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Journal of Neurology, Neurosurgery, and Psychiatry logoLink to Journal of Neurology, Neurosurgery, and Psychiatry
. 2005 May;76(5):700–705. doi: 10.1136/jnnp.2004.038695

A double blind, randomised study of sildenafil citrate for erectile dysfunction in men with multiple sclerosis

C Fowler 1, J Miller 1, M Sharief 1, I Hussain 1, V Stecher 1, M Sweeney 1
PMCID: PMC1739638  PMID: 15834030

Abstract

Objective: Identifying and effectively treating erectile dysfunction (ED) can result in an improvement of the quality of life (QoL) in men with multiple sclerosis (MS).

Methods: This randomised, double blind (DB), placebo controlled, flexible dose study with an open label extension (OLE) assessed efficacy, QoL, and safety of sildenafil citrate in men with MS and ED. Overall, 217 men received sildenafil (25–100 mg; n = 104) or placebo (n = 113) for 12 weeks. Efficacy was assessed by the International Index of Erectile Function (IIEF) questionnaire that includes questions on achieving (Q3) and maintaining (Q4) an erection as well as a global efficacy question (GEQ). QoL was also assessed.

Results: After 12 weeks, patients receiving sildenafil had higher mean scores for IIEF Q3 and Q4 compared with those receiving placebo (p<0.0001), and 89% (92/103) reported improved erections compared with 24% (27/112) of patients receiving placebo (p<0.0001). At the end of the OLE phase, 95% of men reported improved erections. Patients receiving placebo during the DB phase showed a nearly fourfold increase in improved erections (97% v 26%). Men receiving sildenafil also showed improvements in five of the eight general QoL questions compared with men receiving placebo (p<0.05). The total mean score for the QoL questionnaire improved by 43% for the sildenafil group versus 13% for the placebo group (p<0.0001). Treatment related AEs were predominantly mild in nature, and no patient discontinued due to an AE.

Conclusion: Sildenafil treatment for ED in men with MS was effective and well tolerated, and resulted in significant improvements in both general and disease specific QoL variables.

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Selected References

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  1. Ballard S. A., Gingell C. J., Tang K., Turner L. A., Price M. E., Naylor A. M. Effects of sildenafil on the relaxation of human corpus cavernosum tissue in vitro and on the activities of cyclic nucleotide phosphodiesterase isozymes. J Urol. 1998 Jun;159(6):2164–2171. doi: 10.1016/S0022-5347(01)63299-3. [DOI] [PubMed] [Google Scholar]
  2. Betts C. D., Jones S. J., Fowler C. G., Fowler C. J. Erectile dysfunction in multiple sclerosis. Associated neurological and neurophysiological deficits, and treatment of the condition. Brain. 1994 Dec;117(Pt 6):1303–1310. doi: 10.1093/brain/117.6.1303. [DOI] [PubMed] [Google Scholar]
  3. Boolell M., Allen M. J., Ballard S. A., Gepi-Attee S., Muirhead G. J., Naylor A. M., Osterloh I. H., Gingell C. Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Int J Impot Res. 1996 Jun;8(2):47–52. [PubMed] [Google Scholar]
  4. Boulton A. J., Selam J. L., Sweeney M., Ziegler D. Sildenafil citrate for the treatment of erectile dysfunction in men with Type II diabetes mellitus. Diabetologia. 2001 Oct;44(10):1296–1301. doi: 10.1007/s001250100656. [DOI] [PubMed] [Google Scholar]
  5. Derry F. A., Dinsmore W. W., Fraser M., Gardner B. P., Glass C. A., Maytom M. C., Smith M. D. Efficacy and safety of oral sildenafil (Viagra) in men with erectile dysfunction caused by spinal cord injury. Neurology. 1998 Dec;51(6):1629–1633. doi: 10.1212/wnl.51.6.1629. [DOI] [PubMed] [Google Scholar]
  6. Derry Fadel, Hultling Claes, Seftel Allen D., Sipski Marca L. Efficacy and safety of sildenafil citrate (Viagra) in men with erectile dysfunction and spinal cord injury: a review. Urology. 2002 Sep;60(2 Suppl 2):49–57. doi: 10.1016/s0090-4295(02)01690-4. [DOI] [PubMed] [Google Scholar]
  7. Fugl-Meyer A. R., Lodnert G., Bränholm I. B., Fugl-Meyer K. S. On life satisfaction in male erectile dysfunction. Int J Impot Res. 1997 Sep;9(3):141–148. doi: 10.1038/sj.ijir.3900269. [DOI] [PubMed] [Google Scholar]
  8. Giuliano F., Hultling C., El Masry W. S., Smith M. D., Osterloh I. H., Orr M., Maytom M. Randomized trial of sildenafil for the treatment of erectile dysfunction in spinal cord injury. Sildenafil Study Group. Ann Neurol. 1999 Jul;46(1):15–21. doi: 10.1002/1531-8249(199907)46:1<15::aid-ana5>3.0.co;2-u. [DOI] [PubMed] [Google Scholar]
  9. Goldstein I., Lue T. F., Padma-Nathan H., Rosen R. C., Steers W. D., Wicker P. A. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N Engl J Med. 1998 May 14;338(20):1397–1404. doi: 10.1056/NEJM199805143382001. [DOI] [PubMed] [Google Scholar]
  10. Kirkeby H. J., Poulsen E. U., Petersen T., Dørup J. Erectile dysfunction in multiple sclerosis. Neurology. 1988 Sep;38(9):1366–1371. doi: 10.1212/wnl.38.9.1366. [DOI] [PubMed] [Google Scholar]
  11. Kurtzke J. F. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444–1452. doi: 10.1212/wnl.33.11.1444. [DOI] [PubMed] [Google Scholar]
  12. Levine A. M. Management of multiple sclerosis. How to improve the quality of life. Postgrad Med. 1985 Apr;77(5):121-3, 126-7. doi: 10.1080/00325481.1985.11698952. [DOI] [PubMed] [Google Scholar]
  13. Lottman P. E., Jongen P. J., Rosier P. F., Meuleman E. J. Sexual dysfunction in men with multiple sclerosis--a comprehensive pilot-study into etiology. Int J Impot Res. 1998 Dec;10(4):233–237. doi: 10.1038/sj.ijir.3900366. [DOI] [PubMed] [Google Scholar]
  14. MILLER H., SIMPSON C. A., YEATES W. K. BLADDER DYSFUNCTION IN MULTIPLE SCLEROSIS. Br Med J. 1965 May 15;1(5445):1265–1269. doi: 10.1136/bmj.1.5445.1265. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Mattson D., Petrie M., Srivastava D. K., McDermott M. Multiple sclerosis. Sexual dysfunction and its response to medications. Arch Neurol. 1995 Sep;52(9):862–868. doi: 10.1001/archneur.1995.00540330040012. [DOI] [PubMed] [Google Scholar]
  16. Minderhoud J. M., Leemhuis J. G., Kremer J., Laban E., Smits P. M. Sexual disturbances arising from multiple sclerosis. Acta Neurol Scand. 1984 Oct;70(4):299–306. doi: 10.1111/j.1600-0404.1984.tb00827.x. [DOI] [PubMed] [Google Scholar]
  17. Morales A., Gingell C., Collins M., Wicker P. A., Osterloh I. H. Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Int J Impot Res. 1998 Jun;10(2):69–74. doi: 10.1038/sj.ijir.3900354. [DOI] [PubMed] [Google Scholar]
  18. Nurnberg H. George, Hensley Paula L., Gelenberg Alan J., Fava Maurizio, Lauriello John, Paine Susan. Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial. JAMA. 2003 Jan 1;289(1):56–64. doi: 10.1001/jama.289.1.56. [DOI] [PubMed] [Google Scholar]
  19. Rendell M. S., Rajfer J., Wicker P. A., Smith M. D. Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. Sildenafil Diabetes Study Group. JAMA. 1999 Feb 3;281(5):421–426. doi: 10.1001/jama.281.5.421. [DOI] [PubMed] [Google Scholar]
  20. Rosen R. C., Cappelleri J. C., Gendrano N., 3rd The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226–244. doi: 10.1038/sj.ijir.3900857. [DOI] [PubMed] [Google Scholar]
  21. Schapiro R. T., Langer S. L. Symptomatic therapy of multiple sclerosis. Curr Opin Neurol. 1994 Jun;7(3):229–233. doi: 10.1097/00019052-199406000-00009. [DOI] [PubMed] [Google Scholar]
  22. Steers W. D. Viagra--after one year. Urology. 1999 Jul;54(1):12–17. doi: 10.1016/s0090-4295(99)00133-8. [DOI] [PubMed] [Google Scholar]
  23. Valleroy M. L., Kraft G. H. Sexual dysfunction in multiple sclerosis. Arch Phys Med Rehabil. 1984 Mar;65(3):125–128. [PubMed] [Google Scholar]
  24. Vas C. J. Sexual impotence and some autonomic disturbances in men with multiple sclerosis. Acta Neurol Scand. 1969;45(2):166–182. doi: 10.1111/j.1600-0404.1969.tb01230.x. [DOI] [PubMed] [Google Scholar]

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