Quality of life in patients with lower urinary tract symptoms associated with BPH: change over time in real-life practice according to treatment--the QUALIPROST study

Int Urol Nephrol. 2016 May;48(5):645-56. doi: 10.1007/s11255-015-1206-7. Epub 2016 Jan 25.


Purpose: To 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.

Methods: Prospective, 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.

Results: 1713 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.

Conclusions: Improvements 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.

Keywords: BII; BPH; IPSS; LUTS; Quality of life; Real-life practice.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 5-alpha Reductase Inhibitors / therapeutic use*
  • Adrenergic alpha-Antagonists / therapeutic use*
  • Aged
  • Drug Therapy, Combination
  • Dutasteride / therapeutic use
  • Finasteride / therapeutic use
  • Humans
  • Longitudinal Studies
  • Lower Urinary Tract Symptoms / etiology
  • Lower Urinary Tract Symptoms / therapy*
  • Male
  • Middle Aged
  • Phytotherapy*
  • Plant Extracts / therapeutic use*
  • Prospective Studies
  • Prostatic Hyperplasia / complications
  • Prostatic Hyperplasia / therapy*
  • Prostatism / etiology
  • Prostatism / therapy*
  • Quality of Life*
  • Serenoa
  • Severity of Illness Index
  • Sulfonamides / therapeutic use
  • Tamsulosin
  • Watchful Waiting


  • 5-alpha Reductase Inhibitors
  • Adrenergic alpha-Antagonists
  • Plant Extracts
  • Prostasan
  • Sulfonamides
  • Finasteride
  • Tamsulosin
  • Dutasteride