Microwave thermotherapy for benign prostatic hyperplasia with the Dornier Urowave: results of a randomized, double-blind, multicenter, sham-controlled trial.

OBJECTIVES: To study the efficacy and safety of a new transurethral microwave thermotherapy device (the Urowave) in the treatment of men with clinical benign prostatic hyperplasia (BPH) in a randomized, double-blind, sham-controlled trial. METHODS: A total of 220 patients (mean age 66.2 years) with clinical BPH, an American Urological Association symptom index (AUA SI) of 13 points or more, and a peak flow rate of 12 mL/s or less were enrolled and randomized 2:1 for active versus sham treatment. All treatments were conducted as an outpatient procedure under local anesthesia, with oral sedation and analgesia only. Patients were followed up at 1 week and 1, 3, and 6 months after treatment. RESULTS: The treatments were well tolerated, and no patient received general or spinal anesthesia. The AUA SI dropped from 23.6 to 12.7 points at 6 months (P < 0.05) in the active group and from 23.9 to 18.0 points in the sham-treated group (P < 0.05, between-group difference). Statistically significant improvements were also noted for peak flow rate (7.7 to 10.7 mL/s at 6 months for active treatment, 8.1 to 9.8 mL/s for sham treatment, P < 0.05, between-group difference) and for average flow rate. A decrease in AUA SI of more than 30% was achieved in 72% versus 38% of patients (active versus sham treatment, respectively) and more than 50% in 50% versus 19% of patients. In general, active Urowave-treated patients perceived "a lot" of improvement, whereas sham-treated patients perceived "a little" to "some" improvement. More of the actively treated patients had dysuria and urgency after treatment, and ejaculatory dysfunction (e.g., hematospermia) was more common in actively treated patients as well. Secondary urinary retention after removal of the catheter occurred in 8 patients (5.4%). CONCLUSIONS: The Dornier Urowave transurethral microwave thermotherapy device for treatment of clinical BPH is effective in decreasing symptoms and bother and improving quality of life and flow rate and is superior to sham treatment. Patients perceive a great deal of improvement, independent of their baseline symptom severity. Adverse events are in general transient and mild in nature. Extended follow-up is necessary to document long-term durability of improvements.

Development of an organ culture experimental system to investigate collagen synthesis in corpora cavernosa.

An organ culture model of rabbit corpus cavernosum has been developed to investigate fibrillar collagen synthesis in intact organ. Rabbit peni were removed en bloc, the corpora cavernosa were dissected, sliced into 5 mm pieces and incubated in culture media up to 24 h. Tissue viability and metabolic and functional integrity were assessed by (a) lactate dehydrogenase (LDH) release, (b) protein synthesis, and (c) ability to respond to exogenously added cytokines. Explants, maintained for 24 h in organ culture, exhibited minimal LDH release and maintained functional integrity determined from protein synthesis and ability to synthesize collagen in response to TGF-beta(1). These data suggest that explants of rabbit corpus cavernosum in organ culture represent a viable model to investigate connective tissue protein biosynthesis in vitro.

Outcome profiles of locoregional disease after radical prostatectomy and radiotherapy.

The purpose of the present study was to examine the outcome profiles of a large number of patients with locally advanced adenocarcinoma of the prostate following radical perineal prostatectomy (RPP) for clinically organ-confined disease. Of 1662 men who underwent RPP performed by a single surgeon between January 1972 and January 1999, 692 patients (41.6%) aged a median of 66.1 years were found to have extracapsular disease on pathological evaluation. The extent of disease was categorized as either specimen-confined (n = 355) or margin-positive (n = 337). The histological grade of the cancer was characterized using the Gleason score. Time to biochemical failure, defined as a prostate-specific antigen (PSA) level of > or = 0.5 ng/ml, and cancer-associated survival were the end points of our outcome analysis using the Kaplan-Meier product-limit method. The median time to cancer-associated death for patients with specimen-confined and margin-positive disease was 18.5 and 13.1 years, respectively. After 5 years, 37% and 54% of the patients with specimen-confined and margin-positive disease, respectively, had PSA failure. Prostate cancer patients with a Gleason score of 5-6, 7, and 8-10 experienced a median time to cancer-associated death of 19.9, 19.2, and 10.5 years, respectively. A subset of patients undergoing adjunctive radiation therapy (XRT) relapsed biochemically after a median period of approximately 18 months. RPP provides a substantial disease-control benefit in patients with specimen-confined cancer. The time to biochemical failure and the time to cancer-associated death are significantly influenced by the biology of the underlying disease, necessitating long-term follow-up in the outcome analysis of any modality of treatment for prostate cancer. A benefit of early adjunctive XRT for local failure remains to be determined.