International Urology and Nephrology

, Volume 39, Issue 4, pp 1137–1146

Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial

Authors

  • Nikolai Lopatkin
    • Institute of Urology
    • Institute of Urology
  • Sandra Schläfke
    • Clinical Research DepartmentDr. Willmar Schwabe GmbH & Co. KG
  • Petra Funk
    • Clinical Research DepartmentDr. Willmar Schwabe GmbH & Co. KG
  • Alexander Medvedev
    • Institute of Urology
  • Udo Engelmann
    • Department of UrologyUniversity Hospital of Cologne
Original Paper

DOI: 10.1007/s11255-006-9173-7

Cite this article as:
Lopatkin, N., Sivkov, A., Schläfke, S. et al. Int Urol Nephrol (2007) 39: 1137. doi:10.1007/s11255-006-9173-7

Abstract

In an open-label extension of a randomized, double-blind clinical trial, the long-term efficacy and tolerability of a fixed combination of 160 mg Sabal fruit extract WS 1473 and 120 mg Urtica root extract WS 1031 per capsule (PRO 160/120) were investigated in elderly men with moderate or severe lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Two hundred and fifty-seven patients were randomly treated with 2 × 1 capsule/day PRO 160/120 or placebo for 24 weeks, followed by a 24-week control period and a 48-week follow-up period in which all patients received PRO 160/120. Efficacy measures included the assessment of LUTS [International Prostate Symptom Score ((I-PSS) self-rating questionnaire] and uroflow and sonographic parameters. Two hundred and nineteen subjects participated in the follow-up. Between baseline and end of observation (week 96) the I-PSS total score was reduced by 53% (P < 0.001), peak and average urinary flow increased by 19% (P < 0.001), and residual urine volume decreased by 44% (P = 0.03). The incidence of adverse events during follow-up was one in 1,181 treatment days; in only one event a causal relationship with intake of PRO 160/120 could not be excluded. Treatment with PRO 160/120 thus provides a clinically relevant benefit over a period of 96 weeks.

Keywords

BPHClinical trialEfficacyI-PSSLong-term follow-upLUTSSabal extractSafetyUrtica extract

Copyright information

© Springer Science+Business Media, Inc. 2007