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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

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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.

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Notes

  1. 1.

    Marketed in Germany under the trade name Prostagutt forte, Dr. Willmar Schwabe, Karlsruhe, Germany.

  2. 2.

    WS 1473 and WS 1031 are registered trademarks of Dr. Willmar Schwabe GmbH & Co. KG.

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Acknowledgements

The study was funded by Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany, manufacturer of PRO 160/120.

Author information

Correspondence to Andrey Sivkov.

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Lopatkin, N., Sivkov, A., Schläfke, S. et al. 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. Int Urol Nephrol 39, 1137–1146 (2007) doi:10.1007/s11255-006-9173-7

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Keywords

  • BPH
  • Clinical trial
  • Efficacy
  • I-PSS
  • Long-term follow-up
  • LUTS
  • Sabal extract
  • Safety
  • Urtica extract