PURPOSE: The aims of this study were to evaluate whether vardenafil, a phosphodiesterase type 5 inhibitor, may be used as a substitute for intracavernosal injection when assessing erectile dysfunction using penile duplex Doppler ultrasonography. MATERIALS AND METHODS: A total of 21 patients with erectile dysfunction underwent penile duplex Doppler ultrasonography after intracavernosal injection of 0.2 ml trimix. Each patient also underwent penile duplex Doppler ultrasonography after a 10-mg oral dose of vardenafil with audio-visual sexual stimulation. There was 1 week interval between each study. In both studies, peak systolic velocity, end-diastolic velocity, and resistive index were measured. Then ultrasonographic diagnoses of erectile dysfunction were classified as arteriogenic, veno-occlusive, and mixed-type. RESULTS: Doppler ultrasonography with trimix intracavernosal injection identified 8(38.1%), 1(4.8%), 10(47.6%), and 2(9.5%) patients with arteriogenic, veno-occlusive, mixed-type, and non-vasculogenic impotence, respectively. After vardenafil oral medication, 10(47.6%), 1(4.8%), and 10(47.6%) patients demonstrated arteriogenic, veno-occlusive, and mixed-type impotence, respectively. There was a difference in diagnosis in 23.8% of cases. CONCLUSIONS: Vardenafil oral administration with audio-visual sexual stimulation showed a similar hemodynamic result compared to trimix intracavernosal injection during penile duplex Doppler ultrasonography. However, there were some differences. These results suggest that vardenafil oral medication may be used as a substitute for intracavernosal injection when assessing erectile dysfunction using penile duplex Doppler ultrasonography. However, further investigation is needed.
Administration, Oral ; Diagnosis ; Erectile Dysfunction* ; Hemodynamics ; Humans ; Male ; Ultrasonography ; Ultrasonography, Doppler ; Ultrasonography, Doppler, Duplex* ; Vardenafil Dihydrochloride

We present an unusual case of a penile cavernosal abscess. This patient did not improve clinically despite repeat percutaneous aspiration of the abscess and administration of oral fluoroquinolone. Surgical drainage was required. Culture of pus and infected tissues were negative. Three months postoperatively, penile deviation to the left side and erectile dysfunction occurred but the patient was able to have sexual intercourse by using the medication of oral vardenafil. Colchicine was administered orally to the patient for 9 months and the penile curvature was improved.
Abscess* ; Coitus ; Colchicine ; Drainage ; Erectile Dysfunction ; Humans ; Male ; Penis ; Suppuration ; Vardenafil Dihydrochloride

PURPOSE: The present study investigated the effects of the type 5 phosphodiesterase(PDE-5) inhibitor, vardenafil on oxytocin expression in the paraventricular nucleus(PVN) of the hypothalamus were investigated. MATERIALS AND METHODS: Spargue-Dawley rats received a 2-week oral treatment with vardenafil(0.25 mg/kg/day oral adminstration, n=5) or(0.5 mg/kg/day oral adminstration, n=5) or(1 mg/kg/day oral adminstration, n=5) or (2 mg/kg/day oral adminstration, n=5) or control(n=3). Oxytocin expression in the paraventricular nucleus was measured. These experiments were performed in the absence of sexual stimulation for at least 36 hours before the experiments. RESULTS: The number of oxytocin-positive cells in the PVN was 46.88+/-15.46/section in the control group, 61.42+/-26.37/section in the 0.25 mg/kg vardenafil-treated group, 78.00+/-33.44/section in the 0.5 mg/kg vardenafil-treated group, 78.81+/-37.18/section in the 1 mg/kg vardenafil-treated group and 94.61+/-57.38/section in the 2 mg/kg vardenafil-treated group. The number of oxytocin-positive cells in the PVN increased in a concentration-dependent manner. CONCLUSIONS: Daily vardenafil administration increases expression of oxytocin in the PVN in a dose-dependent fashion in the absence of sexual stimulation. Thus, these results imply that the PDE-5 inhibitor vardenafil has a direct effect on the erectile pathway in the central nervous system in the absence of sexual stimulation.
Animals ; Central Nervous System ; Hypothalamus ; Oxytocin* ; Paraventricular Hypothalamic Nucleus* ; Rats* ; Vardenafil Dihydrochloride

PURPOSE: The present study investigated the effects of the type 5 phosphodiesterase(PDE-5) inhibitor, vardenafil on oxytocin expression in the paraventricular nucleus(PVN) of the hypothalamus were investigated. MATERIALS AND METHODS: Spargue-Dawley rats received a 2-week oral treatment with vardenafil(0.25 mg/kg/day oral adminstration, n=5) or(0.5 mg/kg/day oral adminstration, n=5) or(1 mg/kg/day oral adminstration, n=5) or (2 mg/kg/day oral adminstration, n=5) or control(n=3). Oxytocin expression in the paraventricular nucleus was measured. These experiments were performed in the absence of sexual stimulation for at least 36 hours before the experiments. RESULTS: The number of oxytocin-positive cells in the PVN was 46.88+/-15.46/section in the control group, 61.42+/-26.37/section in the 0.25 mg/kg vardenafil-treated group, 78.00+/-33.44/section in the 0.5 mg/kg vardenafil-treated group, 78.81+/-37.18/section in the 1 mg/kg vardenafil-treated group and 94.61+/-57.38/section in the 2 mg/kg vardenafil-treated group. The number of oxytocin-positive cells in the PVN increased in a concentration-dependent manner. CONCLUSIONS: Daily vardenafil administration increases expression of oxytocin in the PVN in a dose-dependent fashion in the absence of sexual stimulation. Thus, these results imply that the PDE-5 inhibitor vardenafil has a direct effect on the erectile pathway in the central nervous system in the absence of sexual stimulation.
Animals ; Central Nervous System ; Hypothalamus ; Oxytocin* ; Paraventricular Hypothalamic Nucleus* ; Rats* ; Vardenafil Dihydrochloride

PURPOSE: The AVSS with 3-D HMD is considered to provide a more realistic image and more comfortable circumstances in which the subjects are absorbed in the stimulation. We investigated the efficacy of using 3-D combined with oral medication and a stimulation (COS) test for the evaluation of vasculogenic erectile dysfunction (ED). MATERIALS AND METHODS: 66 patients with complaints of ED, 28 patients diagnosed with vasculogenic ED and 38 patients diagnosed with psychogenic ED were included in this study. The patients were randomly divided into the 2-D group and the 3-D group. The 2-D group patients were examined with using 2-D combined an injection and a stimulation (CIS) test. The 3-D group patients were examined with 3-D CIS test. Then a week later, the patients underwent the AVSS with 3-D HMD 1 hour after oral PDE 5 inhibitor medication. The degree of erection was monitored using the Nocturnal Electrobioimpedance Volumetric Assessment (NEVA) system. RESULTS: On the 2-D CIS tests, 12 of 27 patients showed normal erection, and this resulted in a sensitivity and specificity of 72.7% and 56.3%, respectively. On the 3-D CIS tests, 20 of 39 patients showed normal erection and on the 3-D COS tests, 17 patients showed normal erection and this resulted in a sensitivity and specificity of 88.2% and 81.8%, and 94.1% and 72.7%, respectively. No significant difference were present in the results of the diagnosis between the 3-D CIS and 3-D COS tests. CONCLUSIONS: Both the 3-D CIS and 3-D COS tests offer the advantage of higher sensitivity and specificity than the conventional CIS test. The 3-D COS test may be used as a substitute for the conventional CIS test due to its simplicity and less invasive nature.
Diagnosis* ; Erectile Dysfunction* ; Genetic Complementation Test ; Humans ; Male ; Photic Stimulation ; Sensitivity and Specificity ; Vardenafil Dihydrochloride

Purpose: This study aimed at evaluating the expected additive blood pressure (BP) lowering effect of vardenafil when administered in the background of chronic alpha1-blocker therapy. Materials and Methods: Patients (n=90) with symptomatic benign prostatic hypertrophy (BPH) and erectile dysfunction (ED) took vardenafil 20mg in the morning following repeated doxazosin gastrointestinal therapeutic system (GITS) 4mg (n=60) or tamsulosin 0.2mg (n=30) HS a day for 30 days. The standing and sitting BP at baseline, before taking the vardenafil and 30 minutes and 1 hour post vardenafil were measured 3 consecutive times. The data were analyzed by Student's t-test (paired), repeated measures of two-way ANOVA, chi-square tests and Pearson correlation analysis. Results: Doxazosin produced a significant reduction in systolic/diastolic BP ( 12.3/ 6.7mmHg), but tamsulosin did not. In the doxazosin group, the average reductions in BP from baseline ( 24.7/ 15.8mmHg) were significantly higher than that for the tamsulosin group ( 14.6/ 7.5mmHg). However, the average BP change was not different in both group ( 12.4/ 9.1mmHg in the doxazosin group and 11.3/ 6.4mmHg in the tamsulosin group) following a single dose of 20mg vardenafil. The higher the BP was at baseline, the more the reduction in BP was in both the doxazosin and tamsulosin groups. Two patients of tamsulosin showed a sitting systolic BP <85mmHg, but they didn't experience dizziness. Conclusions: We recommend starting Vardenafil treatment in the background of chronic aalpha1 blocker therapy, including tamsulosin, with a low dose and to increase the dose by monitoring the BP, particularly for the patients with hypertension.
Blood Pressure* ; Dizziness ; Doxazosin* ; Drug Interactions* ; Erectile Dysfunction* ; Humans ; Hypertension ; Male ; Prostatic Hyperplasia* ; Vardenafil Dihydrochloride

BACKGROUND/AIMS: To evaluate the effects of the phosphodiesterase type 5 (PDE5) inhibitor vardenafil on esophageal function, including bolus transit, using multichannel intraluminal impedance and esophageal manometry (MII-EM). METHODS: Sixteen healthy volunteers (15 men) underwent an MII-EM study including 10 liquid swallows and 10 viscous swallows in a seated position after fasting. Then, each subject was asked to ingest 50 mL distilled water or 10 mg vardenafil dissolved in 50 mL water, in a double-blind manner. After 25 minutes, the MII-EM study was repeated. RESULTS: Eight men received vardenafil and eight subjects received water. Resting and residual lower esophageal sphincter pressures differed significantly only in the vardenafil group (from 18 +/- 6.7 to 6.6 +/- 5.3 mmHg, P < 0.001 and from 4.9 +/- 2.6 to 2.1 +/- 3.6 mmHg, P = 0.006, respectively). Mean distal esophageal amplitude decreased significantly only in the vardenafil group (from 86.7 +/- 41.6 to 34.0 +/- 38.0 mmHg, P < 0.05). Complete bolus transits of liquid and viscous meals decreased significantly only after vardenafil ingestion (from 80.2% +/- 13.8% to 49.4% +/- 27.9%, P < 0.05 and from 72.8% +/- 33.6% to 21.5% +/- 29.0%, P = 0.01, respectively). CONCLUSIONS: Vardenafil decreased esophageal bolus transit in the seated position, despite decreased lower esophageal sphincter pressure.
Eating ; Electric Impedance ; Esophageal Sphincter, Lower ; Fasting ; Humans ; Imidazoles ; Male ; Manometry ; Meals ; Piperazines ; Sulfones ; Swallows ; Triazines ; Water ; Vardenafil Dihydrochloride

PURPOSE: It is well known that male erectile dysfunction and lower urinary tract symptoms are common in aging men. We evaluated whether treatment for erectile dysfunction with vardenafil might improve lower urinary tract symptoms. MATERIALS AND METHODS: From January 2004 to May 2005, 34 patients with erectile dysfunction attending the outpatient clinic were treated with vardenafil and followed up 1, 3, and 6 months after the treatment. They completed the International Index of Erectile Function (IIEF) and the International Prostate Symptom Score (IPSS) questionnaire at baseline and at each follow-up (1, 3, 6 months). RESULTS: After treatment with vardenafil, IIEF and IPSS were significantly improved at 1 month compared to baseline,and the improvement was maintained during the 3 to 6 month follow-up period. There was no correlation between IPSS and IIEF score either before or after treatment. There was no statistical significance between the severity of IPSS and the response to vardenafil. There were mild side effects, including 2 patients with headache, 2 patients with facial flushing, and 1 patient with eye discomfort. CONCLUSIONS: Vardenafil appears to improve not only erectile function but also lower urinary tract symptoms in men with erectile dysfunction. However, the severity of IPSS does not appear to predict the response to vardenafil therapy.
Aging ; Ambulatory Care Facilities ; Erectile Dysfunction* ; Flushing ; Follow-Up Studies ; Headache ; Humans ; Lower Urinary Tract Symptoms* ; Male ; Prostate ; Vardenafil Dihydrochloride

PURPOSE: To clarify whether vardenafil can be used as a substitute for intracavernosal injection as a method of induction of penile erection, we compared the outcome of penile duplex Doppler ultrasonography using both methods in the same patient with erectile dysfunction. MATERIALS AND METHODS: A total of 23 patients underwent penile duplex ultrasonography twice with a one week interval between procedures. Twelve were randomly selected for intracavernosal injection first with prostaglandin E1(PGE1) 20microgram and the remaining 11 were initially treated with oral vardenafil 20mg 1 hour before the Doppler study and in addition had visual sexual stimulation using a head-mounted display during the study. The peak systolic velocity(PSV), end diastolic velocity(EDV) and the degree of maximum erectile response were measured and compared between the two groups. RESULTS: Measurements from the PGE1 treatment were not significantly different from those with the vardenafil treatment. The percentage of compatibility between the two methods with regard to hemodynamic diagnosis and pharmaceutical erectile response was as high as 83%(19 of 23) and 91%(21 of 23), respectively. Both methods were tolerable and safe without severe complications. However, in 4 patients where the diagnosis was uncertain, the injection method provided a more accurate interpretation of the penile vascular status with duplex ultrasonography. CONCLUSIONS: These results suggest that oral vardenafil can be used as an initial method for inducing penile erection when assessing erectile dysfunction with penile duplex Doppler ultrasonography in selected patients with erectile dysfunction.
Alprostadil ; Erectile Dysfunction ; Hemodynamics ; Humans ; Imidazoles ; Male ; Penile Erection ; Phosphodiesterase Inhibitors ; Piperazines ; Sulfones ; Triazines ; Ultrasonography, Doppler, Duplex ; Vardenafil Dihydrochloride

Objective: To develope and validate a reliable and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for determination of vardenafil concentration in plasma of rat. Methods: Plasma samples of normal Sprague-Dawley rats were collected. A Phenomenex Synergi Polar-RP 80A column (2.0 mm×50 mm, 4 µm) was used. Column temperature was set at 30 ℃. Mobile phase A was 0.1% formic acid in water; mobile phase B was 0.1% formic acid in acetonitrile. The flow rate was 0.4 ml/minutes. Quantitative determination was performed by electrospray ionization, operating in positive ion multiple reaction monitoring (MRM) mode. Cisapride was used as the internal standard. The feasibility of the method was evaluated by examining its specificity, linearity and quantitative range, precision and accuracy, matrix effects, and stability. Results: Under the selected chromatographic and mass spectrometry conditions, the monitoring ions of vardenafil and internal standard were mass-to-charge ratio（m/z) 489.3/151.2 and 466.4/234.2, the retention times of vardenafil and internal standard were 2.62 and 2.80 minutes, respectively, and the peak shape was satisfactory. The method has good linearity in the concentration range of 0.2-200 ng/ml. The intra-batch precision (%CV) and accuracy (%DEV) of vardenafil were 1.5%-9.7% and -6.8%-6.6%, respectively. The inter-batch precision and accuracy of vardenafil were 3.1% -8.4% and -3.7%-4.6%, respectively. In this sample processing method, the extraction recovery rate of vardenafil was obtained at range of 88.2%-104.6%, which met the requirements for the investigation of extraction recovery rate. In this sample processing method, the normalized matrix factor of each quality control concentration of vardenafil was 1.04, 0.85, and 1.04, and the coefficient of variation (%CV) was in the range of 1.7%-10.7%, which met the requirements for the investigation of matrix effects. Variations of short-term stability, long-term stability, and stability of 4 freeze-thaw cycles of vardenafil was within ±15%, and the coefficient of variation were within 5%. Conclusion: The high performance liquid chromatography-tandem mass spectrometry method established in this study is feasible for the measurement of concentration of vardenafil in rat plasma and this method has good specificity and high accuracy, and can be used to detect the concentration of vardenafil in rat plasma.
Animals ; Chromatography, Liquid ; Feasibility Studies ; Rats ; Rats, Sprague-Dawley ; Reproducibility of Results ; Sensitivity and Specificity ; Tandem Mass Spectrometry ; Vardenafil Dihydrochloride