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

  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.

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Authors and Affiliations

  1. Institute of Urology, 3rd Parkovaya Street 51, 105425, Moscow, Russia

    Nikolai Lopatkin, Andrey Sivkov & Alexander Medvedev

  2. Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany

    Sandra Schläfke & Petra Funk

  3. Department of Urology, University Hospital of Cologne, Cologne, Germany

    Udo Engelmann

Authors
  1. Nikolai Lopatkin
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  2. Andrey Sivkov
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  3. Sandra Schläfke
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  4. Petra Funk
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  5. Alexander Medvedev
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  6. Udo Engelmann
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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). https://doi.org/10.1007/s11255-006-9173-7

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