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

Ergin, Süreyya; Gündüz, Berrin; Uğurlu, Hatice; Sivrioğlu, Konçuy; Oncel, Serna; Gök, Haydar; Erhan, Belgin; Levendoğlu, Funda; Şenocak, Özlem

doi:10.1080/10790268.2008.11753647

Cited by 34 publications

(38 citation statements)

References 27 publications

(35 reference statements)

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“…Information on response of GEQ was primarily based on four RCTs, 25,[27][28][29] and the data on response of SEP were collected from two RCTs, 28,29 and the data on incidence of adverse events synthesized from five articles. [24][25][26]28,29 The reason why we did not analyze efficacy of PDE5 inhibitors with international index of erectile function was that they did not report values of standard deviation, although it has been deemed to have a high degree of sensitivity and specificity for extrapolating treatment-related changes in the erectile function.…”

Section: Discussionmentioning

confidence: 99%

“…Fifty-nine studies were excluded on account of duplicate, and 29 studies were excluded because they did not meet our inclusion criteria after reading full-text. In all, six articles [24][25][26][27][28][29] involving six RCTs were adopted for analysis: four RCTs that compared sildenafil with placebo, one RCT that compared vardenafil with placebo and one RCT that compared tadalafil with placebo. The baseline characteristics of the trials included in our meta-analysis are listed in Table 1.…”

Section: Study Identification and Selectionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy and safety of phosphodieterase-5 inhibitors for treatment of erectile dysfunction secondary to spinal cord injury: a systemic review and meta-analysis

Cheng

et al. 2016

Spinal Cord

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Objective: We carried out a systematic review and meta-analysis to assess the efficacy and safety of phosphodieterase-5 (PDE5) inhibitors on erectile dysfunction (ED) secondary to spinal cord injury (SCI). Methods: A literature review was performed to identify all published randomized, double-blind, placebo-controlled trials of PDE5 inhibitors for treatment of ED secondary to SCI. The search included the following database: MEDLINE, EMBASE and the Cochrane Library. The outcomes and complications analyzed involved the Global Efficacy Question (GEQ), sexual encounter profile diary question 2 and 3 (SEP2 and SEP3) and adverse events. All statistical analysis was performed using Stata 12.0 software (Stata Corp., College Station, TX, USA). Results: Six publications were used in analysis, including six randomized controlled trials that compared PDE5 inhibitors with placebo. Compared with placebo, PDE5 inhibitors were associated with significant improvements in GEQ (OR 11.997, 95% CI 8.073-17.830, Po0.0001), SEP2 (RR 1.847, 95% CI 1.561-2.185, Po0.0001) and SEP3 (RR 2.738, 95% CI 2.084-3.598, Po0.0001). Despite significant greater incidences of some adverse events observed (headache: RR 3.717, 95% CI 2.309-5.982, Po0.0001; flushing: RR 9.281, 95% CI 2.858-30.147, Po0.0001; gastrointestinal discomfort: RR 9.064, 95% CI 2.116-38.827, P = 0.003), most adverse events were mild to moderate and transient. Conclusions: This systematic review and meta-analysis indicate that PDE5 inhibitors are effective and well tolerated to treat ED secondary to SCI compared with placebo, as measured by response to GEQ, SEP2, SEP3 and incidence of adverse events. PDE5 inhibitors could be considered as the first choice in the treatment of ED patients with SCI. INTRODUCTIONApproximately 11 000 new cases are estimated to suffer from spinal cord injury (SCI) in America each year and 60% of them are between 16 and 30 years of age. Moreover, men account for 82% of all patients with SCI. 1,2 Erectile dysfunction (ED) is a common condition in individuals with SCI. 3 A high prevalence of ED is reported in about 80% of SCI patients. 4 It is an especially bothersome condition in young men who usually had an active sexual activity before their accident. 5 ED is defined as the persistent inability to achieve or maintain a penile erection for satisfactory sexual performance. 6 Most men with SCI have some type of penile erection, but it is usually not hard enough or does not last long enough for sexual life. 1 ED not only often results in disorder of self-esteem but also deteriorates partner relationship. Hence, ED has a negative effect on the life of men and their sexual partner. 7 Health-care providers deem sex life significant in the process of rehabilitation after SCI and give high priority to improving sexual activity for subjects with SCI. 8,9 Nitric oxide (NO) released by nonadrenergic-noncholinergic nerves in the penis has an important role in initiating and maintaining of the

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Section: Discussionmentioning

confidence: 99%

Section: Study Identification and Selectionmentioning

confidence: 99%

Efficacy and safety of phosphodieterase-5 inhibitors for treatment of erectile dysfunction secondary to spinal cord injury: a systemic review and meta-analysis

Cheng

et al. 2016

Spinal Cord

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“…During the 1970s and 1980s, efforts to improve male sexual function included implantation of penile prostheses, injections of vasoactive agents into the corpus cavernosus, and application of vacuum erection devices, 31 but since the 1990s these interventions have been largely replaced by use of oral medications, such as sildenafil, which have restored erection and intercourse capabilities in 87.5% and 66%, respectively, of men with SCI. 32 However, these drugs do not improve orgasmic and ejaculatory function or increase fertility, which require different interventions. For that purpose, electrical or vibratory stimulation has been shown to help as many as 86% of men with SCI to achieve orgasm and ejaculate; with artificial insemination, pregnancy rate has rapidly increased and been reported as high as 74% in recent studies.…”

Section: Sexual Function and Fertilitymentioning

confidence: 99%

American Spinal Injury Association (ASIA) 40th Anniversary: Beginnings, Accomplishments and Future Challenges

Ragnarsson

2013

Topics in Spinal Cord Injury Rehabilitation

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“…Bugüne kadar az say›da çal›flmada bu hastalar›n cinsel disfonksiyonlar› araflt›r›lm›flt›r (6,(12)(13)(14)(15)(16).…”

Section: G Gi Ir Ri Ifl Flunclassified

Evaluation of Erectile Dysfunction in Spinal Cord Injured Patients

Gündüz¹,

Baran²,

Erhan³

et al. 2010

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Ö Öz ze et tA Am ma aç ç: : Omurilik yaralanmas›, cinsel fonksiyonu önemli ölçüde etkileyerek ereksiyon, ejakulasyon, orgazm ve fertilite bozukluklar›na neden olur. Bu bozukluklar›n en önemlilerinden biri erektil disfonksiyondur. Bu çal›flma-n›n amac› omurilik yaralanmas› sonras› erkek hastalarda görülen erektil disfonksiyonun de¤erlendirilmesidir. G Ge er re eç ç v ve e Y Yö ön nt te em m: : Çal›flmaya T10 ve üzeri, T11-L2 ve konus-kauda seviyelerinde 20'fler olmak üzere 60 omurilik yaralanmal› erkek hasta dahil edildi. Hastalar 2002 American Spinal Injury Association (ASIA) nörolo-jik muayene ve s›n›flama standartlar›na göre de¤erlendirildi; erektil disfonksiyonlar› ve ereksiyon tipi yönünden ayn› kifli taraf›ndan sorguland›. Ayr›ca, erektil disfonksiyon International Index of Erectile Function (IIEF) ile de¤erlendirildi. B Bu ul lg gu ul la ar r: : Hastalar›n %85'inde erektil disfonksiyon mevcuttu. IIEF ile de¤erlendirmede hastalar›n %73'ünde orta-a¤›r düzeyde erektil disfonksiyon saptand›. Ereksiyon tipi lezyon seviyesi ile iliflkili bulundu. S So on nu uç ç: : Omurilik yaralanmas› özellikle genç erkekleri etkilemektedir; son y›llarda bu hastalar›n yaflam süreleri uzay›p normal toplumun yaflam sü-relerine yaklaflmaktad›r. Hastalarda s›kl›kla cinsel disfonksiyon ve erektil disfonksiyona rastlanmaktad›r. Rehabilitasyon ekibinin bu konu ile ilgilenmesi ile hastalar›n tedavisinde daha iyi noktalara ulafl›lacakt›r. Türk Fiz T›p Rehab Derg 2010;56:71-4. A An na ah ht ta ar r K Ke el li im me el le er r: : Omurilik yaralanmas›, erektil disfonksiyon, seksüel disfonksiyon, IIEF-ED S Su um mm ma ar ry y O Ob bj je ec ct ti iv ve e: : Spinal cord injuries affect sexual function and cause problems in erection, ejaculation, orgasm and fertility; erectile dysfunction is the most important one. The aim of this study is to evaluate the erectile dysfunction seen after spinal cord injury. M Ma at te er ri ia al ls s a an nd d M Me et th ho od d: : Sixty male patients with spinal cord injury, 20 above the level of T10, 20 between T11 and L2, 20 with conus/cauda equina lesions were included in this study. The patients were evaluated according to the American Spinal Injury Association (ASIA); 2002 standards of neurological examination and classification and they were interviewed by the same doctor for erectile dysfunction and type of erection. Erectile dysfunction was also assessed by the International Index of Erectile Function (IIEF). R Re es su ul lt ts s: : Erectile dysfunction was observed in 85% of patients. Seventythree percent of patients was found to have mild-severe erectile dysfunction according to the IIEF. Type of erection was associated with the level of the injury. C Co on nc cl lu us si io on n: : Spinal cord injury usually affects young men; life expectancy for this group is getting longer, nearly reaching that of the normal population. Sexual and erectile dysfunctions are common among these patients. Better results can be achieved in rehabilitation of this group by paying attention to this problem. Turk J Phys ...

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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

Cited by 34 publications

References 27 publications

Efficacy and safety of phosphodieterase-5 inhibitors for treatment of erectile dysfunction secondary to spinal cord injury: a systemic review and meta-analysis

Efficacy and safety of phosphodieterase-5 inhibitors for treatment of erectile dysfunction secondary to spinal cord injury: a systemic review and meta-analysis

American Spinal Injury Association (ASIA) 40th Anniversary: Beginnings, Accomplishments and Future Challenges

Evaluation of Erectile Dysfunction in Spinal Cord Injured Patients

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