Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US.

The efficacy and safety of tadalafil, dosed once a day for the treatment of erectile dysfunction, was assessed in a randomized, double-blind, placebo-controlled, parallel-design study at 15 US centers. Following a 4-week treatment-free run-in period, patients (>or=18 years of age) were randomly assigned to 24 weeks treatment with tadalafil 2.5 mg, tadalafil 5 mg or placebo. Primary efficacy endpoints were change at 24 weeks in International Index of Erectile Function Erectile Function (EF) Domain score and mean per-patient percentage 'yes' responses to Sexual Encounter Profile diary questions 2 and 3. Tadalafil significantly improved erectile function compared with placebo for all three co-primary efficacy endpoints. Few patients discontinued because of adverse events (2.1%, placebo; 6.3%, tadalafil 2.5 mg; 4.1%, tadalafil 5 mg). Common treatment-emergent adverse events (>or=5%) were nasopharyngitis, influenza, viral gastroenteritis and back pain. Tadalafil 2.5 mg and 5 mg, dosed once a day for 24 weeks, was well tolerated and significantly improved erectile function.

Cryptorchidism in newborns with gastroschisis and omphalocele.

A retrospective study was undertaken to determine if there exists an association between cryptorchidism and the intra-abdominal wall defects of gastroschisis and omphalocele. The records of 25 newborn male infants (13 with omphalocele, 12 with gastroschisis) were examined. In this sample there was no statistically significant association between these defects and cryptorchidism in either the premature or the full-term infants, when compared with a healthy population. Further clinical studies with larger numbers of patients are recommended.

Primary mediastinal germ cell tumors. Histologic patterns of treatment failures at autopsy.

Twenty-five patients presented with primary mediastinal germ cell tumors at Roswell Park Memorial Institute between 1959 and 1984. All patients were treated by surgery and chemotherapy with or without radiotherapy. Four patients are still alive, and 21 patients died of mediastinal germ cell tumor and its sequelae. Two patients were found to have testicular scars and were dropped from the study. Nongerm cell malignant transformation of a teratoma occurred in five of the remaining 17 patients (29%), resulting in three adenocarcinomas and two sarcomas. Another patient developed leukemia. Metastatic disease most commonly involved the lungs, mediastinal lymph nodes, liver, bone, retroperitoneum, and heart. Respiratory failure was the cause of death in 12 patients. Of the possible mechanisms of germ cell transformation into malignant nongerm cell tumors discussed, this study suggests that chemotherapy alone is unlikely to induce stem cell differentiation. The presence of mature, differentiated teratoma within the primary lesion may be indicative of a poorer prognosis.

Giant hydronephrosis presenting as unilateral iliofemoral vein thrombosis.

We report a case of left iliofemoral vein thrombosis with extension to the inferior vena cava associated with giant right hydronephrosis secondary to ureteropelvic junction obstruction. Surgery revealed marked infrarenal vena caval compression and deviation to the left side caused by the dilated right renal pelvis, with resultant kinking of the origin of the left iliac vein. It is postulated that the reduction in blood flow caused by this compression and distortion predisposed this patient to venous thrombosis.

Renal malposition in patients with omphalocele.

We describe a boy with a history of omphalocele who presented with gross hematuria. Subsequent evaluation revealed a cephalad right kidney malposition and the hematuria was of lower tract origin. To investigate the frequency of this radiographic finding the medical records of 15 patients with omphalocele who presented between 1979 and 1985 were reviewed. Studies of the urinary tract were performed after omphalocele closure. Of 7 cases (46 per cent) with abnormal cephalad renal displacement the kidney was on the right side only in 3 and it was bilateral in 4. The omphalocele contents consisted of gastrointestinal tract only in 9 patients, and liver and gastrointestinal tract in 6. All 6 patients with omphaloceles that included the liver had cephalad renal displacement. One patient with small bowel alone in the omphalocele had right kidney displacement. Clinicians should be aware of this variation to avoid confusion and further unnecessary evaluation.