Vardenafil improves ejaculation success rates and self-confidence in men with erectile dysfunction due to spinal cord injury

Francois Giuliano, Eusebio Rubio-Aurioles, Michael Kennelly, Francesco Montorsi, Edward Kim, Alex E. Finkbeiner, Peter J. Pommerville, Michael W. Colopy, Barton H. Wachs

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

STUDY DESIGN. Multicenter, double-blind, placebo-controlled, parallel-group study. OBJECTIVE. To assess the effect of the oral phosphodiesterase type-5 inhibitor, vardenafil, on ejaculation rates and self-confidence in men with spinal cord injury (SCI). SUMMARY OF BACKGROUND DATA. Spinal command of male sexual functions is often seriously impaired by traumatic spinal cord injury (SCI). A high proportion of men with SCI cannot ejaculate during sexual intercourse. SCI-related ejaculatory disorders are often responsible for male infertility. Sexual dysfunction associated with SCI can also affect men's self-confidence. METHODS. In this 12-week study, 418 men aged ≥18 years with erectile dysfunction >6 months resulting from a traumatic SCI were randomized to vardenafil (n = 207) or placebo (n = 211) 10 mg for 4 weeks, then maintained or titrated to 5 or 20 mg at weeks 4 and 8. Assessments included questions of the International Index of Erectile Function (IIEF) about ejaculation success and orgasmic perception; the Global Confidence Question; and quality-of-life scales to measure psychological well-being, self-esteem, depression, and mental health status. RESULTS. Overall per patient ejaculation success rates were significantly greater with vardenafil than placebo over 12 weeks of treatment (19% vs. 10%; P < 0.001). At last observation carried forward, the IIEF "orgasmic function" score increased from 2.9 at baseline to 4.0 for vardenafil and from 3.0 at baseline to 3.4 for placebo. Sixteen percent of men receiving vardenafil and 8% receiving placebo felt orgasm "almost always" or "always" at weeks 8-12, compared with 4% and 6%, respectively, at baseline. Significant improvements in confidence scores were observed with vardenafil compared with placebo (P < 0.0001). There were no clinically significant differences between vardenafil and placebo in the quality-of-life measures at the study endpoint, but these had been in the normal range at baseline. CONCLUSION. Vardenafil significantly improved ejaculation and self-confidence in men with erectile dysfunction due to SCI.

Original languageEnglish (US)
Pages (from-to)709-715
Number of pages7
JournalSpine
Volume33
Issue number7
DOIs
StatePublished - Apr 1 2008

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Ejaculation
Erectile Dysfunction
Spinal Cord Injuries
Placebos
Quality of Life
Orgasm
Phosphodiesterase 5 Inhibitors
Vardenafil Dihydrochloride
Coitus
Male Infertility
Self Concept
Health Status
Mental Health
Reference Values
Observation
Depression
Psychology

All Science Journal Classification (ASJC) codes

  • Orthopedics and Sports Medicine
  • Clinical Neurology

Cite this

Giuliano, F., Rubio-Aurioles, E., Kennelly, M., Montorsi, F., Kim, E., Finkbeiner, A. E., ... Wachs, B. H. (2008). Vardenafil improves ejaculation success rates and self-confidence in men with erectile dysfunction due to spinal cord injury. Spine, 33(7), 709-715. https://doi.org/10.1097/BRS.0b013e3181695040

Vardenafil improves ejaculation success rates and self-confidence in men with erectile dysfunction due to spinal cord injury. / Giuliano, Francois; Rubio-Aurioles, Eusebio; Kennelly, Michael; Montorsi, Francesco; Kim, Edward; Finkbeiner, Alex E.; Pommerville, Peter J.; Colopy, Michael W.; Wachs, Barton H.

In: Spine, Vol. 33, No. 7, 01.04.2008, p. 709-715.

Research output: Contribution to journalArticle

Giuliano, F, Rubio-Aurioles, E, Kennelly, M, Montorsi, F, Kim, E, Finkbeiner, AE, Pommerville, PJ, Colopy, MW & Wachs, BH 2008, 'Vardenafil improves ejaculation success rates and self-confidence in men with erectile dysfunction due to spinal cord injury', Spine, vol. 33, no. 7, pp. 709-715. https://doi.org/10.1097/BRS.0b013e3181695040
Giuliano, Francois ; Rubio-Aurioles, Eusebio ; Kennelly, Michael ; Montorsi, Francesco ; Kim, Edward ; Finkbeiner, Alex E. ; Pommerville, Peter J. ; Colopy, Michael W. ; Wachs, Barton H. / Vardenafil improves ejaculation success rates and self-confidence in men with erectile dysfunction due to spinal cord injury. In: Spine. 2008 ; Vol. 33, No. 7. pp. 709-715.
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AU - Kennelly, Michael

AU - Montorsi, Francesco

AU - Kim, Edward

AU - Finkbeiner, Alex E.

AU - Pommerville, Peter J.

AU - Colopy, Michael W.

AU - Wachs, Barton H.

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N2 - STUDY DESIGN. Multicenter, double-blind, placebo-controlled, parallel-group study. OBJECTIVE. To assess the effect of the oral phosphodiesterase type-5 inhibitor, vardenafil, on ejaculation rates and self-confidence in men with spinal cord injury (SCI). SUMMARY OF BACKGROUND DATA. Spinal command of male sexual functions is often seriously impaired by traumatic spinal cord injury (SCI). A high proportion of men with SCI cannot ejaculate during sexual intercourse. SCI-related ejaculatory disorders are often responsible for male infertility. Sexual dysfunction associated with SCI can also affect men's self-confidence. METHODS. In this 12-week study, 418 men aged ≥18 years with erectile dysfunction >6 months resulting from a traumatic SCI were randomized to vardenafil (n = 207) or placebo (n = 211) 10 mg for 4 weeks, then maintained or titrated to 5 or 20 mg at weeks 4 and 8. Assessments included questions of the International Index of Erectile Function (IIEF) about ejaculation success and orgasmic perception; the Global Confidence Question; and quality-of-life scales to measure psychological well-being, self-esteem, depression, and mental health status. RESULTS. Overall per patient ejaculation success rates were significantly greater with vardenafil than placebo over 12 weeks of treatment (19% vs. 10%; P < 0.001). At last observation carried forward, the IIEF "orgasmic function" score increased from 2.9 at baseline to 4.0 for vardenafil and from 3.0 at baseline to 3.4 for placebo. Sixteen percent of men receiving vardenafil and 8% receiving placebo felt orgasm "almost always" or "always" at weeks 8-12, compared with 4% and 6%, respectively, at baseline. Significant improvements in confidence scores were observed with vardenafil compared with placebo (P < 0.0001). There were no clinically significant differences between vardenafil and placebo in the quality-of-life measures at the study endpoint, but these had been in the normal range at baseline. CONCLUSION. Vardenafil significantly improved ejaculation and self-confidence in men with erectile dysfunction due to SCI.

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