A European Registry Evaluating Symptomatic Effectiveness of Pharmacologically Treated Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Enlargement: Lessons Learned

J Urol. 2021 Apr;205(4):1145-1152. doi: 10.1097/JU.0000000000001506. Epub 2020 Dec 1.

Abstract

Purpose: We evaluated unmet needs of lower urinary tract symptoms-benign prostatic enlargement pharmacological treatment by measuring symptom improvement, persistence and deterioration in real life. A prospective registry was conducted for 24 months in 5 European countries and analyzed by the European Association of Urology Research Foundation.

Materials and methods: Previously untreated and treated patients were enrolled to the registry in both primary care and urology referral centers in France, Germany, Italy, Spain and the UK.

Results: Overall, 2,175 patients were enrolled with 1,838 analyzed, consisting of 575 previously untreated lower urinary tract symptoms-benign prostatic enlargement patients (no alpha blockers for at least 1 month or no 5-alpha reductase inhibitors for at least 6 months) and 1,263 previously treated patients. During the registry 90% of patients adhered to the prescribed regimen. After 24 months, 70% of previously untreated and 42% of previously treated patients experienced symptom improvement (International Prostate Symptom Score [IPSS] reduction of ≥3 points). Symptomatic patients (IPSS ≥8) remained in both groups (59% in previously untreated and 61% in previously treated), with greater symptom deterioration (IPSS increase ≥3 points) in 18.9% in previously treated vs 7.8% in previously untreated patients. Both clinical lower urinary tract symptoms-benign prostatic enlargement progression and surgery rates were similar in untreated vs treated groups at 16% vs 17% and 5% vs 7%, respectively, at 24 months.

Conclusions: This prospective registry confirmed lower urinary tract symptoms-benign prostatic enlargement pharmacological treatment effectiveness in a real-world setting, with low clinical progression observed in about 1 in 6 patients and lower surgery rates below 1 in 20, by 24 months.

Keywords: drug therapy; prostatic hyperplasia; registries.

Publication types

  • Multicenter Study

MeSH terms

  • 5-alpha Reductase Inhibitors / therapeutic use
  • Adrenergic alpha-Antagonists / therapeutic use
  • Aged
  • Disease Progression
  • Europe
  • Humans
  • Lower Urinary Tract Symptoms / drug therapy*
  • Male
  • Middle Aged
  • Prospective Studies
  • Prostatic Hyperplasia / drug therapy*
  • Registries

Substances

  • 5-alpha Reductase Inhibitors
  • Adrenergic alpha-Antagonists