[Safety and efficacy of China-made sildenafil citrate in the treatment of erectile dysfunction].

OBJECTIVE: To evaluate the safety, efficacy and tolerability of China-made sildenafil citrate (Jinge) in the treatment of ED. METHODS: We conducted a multi-center, randomized, double-blind and placebo-controlled clinical trial among 222 ED patients in five urological or andrological clinics of China. The patients were randomly assigned to receive sildenafil citrate (SC, n = 111) or placebo (n = 111) for 8 weeks. We obtained and analyzed the demographic and clinical characteristics of the patients, the scores of International Index of Erectile Function (IIEF), the success rate of sexual intercourse, and the incidence of adverse events. RESULTS: No statistically significant differences were found between the patients of the SC and those of the placebo group in the mean age (ï¼»47.2±11.32ï¼½ yr vs ï¼»46.67±13.08ï¼½ yr, P>0.05), psychological etiology (27.93% vs 23.42%, P>0.05), organic etiology (21.62% vs 29.73%, P>0.05) or mixed etiology (50.45% vs 46.85%, P>0.05), nor in height, weight, nationality, or history of smoking, drinking or allergy. Compared with the placebo controls, the SC-treated patients showed significant increases in the excellence rate of effectiveness (29.91% vs 78.90%, P<0.01), success rate of sexual intercourse (29.16% vs 63.87%, P<0.01), and total effectiveness rate (34.58% vs 77.98%, P<0.01). The effectiveness rates on organic, psychogenic and mixed types ED were remarkably higher in the SC group (64.52%, 83.33%, and 82.14%) than in the placebo control (46.15%, 21.21%, and 25.00%) (P<0.01). Mild or temporary adverse events were observed in 32 cases in the SC group as compared with 13 in the placebo control. CONCLUSIONS: China-made sildenafil citrate is an effective, safe and well-tolerated drug for ED of different etiologies in the Chinese population.

[Testicular histology does not affect the clinical outcomes of ICSI in men with non-obstructive azoospermia].

OBJECTIVE: To investigate whether testicular histology influences the clinical outcomes of intracytoplasmic sperm injection (ICSI) in men with non-obstructive azoospermia (NOA). METHODS: We retrospectively analyzed the clinical data about 73 cases of NOA undergoing ICSI, including 105 ICSI cycles and 79 embryo transfer cycles. The infertility of the patients was attributed to male factors only or both male and female tube factors and the females' age was ≤38 years. Based on testicular histology, we divided the ICSI cycles into three groups: hypospermatogenesis (HS, n = 72), maturation arrest (MA, n = 21) and Sertoli cells only (SCO, n = 12). We recorded and analyzed the age of both the males and females, infertility duration, base follicle-stimulating hormone (FSH) level, dose and days of gonadotropin (Gn) administration, estradiol (E2) and progesterone (P) levels on the day of human chorionic gonadotropin (hCG) administration, endometrial thickness, number of metaphase II (MII) oocytes, and rates of fertilization, transferrable embryos, high-quality embryos, clinical pregnancy, and abortion. RESULTS: The rates of fertilization, failed fertilization, transferrable embryos, and high-quality embryos, and the average number of transferred embryos were 67.03% (553/825), 9.52% (10/105), 85.66% (472/551), 35.03% (193/551), and 2.10, respectively, resulting in 44 pregnancies (55.70%) and 42 live births (53.16%), with no birth defects. No statistically significant differences were observed among the HS, MA and SCO groups in the mean age of the men and women, infertility duration, base FSH level, Gn dose, Gn days, E2 and P levels on the hCG day, endometrial thickness, or number of MII oocytes, nor in the rates of fertilization (68.51% vs 64.39% vs 61.45%), transferrable embryos (85.05% vs 90.48% vs 83.05%), or high-quality embryos (33.09% vs 41.67% vs 38.98%). The rates of clinical pregnancy and embryo implantation were higher in the HS (60.00% and 37.61%) and SCO (62.50% and 50.00%) than in the MA group (37.50% and 21.21%), but with no statistically significant differences (P >0.05). CONCLUSIONS: Once testicular sperm is retrieved, desirable clinical outcomes can be achieved in ICSI for NOA patients, which is not affected by testicular histopathology.

[Effect of Y chromosomal length variation on male reproductive dysfunction].

OBJECTIVE: To investigate the effects of big and bit Y chromosome configurations on male fertility and to evaluate the relevant clinical significance. METHODS: The relevant cases were divided into A and B groups. Group A included male infertile cases. Group B included cases whose wives had adverse pregnancy history or the abnormal amniotic fluid punctures. The cytogenetics of the patients were examined by culturing peripheral-blood lymphocytes and G-banding technology, and karyotyping analysis techniques were used to study the big and bit Y chromosomes in the two different groups. RESULTS: Among 2 139 cases, 98 cases were found with abnormal karyotype of big and bit Y chromosomes. There was no significant difference in the abnormal rate of the length variation of the Y chromosomal karyotypes between the male infertility group and the adverse pregnancy outcome group. In the male infertile group (group A), there was no significant difference in the abnormal rate between the big Y chromosome and the bit Y chromosome. In the group with adverse pregnancy outcomes (group B), the abnormal rate of the big Y chromosome karyotyping was significantly higher than that of the bit Y chromosome karyotyping. The main clinical effects of groups A and B were azoospermia, oligozoospermia, poor spermia, abortion, embryonic diapause and fetal anomalies, etc . CONCLUSION: The big and bit Y chromosomal abnormality results in not only the male infertility directly, but also an important and continuous reason of adverse pregnancy outcomes, of which the detailed mechanism needs to be further investigated.

Help-seeking behavior for erectile dysfunction: a clinic-based survey in China.

The behavior of Chinese patients seeking help for erectile dysfunction (ED) has not been described in detail. This was an observational study conducted using an outpatient clinic-based questionnaire survey of ED patients. From 2008 to 2009, physicians in 10 medical centers in China enrolled 2693 men (aged 25-70 years) diagnosed with ED. The diagnosis was based on the International Index of Erectile Function 5 (IIEF-5) Questionnaire. The men completed a survey that asked questions about demographics, marital status, education level and household income as well as help-seeking behavior and awareness of medical therapy. The mean age of the 2693 men was 43.4 ± 5.3 years; 73% were <50-years-old and 49% had a high household income. The mean time between noticing ED and taking the first treatment was 4.3 ± 2.1 months. Of the 2577 respondents, physicians (54%) and the internet (52%) were most frequently consulted sources for information about ED. Young ED patients preferred using the internet and older patients preferred consulting with physicians. Western medicine (19%) and traditional Chinese medicine (16%) were most frequently used for treatment. Young ED patients preferred to first search the internet for information, whereas older patients first asked physicians for help. Side effects of treatment were the greatest concern, especially for older patients. Physicians and the internet are frequently consulted for ED information and therapy. On the basis of these survey results, we believe that physicians in China should enhance health education about ED, especially via the internet.

[Testicular sperm cryopreservation for male fertility preservation].

OBJECTIVE: To investigate the effectiveness of testicular sperm cryopreservation in male fertility preservation by evaluating the clinical outcome of ICSI cycles with frozen-thawed testicular sperm for azoospermia patients. METHODS: We retrospectively analyzed 96 samples of cryopreserved testicular sperm obtained by testicular biopsy, vasovasostomy (V-V), vasoepididymostomy (V-E) , of which 55 were subjected to 60 ICSI cycles with frozen-thawed testicular sperm. We evaluated the rates of sperm recovery, fertilization, cleavage, transferable and good-quality embryos, clinical pregnancy, pregnancy outcome, and health of the newborns. RESULTS: All the frozen testicular sperm samples were recovered successfully. The rates of fertilization, 2PN fertilization, cleavage, available embryos and good-quality embryos were 77.6, 69.4, 99.4, 84.5 and 40.8%, respectively. There were transferable embryos in all cycles. Fresh embryos were transferred in 52 of the 60 cycles, with the clinical pregnancy rate of 57.7% (30/52), including 19 singletons and 11 twins, and the rates of implantation and miscarriage were 38.7% (41/106) and 3.33% (1/30). Up to the present time, there have been 20 healthy newborns, including 12 boys and 8 girls, and another 13 ongoing pregnancies. No birth defects have been found so far. CONCLUSION: Desirable clinical outcomes can be obtained from ICSI cycles with frozen-thawed testicular sperm, and testicular sperm cryopreservation is an effective method of fertility preservation for azoospermia males.

[Sex therapy is effective for erectile dysfunction].

OBJECTIVE: To evaluate the sex therapy for erectile dysfunction (ED). METHODS: We recommended the sex therapy to ED patients and their partners (11 couples in all) in the outpatient department. Of the total number of volunteers, 2 males were accompanied by ejaculation disorder, another 2 with hyposexuality, and 1 female had vaginismus. The effect of the therapy was assessed and the problems with it analyzed by interviews with the subjects and the results of International Index of Erectile Function (IIEF) before and after the treatment. RESULTS: Of the 11 pairs of volunteers, 5 quitted halfway and 1 discontinued at the therapists' decision. The 5 couples who accomplished the whole therapy felt more satisfied with their sexual life and general relationship, with improved scores on all the items of IIEF, particularly on erectile function (EF), with the only exception of sexual desire (SD). CONCLUSION: The sex therapy is effective not only for ED but also for other accompanying sexual dysfunctions, the sexual dysfunctions of the patients' partners and the improvement of the general relationship of the couples.

[Factors affecting clinical application of sex therapy for erectile dysfunction].

OBJECTIVE: To discuss the factors that affect the clinical application of sex therapy for erectile dysfunction (ED). METHODS: Urological researchers recommended free sex therapy to ED patients and their partners in the outpatient department and studied the factors affecting the patients of Medicaid their partnersology, acceptance of sex therapy by interview and observation. RESULTS: Many patients refused sex therapy. Only 11 pairs of volunteers underwent it, of whom 5 pairs gave up halfway, 1 pair were stopped by the therapist due to the breakup of their marriage, and merely 5 pairs accomplished the whole course. Among the 5 pairs of quitters, 2 pairs thought of their problem as organic and turned to drug therapy, 1 pair withdrew because the patient's girlfriend broke up with him, 1 pair gave up because they lived in another city too far away from the clinic, and the other pair discontinued because they could not spare the time from their work. CONCLUSIONS: Many factors affect the clinical application of sex therapy for ED in China. Apart from the shortage of qualified professional sex therapists, some factors from the patients and their partners are at work, such as stress of work, lack of time, home location, education background, relationship between the patient and his partner, attitude to sex therapy, and so on.

[Diagnosis and differential diagnosis value of ultrasound in epididymal mass].

OBJECTIVE: To elevate the diagnosis and differential diagnosis levels of epididymal mass by sonography. METHODS: This was a retrospective study of 179 cases of epididymal mass treated by surgery in our hospital between 1990 and 2005. The analysis was focused on pathological and sonographic features. RESULTS: 179 patients with mean age of 51.4 +/- 14.7 were enrolled. The epididymal mass was classified into four groups: epididymal cyst (n = 98), nonspecific epididymitis (n = 27), tuberculous epididymitis (n = 33) , and epididymal tumor (n = 21). Epididymal cyst could be easily diagnosed by ultrasound, the diagnostic rate was 93.8%, but nonspecific epididymitis and tuberculous epididymitis were hard to differentiate, complicating with multiple organs lesions may distinguish tuberculous from nonspecific epididymitis. Tuberculous epididymitis could be easily diagnosed when cold abscess, calcification and sinus tract emerged. The majority epididymal tumors were benign, and malignant cases were rarely seen. Patient's history, physical examination and sonographic features were all essential to make a right diagnosis. CONCLUSION: Ultrasound features may be helpful to the differential diagnosis of epididymal mass and ultrasound should be the first choice of image detection in epididymal lesions.

[The value of dynamic color duplex scanning in the diagnosis of vascular erectile dysfunction].

OBJECTIVE: To evaluate deep penile arterial flow after an intracavernosal injection with prostaglandin E1 in patients with erectile dysfunction (ED). METHODS: 527 patients with ED were evaluated using Color Doppler Ultrasonography. Diagnostic tests were undertaken after an intracavernosal injection with 20 microg prostaglandin El. The peak systolic velocity (PSV), end diastolic velocity (EDV) and resistive index (RI) were analysed. RESULTS: There were 112 patients (26.99%) with nonvasculogenic ED, 207 patients (49.88%) with arteriogenic ED, 144 patients (34.70%)with venogenic ED, 64 patients (15.42%)with mixed ED. CONCLUSION: The Color Doppler Ultrasonography technique allows accurate location and evaluation of deep penile arteries. Vascular pathology may be differentiated after an intracavernosal injection with a vasomotor agent. Recognising the pathological pattern assists in choosing the best method of treatment.

[Aildenafil citrate: a new potent and highly selective phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction].

OBJECTIVE: To evaluate the efficacy and safety of aildenafil citrate, an oral phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction. METHODS: Integrated analyses were made of 8-week, randomized, double-blind, placebo-controlled phase 2 clinical trials involving 250 men with mild-to-severe erectile dysfunction of various etiologies who received aildenafil citrate 30 or 60 mg (n = 167) or placebo (n = 83). RESULTS: The statistic results of International Index of Erectile Function, Patient Sexual Encounter Profile (SEP) diaries and Global Assessment Question (GAQ) were significantly higher in the aildenafil citrate patients than in the placebo controls. The main drug-related adverse events were flushing, headache, dizziness and naupathia, which were mild and could be self-relieved. CONCLUSION: The aildenafil citrate therapy significantly ameliorated erectile function and was well tolerated by a wide range of patients with erectile dysfunction.

[Effects of sildenafil on erectile dysfunction in the aged men with diabetes].

OBJECTIVE: To evaluate the efficacy and safety of sildenafil on erectile dysfunction in the aged men with diabetes. METHODS: One hundred and ten patients aged 55 years old above with type I or II diabetes and a minimum 3-month history of ED were studied. Patients were instructed to take one dose of their treatment orally at any time before anticipated sexual activity. Changes from baseline in mean scores on the erectile function domain of the International index of Erectile Function and changes from baseline in the proportion of "yes" responses to question 2, and 3, of the Sexual Encounter Profile were coprimary outcome measures. RESULTS: Treatment with sildenafil significantly improved all primary efficacy variables. CONCLUSION: Sildenafil therapy significantly enhanced erectile function and was well tolerated by men with diabetes and ED.

[Long-term efficacy of TRUS-guided transperineal needle aspiration and irrigation on persistent hematospermia].

OBJECTIVE: To evaluate the long-term efficacy of transrectal ultrasonography (TRUS)-guided transperineal needle aspiration and irrigation for persistent hematospermia. METHODS: Included in the study were 12 patients with persistent hematospermia, aged (36.4 +/- 10.8) years, and with a course of the disease of (13.9 +/- 6.4) months. After the expressed prostatic secretion (EPS) by prostatic massage cultured, the patients received TRUS-guided transperineal needle aspiration for seminal vesicle fluid (SVF) for bacteriological examination. For the EPS positive patients, antibiotics were selected according to the drug sensitivity assay and injected into the abnormal seminal vesicle (SV) via TRUS-guided transperineal needle puncture. The treatment was repeated one month later for those still with hematospermia. The patients were followed up every three months. RESULTS: Abnormal images were found in the SV and/or ejaculatory duct in 9 cases, including SV and/or ejaculatory duct dilation, SV wall thickening, calcification or calculi of SV, and müllerian duct cyst. SVF cultures were positive in 7 cases, including 4 cases of methicillin-resistant Staphylococcus aurous (MRSA), 1 case of methicillin-resistant coagulase-negative staphylococcus (MRCNS), 1 case of E. Coli, and 1 case of Proteus mirabili. All the patients were treated by TRUS-guided transperineal injection of certain antibiotics into SV. Ten of them were followed up for (31.4 +/- 5.7) months. Hematospermia disappeared in 3 cases and relapsed at least once in the other 7. The last follow-up showed hematospermia recurrence in 2 cases. CONCLUSION: TRUS-guided transperineal irrigation of antibiotics into SV is effective to a certain extent for persistent hematospermia.

[Effects of food and alcohol on the pharmacokinetics of vardenafil].

There is a close relationship between sexual activity and meals or alcohol consumption. It is of great clinical significance for clinicians to understand the effects of food and alcohol on the pharmacokinetics of phosphodiesterase-5 inhibitor vardenafil so as to give correct instructions to patients. Although a high-fat ( > 55% fat calories) meal modestly reduces C(max) by 18% and prolongs t(max) of vardenafil by approximately 1 hour, no significant effects of a typical moderate-fat meal (30% fat calories) on vardenafil pharmacokinetics were observed in a study carried out in 25 healthy adult males. So the adjustment of vardenafil dosage is not warranted based on a wide therapeutic index and the efficacy observed with vardenafil in Phase III studies, which need not be restricted with respect to food. In another study, the pharmacokinetics and safety profile of vardenafil were not affected if it was taken together with 0.5 g/kg ethanol. The above characteristics of vardenafil make the administration more convenient for patients.

[Etiology and management of persistent hematospermia: a pilot study].

OBJECTIVES: To study the etiology of persistent hematospermia and to evaluate the efficacy of transrectal ultrasonography (TRUS)-guided transperineal needle aspiration and irrigation for diagnosis and treatment of persistent hematospermia. METHODS: Twelve patients were included in the study, with a mean age of (36.4 +/- 10.8) years old, and a mean duration of the disease of (13.9 +/- 6.4) months. After the expressed prostatic secretion (EPS) by prostatic massage was cultured, patients with recurrent hematospermia received TRUS-guided transperineal needle aspiration for seminal vesicle fluid (SVF), which was sent for bacteriological and cytological examination. If the EPS culture were positive, certain antibiotics according to the drug sensitivity assay were injected into the abnormal seminal vesicle(s) via TRUS-guided transperineal needle puncture. The treatment would be repeated one month later if the patients still had hematospermia. The patients were followed up every three months. RESULTS: Abnormal images were found in left seminal vesicle (SV) in 4 cases, right in 3 cases, bilateral in 2 cases, and no abnormal findings in 3 cases. The abnormal findings included: 7 cases of SV and/or ejaculatory duct dilation, 3 cases of thickening SV wall, 3 cases of calcification or calculi of SV, and 1 case of Müllerian duct cyst. SVF cultures were positive in 7 cases: methicillin-resistant Staphylococcus aureus (MRSA) 4 cases, methicillin-resistant coagulase-negative Staphylococcus (MRCNS), E. Coli, Proteus mirabilis 1 case, respectively. In five of these 7 cases, bacteriological cultures of SVF and EPS showed the same results. All patients were treated by TRUS-guided transperineal injection of certain antibiotics into SV. Seven cases were injected once, 5 cases twice. The mean follow-up period of 10 patients was (16.7 +/- 5.9) months. Hematospermia disappeared in 6 cases. CONCLUSIONS: SV infection of bacteria, especially infection of the drug resistant strains was one of the main causes of persistent hematospermia. The difficulties in treatment of persistent hematospermia were due to infection of drug resistant bacteria, calcification or calculi of SV, obstruction of ejaculatory duct. TRUS-guided transperineal aspiration of SVF was helpful to the etiologic diagnosis of persistent hematospermia.

[Physicians' knowledge and attitude to erectile dysfunction].

OBJECTIVES: The physicians knowledge and attitude to erectile dysfunction (ED) is very important to the diagnosis and management of this disease. We investigated the physicians and practitioners knowledge of ED, attitude to ED, and if they actively find the underlying ED patients. METHODS: Three hundreds and one physicians and practitioners in Beijing completed a questionnaire. The subjects included urologists, cardiologists, endocrinologists, surgeons, orthopaedicians and community practitioners. RESULTS: The definition of ED was well known by most subjects (83.4%). Many agreed that ED was a common condition in the aging men (85.0%), and it was an important health problem (78.7%) and it was the local signs of certain systemic diseases (89.7%). The most common risk factors of ED enumerated by the physicians were diabetes (45.5%), hypertension (12.6%) and coronary artery diseases (12.0%). 45.5% physicians met the patients who initiated questions about ED. 32.6% physicians would discuss ED with the patients if the patients initiate questions about ED. 95.0% non-urological physicians would refer the ED patients to urologists or andrologists. 43.5% of all the physicians never asked their patients about erectile function, this proportions in the subgroups of urologists, non-urological physicians and community practitioners were 7.2%, 55.3% and 60.5% respectively (P < 0.01). The most common reasons for the physicians not to initiate the inquiries about ED was "the patients would not have ED if they didnt complain about it" (42.2%), "there was no ED patients in my specialty" (20.9%), "diagnosis and treatment of ED was not my business" (17.3%), "have no time" (15.6%), "feel embarrassed" (13.6%). CONCLUSIONS: Most physicians regarded ED as an important health problem and a common condition in aging men, but they didnt take an active attitude to ED in their clinical practice.