Abstract
PurposeTo evaluate change in quality of life (QoL) and symptoms in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in conditions of current clinical practice.MethodsProspective, longitudinal, multicenter open-label study was carried out in urology outpatient clinics. Patients were ≥40 years of age with an International Prostate Symptom Score (IPSS) score ≥8. QoL and symptoms were measured at baseline and 6 months using the Benign Prostatic Hyperplasia Impact Index (BII) and the IPSS.Results1713 patients were included for analysis. Mean (SD) IPSS and BII scores at baseline were 16.8 (5.4) and 6.8 (2.6), respectively. 8.9 % (n = 153) of study participants did not receive treatment (watchful waiting, WW), 70.3 % (n = 1204) were prescribed monotherapy (alpha-adrenergic blockers [AB]; phytotherapy [PT, of which 95.2 % was the hexanic extract of Serenoa repens, HESr]; or 5-alpha-reductase inhibitors [5ARI]), and 20.8 % (n = 356) received combined treatment (AB + 5ARI; AB + HESr; others). At 6 months, improvements in QoL were similar across the different medical treatment (MT) groups, both for monotherapy (AB: mean improvement [SD] of 2.4 points [2.4]; PT: 1.9 [2.4]; 5ARI: 2.5 [2.3]) and combined therapy (AB + 5ARI: 3.1 [2.9]; AB + PT: 3.1 [2.5]). There were no clinically significant differences between MT groups and all showed significant improvement over WW (p < 0.05). HESr showed similar efficacy to AB and 5ARI both as monotherapy and in combination with AB. Results on the IPSS were similar.ConclusionsImprovements in QoL and symptoms were equivalent across the medical treatments most widely used in real-life practice to manage patients with moderate or severe LUTS. HESr showed an equivalent efficacy to AB and 5ARI with fewer side effects.
Highlights
Benign prostatic hyperplasia (BPH) is a common condition in older men that can often result in lower urinary tract symptoms (LUTS) [1]
A total of 119 urologists participated in the study and a total of 1888 patients were recruited, of which 1713 were available for ITT analysis (Fig. 1). 6.5 % of patients were lost to follow-up. 11.1 % of patients included in the watchful waiting group switched to another treatment before study end
This study has evaluated changes in symptoms and quality of life (QoL) in a large cohort of patients with LUTS/BPH managed in conditions of real-life practice
Summary
Benign prostatic hyperplasia (BPH) is a common condition in older men that can often result in lower urinary tract symptoms (LUTS) [1]. The efficacy and safety of medical treatments such as alpha-adrenergic blockers, 5-alpha-reductase inhibitors, phytotherapy, combination therapy, antimuscarinic agents and phosphodiesterase type 5 inhibitors have been assessed in numerous clinical trials [7], fewer studies have evaluated those treatments in current clinical practice. There is a need for large-scale studies which evaluate the range of treatments used to treat LUTS/ BPH in daily practice and which allow results to be compared across treatments. Such studies are useful in that they provide complementary data to that obtained in controlled clinical trials, where patients, centers, and compliance may not be representative of broader clinical practice [10]
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