A randomised comparison of bicalutamide ('Casodex') 150 mg versus placebo as immediate therapy either alone or as adjuvant to standard care for early non-metastatic prostate cancer. First report from the Scandinavian Prostatic Cancer Group Study No. 6.

OBJECTIVES: To assess the efficacy and tolerability of bicalutamide 150 mg ('Casodex'(1)) as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with early (T1b-T4, any N, M0) prostate cancer. METHODS: This randomised, double-blind study was conducted in the Nordic countries as part of the 'Casodex' Early Prostate Cancer programme. Patients received bicalutamide 150 mg (n=607) or placebo (n=611) in addition to standard care. RESULTS: More than 80% of patients had not received therapy of primary curative intent. Median follow-up in both groups was 3 years. Median exposure to study treatment in the bicalutamide and standard care alone groups was 2.5 and 2.3 years, respectively. Bicalutamide reduced the risk of objective disease progression by 57% compared with standard care alone (HR 0.43; 95% CI 0.34, 0.55; p<<0.0001). Survival data were immature (11.4% deaths) with no difference between the two treatment groups. CONCLUSIONS: Bicalutamide 150 mg as immediate therapy, either alone or as adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with early prostate cancer. The trial is ongoing to assess whether the reduction in risk of objective progression translates into an overall survival benefit.

Measurement of sound emission by endoscopic lithotripters: an in vitro study and theoretical estimation of risk of hearing loss in a fetus.

BACKGROUND: There is concern about applying intraureteral lithotripsy in pregnant patients, as the sound created by the equipment may damage fetal hearing. MATERIALS AND METHODS: The sound intensities produced by electrokinetic, pneumomechanic, holmium laser, ultrasound, and electrohydraulic intraluminal lithotripters were measured in an in vitro model. RESULTS: The purely mechanical modalities (electrokinetic and pneumomechanic) generated lower peak pressures than the other devices. Theoretical calculations were performed based on the fact that in vivo, the sound path and the fetal middle ear cavities are filled with fluid. Calculated pressure levels that give displacement amplitudes of the tympanic membrane, the ossicles, and the basilar membrane comparable to hearing loss risk criteria for airborne impulsive noise are greater than measured for all of the lithotripters. The fluid-filled middle ear thus seems to give the fetus protection against sound. The fluid also improves the symmetry of the cochlea structure, reducing the influence of direct bone transmission. CONCLUSIONS: The peak pressure of the sound emitted by lithotripsy in the ureter during pregnancy is unlikely to be harmful to fetal hearing. Other risk factors, such as the form of the sound waves and the pulse duration were not evaluated. The theoretical assessments are simplified, and one should be careful about drawing conclusions from theoretical considerations and calculations alone.

Bladder and sexual dysfunction after mesorectal excision for rectal cancer.

BACKGROUND: Urinary and sexual dysfunction are recognized complications of rectal excision for cancer. The aim of this study was to examine the frequency of such complications after mesorectal excision, shortly after this method was introduced. METHODS: Spontaneous flowmetry, residual volume of urine measurement and urodynamic examination, including cystometry and simultaneous detrusor pressure and urinary flow recording, was carried out before and 3 months after curative rectal excision. Urinary symptoms and sexual function were evaluated by means of questionnaires before and after operation. Each patient served as his or her own control. RESULTS: Forty-nine consecutive patients, 39 of whom had a total mesorectal excision (TME) and ten a partial mesorectal excision, were examined before surgery and 35 again after operation. In two patients, a weak detrusor was detected before operation. Two patients developed signs of bladder denervation after operation. Transitory moderate urinary incontinence appeared in four other women. Six of 24 men reported some reduction in erectile function and one became impotent. Two men reported retrograde ejaculation. All the complications were seen in the TME group. CONCLUSION: Mesorectal excision for rectal cancer resulted in a low frequency of serious bladder and sexual dysfunction.

[Visual laser coagulation for benign prostatic hyperplasia. Preliminary experiences]. / Visuell laserkoagulasjon for benign prostatahyperplasi. Preliminaere erfaringer.

A total of 28 patients with symptomatic bladder outlet obstruction due to benign prostatic hyperplasia were treated by visual laser coagulation (VLAP) performed with the Myriadlase sidefiring neodymium: YAG laser fibre at 40 Watts power. The treatment was performed as an outpatient procedure using intraurethral gel anaesthesia and light intravenous sedation and analgesia. Prostatic volume was 32 g (18-90 g), and 650 Joule per gram prostatic tissue (516-1000 J/g) was administered. The patients were evaluated at mean 9.2 weeks. The mean operative time was 34 minutes. The procedure was very gentle, all patients tolerated it well and there was no bleeding. Most patients experienced some dysuria for three to four weeks after the procedure, two had severe symptoms. Two patients remained in retention and required transurethral resection. The rest expressed subjective satisfaction with the results. Peak urinary flow increased from mean 9.0 ml/sec preoperatively to 15.4 ml/sec; a mean increase of 78%. One patient developed clinical urinary tract infection. There were no other complications of clinical significance.