A 6-month study of the efficacy and safety of tadalafil in the treatment of erectile dysfunction: a randomised, double-blind, parallel-group, placebo-controlled study in Australian men.

The efficacy and safety of tadalafil for the treatment of erectile dysfunction (ED) were assessed in a 6-month, randomised, double-blind, placebo-controlled study. Australian men with mild, moderate or severe ED of organic, psychogenic or mixed aetiology were randomised to tadalafil 20 mg as needed (n = 93) or placebo (n = 47). Efficacy assessments included the international index of erectile function (IIEF) and the sexual encounter profile (SEP) diary. Tadalafil significantly improved erectile function compared with placebo (p < 0.001, all measures). At the end of the study, the mean per-patient proportion of successful sexual intercourse attempts (SEP question three) was 73.5% for patients treated with tadalafil and 26.8% for placebo-treated patients. Improved erections were reported by 78% of tadalafil-treated patients compared to 12.8% of placebo-treated patients. The most common treatment-emergent adverse events--headache and dyspepsia--were generally mild or moderate. Tadalafil was effective and well tolerated in Australian men with mild to severe ED.

Use, misuse and abuse of androgens. The Endocrine Society of Australia consensus guidelines for androgen prescribing.

Androgen replacement therapy (ART) is usually life-long, and should only be started after androgen deficiency has been proven by hormone assays. The therapeutic goal is to maintain physiological testosterone levels. Testosterone rather than synthetic androgens should be used. Oral 17 alpha-alkylated androgens are hepatotoxic and should not be used for ART. There is no indication for androgen therapy in male infertility. Although androgen deficiency is an uncommon cause of erectile dysfunction, all men presenting with erectile dysfunction should be evaluated for androgen deficiency. If androgen deficiency is confirmed, investigation for the underlying pathological cause is required. Contraindications to androgen therapy are prostate and breast cancer. Precautions include using lower starting doses for older men and induction of puberty. Intramuscular injections should be avoided in men with bleeding disorders. Androgen-sensitive epilepsy, migraine, sleep apnoea, polycythaemia or fluid overload need to be considered. Competitive athletes should be warned about the risks of disqualification. ART should be initiated with intramuscular injections of testosterone esters, 250 mg every two weeks [corrected]. Maintenance requires tailoring treatment modality to the patient's convenience. Modalities currently available include testosterone injections, implants, or capsules. Choice depends on convenience, cost, availability and familiarity. There is no convincing evidence that, in the absence of proven androgen deficiency, androgen therapy is effective and safe for older men per se, in men with chronic non-gonadal disease, or for treatment of non-specific symptoms. Until further evidence is available, such treatment cannot be recommended.

The impact of diabetes on the lower limb. Give diabetes an inch and it will take a foot.

The author describes the role of vascular disease, neuropathy, trauma, and impaired inflammatory response and wound healing in the pathogenesis of foot disease. He discusses the general principles of management. Important management issues are highlighted including the need to look at the feet, to teach the diabetic how to care for them and how to get appropriate advice.

Deaths associated with diabetic ketoacidosis and hyperosmolar coma. 1973-1988.

We assessed the possibility of improvements in the management of the potentially fatal acute hyperglycaemic complications of diabetes by a review of all deaths in patients who presented to the Alfred Hospital, Melbourne, with diabetic ketoacidosis or hyperosmolar coma during the 16 years, 1973-1988. All late deaths of patients during hospitalization were included in the mortality data. In the 610 episodes of diabetic ketoacidosis (pH, 7.30 or lower) or hyperosmolar coma (osmolality, 350 mOsmol/kg or greater), only one death occurred as a result of the acute metabolic disturbance--in a patient who had suffered a cardiac arrest before admission to hospital. The over-all mortality rate was 6.2% (38 deaths). The mortality rate was 4.9% (26 deaths) for 528 episodes of diabetic ketoacidosis and 14.6% (12 deaths) for 82 episodes of hyperosmolar coma. Patients with diabetic ketoacidosis who died were older than were those who survived (64 +/- 13 years compared with 40 +/- 21 years, respectively; P less than 0.001). Mortality in patients with hyperosmolar coma did not relate to age, initial blood-glucose level or osmolality. Twelve deaths resulted from bacterial pneumonia and two deaths resulted from aspiration pneumonia. Other major causes of death were mesenteric and iliac thromboses (six cases), myocardial infarction (eight cases) and cerebral haemorrhage (two cases). Of the 26 deaths that were associated with diabetic ketoacidosis, only two deaths--as a result of aspiration pneumonia and bowel infarction, respectively--were assessed as potentially avoidable after the patient's admission to hospital. Eight of the 12 hyperosmolar-coma-associated deaths occurred in newly recognized diabetic patients in whom there were avoidable delays in diagnosis. We conclude that further improvements in outcome will be difficult to achieve, but that efforts should be directed towards the earlier diagnosis of diabetes and the earlier recognition and treatment of associated acute pulmonary and vascular complications.

Assisted fertility in complete paraplegia: case report.

A 34-year-old paraplegic man with a spinal cord injury complete below the 6th thoracic segment fathered a child by artificial insemination using semen obtained by electro-ejaculation. A long fertility programme culminated in the delivery of a healthy male child weighing 3665 g in April 1987. Guidelines for a comprehensive fertility programme are discussed briefly.

Experience with the Jonas penile prosthesis in the treatment of impotence.

The penile prosthesis has become established as a mode of therapy for organic and chronic psychogenic impotence. The Jonas type of penile prosthesis has been implanted into 10 patients and has achieved both functional success and excellent acceptance by the partner. Mechanical and pathological complications have a very low incidence. This penile prosthesis should be made available to carefully selected impotent patients who are deemed psychologically suitable candidates and in whom medical treatment has failed or is not indicated. It represents an important advance in the treatment of the male with erectile impotence.

Factors affecting the variability of semen analysis results in infertile men.

UNLABELLED: Infertile men who had 3 or more semen analyses performed in one laboratory were placed in 2 groups (I) oligozoospermic group (n = 106), mean sperm concentration between 1 and 20 million/ml (II) asthenozoospermic group (n = 71), mean sperm concentration greater than 20 million/ml, and mean motility less than 60%. With increasing durations of abstinence from ejaculation before the tests there were significant increases in semen volume and sperm concentration. Semen volume increased over the first 4 days to a similar extent in both groups. Sperm concentrations increased over 15 days, but the effect of abstinence was much greater in the asthenozoospermic group than in the oligozoospermic group (14% compared with 1.4% of the within subject variation). Significant changes in results accompanied repeated testing, notably rises in sperm concentration and motility. Sperm motility was lower in winter and higher in summer in both groups and also, but to a lesser extent, in artificial insemination donors who collected semen in the laboratory. CONCLUSIONS: duration of abstinence, the elapse of time and seasonal temperature changes affect semen analysis results, and therefore controls for these variables must be incorporated in any therapeutic trial for male infertility. On the other hand, they only account for a small proportion of the total variability and thus routine correction of results would not greatly improve the value of semen analysis in the prediction of fertility. Furthermore because differences in the duration of abstinence have only a small effect on sperm concentration in oligozoospermic men, restricting sexual intercourse to the time of ovulation may not enhance fertility.

Artificial insemination with donor semen. Review of 252 patients.

The total three year experience with frozen sperm used with artificial insemination by donor (AID) at Prince Henry's Hospital. Melbourne is presented. During this period, 252 women have had one or more cycles of treatment, with life table pregnancy rates of 47.6 +/- 3.55 after six cycles and 62.8 +/- 4.00 after 12 cycles. There was no difference in outcome between patients with azoospermic or oligospermic husbands, but patients requiring ovulatory stimulants or who have tubal abnormalities have a much lower success rate.

Bromocriptine in treatment of acromegaly: Australian experience.

Ten acromegalics, 6 females and 4 males, aged 24 to 75, have been treated with bromocriptine (CB). Six patients responded clinically to CB: two subsequently escaped control, three have been treated continuously for from 14 to 32 months, and one withdrew because of side effects. Four patients failed to respond: one at 60 mg/day, two at only 20 mg/day and the fourth at 5 mg/day when treatment was ceased because of side effects. Three patients had severe illnesses during treatment and four patients were troubled by side effects. CB is useful in the treatment of acromegaly where other modalities are unsuitable.