Efficacy and tolerability of lodenafil carbonate for oral therapy in erectile dysfunction: a phase II clinical trial.

INTRODUCTION: Oral treatment with phosphodiesterase type 5 inhibitor (PDE5) is considered the first-line treatment for patients with erectile dysfunction (ED). Lodenafil carbonate (LC) is a novel PDE5. AIM: This is a phase II, prospective, randomized, double-blind, and placebo controlled clinical trial of LC. MAIN OUTCOME MEASURES: Efficacy end points were International Index of Sexual Function (IIEF) erectile domain, IIEF questions 3 and 4, and Sexual Encounter Profile (SEP) questions 2 and 3, before and after the use of LC or placebo. METHODS: Seventy-two men older than 18 years, with ED for at least 6 months with stable sexual relationship were enrolled. Patients were randomized to placebo or LC 80 mg, 40 mg, or 20 mg and followed for 4 weeks. RESULTS: IIEF erectile domain scores before and after the use of medications were (mean +/- standard deviation [SD]): placebo: 11.9 +/- 3.4 and 12.6 +/- 5.5; LC 20 mg: 15.8 +/- 4.1 and 18.9 +/- 6.6; LC 40 mg: 11.9 +/- 4.4 and 15.4 +/- 8.1; LC 80 mg: 14.2 +/- 4.7 and 22.8 +/- 6.0 (ANOVA P < 0.01). The SEP-2 scores before and after the use of medications were (Mean +/- SD): placebo: 71.0 +/- 33.1 and 51.2 +/- 43.1; LC 20 mg 70.3 +/- 34.2 and 75.5 +/- 31.5; LC 40 mg: 48.4 +/- 42.1 and 60.8 +/- 42.5; LC 80 mg: 68.6 +/- 33.5 and 89.6 +/- 26.0. The SEP-3 scores were: placebo 23.3 +/- 27.6 and 33.6 +/- 42.3; LC 20 mg: 32.3 +/- 38.9 and 51.2 +/- 41.7; LC 40 mg: 39.7 +/- 44.7 and 46.7 +/- 41.1; LC 80 mg* 17.2 +/- 29.5 and 74.3 +/- 36.4 (*P < 0.05 for difference to placebo). CONCLUSIONS: The drug was well tolerated. Adverse reactions were mild and self-limited and included headache, rhinitis, flushing, color visual disorders, and dyspepsia. This study showed that the dosage of 80 mg of LC was significantly more efficacious than placebo and well tolerated.

Is it worthwhile to operate on subclinical right varicocele in patients with grade II-III varicocele in the left testicle?

PURPOSE: To determine whether repair of subclinical varicoceles in the right testicle results in significant seminal improvement in patients with clinical left varicocele. METHODS: Patients were divided into two groups: Group I (unilateral varicocelectomy) and Group II (bilateral varicocelectomy-subclinical left varicocele). The mean sperm concentration before treatment was higher in Group I (21.01 +/- 19.1) compared to Group II (5.7 +/- 10.7) (p = 0.04). RESULTS: An increase in volume was detected in the left testicle of patients in Group I (17 +/- 7.9 vs. 22.81 +/- 8.2; p = 0.04) and in the right testicle of patients in Group II (18.4 +/- 6.2 vs. 22.3 +/- 6.5; p = 0.04). Although the mean postoperative sperm concentration in Group I increased slightly (25.7 +/- 22.8), the mean sperm concentration in Group II increased significantly (30.32 +/- 9.8; p = 0.03). Pregnancy rate was higher in Group II (66.7%) compared to Group I (33.3%). CONCLUSIONS: Even a small, subclinical unrepaired varicocele continues to have a detrimental effect on bilateral testis function in a patient with grade II-III left varicocele.

Relationship between the number of veins ligated in a varicocelectomy with testicular volume, hormonal levels and semen parameters outcome.

PURPOSE: Correlate semen analysis, hormones, and testicular volume with the number of veins ligated. METHODS: Patients were divided into three groups: Group 1 (< or = 5 veins), Group 2 (6-10 veins), and Group 3 (> 10 veins). We evaluated testicular volume, hormonal levels, sperm concentration, and motility before and after the surgical procedure. RESULTS: In Group 1, even though there was an improvement in both testicular volume and sperm concentration; testosterone levels and sperm motility did not improve with surgery. In Group 2, no changes were detected in the both testicular volumes, in sperm concentration, motility, and testosterone levels. In Group 3, an improvement was seen in the right testicle volume, testosterone levels, and sperm concentration. Follicle-stimulating hormone levels decreased following the surgical procedure in all groups. CONCLUSION: Patients with more than 10 ligated veins have better chances to improve sperm concentration. FSH levels decreased in all groups of patients.

Testicular growth, sperm concentration, percent motility, and pregnancy outcome after varicocelectomy based on testicular histology.

OBJECTIVE: To evaluate the outcome following surgery in two different patterns of testicular histology in patients with varicocele. DESIGN: Prospective study. SETTING: Academic medical center. PATIENT(S): Sixty patients underwent varicocelectomy and had a testicular histology diagnosis of germ-cell aplasia (group I, n = 28) or maturation arrest (group II, n = 32). INTERVENTION(S): Varicocelectomy. MAIN OUTCOME MEASURE(S): Preoperative hormone levels, testicular size, and sperm parameters. After varicocelectomy, variations in testicular size, semen parameters, and pregnancy rates were evaluated. RESULT(S): The mean volume of the right and left testicle was smaller in group I patients than in group II. In addition, the mean sperm concentration before treatment was lower in group I than in group II. The mean volume of the left and right testicle increased in group I after the intervention. The mean postoperative sperm concentration and motility in group II showed no increase, whereas the mean sperm concentration in group I did increase. The pregnancy rate was higher in group II (14/26, 53.8%) than in group I (4/16, 25%) (P=.02). CONCLUSION(S): Patients with germ-cell aplasia present a postoperative increase in testicular size but the pregnancy rate is higher in patients with maturation arrest following surgery.

Semen profile, testicular volume, and hormonal levels in infertile patients with varicoceles compared with fertile men with and without varicoceles.

OBJECTIVE: To assess semen analysis, testicular volume, and hormone levels in fertile and infertile patients with varicoceles and fertile men without varicoceles. DESIGN: Retrospective study. SETTING: Academic medical center. PATIENT(S): Patients were divided into three groups: fertile men with varicoceles (n = 79), infertile men with varicoceles (n = 71), and fertile men without varicoceles (n = 217). INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Levels of LH, FSH, and total T and testicular volume in fertile and infertile men with varicoceles and fertile controls without varicoceles. RESULT(S): LH (IU/L) and T (ng/dl) levels were not statistically different across the three groups. FSH levels were significantly higher in infertile men with varicoceles (7.8 +/- 7.6 IU/L) than in the fertile men with varicoceles (3.5 +/- 2.1 IU/L) or in fertile men without varicoceles (3.5 +/- 1.9 IU/L). The right testicle was smaller in infertile patients with varicoceles (18.7 +/- 8.3 cm(3)) than in fertile men with varicoceles (25.2 +/- 13 cm(3)) or in fertile men without varicoceles (24.9 +/- 10.7 cm(3)). In addition, the left testicle was smaller in infertile men with varioceles (17.6 +/- 8.9 cm(3)) than in fertile men with varicoceles (21.6 +/- 7.8 cm(3)) or in fertile men without varicoceles (23.4 +/- 8.3 cm(3)). Sperm concentration was lower in infertile men with varicoceles (33.7 +/- 23.3 x 10(6)/mL) than in fertile men with varicoceles (101.8 +/- 76.6 x 10(6)/mL) or in fertile men without varicoceles (111.8 +/- 74.2 x 10(6)/mL). In addition, sperm motility was lower in infertile men with varicoceles (37.2% +/- 23.9%) than in fertile men with varicoceles (53.9% +/- 17.4%) or fertile men without varicoceles (58.9% +/- 15.8%). CONCLUSION(S): Infertile patients with varicoceles have higher levels of FSH, smaller testes, and lower sperm concentration and motility compared with controls with or without varicoceles. No statistical differences were seen in the variables evaluated among the fertile men with incidental varicoceles detected at physical examination and those without varicoceles.