sildenafil-citrate and Spinal-Cord-Injuries

Spinal cord injury (SCI) is estimated to affect approximately 276,000 individuals in the United States. Since 2010, the mean age of individuals at the time of the SCI has been 42 years, with nearly 80% of cases involving men. This means that individuals with SCI generally are young men who typically place a great deal of importance on normal sexual and reproductive function.. To assess the effect of sildenafil treatment on erectile function and the frequency of ejaculation in men with SCI.. This study was a post hoc analysis of pooled data from two randomized, double-blinded, placebo-controlled, flexible-dose, crossover sildenafil trials conducted in Europe, Australia, and Turkey. Two hundred forty-eight men at least 18 years old with traumatic SCI of at least 6 months' duration, with erectile dysfunction solely attributed to SCI, and in a stable heterosexual relationship were treated sequentially with sildenafil and placebo. Exclusion criteria included taking nitrate therapy, severe cardiac failure, and recent stroke or myocardial infarction. The starting sildenafil dose was 50 mg, taken approximately 1 hour before sexual activity, with subsequent dose adjustment to 100 or 25 mg based on efficacy and safety during treatment. There was a 2-week washout between 6-week treatments.. Change from baseline in International Index of Erectile Function question 3 (frequency of penetration), question 4 (maintaining erection after penetration), question 9 (frequency of ejaculation), and erectile function domain scores; intercourse success; and treatment preference.. All International Index of Erectile Function outcomes, including achieving and maintaining erections and ejaculation frequency, were statistically significantly greater with sildenafil vs placebo, including the subgroup with complete SCI (P < .01 for all comparisons). The percentage of successful intercourse attempts with sildenafil (53% vs 12%) and preference for sildenafil (96% vs 4%) vs placebo were significant (P < .001), including the subgroup with complete SCI. The most common all-cause adverse events with sildenafil were headache (16.1%) and urinary tract infection (11.6%).. Sildenafil significantly improves erections, intercourse success, and ejaculation frequency vs placebo, including in men with complete SCI. Sildenafil is an effective and well-tolerated treatment for sexual dysfunction in men with SCI. The increase in frequency of ejaculation could allow the possibility of having children without medical intervention in this patient population. Ohl DA, Carlsson M, Stecher VJ, Rippon GA. Efficacy and Safety of Sildenafil in Men With Sexual Dysfunction and Spinal Cord Injury. Sex Med Rev 2017;5:521-528.

Topics: Ejaculation; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Spinal Cord Injuries

To determine the effectiveness of the Phosphodiesterase 5 (PDE5) Inhibitors for the treatment of erectile dysfunction in patients with spinal trauma.. A systematic review and meta-analysis comparing PDE5 inhibitors versus placebo were carried out for clinical trials conducted between 1980 and 2014 that evaluated male patients older than 18 years, diagnosed with spinal cord trauma and erectile dysfunction. We designed a search strategy for Medline, CENTRAL, EMBASE and other electronic sources. Two investigators independently and blindly screened the studies for inclusion. A random effect meta-analysis was performed.. Six studies involving 963 patients were included. Male patients over 18 years with ED attributable or subsequent to traumatic spinal cord injury (SCI) were included from these studies. In 4 of these studies, patients were randomized to the treatment group receiving sildenafil and the comparison group was placebo. Out of the remaining 2 trials, one compared tadalafil against the placebo and the other vardenafil versus placebo. The improvement on SCIs with PDE5 inhibitors was found to be large (standardized mean difference 0.71; 95% CI 0.39-1.03), with a high heterogeneity (I2 = 74.4%).. PDE5 inhibitors are effective for the treatment of erectile dysfunction secondary to SCI.

Topics: Adult; Aged; Carbolines; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Randomized Controlled Trials as Topic; Sildenafil Citrate; Spinal Cord Injuries; Tadalafil; Treatment Outcome; Vardenafil Dihydrochloride; Young Adult

Spinal cord injured (SCI) patients have sexual disorders including erectile dysfunction (ED), impotence, priapism, ejaculatory dysfunction and infertility. Treatments for erectile dysfunction include four steps. Step 1 involves smoking cessation, weight loss, and increasing physical activity. Step 2 is phosphodiesterase type 5 inhibitors (PDE5I) such as Sildenafil (Viagra), intracavernous injections of Papaverine or prostaglandins, and vacuum constriction devices. Step 3 is a penile prosthesis, and Step 4 is sacral neuromodulation (SNM). Priapism can be resolved spontaneously if there is no ischemia found on blood gas measurement or by Phenylephrine. For anejaculatory dysfunction, massage, vibrator, electrical stimulation and direct surgical biopsy can be used to obtain sperm which can then be used for intra-uterine or in-vitro fertilization. Infertility treatment in male SCI patients involves a combination of the above treatments for erectile and anejaculatory dysfunctions. The basic approach to and management of sexual dysfunction in female SCI patients are similar as for men but do not require treatment for erectile or ejaculatory problems.

Topics: Cognitive Behavioral Therapy; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Dysfunction, Physiological; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Testosterone

The majority of men with spinal cord injury (SCI) require chronic treatment for erectile dysfunction (ED), but most of them, prior to taking phosphodiesterase type 5 (PDE5) inhibitors, stopped therapy due to side-effects or low compliance rate.. Analysis of literature on oral PDE5 inhibitors in individuals with SCI and ED in order to evaluate how much their release changed the management of ED in SCI subjects and what remains to be seen of their potential or limits.. Questionnaires on sexual function.. 18 internationally published clinical studies that enrolled SCI males treated with at least one of the PDE5 inhibitors were analyzed.. The small numbers of papers with large and diverse outcome measures did not consent a meta-analysis of treatment results. 705 used sildenafil, 305 vardenafil and 224 tadalafil. Median age was less than 40 years. Only 1 study excluded tetraplegic individuals. For measures of ED evaluated, 11 out of 13 studies reported a significant statistical improvement with PDE5 inhibitors versus placebo or erectile baseline (P < 0.01, or p < 0.005). The most frequent predicable factor for the therapeutic success of PDE5 inhibitors was upper motoneuron lesion. Statistical impact on ejaculation success rates was shown in at least one paper for all PDE5 inhibitors (p < 0.05). Overall, 15 patients, (7 using sildenafil), discontinued the therapies due to drawbacks. Only 1 sildenafil study reported a follow-up maximum of 24 months.. Literature suggests that all oral PDE5 inhibitors represent a safe and effective treatment option for ED caused by SCI. Further research is needed on head-to-head comparative trials and SCI patient preference for these drugs; their impact on ejaculation and orgasm function, their early use after SCI for increasing the recovery rate of a spontaneous erection, and their effectiveness and tolerability in the long-term are still to be investigated.

Topics: Administration, Oral; Adolescent; Adult; Aged; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Reproduction; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Tadalafil; Triazines; Vardenafil Dihydrochloride; Young Adult

Multiple dramatic consequences follow medullary lesions. Not only are voluntary motor control and sensitivity of the body segment below the lesion lost, but it also becomes impossible to control erection and ejaculation as well as urinary and faecal continency. The first investigations into genito-sexual function in paraplegics have brought about the idea, commonly admitted in the medical world, that this kind of patient is impotent and sterile. Fortunately this idea is disappearing gradually and many data have demonstrated that appropriate treatment is required and some therapies efficient. This is particularly important in the case of the population concerned, namely young men in 70% of the cases, since the usual age bracket at trauma is between 25 and 35 years old. At this time of life, sexual activity is often at its peak, so that the fertility potential becomes erased.

Topics: Adult; Electric Stimulation Therapy; Erectile Dysfunction; Humans; Insemination, Artificial; Male; Papaverine; Paraplegia; Piperazines; Prostaglandins; Purines; Reflex, Abnormal; Sildenafil Citrate; Sperm Motility; Spinal Cord Injuries; Sulfones; Vibration

Topics: Erectile Dysfunction; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Vasodilator Agents

Spinal cord injury (SCI) affects a substantial number of men who are young, active, and otherwise healthy. Erectile dysfunction (ED) is a common consequence of SCI. Since its approval, sildenafil citrate (Viagra) has been shown to effectively treat ED of various etiologies. We review the evidence for the efficacy and safety of sildenafil treatment of ED in men with SCI. A literature search identified 2 randomized controlled trials and 4 prospective case series that evaluated sildenafil treatment for ED from SCI. Efficacy was evaluated using an assessment of global efficacy and a more specific assessment of erectile function. For general efficacy, the proportion of patients who reported improved erections and ability to have intercourse was as high as 94%. Up to 72% of intercourse attempts were successful. For measures of erectile function, 5 of the 6 studies showed statistically significant improvements among sildenafil-treated versus placebo-treated patients. Erectile response rates were generally higher in patients with incomplete versus complete SCI and in patients with upper versus lower motor neuron lesions. Nevertheless, a substantial proportion of patients with complete lesions, regardless of level or lower motor neuron lesions, also benefited from sildenafil. Sildenafil was well tolerated. Incidence rates and types of adverse events that occurred in these studies were similar to those published previously. Symptoms of autonomic dysreflexia were not reported in any study. Existing evidence suggests that oral sildenafil is a highly effective and well-tolerated treatment for ED associated with SCI.

Topics: Coitus; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Randomized Controlled Trials as Topic; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Vasodilator Agents

This review provides an overview of the pharmacology mechanism of sildenafil. The efficacy and safety of the medicine are briefly summarized. The special conclusion was made for the usage of sildenafil to the particular patients such as those with hypertension or those taking any antihypertensive agent, with cardiovascular disease, with diabetes, with spinal cord injury, after radical prostatectomy and on chronic dialysis. In general, sildenafil is effective and safe for various ED patients.

Topics: Antihypertensive Agents; Diabetes Complications; Drug Interactions; Erectile Dysfunction; Heart Diseases; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Neurologic erectile dysfunction presents a diagnostic and treatment challenge to the internist and urologist. Multiple chronic disease modalities and traumatic etiologies exist. Education regarding these conditions and a detailed and thorough history and office work-up are the best resources for the clinician. Treatment can follow the model of proceeding from the least to most invasive procedure (process of care), taking into account patient and partner satisfaction. Because the psychology of grief and loss may enter into treatment of some neurologic conditions (e.g., erectile dysfunction after radical retropubic prostatectomy, spinal cord injury, or chronic diseases), a whole-patient approach encompassing psychotherapy is warranted.

Topics: Chronic Disease; Diabetic Neuropathies; Erectile Dysfunction; Humans; Intervertebral Disc Displacement; Male; Multiple Sclerosis; Parkinson Disease; Penile Prosthesis; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Oral drugs are a well-established, first-line therapy for erectile dysfunction. As a result of the success of sildenafil, a plethora of new drugs for erectile dysfunction are on the horizon. Apomorphine and IC351 are in late phase III development. Vardenafil (Bayer, New Haven, CT), a PDE5 inhibitor, and the combination of yohimbine and L-arginine (NitroMed, Boston, MA) are in early phase III development. Early clinical and preclinical studies are investigating new phosphodiesterase inhibitors, cyclic AMP activators, alpha-adrenergic antagonists, dopamine agonists, melanocyte-stimulating hormone, potassium channel modulators, endothelin antagonists, and new nitric oxide donors. The future is bright for this infant field of sexual pharmacotherapy.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Administration, Oral; Apomorphine; Cardiovascular System; Contraindications; Coronary Disease; Cyclic Nucleotide Phosphodiesterases, Type 5; Dopamine Agonists; Erectile Dysfunction; Heart; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Prostatectomy; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Review of literature.. To review the physical aspects related to penile erection, ejaculatory dysfunction, semen characteristics, and techniques for enhancement of fertility in spinal cord lesioned (SCL) men.. Worldwide: individuals with traumatic as well as non-traumatic SCL.. Recommendations for management of erectile dysfunction in SCL men: If it is possible to obtain a satisfactory erection but of insufficient duration, then try to use a venous constrictor band to find out if this is sufficient to maintain the erection. Otherwise we recommend Sildenafil. If Sildenafil is not satisfactory then use intracavernous injection with prostaglandin E(1) (some SCL men may prefer cutaneous or intraurethral application). We discourage the implantation of penile prosthesis for the sole purpose of erection. Recommendations for management of ejaculatory dysfunction in SCL men: Penile vibratory stimulation (PVS) to induce ejaculation is recommended as first treatment choice. If PVS fails, SCL men should be referred for electroejaculation (EEJ). Semen characteristics: Impaired semen profiles with low motility rates are seen in the majority of SCL men. Recently reported data gives evidence of a decline in spermatogenesis and motility of ejaculated spermatozoa shortly after (few weeks) an acute SCL. It is suggested that some factors in the seminal plasma and/or disordered storage of spermatozoa in the seminal vesicles are mainly responsible for the impaired semen profiles in men with chronic SCL. Fertility: Home insemination with semen obtained by PVS and introduced intravaginally in order to achieve successful pregnancies may be an option for some SCL men and their partners. The majority of SCL men will further enhance their fertility potential when using either PVS or EEJ combined with assisted reproduction techniques such as intrauterine insemination or in vitro fertilization with or without intracytoplasmic sperm injection.

Topics: Alprostadil; Ejaculation; Electric Stimulation Therapy; Erectile Dysfunction; Humans; Infertility, Male; Male; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Purines; Reproductive Techniques; Semen; Sildenafil Citrate; Sperm Motility; Spinal Cord Injuries; Sulfones; Vasodilator Agents; Vibration

Double-blind, placebo-controlled, flexible-dose study.. To evaluate the efficacy, safety and tolerability of oral sildenafil in women with female sexual arousal disorder as a result of SCI (paraplegia/tetraplegia).. The study was conducted at clinical practice sites in North America (n =23), 11 European countries (n =23), Australia (n =4) and South Africa (n =2).. 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.. 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.. The results of this study are similar to other reports regarding a lack of clinically meaningful benefit of sildenafil in other populations of women.. This study was sponsored by Pfizer Inc.

Topics: Adult; Double-Blind Method; Female; Humans; Middle Aged; Paraplegia; Phosphodiesterase 5 Inhibitors; Piperazines; Placebo Effect; Purines; Quadriplegia; Sexual Dysfunctions, Psychological; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Young Adult

To evaluate the efficacy of sildenafil in the treatment of neurogenic erectile dysfunction (ED) secondary to upper motor neuron (UMN) and lower motor neuron (LMN) spinal cord injury (SCI). After taking consents 105 patients suffering from ED were enrolled in this prospective study. Seventy-two patients had signs and symptoms of UMN and 33 patients had signs and symptoms of LMN or mixed (UMN and LMN) spinal cord injuries. The patients took 50-100 mg sildenafil or placebo tablet at least 45 min before sexual intercourse. Based on a IIEF questionnaire, success in achieving erection adequate for sexual intercourse was compared between sildenafil and placebo groups in UMN and non-UMN spinal cord injuries. In patients with UMN disease, sildenafil was effective in 82% of patients and its efficacy was statistically higher than placebo (82 vs. 25%, p < 0.05). Twenty-eight per cent of patients with non-UMN disease had a favourable response to sildenafil that was not statistically different from placebo. Sildenafil seems more effective in the treatment of neurogenic ED secondary to UMN spinal cord injury compared with that secondary to LMN injury. Actually, its efficacy on LMN injuries does not seem different from placebo and administration of this treatment may not be effective in spinal cord injury which has caused LMN symptoms.

Topics: Adult; Erectile Dysfunction; Humans; Male; Middle Aged; Paraplegia; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

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.. 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 < or =21) received 50 to 100 mg sildenafil (n = 24) or placebo (n = 26).. 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.. 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.

Topics: Adult; Analysis of Variance; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Evaluation Studies as Topic; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Severity of Illness Index; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Time Factors

Open, before-after study.. To assess the efficacy and safety of phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction (ED) in spinal cord-injured (SCI) patients.. Home- and clinic-based assessments in the outpatient department at the Centre Bouffard Vercelli, Cerbère France.. Clinic trials with Sildenafil (Viagra) on 120 patients, Tadalafil (Cialis) on 54 patients and Vardenafil (Levitra) on 66 patients were performed. Flexible doses of PDE5 inhibitors were given depending on efficacy and tolerability, from 50 to 100 mg for Sildenafil, and from 10 to 20 mg for Vardenafil and Tadalafil. Each trial was performed after a week's interval. The efficacy was self-assessed by the patients on a six-point quantitative scale assessment. The response to treatment was assessed at home in 90 patients (57 patients on Sildenafil, 12 patients on Vardenafil and 21 patients on Tadalafil) using the International Index of Erectile Function (IIEF).. In clinic trials, PDE5 inhibitors were effective (rigidity enough for penetration) in 85% of the patients on Sildenafil, 74% of the patients on Vardenafil and 72% of the patients on Tadalafil. The mean duration of erection was 34, 28 and 26 min, respectively. Adverse effects were mild, usually attenuated with continued dosing. More than 70% of the patients on Vardenafil and Tadalafil required higher doses of 20 mg, whereas 50 mg of Sildenafil was effective in 55% of the patients. Two-thirds of our patients on Tadalafil reported a duration of action longer than 24 h. The presence of an upper motor neuron lesion was significantly associated with therapeutic success, lower motor neuron lesions and cauda equina patients were poor responders. Other variables such as completeness of lesion had no impact. In the follow-up visits, the IIEF global scores and three IIEF domains (erectile function, intercourse satisfaction and overall satisfaction) were significantly improved in all patients. Patients on Sildenafil showed a significant improvement of orgasmic function, ejaculation (Question 9) and orgasm (Question 10).. Sildenafil, Vardenafil and Tadalafil are all effective and well-tolerated treatments for ED in SCI patients. Although no statistical analysis could be applied on these data, these results might indicate that Sildenafil is more effective in treating ED. Clinic trials are important for proper dose titration and appropriate education of the patients.

Topics: Adult; Analysis of Variance; Carbolines; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Reaction Time; Retrospective Studies; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Tadalafil; Triazines; Vardenafil Dihydrochloride

Prospective, open-label, comparative study, to assess the effects of sildenafil on blood pressure in a population of patients with spinal cord injury (SCI).. To determine the effect of sildenafil on blood pressure in patients with erectile dysfunction secondary to SCI by comparing changes in blood pressure in SCI patients with a neurologic level below T5 versus higher levels. To establish a relationship between the potential hypotensive effect and protective muscle spasm against blood pressure reduction. To assess the effects of age, complexity and duration of SCI on changes in blood pressure. To record any adverse effects occurring during the study.. Spinal Cord Injury Unit, Insular University Hospital of Gran Canaria, Canary Islands, Spain.. In total, 22 male SCI patients aged 18 years or older with a history of SCI greater than 3 months in duration.. Patients with erectile dysfunction secondary to SCI were included in the study, without excluding patients with a neurologic level above 75 or asymptomatic low blood pressure. Patients with specific contraindications for use of the drug were excluded. A personal history was obtained, and the level of injury (ASIA/IMSOP scales of international standards), impairment grade (ASIA impairment scale), spasticity grade (modified Ashworth scale) and baseline sitting and supine blood pressure values were determined. A single dose of 50 mg of sildenafil was administered, and patients remained sitting at 45 degrees . Blood pressure was monitored every 10 min for 4 h and whenever the patient reported symptoms. Any relevant signs and symptoms manifested during the study period were also recorded. Analysis of the changes in blood pressure values was performed using a paired t-test in each group of patients according to neurologic level and spasticity grade.. A decrease in blood pressure was observed in all patients, although patients with a level of injury at T5 or above and those with a complete SCI showed a less intense decrease (P<0.05). The spasticity grade of the patients was protective against the fall in blood pressure, as it was less significant in patients with grade 3 (P>0.1) than in those with grade 0. Adverse effects were few and transient. None were related to hypotension.. Sildenafil caused a decrease in blood pressure in SCI patients with a neurologic level of injury above T5 and complete injuries (grade A), but did not have clinical implications in the patients studied. A higher spasticity grade tends to protect the patient from the fall in blood pressure. Age and duration of injury do not appear to influence this decrease.

Topics: Adult; Blood Pressure; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Severity of Illness Index; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Time Factors; Treatment Outcome

Autonomic dysreflexia (AD) can occur during penile vibratory stimulation in men with spinal cord injury, but this is variable, and the association with lesion level is unclear. The purpose of this study was to characterize the cardiovascular responses to penile vibratory stimulation in men with spinal cord injury. We hypothesized that those with cervical injuries would demonstrate a greater degree of AD compared with men with thoracic injuries. We also questioned whether the rise in blood pressure could be attenuated by sildenafil citrate. Participants were classified as having cervical (n = 8) or thoracic (n = 5) injuries. While in a supine position, subjects were instrumented with an ECG, and arterial blood pressure was determined beat by beat. Subjects reported to the laboratory twice and received an oral dose of sildenafil citrate (25-100 mg) or no medication. Penile vibratory stimulation was performed using a handheld vibrator to the point of ejaculation. At ejaculation during the nonmedicated trials, the cervical group had a significant decrease in heart rate (-5-10 beats/min) and increase in mean arterial blood pressure (+70-90 mmHg) relative to resting conditions, whereas the thoracic group had significant increases in both heart rate (+8-15 beats/min) and mean arterial pressure (+25-30 mmHg). Sildenafil citrate had no effect on the change in heart rate or mean arterial pressure in either group. In summary, men with cervical injuries had more pronounced AD during penile vibratory stimulation than men with thoracic injuries. Administration of sildenafil citrate had no effect on heart rate or blood pressure during penile vibratory stimulation in men with spinal cord injury.

Topics: Adult; Autonomic Dysreflexia; Blood Pressure; Cervical Vertebrae; Cross-Over Studies; Ejaculation; Heart Rate; Humans; Male; Physical Stimulation; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Thoracic Vertebrae; Vasodilator Agents; Vibration

A randomized, blinded, crossover clinical trial comparing sildenafil versus tadalafil for erectile dysfunction (ED) in male spinal cord-injured (SCI) patients.. To compare the safety, time/duration effectiveness, and the impact on the quality of life (QoL) of tadalafil 10 mg versus sildenafil 50 mg.. Neurourology Section, Careggi Hospital, Florence, Italy.. During a screening (visit 1), a diary card was distributed, in which the subjects assessed, after each attempt at intercourse the quality of their erection, responding (Yes/No) to both Sexual Encounter Profile Questions 2 (SEP2) and 3 (SEP3). The subjects made at least four attempts at intercourse. At visit 2, 15 patients (group 1) were assigned sildenafil and 15 (group 2) started with tadalafil. Responses to baseline International Index of Erectile Function 5 items (IIEF-5), Questions 13-14 (IIEF 15 items) and SEP diary were recorded. Patients attempted intercourse on four separate occasions: within 4 h of taking the first tablet, within 12 h for the second tablet, 24 h for the third, and the fourth from 24 to 36 h. At visit 3, the investigators evaluated the effectiveness with the same measures used at baseline. After a wash-out period, at visit 4, Group 1 was given tadalafil, and Group 2 was given sildenafil. Patients were required to observe the same criteria in taking the four tablets as in visit 2. After 4 weeks (visit 5), we evaluated the patients as we did in visit 3.. Overall, 28 patients completed the study. No subjects discontinued the drugs due to drawbacks. Tadalafil allowed a majority of men in this trial to achieve both normal sexual functioning up to 24 h postdosing compared to sildenafil (P<0.01) and improved overall sex life satisfaction as well as sexual relations with partner.. Based on these data, tadalafil may have the potential to become an important treatment option for ED in SCI patients.. This study was not sponsored.

Topics: Carbolines; Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Tadalafil; Time Factors; Vasodilator Agents

Sildenafil is efficacious for erectile dysfunction in men with spinal cord injury (SCI), but can induce hypotension in neurologically intact people. Those with SCI at or above the sixth thoracic level (T6) often have pre-existing hypotension, yet the cardiovascular response to sildenafil has not been studied in this group.. To evaluate the effect of sildenafil on the cardiovascular response in men with complete SCI at or above T6.. This was a randomized, double-blind, placebo-controlled, cross-over study. Twenty-three SCI participants were each randomly given placebo; sildenafil, 50 mg; and sildenafil, 100 mg; separated by at least 1 week. The following were measured before administration, and hourly for 4 hours afterward: (a) blood pressure (BP) and heart rate (HR), both supine and sitting; and (b) perceived dizziness on a visual analog scale upon sitting.. Analysis was done using a 4-way repeated-measures analysis of variance. No significant changes occurred with placebo. Sildenafil caused the following changes. Systolic BP changed little in thoracic spinal cord-injured (TSCI) participants, but decreased significantly (P < 0.005) in cervical spinal cord-injured (CSCI) participants. Diastolic BP decreased in all participants (P < 0.005). HR increased in the TSCI participants for 1 hour (P < 0.05), but was not altered in the CSCI participants. Dizziness increased in the TSCI participants after administration of 100 mg (P < 0.05) and in the CSCI participants after administration of 50 mg (P < 0.05). There were no adverse events or outcomes.. Sildenafil induces significant hypotension in people with cervical-level injuries--more so than in thoracic-level injuries--and can cause dizziness in both populations. It should be prescribed with caution and informed consent from the patient.

Topics: Adult; Blood Pressure; Cervical Vertebrae; Cross-Over Studies; Dizziness; Dose-Response Relationship, Drug; Double-Blind Method; Heart Rate; Humans; Male; Middle Aged; Piperazines; Posture; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Thoracic Vertebrae; Vasodilator Agents

Multicenter, open, prospective, before-after study.. To assess the efficacy and safety of sildenafil therapy for erectile dysfunction in patients with spinal cord injury, and the association between the response to sildenafil and factors such as causes and levels of spinal cord injury, grade of ASIA deficit, time since injury, orgasmic perception, and degree of baseline erection.. Homes of outpatients of 16 spinal cord injury units in Spain.. One hundred and seventy patients with erectile dysfunction secondary to spinal cord injury, from whom baseline data were collected on their sexual function, and who started treatment with sildenafil 50 mg. An efficacy assessment was made by the patient and his partner, and the score of the International Index of Erectile Function (IIEF) was recorded.. It was reported by 88.2% of the patients and 85.3% of their partners that treatment with sildenafil had improved their erections, regardless of the baseline characteristics of the spinal cord injury and erectile function. In responders, this improvement was confirmed by an increase from 12.5 to 24.8 points (P<0.001) of the Erectile Function Domain of IIEF. A significant improvement was also seen in patients' satisfaction with sexual activity and general satisfaction derived from sexual life. Preservation of orgasmic perception and a baseline degree of erection of 3 or 4 (P=0.006) were predictors of therapeutic success. No serious adverse events occurred.. Sildenafil is an effective, well-tolerated treatment for erectile dysfunction caused by spinal cord injury, regardless of the cause, neurological level, ASIA grade, and time since injury.. Spanish Society of Paraplegia.

Topics: Adult; Aged; Chi-Square Distribution; Drug Administration Schedule; Erectile Dysfunction; Follow-Up Studies; Humans; Logistic Models; Male; Middle Aged; Paraplegia; Piperazines; Predictive Value of Tests; Probability; Prospective Studies; Purines; Quadriplegia; Sildenafil Citrate; Spinal Cord Injuries; Statistics, Nonparametric; Sulfones; Treatment Outcome

Sexual dysfunction is common in women with spinal cord injuries (SCIs) and other neurologic conditions. Sildenafil has previously been shown to be safe and effective in the treatment of erectile dysfunction due to SCI. This study is the first to evaluate the sexual and cardiovascular effects of sildenafil in women with SCIs in a controlled, laboratory setting.. Nineteen premenopausal women with SCIs were randomly assigned to receive either sildenafil (50 mg) or placebo in a double-blind, crossover design study. Physiologic and subjective measures of sexual response, heart rate, and blood pressure were recorded during baseline and sexual stimulation conditions. Adverse events were also recorded.. Significant increases in subjective arousal (SA) were observed with both drug (P <0.01) and sexual stimulation conditions (P <0.001), and a borderline significant (P <0.07) effect of drug administration on vaginal pulse amplitude (VPA) was noted. Maximal responses occurred when sildenafil was combined with visual and manual sexual stimulation. Cardiovascular data showed modest increases in heart rate (+/-5 bpm) and mild decreases in blood pressure (+/-4 mm Hg) across all stimulation conditions, consistent with the peripheral vasodilatory mechanism of the drug. Sildenafil was well tolerated with no evidence of significant adverse events.. Findings suggest that sildenafil may partially reverse the sexual dysfunction commonly associated with SCI in women. Consistent with previous findings in men, the sexual effects of the drug were most evident under conditions of optimal stimulation. Mild, clinically insignificant cardiovascular effects were also noted. Further large-scale studies of sildenafil's effects in women with neurogenic sexual dysfunction are strongly indicated.

Topics: Adult; Blood Pressure; Cross-Over Studies; Double-Blind Method; Female; Heart Rate; Humans; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Behavior; Sexual Dysfunction, Physiological; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

A multicenter, randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover study conducted June 1996 through January 1997.. To evaluate the effect of sildenafil citrate (VIAGRA(R)) on the quality of life (QoL) of men with erectile dysfunction (ED) caused by spinal cord injury (SCI).. Study centers in Australia, Belgium, France, Germany, Norway, Sweden and the United Kingdom.. Questions 13 and 14 of the 15-item International Index of Erectile Function (IIEF) addressed QoL issues directly related to ED in 178 men with SCI. A 5-item questionnaire addressing concerns that men had about their erection problems was also used to evaluate the impact of ED on QoL. Several commonly used psychometric instruments, including the Medical Outcomes Survey (MOS) Short Form-12, Psychological General Well-Being Index, and MOS Family Survey, assessed general QoL issues.. Significant improvements were seen for overall satisfaction with sex life (IIEF Q13), sexual relationship with partner (IIEF Q14), and concerns about erectile problems (P<0.0001). Improvements were reported in scores for the generic QoL parameters of mental health, well-being, depression, and anxiety (P<0.05 sildenafil versus placebo).. Treatment with sildenafil can significantly improve key QoL parameters in men with ED caused by SCI.. This study was funded by Pfizer Inc. Spinal Cord (2000) 38, 363 - 370.

Topics: Adult; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Health Surveys; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Quality of Life; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Treatment Outcome

The aim of this study was to evaluate the efficacy and safety of sildenafil in the treatment of erectile dysfunction (ED) in spinal cord-injury (SCI) patients. Moreover, we looked for neurological conditions permitting therapeutic success and for the ideal dose needed to achieve sufficient erections.. 41 SCI patients were prospectively examined. Sexual dysfunction was assessed by means of anamnesis, the International Index of Erectile Function (IIEF) questionnaire, and neurological examination. Psychogenic erection capacity was tested by audiovisual stimulation and reflexive erection using a vibrator device. Neurophysiological recordings and cystomanometry were performed in parallel to clinical examinations. Neurophysiological recordings included sympathetic skin responses (SSR), pudendus somatosensory evoked potentials (pSSEP), and bulbocavernous reflex (BCR). Urodynamics aimed at classifying the neurogenic bladder dysfunction (upper motoneuron lesion versus lower motoneuron lesion). Intracavernous injection tests with PGE1 were performed in all patients to exclude major organic disease. 50 mg sildenafil was first given 3 times. Thereafter, the doses were adapted according to patients' reports.. Clinically, 28 subjects preserved either reflexive erections (24) or psychogenic erections (4), 11 had both types and only 2 presented with a complete loss of erection. 38 patients (93%) had a positive response to sildenafil and reached a penile rigidity sufficient to permit sexual intercourse. 3 patients dropped out because of non-response despite having increased the dosis up to 100 mg. 22 patients (58%) showed functional erections 1 h after 50 mg sildenafil, whereas 14 (37%) required higher doses of 75-100 mg. By comparing the IIEF questionnaire scores before and after therapy, there was a significant improvement in erectile function and intercourse satisfaction from 9.2+/-4.4 SD) and 4.5 (+/-2.5 SD) to 25.5 (+/-4.2 SD) and 10.5 (+/-2.1 SD) points, respectively (p<0.05). Nearly 10% (4/41) suffered from side effects such as headache or dizziness. Two of them stopped therapy because of the side effects. At least 36 patients (88%) continue treatment with sildenafil. Absence of both psychogenic (nonsomesthetic supraspinally elicited) and reflexive (somesthetic spinally elicited) erections, confirmed by urodynamical and electrophysiological findings (SSR perineum, BCR and pSSEP), seems to exclude a successful treatment. In contrast, SCI male patients with preserved function of at least one component of the erection phenomenon (psychogenic/reflexive) responded well to sildenafil and the dose required to achieve erections sufficient for sexual intercourse did not differ between the two groups.. Sildenafil proves to be a valuable and safe therapeutic management in ED of SCI patients. Therefore, patient acceptance and satisfaction are high. The most common dose required to achieve a satisfying erection is 50 mg. The efficacy of sildenafil depends on sparing of either sacral (S2-S4) or thoracolumbar (T10-L2) spinal segments which, in this study, have been shown to be of relevance in mediating psychogenic erections in male SCI patients. Complete disturbance of any neurogenic impulses excludes successful treatment.

Topics: Adult; Electrophysiology; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Urodynamics

This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildenafil 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days.. To assay the efficacy and safety of sildenafil 50 mg and placebo.. Clinic- and home-based assessments in the United Kingdom.. A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global efficacy. questionniare, diary).. In Part I, 17/26 (65%) subjects had erections of >60% rigidity at the penile base (median duration 3.5 min) after sildenafil compared with 2/26 (8%) (median duration 0 min) alter placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildenafil and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P<0.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P<0.02). An analysis of diary data showed no difference between the groups with respect to the mean number of erections hard enough for penetration (P = 0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildenafil due to adverse events.. Sildenafil is an effective, well-tolerated oral treatment for ED in SCI subjects.

Topics: Adult; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Pilot Projects; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Treatment Outcome

Erectile dysfunction is a common complication of spinal cord injury. This double-blind, placebo-controlled, two-way crossover study assessed the efficacy and safety of oral sildenafil in men with erectile dysfunction caused by traumatic spinal cord injury. A total of 178 men (mean age, 38 years) received placebo or sildenafil 1 hour before sexual activity for 6 weeks; after a 2-week washout period, the men received the alternate treatment for 6 weeks. The 50-mg starting dose could be adjusted to 100 or 25 mg based on efficacy and tolerability. Efficacy was assessed by using global efficacy questions, the International Index of Erectile Function (IIEF), and a patient log of erectile activity. Of 143 men with residual erectile function at baseline, 111 (78%) reported improved erections and preferred sildenafil to placebo. For all men (including those who reported no residual erectile function at baseline), 127 of 168 (76%) reported improved erections and preferred sildenafil to placebo. For all men, 132 of 166 (80%) reported that sildenafil improved sexual intercourse compared with 17 of 166 men (10%) reporting improvement with placebo. IIEF questions assessing the ability to achieve and maintain erections and satisfaction with sexual intercourse demonstrated significant improvement with sildenafil. Sildenafil was well tolerated, with a low rate of discontinuation because of treatment-related adverse events (2% vs 1% for placebo). Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction caused by spinal cord injury.

Topics: Administration, Oral; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Topics: Adult; Aged; Aged, 80 and over; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Female; Humans; Male; Middle Aged; Penile Erection; Perception; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Partners; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Topics: Administration, Oral; Adult; Cross-Over Studies; Double-Blind Method; Erectile Dysfunction; Humans; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

To evaluate the efficacy and safety of 50-mg doses of sildenafil during a 28-day period in patients with erectile dysfunction caused by spinal cord injury (cord level range, T6 through L5).. Sildenafil is an orally active, potent, and selective inhibitor of phosphodiesterase type 5, an important regulator of cyclic guanosine monophosphate in the human corpus cavernosum.. To be included in this double-blind, placebo-controlled study, all patients had to be able to achieve at least a partial reflexogenic erectile response to penile vibratory stimulation. The study utilized a single triangular sequential trial design. A total of 27 patients were randomized to receive 50 mg of sildenafil or placebo, taken orally as required (not more than once daily) approximately 1 hour before sexual activity.. After 28 days of treatment, nine of 12 patients (75%) on sildenafil and one of 14 patients (7%) on placebo reported that treatment had improved their erections (p=0.0043). Furthermore, eight of 12 patients (67%) on sildenafil and two of 13 patients (15%) on placebo indicated that they wished to continue treatment (p=0.018). A significant improvement in satisfaction with their sex life was reported by patients taking sildenafil (p=0.012). No patients discontinued treatment due to adverse events.. Oral sildenafil, taken as required (not more than once daily), significantly improves the quality of erections and satisfaction with sex life in men with erectile dysfunction caused by a spinal cord injury between T6 and L5.

Topics: Administration, Oral; Adult; Double-Blind Method; Enzyme Inhibitors; Erectile Dysfunction; Humans; Male; Middle Aged; Piperazines; Purines; Reflex; Sexuality; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

PDE inhibitors such as sildenafil alleviate lower urinary tract symptoms; however, a complete understanding of their action on the bladder remains unclear. We are investigating the effects of sildenafil, on post and preganglionic nerve-mediated contractions of the mouse bladder, and neuronal and urothelial ATP release.. Bladders were used from young (12 weeks), aged (24 months), and spinal cord transected (SCT), mice, for in vitro contractility experiments. An arterially perfused in situ whole mouse model was used to record bladder pressure. Nerve-mediated contractions were generated by electrical field stimulation (EFS) of postganglionic nerve terminals or the pelvic nerve. ATP release during EFS in intact detrusor strips, and during stretch of isolated mucosa strips, was measured using a luciferin-luciferase assay.. Sildenafil (20 μM) inhibited nerve-mediated contractions in young mice, with an increase in f. Sildenafil has a greater effect on the low-frequency, purinergic-mediated contractions and suppresses neuronal ATP release. In addition, sildenafil reduces stretch-induced urothelial ATP release. These results demonstrate a novel action of sildenafil to selectively inhibit ATP release from nerve terminals innervating detrusor smooth muscle and the urothelium.

Topics: Adenosine Triphosphate; Animals; Male; Mice, Inbred C57BL; Muscle, Smooth; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Spinal Cord; Spinal Cord Injuries; Urinary Bladder; Urothelium

Neuroprotective agents such as methylprednisolone and sildenafil may limit damage after spinal cord injury. We evaluated the effects of methylprednisolone and sildenafil on biochemical and histologic changes after spinal cord injury in a rabbit model. Female New Zealand rabbits (32 rabbits) were allocated to 4 equal groups: laminectomy only (sham control) or laminectomy and spinal trauma with no other treatment (trauma control) or treatment with either methylprednisolone or sildenafil. Gelsolin and caspase-3 levels in cerebrospinal fluid and plasma were determined, and spinal cord histology was evaluated at 24 hours after trauma. There were no differences in mean cerebrospinal fluid or plasma levels of caspase-3 between the groups or within the groups from 0 to 24 hours after injury. From 0 to 24 hours after trauma, mean cerebrospinal fluid gelsolin levels significantly increased in the sildenafil group and decreased in the sham control and the trauma control groups. Mean plasma gelsolin level was significantly higher at 8 and 24 hours after trauma in the sildenafil than other groups. Histologic examination indicated that general structural integrity was better in the methylprednisolone in comparison with the trauma control group. General structural integrity, leptomeninges, white and grey matter hematomas, and necrosis were significantly improved in the sildenafil compared with the trauma control group. Caspase-3 levels in the cerebrospinal fluid and blood were not increased but gelsolin levels were decreased after spinal cord injury in trauma control rabbits. Sildenafil caused an increase in gelsolin levels and may be more effective than methylprednisolone at decreasing secondary damage to the spinal cord. 

Topics: Animals; Caspase 3; Female; Gelsolin; Models, Animal; Necrosis; Neuroprotective Agents; Rabbits; Sildenafil Citrate; Spinal Cord; Spinal Cord Injuries

Nitric oxide (NO) is an important regulator of vasodilation and angiogenesis in the central nervous system (CNS). Signaling initiated by the membrane receptor CD47 antagonizes vasodilation and angiogenesis by inhibiting synthesis of cyclic guanosine monophosphate (cGMP). We recently found that deletion of CD47 led to significant functional locomotor improvements, enhanced angiogenesis, and increased epicenter microvascular perfusion in mice after moderate contusive spinal cord injury (SCI). We tested the hypothesis that improving NO/cGMP signaling within the spinal cord immediately after injury would increase microvascular perfusion, angiogenesis, and functional recovery, with an acute, 7-day administration of the cGMP phosphodiesterase 5 (PDE5) inhibitor sildenafil. PDE5 expression is localized within spinal cord microvascular endothelial cells and smooth muscle cells. While PDE5 antagonism has been shown to increase angiogenesis in a rat embolic stroke model, sildenafil had no significant effect on angiogenesis at 7 days post-injury after murine contusive SCI. Sildenafil treatment increased cGMP concentrations within the spinal cord and improved epicenter microvascular perfusion. Basso Mouse Scale (BMS) and Treadscan analyses revealed that sildenafil treatment had no functional consequence on hindlimb locomotor recovery. These data support the hypothesis that acutely improving microvascular perfusion within the injury epicenter by itself is an insufficient strategy for improving functional deficits following contusive SCI.

Topics: Animals; Antigens, CD; Antigens, Differentiation, Myelomonocytic; Capillaries; Cyclic GMP; Cyclic Nucleotide Phosphodiesterases, Type 5; Endothelial Cells; Female; Hindlimb; Image Processing, Computer-Assisted; Immunoenzyme Techniques; Immunohistochemistry; Locomotion; Mice; Mice, Inbred C57BL; Microcirculation; Nitric Oxide; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Recovery of Function; Regional Blood Flow; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Topics: Erectile Dysfunction; Humans; Male; Penile Erection; Piperazines; Placebos; Purines; Reflex; Sildenafil Citrate; Spinal Cord Injuries; Sulfones

Data are sparse concerning the long-term effects of phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction (ED).. To evaluate the efficacy and safety of long-term sildenafil use in subjects with ED caused by spinal cord injury (SCI).. Phase 1: From October 1998 to January 1999, 113 SCI patients with ED were given 50 mg of sildenafil after a 4-week treatment-free period. Those with a score lower than 26 on the International Index of Erectile Function (IIEF-15) and with less than 75% total successful sexual attempts the dosage of sildenafil was increased to 100 mg. Attempts were evaluated using the Sexual Encounter Profile Questions 2 and 3 (SEP2 and 3) regarding respectively the capacity to penetrate their partner and to maintain the erection after penetration. Phase 2: Only responding patients entered phase 2 where they were evaluated every 6 months. The final visit was concluded by January 2009.. Follow-up using the IIEF-15 questionnaire every 6 months.. Seventy-five patients entered Phase 2. Thirty-eight patients were excluded, 35 of them because they did not respond to the drug. Lesions higher than T12, an incompleteness of lesions, and higher residual erection were significant predictable factors for the success of the therapy (P < 0.05). Phase 2: the most frequent reason (68.3%) for discontinuing treatment was the desire to try a new oral therapy especially for patients using 100 mg. Thirty-four individuals continued treatment, 28 of whom took 50 mg.. Sildenafil represents an effective and safe long-term option for SCI subjects with ED. Further investigation of long-term use of oral PDE5 inhibitors in SCI patients is needed for evaluating both factors that are determinant in the choice of a starter treatment and in detecting elements that influence the switching from initial treatment.

Topics: Adult; Aged; Drug Administration Schedule; Erectile Dysfunction; Follow-Up Studies; Humans; Male; Middle Aged; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Piperazines; Purines; Sexual Behavior; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Time Factors; Young Adult

There is a high incidence of erectile dysfunction after spinal cord injury. This can have a profound effect on quality of life. Treatment options for erectile dysfunction include sildenafil, intracavernous injections of papaverine/alprostadil (Caverject), alprostadil/papaverine/phentolamine ("Triple Mix"), transurethral suppository (MUSE), surgically implanted prosthetic device and vacuum erection devices. However, physical impairments and accessibility may preclude patient self-utilization of non-oral treatments.. The costs and utilities of oral and non-oral erectile dysfunction treatments in a spinal cord injury population were examined in a cost-utility analysis conducted from a government payer perspective. Subjects with spinal cord injury (n=59) reported health preferences using the standard gamble technique.. There was a higher health preference for oral therapy. The cost-effectiveness results indicated that sildenafil was the dominant economic strategy when compared with surgically implanted prosthetic devices, MUSE(R) and Caverject. The incremental cost-utility ratios comparing sildenafil with triple mix and vacuum erection devices favoured sildenafil, with ratios less than CAN$20,000 per quality adjusted life year gained.. Based on this study, we conclude that sildenafil is a cost-effective treatment for erectile dysfunction in the spinal cord injury population.

Topics: Adrenergic alpha-Antagonists; Adult; Aged; Alprostadil; Cost-Benefit Analysis; Drug Costs; Erectile Dysfunction; Female; Humans; Male; Middle Aged; Papaverine; Penile Erection; Penile Prosthesis; Phentolamine; Piperazines; Purines; Quality of Life; Sexual Partners; Sildenafil Citrate; Socioeconomic Factors; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Vasodilator Agents

To assess the efficacy of sildenafil in men with spinal cord injury (SCI) and erectile dysfunction (ED).. Seventeen men with SCI were selected from February to September 1998 for sildenafil treatment of ED. The initial dose of 25 mg was increased by 25-mg increments as needed. Patients underwent baseline physical examination and answered questions from the abridged International Index of Erectile Function before and during therapy.. Sixteen patients tolerated therapy; 1 developed hypotension and discontinued therapy. There was significant improvement in erectile function (P < .05) after 5.3 +/- 2.2 months when compared with baseline or previous therapies (P < .05). Of the 17 patients, 94% recommended sildenafil to others. Six of these 16 patients were available for long-term follow-up. There was further significant improvement in quality of erection (P < .05), but no change in satisfaction.. Sildenafil is effective and well tolerated in men with SCI and ED.

Topics: Administration, Oral; Adult; Erectile Dysfunction; Humans; Male; Middle Aged; Patient Satisfaction; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones; Time Factors

Topics: Enzyme Inhibitors; Erectile Dysfunction; Female; Follow-Up Studies; Humans; Male; Piperazines; Purines; Sildenafil Citrate; Spinal Cord Injuries; Sulfones