Sildenafil effects on sexual and cardiovascular responses in women with spinal cord injury

Study design: Double-blind, placebo-controlled, flexible-dose study. Objective: To evaluate the efficacy, safety and tolerability of oral sildenafil in women with female sexual arousal disorder as a result of SCI (paraplegia/tetraplegia). Setting: The study was conducted at clinical practice sites in North America (n ¼ 23), 11 European countries (n ¼ 23), Australia (n ¼ 4) and South Africa (n ¼ 2). Methods: 129 women were randomized and treated with sildenafil or matching placebo. A 4-week baseline period was followed by 12 weeks of treatment, which could be increased from 50 to 100 mg or decreased to 25 mg once during the treatment period, depending on efficacy and tolerability. By use of an event log, sexual activity was monitored between screening and the end of treatment. The Sexual Function Questionnaire, the Sexual Quality of Life Questionnaire-Female, a global efficacy question and Sexual Distress Question were also assessed. Results: Sildenafil-treated women and placebo-treated women had an increase in their percentage of sexual activities throughout the course of the study, with no statistically significant difference between groups in the percentage of successful sexual activities at end of treatment versus baseline. There were also no statistically significant differences between sildenafil-and placebo-treated women on the aforementioned measures. The most common adverse events included headache and vasodilatation. Conclusion: The results of this study are similar to other reports regarding a lack of clinically meaningful benefit of sildenafil in other populations of women. Sponsorship: This study was sponsored by Pfizer Inc.

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“…Despite the beneficial results shown in a laboratory study, 11 the results in this randomized clinical trial were less convincing.…”

Section: Discussioncontrasting

confidence: 55%

Sildenafil in women with sexual arousal disorder following spinal cord injury

Alexander¹,

Rosen

Steinberg

et al. 2010

Spinal Cord

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“…8,21 The first controlled study was carried out by Sipski et al 21 and revealed a partial improvement in the arousal and orgasmic phases of sexual response with the sildenafil. Other studies have been carried out in women without SCI with positive results, but for the moment its use has not been approved by the Food and Drug Administration (FDA) for female sexual dysfunction.…”

Section: Discussionmentioning

confidence: 99%

Sexual issues in a sample of women with spinal cord injury

et al. 2004

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Study design: Semistructured interview. Objectives: To assess the degree of participation in sexual intercourse of a sample of women with spinal cord injury (SCI) in our community, to establish to what extent their sexual lives have been affected in comparison to before the injury, and to search for those factors that may have a major influence on both aspects. Setting: Spinal Cord Injuries Unit, A Corun˜a, Spain. Participants: A total of 37 women, average age 40 years, time since onset average 10 years. Results: In all, 62% claimed regular sexual activity after the injury. The women who suffered the injury before reaching the age of 18 years run a higher risk of not having physical relationships than those who were above that age when they incurred the SCI (P ¼ 0.04, OR 4.75). We discovered a significant drop in the frequency of intercourse (P ¼ 0.003) and the ability to reach an orgasm (P ¼ 0.008), after the injury. Of these women, 69% were satisfied with their current sexual activity and 77.4% considered the information they received from their doctors on the changes the SCI would cause in their sexuality to be either insufficient or nonexistent. Conclusions: There is a noticeable decrease in the frequency of intercourse as well as a significant reduction in the capability of reaching orgasm. Despite these changes and problems that ensue during intercourse as a result, most show satisfaction with their current sexual lives. On the other hand, the occurence of the injury before the age of 18 years may imply a greater risk of not having an active sex life in adult years. We consider it is essential to provide the appropriate sexual information during the process of rehabilitation, aimed at helping women with SCI to adapt to their new situation.Spinal Cord (2005) 43, 51-55.

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“…9,[21][22][23] Although the preliminary results were not satisfactory in postmenopausal women treated with the PDE5 inhibitor sildenafil, 24 maybe because of the poor expression of NOS in the vaginal wall of these women, 17 additional encouraging results have been obtained with this drug in selected cohorts. [25][26][27] In conclusion, further research efforts are needed to augment the knowledge of the physiology and pathophysiology of female sexual function, including the development of animal models for the evaluation of new therapeutic approaches to treat sexual dysfunction. The results obtained in this study demonstrate that vardenafil enhances the sexual vascular response in anesthetized female dogs.…”

Section: Discussionmentioning

confidence: 99%

Vardenafil enhances clitoral and vaginal blood flow responses to pelvic nerve stimulation in female dogs

Angulo

Cuevas

et al. 2003

Int J Impot Res

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The relaxation of the smooth muscle in the vagina and clitoris and the increase of blood flow into these organs is thought to be essential in the female sexual response. Vardenafil is a type 5 phosphodiesterase (PDE5) inhibitor that potentiates the nitric oxide (NO)/cGMP pathway facilitating penile smooth muscle relaxation and improving penile erection in men. Although the potentiation of the NO/cGMP pathway through PDE5 inhibitors can clearly enhance blood flow into the penis and is used in the therapy of male sexual dysfunction, there is controversy about the efficacy of these agents in improving female sexual function. The aim of this work was to evaluate the effects of vardenafil on the increase of blood flow into the vagina and clitoris induced by pelvic nerve electrical stimulation (PNES) in a female dog model. Application of PNES produced consistent and frequency-related increased blood flow into the vagina and clitoris of anesthetized female dogs. The magnitude and duration of the blood flow responses to PNES were variable among the different animals but remained stable over time within the same animal. The intravenous administration of vardenafil (1 mg/kg) significantly potentiated the increases in blood flow produced by PNES into the vagina (381.4 and 206.2% of control response at 5 and 10 Hz, respectively, Po0.01, n ¼ 6) and clitoris (379.4 and 238.5% of control response at 5 and 10 Hz, respectively, Po0.01, n ¼ 6) 20 min after administration. The significant enhancement of PNESinduced responses was maintained 50 min (224.5 and 181.0%, Po0.01 in vagina; 294.8 and 258.9%, Po0.05 in clitoris) and 80 min after vardenafil administration (209.5 and 156.9%, Po0.05 in vagina; 268.9 and 194.9%, Po0.05 in clitoris). Here we present a feasible model for research into female sexual function. Our results show that vardenafil effectively potentiates the blood flow responses to PNES in the genitalia of female dogs. These results emphasize the role of the NO/cGMP pathway in the local vasodilatory response in female sexual organs and provide a rationale for testing PDE5 inhibitors, such as vardenafil, as a treatment for certain forms of female sexual dysfunction.

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Sildenafil effects on sexual and cardiovascular responses in women with spinal cord injury

Cited by 172 publications

References 12 publications

Sildenafil in women with sexual arousal disorder following spinal cord injury

Sildenafil in women with sexual arousal disorder following spinal cord injury

Sexual issues in a sample of women with spinal cord injury

Vardenafil enhances clitoral and vaginal blood flow responses to pelvic nerve stimulation in female dogs

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