Gastroenterology-urology devices: reclassification of the penile rigidity implant. Food and Drug Administration, HHS. Final rule. (33/997)

The Food and Drug Administration (FDA) is reclassifying the penile rigidity implant from class III to class II when intended to provide penile rigidity in men diagnosed as having erectile dysfunction. The special control is the FDA guidance document entitled "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants." This action is taken on FDA's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.  (+info)

Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study. (34/997)

BACKGROUND: Radical prostatectomy and external beam radiotherapy are the two major therapeutic options for treating clinically localized prostate cancer. Because survival is often favorable regardless of therapy, treatment decisions may depend on other therapy-specific health outcomes. In this study, we compared the effects of two treatments on urinary, bowel, and sexual functions and on general health-related quality-of-life outcomes over a 2-year period following initial treatment. METHODS: A diverse cohort of patients aged 55-74 years who were newly diagnosed with clinically localized prostate cancer and received either radical prostatectomy (n = 1156) or external beam radiotherapy (n = 435) were included in this study. A propensity score was used to balance the two treatment groups because they differed in some baseline characteristics. This score was used in multivariable cross-sectional and longitudinal regression analyses comparing the treatment groups. All statistical tests were two-sided. RESULTS: Almost 2 years after treatment, men receiving radical prostatectomy were more likely than men receiving radiotherapy to be incontinent (9.6% versus 3.5%; P:<.001) and to have higher rates of impotence (79.6% versus 61.5%; P:<.001), although large, statistically significant declines in sexual function were observed in both treatment groups. In contrast, men receiving radiotherapy reported greater declines in bowel function than did men receiving radical prostatectomy. All of these differences remained after adjustments for propensity score. The treatment groups were similar in terms of general health-related quality of life. CONCLUSIONS: There are important differences in urinary, bowel, and sexual functions over 2 years after different treatments for clinically localized prostate cancer. In contrast to previous reports, these outcome differences reflect treatment delivered to a heterogeneous group of patients in diverse health care settings. These results provide comprehensive and representative information about long-term treatment complications to help guide and inform patients and clinicians about prostate cancer treatment decisions.  (+info)

Anatomical basis for impotence following haemorrhoid sclerotherapy. (35/997)

Impotence has been reported as a rare but important complication of sclerotherapy for haemorrhoids. The relationship between the anterior wall of the rectum and the periprostatic parasympathetic nerves responsible for penile erection was studied to investigate a potential anatomical explanation for this therapeutic complication. A tissue block containing the anal canal, rectum and prostate was removed from each of six male cadaveric subjects. The dimensions of the components of the rectal wall and the distance between the rectal lumen and parasympathetic nerves in the periprostatic plexus were measured in horizontal transverse histological sections of the tissue blocks at the level of the lower prostate gland (i.e. the correct level for sclerosant injection). The correct site of sclerosant in the submucosa was on average 0.6 mm (SD 0.3 mm) deep to the rectal mucosal surface and only 0.7 mm (SD 0.5 mm) in thickness. The nearest parasympathetic ganglion cells were a mean of only 8.1 mm (SD 2.0 mm) deep to the rectal lumen. The close proximity of the rectum to the periprostatic parasympathetic nerves defines an anatomical basis for impotence following sclerotherapy. This emphasises the need for all practitioners to be particularly careful when injecting in this area and for strict supervision of trainees.  (+info)

Thalassaemic men affected by erectile dysfunction treated with transurethral alprostadil: case report. (36/997)

The aim of this controlled clinical study, performed in a specialized institutional unit for thalassaemic men, was to consider the possibility of restoring erection in beta-thalassaemic patients with erectile dysfunction by administering E(1) prostaglandins (alprostadil) transurethrally. Four patients affected by beta-thalassaemia, aged between 32 and 52 years, and having an erectile dysfunction were included in the study. Each patient was given 500 microg alprostadil in the distal urethra. Response was evaluated by the erection assessment scale. The main outcome measures were: (i) the clinical study; (ii) FSH, LH, total and free testosterone plasma concentrations; and (iii) basal and dynamic Doppler sonography of cavernous arteries. The treatment produced a response of 3-4 on the erection assessment scale. Average minimum response time was 20 min, while average maximum response time was about 60 min. There was no evidence of significant side effects. Our hypothesis is that the delayed reaction was due to organ damage induced by iron load, causing a reduction or absence of elasticity in the interstitial tissue of the corpora cavernosa. Thus, we believe that treatment with alprostadil can be considered an effective, non-invasive therapy for thalassaemic patients with erectile dysfunction.  (+info)

Sildenafil: from the bench to the bedside. (37/997)

Erectile dysfunction affects a large segment of the male population, and in most cases impaired relaxation of the smooth muscle cells in the corpus cavernosum and the penile arteries is a factor. Sildenafil, a relatively specific vasodilator of the penile circulation, has revolutionized the treatment of impotence. This article describes the biochemistry of erection, outlines the problems that can lead to erectile dysfunction and explains how sildenafil acts to relieve these problems at the cellular and molecular level. Other aspects of therapy, such as potential side effects and absolute and relative contraindications, are also discussed.  (+info)

The effect of HCG on testicular androgen production in adult men with chronic renal failure. (38/997)

In sixteen male patients undergoing regular haemodialysis of peritoneal dialysis for chronic renal failure, the testosterone levels were studied before and after treatment with HCG. Testosterone values before (186 ng/100 ml) and after (456 ng/100 ml) HCG were significantly lower than those for normal healthy males. The mean plasma dihydrotestosterone (5alpha-DHT) value of 11.5 ng/100 ml for the treated patients was significantly lower than that of 64 ng/100 ml for the control patients. With HCG, increments in DHT were recorded in three patients, and definite increments in testosterone were observed in six patients. The percentage binding and combining affinity showed little change due to HCG stimulation. Achieving ejaculation was a serious problem for the patients in whom the lowest increases in testosterone and 5 alpha-DHT levels were observed after HCG stimulation. Low plasma testosterone values were also associated with a low mean area for Type-2 muscle fibres.  (+info)

Current concepts in erectile dysfunction. (39/997)

As the population ages, the prevalence of sexual dysfunction has steadily increased. Erectile dysfunction (ED) is defined as the consistent inability to obtain and/or maintain an erection sufficient for satisfactory sexual relations. Complete ED is defined as the absolute inability to participate in penetrative relations at any stage. Results from the Massachusetts Male Aging Study of 1300 men between the ages of 40 and 70 years show 52% of men--1 in 2--have some degree of ED; 5% of 40-year-olds and 25% of 75-year-olds have complete ED. Taking a detailed medical history and performing a thorough physical examination are essential for the safe and effective treatment of men with ED. This article reviews the physiology and pharmacology of ED. Although effective therapies are available, including surgery, external devices, and subcutaneous penile injections, many find those modalities unacceptable. The oral agent sildenafil is now widely used but not without concern about specific health risks as well as lifestyle issues. This article also reports clinical trial results for new oral agents that will soon offer new options for men who cannot use or are dissatisfied with other therapies.  (+info)

Access to innovative treatment of erectile dysfunction: clinical, economic, and quality-of-life considerations. (40/997)

While effective therapies exist for health conditions that diminish the quality of life, there remain hurdles in healthcare delivery that may limit access to such therapies for individuals who would benefit from them. Limited company resources coupled with double-digit increases in pharmaceutical costs--frequently designated as the "culprit" behind recent increases in medical expenditures--may not allow health plans to cover every effective drug in every clinical circumstance for every affected individual. Managed care companies currently employ several mechanisms to counter runaway pharmaceutical costs, such as excluding some drugs from coverage, imposing significant limitations, or requiring higher copayments through tiered pharmaceutical coverage structures. The trend toward greater patient contribution for indicated agents could well invoke cries of bias, in that a tiered copayment system may discriminate based on income and ability to pay. The practical inability within the healthcare community to compare healthcare interventions such as treatments for erectile dysfunction with those for asthma, hypertension, or other conditions prevents the optimal allocation of healthcare services.  (+info)