vardenafil-dihydrochloride and 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

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

Multicenter, double-blind, placebo-controlled, parallel-group study.. 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).. 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.. In this 12-week study, 418 men aged >or=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.. 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.. Vardenafil significantly improved ejaculation and self-confidence in men with erectile dysfunction due to SCI.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Coitus; Double-Blind Method; Ejaculation; Erectile Dysfunction; Humans; Imidazoles; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Quality of Life; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

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

We assessed urodynamic changes after vardenafil administration in spinal cord injured male patients on oxybutynin treatment.. We performed a single center, randomized, double-blind, placebo controlled trial in 25 patients with spinal cord injury who had erectile dysfunction and micturition disorders. A baseline urodynamic test was performed as well as a second urodynamic test 1 to 3 hours after the administration of 20 mg vardenafil and placebo in 15 and 10 cases, respectively. In all patients standard oral oxybutynin administration was not discontinued. Statistical assessment included the 3 urodynamic parameters maximum detrusor pressure during voiding, maximum cystometric capacity and detrusor overactivity volume.. Placebo administration did not affect urodynamic parameters. After vardenafil administration maximum detrusor pressure was significantly decreased (59.3 vs 52.1 cm H(2)O, p <0.001) and maximum cystometric capacity considerably improved (233.5 vs 272 ml, p <0.001). The most dramatic variations were observed for detrusor overactivity volume (174 vs 218 ml, p <0.0001). In 7 patients with American Spinal Injury Association classification A and spinal cord injury above T6 we observed the most significant improvement in the evaluated urodynamic items, including maximum detrusor pressure 57 vs 52 cm H(2)O (p = 0.039), maximum cystometric capacity 253 vs 296 ml (p = 0.004) and detrusor overactivity volume 177 vs 229 ml (p = 0.003).. This trial demonstrates that in spinal cord injured patients a single 20 mg vardenafil administration achieved a significant decrease in maximum detrusor pressure, an improvement in maximum cystometric capacity and a remarkable increase in detrusor overactivity volume value.

Topics: Administration, Oral; Adult; Dose-Response Relationship, Drug; Double-Blind Method; Erectile Dysfunction; Follow-Up Studies; Humans; Imidazoles; Male; Mandelic Acids; Middle Aged; Parasympatholytics; Phosphodiesterase Inhibitors; Pilot Projects; Piperazines; Retrospective Studies; Spinal Cord Injuries; Sulfones; Treatment Outcome; Triazines; Urination Disorders; Urodynamics; Vardenafil Dihydrochloride

To assess the efficacy and tolerability of vardenafil in men with erectile dysfunction (ED) due to traumatic spinal cord injury (SCI).. In this multicenter, double-blind, placebo-controlled, parallel-group 12-week study, 418 men aged 18 years and older with ED for more than 6 months consequent to 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). Efficacy assessments included the erectile function (EF) domain score of the International Index of Erectile Function questionnaire and diary questions regarding penetration, maintenance of erection to completion of intercourse, and ejaculation.. Baseline patient characteristics were similar in the vardenafil (mean age 40 years) and placebo (mean age 39 years) groups. Mean baseline EF domain scores were 11.6 in the vardenafil group and 12.1 (moderate ED) in the placebo group. EF domain score in the vardenafil group improved to 22.0 (mild ED) at last observation carried forward vs 13.5 in the placebo group (p < 0.001). Over 12 weeks of treatment, mean per-patient penetration (76% vs 41%), maintenance (59% vs 22%), and ejaculation (19% vs 10%) success rates were significantly greater vs placebo (all p < 0.001). The most frequently reported drug-related adverse events were headache (vardenafil 15%, placebo 4%), flushing (vardenafil 6%, placebo 0%), nasal congestion (vardenafil 5%, placebo 0%), and dyspepsia (vardenafil 4%, placebo 0%).. Vardenafil significantly improved erectile and ejaculatory function and was generally well tolerated in men with erectile dysfunction due to spinal cord injury.

Topics: Adult; Coitus; Double-Blind Method; Dyspepsia; Ejaculation; Erectile Dysfunction; Flushing; Headache; Humans; Imidazoles; Male; Medical Records; Nasal Obstruction; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Spinal Cord Injuries; Sulfones; Surveys and Questionnaires; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Vardenafil is a highly selective phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction (ED). Efficacy of vardenafil has been demonstrated in various ED populations, but that in Japanese patients with spinal cord injury (SCI) has not been assessed.. This was an open-label, multicenter, flexible dose, 12-week study in patients with ED due to SCI. Following a 4-week observation period, patients received vardenafil 10 mg for 4 weeks, and based on efficacy, tolerability and patient preference, doses for the remaining 8 weeks were decided by investigators. The primary efficacy parameter was erectile function domain score of the International Index of Erectile Function.. Ten patients took 10 mg all through the study, while 22 patients took 20 mg after completing 4 weeks' treatment with 10 mg. The erectile function domain score increased from 12.2 at baseline to 25.0 at Last Observation Carried Forward (LOCF) in the former group and from 10.3 to 22.5 in the latter group, respectively. Importantly, there was a 5.0 point increase in erectile function domain score after up-titration in the latter group. Drug-related adverse events were observed in 22% of patients including hot flushes (9%) and headache (6%), but these were transient and mild in intensity. Serious adverse events and adverse events leading to discontinuation of the study drug were not reported.. Vardenafil 10 and 20 mg was well tolerated and improved erectile function in patients with SCI. Of interest, erectile function was further improved by 20 mg in patients who were not sufficiently treated with 10 mg.

Topics: Adult; Dose-Response Relationship, Drug; Drug Administration Schedule; Erectile Dysfunction; Headache; Hot Flashes; Humans; Imidazoles; Japan; Male; Middle Aged; Penile Erection; Phosphodiesterase Inhibitors; Piperazines; Spinal Cord Injuries; Sulfones; Time Factors; Treatment Outcome; Triazines; Vardenafil Dihydrochloride

Phosphodiesterase type 5 inhibitors (PDE5-Is) improve storage symptoms in benign prostatic hyperplasia patients, despite a lack of effect on peak urinary flow rate. Moreover, vardenafil improves urodynamic parameters in spinal cord-injured (SCI) patients with neurogenic detrusor overactivity (NDO). SCI rats also display NDO characterized by nonvoiding contractions (NVCs) during bladder filling, resulting in an increased bladder afferent nerve firing (BANF).. We postulated that vardenafil could improve urodynamic parameters by reducing BANF. The effect of vardenafil has been investigated on intravesical pressure by cystometry experiments while recording BANF in response to bladder filling.. Complete T7-T8 spinalization was performed in 15 female adult Sprague-Dawley rats (250-275 g).. At 21-29 d postspinalization, fine filaments were dissected from the L6 dorsal roots and placed across a bipolar electrode. Bladder afferent nerve fibers were identified by electrical stimulation of the pelvic nerve and bladder distension. SCI rats were decerebrated before cystometry experiments. Bladders were filled to determine the maximal bladder filling volume (BFV) for each rat. Then, after bladder stabilization at 75% of maximal BFV, saline (n=7) or vardenafil 1 mg/kg (n=8) was delivered intravenously. NVCs and BANF were recorded for 45 min.. In all SCI rats, BANF was already present and regular at resting conditions (26.2±4.1 spikes per second). During bladder filling, intravesical pressure (IVP) slowly increased with transient NVCs superimposed. Concomitantly, BANF progressively increased up to 2.4-fold at maximal BFV (2.08±0.24 ml). After stabilization at submaximal BFV, BANF was increased by 186±37%. Vardenafil injection induced an immediate decrease in NVCs compared to saline (p<0.001) and BANF (52% decrease vs 28% in saline after 45 min; p<0.001).. Systemic vardenafil reduced both NVCs and BANF in unanesthetized, decerebrate, SCI rats. These findings provide new insights into the mechanism of action by which PDE5-Is improve storage symptoms in SCI patients.

Topics: Animals; Decerebrate State; Disease Models, Animal; Female; Imidazoles; Neurons, Afferent; Phosphodiesterase 5 Inhibitors; Piperazines; Pressure; Rats; Rats, Sprague-Dawley; Spinal Cord Injuries; Spinal Nerve Roots; Sulfones; Triazines; Urinary Bladder; Urinary Bladder, Overactive; Vardenafil Dihydrochloride