A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Flexible-Dose, Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

dc.contributor.authorErgin, Sureyya
dc.contributor.authorGunduz, Berrin
dc.contributor.authorUgurlu, Hatice
dc.contributor.authorSivrioglu, Koncuy
dc.contributor.authorOncel, Sema
dc.contributor.authorGok, Haydar
dc.contributor.authorErhan, Belgin
dc.date.accessioned2020-03-26T17:26:21Z
dc.date.available2020-03-26T17:26:21Z
dc.date.issued2008
dc.departmentSelçuk Üniversitesien_US
dc.description.abstractBackground/Objective: To show the efficacy, safety, and tolerability of sildenafil in men with erectile dysfunction (ED) associated with complete or incomplete spinal cord injury (SCI) and to assess its effects on quality of life (QoL) using the Life-Satisfaction Check List. Methods: This was a placebo-controlled, multicenter, randomized, double-blind, flexible-dose, 2-way crossover study with a 2-week washout period between each phase. Patients with ED attributable to SCI (Sexual Health Inventory-Male score <= 21) received 50 to 100 mg sildenafil (n = 24) or placebo (n = 26). Results: Compared with placebo, sildenafil produced higher levels of successful sexual stimulation, intercourse success, satisfaction with sexual life and sexual relationship, erectile function, overall sexual satisfaction, and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score, with no clinically relevant effects on vital signs. Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI, producing significant improvements, compared with placebo, in a number of measures only in patients with incomplete SCI. All patients who expressed a preference selected sildenafil over placebo, although the drug had no effect on patient QoL. Sildenafil was well tolerated, with a profile comparable to that of placebo. Conclusions: Compared with placebo, treatment with oral sildenafil safely and effectively improved erectile function in patients with ED attributable to SCI, especially in those with incomplete injury, and was the agent of choice in those who expressed a preference.en_US
dc.identifier.doi10.1080/10790268.2008.11753647en_US
dc.identifier.endpage531en_US
dc.identifier.issn1079-0268en_US
dc.identifier.issn2045-7723en_US
dc.identifier.issue5en_US
dc.identifier.pmid19086709en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage522en_US
dc.identifier.urihttps://dx.doi.org/10.1080/10790268.2008.11753647
dc.identifier.urihttps://hdl.handle.net/20.500.12395/22172
dc.identifier.volume31en_US
dc.identifier.wosWOS:000261426000008en_US
dc.identifier.wosqualityQ3en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherTAYLOR & FRANCIS LTDen_US
dc.relation.ispartofJOURNAL OF SPINAL CORD MEDICINEen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.selcuk20240510_oaigen_US
dc.subjectSildenafilen_US
dc.subjectSpinal cord injuriesen_US
dc.subjectTetraplegiaen_US
dc.subjectParaplegiaen_US
dc.subjectErectile dysfunctionen_US
dc.subjectImpotenceen_US
dc.titleA Placebo-Controlled, Multicenter, Randomized, Double-Blind, Flexible-Dose, Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunctionen_US
dc.typeArticleen_US

Dosyalar