessment of sexual functioning and behavior in any further evaluations of BPH treatments effects on QoL.