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A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.
Eur Urol. 2008 Jun; 53(6):1236-44.EU

Abstract

INTRODUCTION

Benign prostatic hyperplasia (BPH) is associated with bothersome lower urinary tract symptoms (LUTS) and reduced patient quality of life (QoL). Phosphodiesterase (type) 5 (PDE5) inhibitors such as vardenafil are commonly used for the treatment of erectile dysfunction (ED), but have also been shown to improve the symptoms of BPH. This randomised, double-blind, placebo-controlled study investigated the effects of vardenafil on LUTS and QoL in men with BPH/LUTS, with or without concomitant ED.

METHODS

Men aged 45-64 yr with BPH/LUTS and an International Prostate Symptom Score (IPSS) > or =12 were randomised to receive either 10mg vardenafil or placebo twice daily. LUTS were assessed with the use of two primary efficacy parameters, IPSS score and maximum urinary flow rate (Qmax), as well as postvoid residual (PVR) urine volume; ED was measured with the use of the erectile function (EF) domain score of the International Index of Erectile Function (IIEF-EF); and QoL was assessed with the Urolifetrade mark QoL-9 questionnaire.

RESULTS

After 8 wk of treatment, there was a significant improvement in the IPSS total score in the vardenafil group compared with placebo (-5.9 and -3.6, respectively; p=0.0013). Nominally significant improvements in irritative and obstructive IPSS subscores (p=0.0017 and p=0.0081, respectively), EF (p=0.0001), and Urolife QoL-9 (p<0.0001) were also associated with vardenafil treatment. Qmax and PVR urine volume did not change significantly with treatment, although baseline values were already considered close to normal. Vardenafil was generally well tolerated, with most adverse events considered mild or moderate in severity.

CONCLUSIONS

Vardenafil treatment significantly improved LUTS, EF, and QoL in men with BPH/LUTS. Vardenafil may be considered a promising treatment option for men with symptoms secondary to BPH.

Authors+Show Affiliations

Department of Urology, Ludwig-Maximilians-University, Munich, Germany. christian.stief@med.uni-muenchen.de <christian.stief@med.uni-muenchen.de>No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18281145

Citation

Stief, Christian G., et al. "A Randomised, Placebo-controlled Study to Assess the Efficacy of Twice-daily Vardenafil in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia." European Urology, vol. 53, no. 6, 2008, pp. 1236-44.
Stief CG, Porst H, Neuser D, et al. A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol. 2008;53(6):1236-44.
Stief, C. G., Porst, H., Neuser, D., Beneke, M., & Ulbrich, E. (2008). A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. European Urology, 53(6), 1236-44. https://doi.org/10.1016/j.eururo.2008.01.075
Stief CG, et al. A Randomised, Placebo-controlled Study to Assess the Efficacy of Twice-daily Vardenafil in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Eur Urol. 2008;53(6):1236-44. PubMed PMID: 18281145.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. AU - Stief,Christian G, AU - Porst,Hartmut, AU - Neuser,Dieter, AU - Beneke,Manfred, AU - Ulbrich,Ernst, Y1 - 2008/02/04/ PY - 2007/10/01/received PY - 2008/01/22/accepted PY - 2008/2/19/pubmed PY - 2008/11/4/medline PY - 2008/2/19/entrez SP - 1236 EP - 44 JF - European urology JO - Eur Urol VL - 53 IS - 6 N2 - INTRODUCTION: Benign prostatic hyperplasia (BPH) is associated with bothersome lower urinary tract symptoms (LUTS) and reduced patient quality of life (QoL). Phosphodiesterase (type) 5 (PDE5) inhibitors such as vardenafil are commonly used for the treatment of erectile dysfunction (ED), but have also been shown to improve the symptoms of BPH. This randomised, double-blind, placebo-controlled study investigated the effects of vardenafil on LUTS and QoL in men with BPH/LUTS, with or without concomitant ED. METHODS: Men aged 45-64 yr with BPH/LUTS and an International Prostate Symptom Score (IPSS) > or =12 were randomised to receive either 10mg vardenafil or placebo twice daily. LUTS were assessed with the use of two primary efficacy parameters, IPSS score and maximum urinary flow rate (Qmax), as well as postvoid residual (PVR) urine volume; ED was measured with the use of the erectile function (EF) domain score of the International Index of Erectile Function (IIEF-EF); and QoL was assessed with the Urolifetrade mark QoL-9 questionnaire. RESULTS: After 8 wk of treatment, there was a significant improvement in the IPSS total score in the vardenafil group compared with placebo (-5.9 and -3.6, respectively; p=0.0013). Nominally significant improvements in irritative and obstructive IPSS subscores (p=0.0017 and p=0.0081, respectively), EF (p=0.0001), and Urolife QoL-9 (p<0.0001) were also associated with vardenafil treatment. Qmax and PVR urine volume did not change significantly with treatment, although baseline values were already considered close to normal. Vardenafil was generally well tolerated, with most adverse events considered mild or moderate in severity. CONCLUSIONS: Vardenafil treatment significantly improved LUTS, EF, and QoL in men with BPH/LUTS. Vardenafil may be considered a promising treatment option for men with symptoms secondary to BPH. SN - 0302-2838 UR - https://www.unboundmedicine.com/medline/citation/18281145/A_randomised_placebo_controlled_study_to_assess_the_efficacy_of_twice_daily_vardenafil_in_the_treatment_of_lower_urinary_tract_symptoms_secondary_to_benign_prostatic_hyperplasia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(08)00126-7 DB - PRIME DP - Unbound Medicine ER -