Skip to main content

Advertisement

SpringerLink
Log in

Effects of tadalafil on nighttime voiding (nocturia) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a post hoc analysis of pooled data from four randomized, placebo-controlled clinical studies

  • Topic Paper
  • Published:
World Journal of Urology Aims and scope Submit manuscript

Abstract

Purpose

The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH (LUTS/BPH), improvements in nocturia were not significant in individual studies. We therefore sought to further assess nocturia based on data integrated from four tadalafil registrational studies.

Methods

Data were integrated from four randomized, placebo-controlled, double-blind, 12-week registrational studies of tadalafil for LUTS/BPH. Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 (IPSS Q7). Efficacy results were analyzed using analysis of covariance.

Results

For the tadalafil 5 mg once daily (N = 752) and placebo (N = 748) groups, baseline characteristics were well balanced, and the overall severity of nocturia per mean IPSS Q7 was 2.3 ± 1.2. The mean treatment change was −0.4 with placebo and −0.5 with tadalafil; the least-squares mean (standard error) treatment difference was −0.2 (0.05), p = 0.002. For patients receiving placebo and tadalafil, respectively, the proportion with improved nocturnal frequency was 41.3 and 47.5 %, with no change was 44.8 and 41.0 %, and with worsening was 13.9 and 11.5 %.

Conclusions

A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo; however, the treatment difference was small and not considered clinically meaningful. Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Abrams P, Cardozo L, Fall M et al (2003) The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology 61:37–49

    Article  PubMed  Google Scholar 

  2. Coyne KS, Zhou Z, Bhattacharyya SK, Thompson CL, Dhawan R, Versi E (2003) The prevalence of nocturia and its effect on health-related quality of life and sleep in a community sample in the USA. BJU Int 92:948–954

    Article  PubMed  CAS  Google Scholar 

  3. Tikkinen KA, Johnson TM, Tammela TL et al (2010) Nocturia frequency, bother, and quality of life: how often is too often? A population-based study in Finland. Eur Urol 57:488–496

    Article  PubMed  Google Scholar 

  4. Weiss JP, Blaivas JG, Bliwise DL et al (2011) The evaluation and treatment of nocturia: a consensus statement. BJU Int 108:6–21

    Article  PubMed  Google Scholar 

  5. Stief CG, 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. Eur Urol 53:1236–1244

    Article  PubMed  CAS  Google Scholar 

  6. Weiss JP, Blaivas JG (2000) Nocturia. J Urol 163:5–12

    Article  PubMed  CAS  Google Scholar 

  7. Oelke M, Bachmann A, Descazeaud A et al (2013) EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol 64:118–140

    Article  PubMed  Google Scholar 

  8. Kingery L, Martin ML, Naegeli AN, Khan S, Viktrup L (2012) Content validity of the Benign Prostatic Hyperplasia Impact Index (BII); a measure of how urinary trouble and problems associated with BPH may impact the patient. Int J Clin Pract 66:883–890

    Article  PubMed  CAS  Google Scholar 

  9. Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L (2008) Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol 180:1228–1234

    Article  PubMed  CAS  Google Scholar 

  10. Porst H, Kim ED, Casabe AR et al (2011) Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol 60:1105–1113

    Article  PubMed  CAS  Google Scholar 

  11. Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L (2012) Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol 61:917–925

    Article  PubMed  CAS  Google Scholar 

  12. Egerdie RB, Auerbach S, Roehrborn CG et al (2012) Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study. J Sex Med 9:271–281

    Article  PubMed  CAS  Google Scholar 

  13. Porst H, Oelke M, Goldfischer ER et al (2013) Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies. Urology 82:667–673

    Article  PubMed  Google Scholar 

  14. (2010) Cialis [package insert]. http://pi.lilly.com/us/cialis-pi.pdf

  15. (2013) Summary of product characteristics (Cialis). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000436/WC500026318.pdf

  16. Madersbacher S, Alivizatos G, Nordling J, Sanz CR, Emberton M, de la Rosette JJ (2004) EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol 46:547–554

    Article  PubMed  Google Scholar 

  17. Porst H, Roehrborn CG, Secrest RJ, Esler A, Viktrup L (2013) Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. J Sex Med 10:2044–2052

    Article  PubMed  Google Scholar 

  18. Tikkinen KAO, Johnson TM II, Cartwright R (2012) Prevalence and bother of nocturia. In: Oelke M, van Kerrebroeck PEV (eds) Current aspects in diagnosis and treatment of nocturia, 1st edn. UNI-MED-Verlag, Bremen, pp 18–26

    Google Scholar 

Download references

Acknowledgments

Thomas Melby (inVentiv Health Clinical, Cary, NC) provided editorial assistance in the preparation of this manuscript. This study was funded by Eli Lilly and Company.

Conflict of interest

MO is a consultant, speaker, or trial investigator for Allergan, Apogepha, Astellas, Ferring, Lilly, Pfizer, Recordati, and Teva. JPW is a consultant for Alleran, Astellas, Ferring, Lilly, Pfizer, and Vantia. CM is a speaker and trial investigator for Lilly. DC, DR, and LV are employees of Eli Lilly and Company.

Author information

Authors and Affiliations

  1. Department of Urology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany

    Matthias Oelke

  2. Department of Urology, SUNY Downstate Medical Center, Brooklyn, NY, USA

    Jeffrey P. Weiss

  3. Department of Urology, University Hospital of Heraklion, University of Crete Medical School, Heraklion, Crete, Greece

    Charalampos Mamoulakis

  4. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

    David Cox, Dustin Ruff & Lars Viktrup

Authors
  1. Matthias Oelke
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jeffrey P. Weiss
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Charalampos Mamoulakis
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. David Cox
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Dustin Ruff
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Lars Viktrup
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Matthias Oelke.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Oelke, M., Weiss, J.P., Mamoulakis, C. et al. Effects of tadalafil on nighttime voiding (nocturia) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a post hoc analysis of pooled data from four randomized, placebo-controlled clinical studies. World J Urol 32, 1127–1132 (2014). https://doi.org/10.1007/s00345-014-1255-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00345-014-1255-z

Keywords

Search

Navigation