Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Original Article
  • Published:

Safety and efficacy of sildenafil citrate in the treatment of Parkinson-emergent erectile dysfunction: a double-blind, placebo-controlled, randomized study

A Retraction to this article was published on 09 May 2011

Abstract

Parkinson's disease (PD) is one of the most commonly occurring neurodegenerative disorders, with lifetime incidence between 1 and 2% among people older than 65 years. ED is one of the more disabling and poorly addressed aspects of PD. The purpose of this study was to assess the efficacy and safety of sildenafil citrate in Parkinson-emergent ED. Sexual function of participants was assessed using responses to the 15-question International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) diary questions 2 and 3, Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and a Global Efficacy Question ‘Has the treatment you have been taking over the study period improved your erections?’ This randomized, double-blind, placebo-controlled study, comprised a screening period of at least 1 month, a placebo-lead in period of 1 week and treatment period. Two hundred thirty-six patients entered the trial. These patients had mild-to-moderate PD (stages I–III Hoehn–Yahr) and were experiencing Parkinson-emergent neurogenic ED. They were randomized to receive 100 mg sildenafil on demand 1 h before sexual activity (group 1, n=118), or similar regimen of placebo (group 2, n=118). Patients were instructed to use at least 24 doses/attempts at home. At the end of the trial, differences between sildenafil and placebo groups were significant for the IIEF erectile function (EF) score (22.6±4.6 vs 14.8±4.2, P=0.01), for percent Global Efficacy Question ‘Yes’ responses (68.1±4.6 vs 12.2±3.2, P=0.001), for SEP2 ‘Yes’ responses (68.1±4.2 vs 32.5±2.2, P=0.003), for SEP3 ‘Yes’ responses (75.9±5.4 vs 33.5±4.4, P=0.004) and for mean EDITS score (69.8±4.2 vs 13.0±2.7, P=0.004). A normal EF domain score (26) at end point was achieved by 56.9 and 8.7% of the patients in the sildenafil and placebo groups, respectively (P=0.001). Sildenafil can be considered as an effective treatment in patients with Parkinson-emergent ED.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

Figure 1
Figure 2
Figure 3
Figure 4

Similar content being viewed by others

References

  1. Benito-Leon J, Bermejo-Pareja F, Rodriguez J, Molina J-A, Gabriel R, Morales J-M . Prevalence of PD and other types of Parkinsonism in three elderly populations of central Spain. Mov Disord 2003; 18: 267–274.

    Article  Google Scholar 

  2. Hamani C, Lozano AM . Physiology and pathophysiology of Parkinson's disease. Ann NY Acad Sci 2003; 991: 15–21.

    Article  Google Scholar 

  3. Papatsoris AG, Deliveliotis C, Singer C, Papapetropoulos S . Erectile dysfunction in Parkinson's disease. Urology 2006; 67: 447–451.

    Article  CAS  Google Scholar 

  4. Bronner G, Royter V, Korczyn AD, Giladi N . Sexual dysfunction in Parkinson's disease. J Sex Marital Ther 2004; 30: 95–105.

    Article  Google Scholar 

  5. Hobson P, Islam W, Roberts S, Adhiyman V, Meara J . The risk of bladder and autonomic dysfunction in a community cohort of Parkinson's disease patients and normal control. Parkinsonism Relat Disord 2003; 10: 67–71.

    Article  Google Scholar 

  6. Mostilea G, Jankovica J . Treatment of dysautonomia associated with Parkinson's disease. Parkinsonism Relat Disord 2009; 15S3: S224–S232.

    Article  Google Scholar 

  7. Meco G, Rubino A, Caravona N, Valente M . Sexual dysfunction in Parkinson's disease. Parkinsonism Relat Disord 2008; 14: 451–456.

    Article  Google Scholar 

  8. Moore O, Gurevich T, Korczyn AD, Anca M, Shabtai H, Giladi N . Quality of sexual life in Parkinson's disease. Parkinsonism Relat Disord 2002; 8: 243–246.

    Article  CAS  Google Scholar 

  9. Raffaele R, Vecchio I, Giammusso B, Morgia G, Brunetto MB, Rampello L . Efficacy and safety of fixed-dose oral sildenafil in the treatment of sexual dysfunction in depressed patients with idiopathic Parkinson's disease. Eur Urol 2002; 41: 382–386.

    Article  CAS  Google Scholar 

  10. Zesiewicz TA, Helal M, Hauser RA . Sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men with Parkinson's disease. Mov Disord 2000; 15: 305–308.

    Article  CAS  Google Scholar 

  11. Hussain IF, Brady CM, Swinn MJ, Mathias CJ, Fowler CJ . Treatment of erectile dysfunction with sildenafil citrate (Viagra) in parkinsonism due to Parkinson's disease or multiple system atrophy with observations on orthostatic hypotension. J Neurol Neurosurg Psychiatry 2001; 71: 371–374.

    Article  CAS  Google Scholar 

  12. Hughes AJ, Daniel SE, Kilford L, Lees AJ . Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry 1992; 55: 181–184.

    Article  CAS  Google Scholar 

  13. Hoehn MM, Yahr MD . Parkinsonism: onset progression and mortality. Neurology 1967; 17: 427–442.

    Article  CAS  Google Scholar 

  14. American Psychiatry Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. American Psychiatry Association: Washington, DC, 1994.

  15. Mattis S . Mental status examination for organic mental syndrome in the elderly patient. In: Bellak L, Karasu TB (eds). Geriatric Psychiatry. Grune and Stratton: New York, 1976, pp 77–121.

    Google Scholar 

  16. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines. Available at: http://www.ich.org. Last accessed 30 January 2007.

  17. Montorsi F, Guazzoni G, Bergamaschi F, Consonni P, Rigatti P, Pizzini G et al. Vascular abnormalities in Peyronie's disease: the role of color Doppler sonography. J Urol 1994; 151: 373–375.

    Article  CAS  Google Scholar 

  18. Wilkins CJ, Sriprasad S, Sidhu PS . Colour Doppler ultrasound of the penis. Clin Radiol 2003; 58: 514–523.

    Article  CAS  Google Scholar 

  19. Rosen RC, Riley A, Wagner G, Osterloh I, Kirkpatrick J, Mishra A . The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997; 49: 822–830.

    Article  CAS  Google Scholar 

  20. Althof SE, Corty EW, Levine SB, Levine F, Burnett AL, McVary K et al. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology 1999; 53: 793–799.

    Article  CAS  Google Scholar 

  21. Fleiss J . The Design and Analysis of Clinical Experiments. John Wiley & Sons: New York, NY, 1986; 49–51.

    Google Scholar 

  22. Fugl-Meyer AR, Lodnert G, Bränholm IB, Fugl-Meyer KS . On life satisfaction in male erectile dysfunction. Int J Impot Res 1997; 9: 141–148.

    Article  CAS  Google Scholar 

  23. Lewis RB, Bennett CJ, Borkon WD, Boykin WH, Althof SE, Stecher VJ et al. Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the erectile dysfunction inventory of treatment satisfaction questionnaire. Urology 2001; 57: 960–965.

    Article  CAS  Google Scholar 

  24. Melis MR, Argiolas A . Dopamine and sexual behavior. Neurosci Biobehav Rev 1995; 19: 19–38.

    Article  CAS  Google Scholar 

  25. Singer C, Weiner WJ, Sanchez-Ramos JR, Ackerman M . Sexual dysfunction in men with Parkinson's disease. J Neurol Rehabil 1989; 3: 199–204.

    Google Scholar 

  26. Brown RG, Jahanshahi M, Quinn N, Marsden CD . Sexual function in patients with Parkinson's disease and their partners. J Neurol Neurosurg Psychiatr 1990; 53: 480–486.

    Article  CAS  Google Scholar 

  27. Goodwin FK, Murphy DL, Brodie HK, Bunney Jr WE . Levodopa: alterations in behavior. Clin Pharmacol Ther 1971; 12: 383–396.

    Article  CAS  Google Scholar 

  28. Weintraub D, Siderowf AD, Potenza MN, Goveas J, Morales KH, Duda JE et al. Association of dopamine agonist use with impulse control disorders in Parkinson disease. Arch Neurol Jul 2006; 63: 969–973.

    Article  Google Scholar 

  29. Harvey NS . Serial cognitive profiles in levodopa-induced hypersexuality. Br J Psychiatry 1988; 153: 833–836.

    Article  CAS  Google Scholar 

  30. Hand A, Gray WK, Chandler BJ, Walker RW . Sexual and relationship dysfunction in people with Parkinson's disease. Parkinsonism Relat Disord 2009; 16: 172–176.

    Article  Google Scholar 

  31. Meco G, Rubino A, Caravona N, Valente M . Sexual dysfunction in Parkinson's disease. Parkinsonism Relat Disord 2008; 14: 451–456.

    Article  Google Scholar 

  32. Safarinejad MR . Oral sildenafil in the treatment of erectile dysfunction in diabetic men: a randomized double-blind and placebo-controlled study. J Diabetes Complications 2004; 18: 205–210.

    Article  Google Scholar 

  33. Rendell MS, Rajfer J, Wicker PA, Smith MD . Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. Sildenafil Diabetes Study Group. JAMA 1999; 281: 421–426.

    Article  CAS  Google Scholar 

  34. Safarinejad MR . Evaluation of the safety and efficacy of sildenafil citrate for erectile dysfunction in men with multiple sclerosis: a double-blind, placebo controlled, randomized study. J Urol 2009; 181: 252–258.

    Article  CAS  Google Scholar 

  35. Safarinejad MR, Kolahi AA, Ghaedi G . Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: a double-blind, randomized and placebo-controlled study. BJU Int 2009; 104: 376–383.

    Article  CAS  Google Scholar 

  36. Levinson IP, Creanga DL . Appropriate starting dose of VIAGRA1 (sildenafil citrate) for the treatment of erectile dysfunction: pooled analysis of flexible-dose, placebo controlled, double-blind studies and open-label extension. J Sex Med 2005; 2 (Suppl 1): 36.

    Google Scholar 

  37. Padma-Nathan H, Steers WD, Wicker PA . Efficacy and safety of oral sildenafil in the treatment of erectile dysfunction: a double blind, placebo-controlled study of 329 patients. Sildenafil Study Group. Int J Clin Pract 1998; 52: 375–379.

    CAS  PubMed  Google Scholar 

  38. Jarow JP, Burnett AL, Geringer AM . Clinical efficacy of sildenafil citrate based on etiology and response to prior treatment. J Urol 1999; 162: 722–725.

    Article  CAS  Google Scholar 

Download references

Acknowledgements

This work was funded by institutional sources.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to M R Safarinejad.

Ethics declarations

Competing interests

The authors declare no conflict of interest.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Safarinejad, M., Taghva, A., Shekarchi, B. et al. Safety and efficacy of sildenafil citrate in the treatment of Parkinson-emergent erectile dysfunction: a double-blind, placebo-controlled, randomized study. Int J Impot Res 22, 325–335 (2010). https://doi.org/10.1038/ijir.2010.23

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/ijir.2010.23

Keywords

This article is cited by

Search

Quick links