Biomedical subjects

Reginald Bruskewitz

Publications and source records attributed to Reginald Bruskewitz.

4 recordsLinked to original sources

PubMed2004

Sustained decrease in incidence of acute urinary retention and surgery with finasteride for 6 years in men with benign prostatic hyperplasia.

PURPOSE: We determined the effect of long-term treatment with finasteride on the incidence of acute urinary retention (AUR) and benign prostatic hyperplasia (BPH) related surgery in men with BPH. MATERIALS AND METHODS: The Proscar (Merck and Co., Inc., Whitehouse Station, New Jersey) Long-Term Efficacy and Safety Study (PLESS) was comprised of 3040 men with enlarged prostates, moderate to severe symptomatic BPH and no clinical evidence of prostate cancer. Patients were randomized to placebo or 5 mg finasteride daily for 4 years. Of the 3016 randomized patients with available efficacy data 62% completed the original 4-year study (1006 on finasteride and 891 on placebo) and 89% of these (908 from the original finasteride arm and 785 from the placebo arm) continued in a 2-year open extension on finasteride. Followup was attempted in discontinued patients. Complete 6-year outcomes data, including 6-year followup in 770 men who had discontinued treatment during years 1 to 6, were available for 2463 (82%) of the 3016 originally randomized patients. RESULTS: For patients on continuous finasteride treatment the decrease in incidence of AUR and/or BPH related surgery in the 4-year base study was sustained during the open extension. In patients who were switched from placebo to finasteride in the extension, the incidence of AUR and/or BPH related surgery was similar to that in the continuous finasteride arm. CONCLUSIONS: The 6-year data from PLESS confirmed and further extended the findings from the original 4-year trial, demonstrating that finasteride treatment led to a sustained decrease in the incidence of AUR and/or BPH related surgery in men with BPH and enlarged prostates.

Acute Disease↗

PubMed2004

Transurethral needle ablation versus transurethral resection of the prostate for the treatment of symptomatic benign prostatic hyperplasia: 5-year results of a prospective, randomized, multicenter clinical trial.

PURPOSE: We report the 5-year efficacy and safety of transurethral needle ablation of the prostate (TUNA) compared to transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 121 men 50 years or older with LUTS secondary to BPH a minimum of 3 months in duration were enrolled in this prospective, randomized clinical trial at 7 medical centers across the United States. Of the participants 65 (54%) were randomly selected to receive TUNA and 56 (46%) were selected to receive TURP. International Prostate Symptom Score, quality of life, peak urinary flow rate, post-void residual urinary volume, and prostate size and configuration were evaluated before the procedure and then annually for 5 years after the procedure. Adverse events were also recorded throughout the study. RESULTS: Improvement from baseline for TUNA and TURP retained statistical significance at each interval for International Prostate Symptom Score, quality of life and peak flow rate. Post-void residual volume was statistically significant at all time points for TURP and at year 5 for TUNA. The TURP group reported 41% retrograde ejaculation, while the TUNA group reported none. The incident of erectile dysfunction, incontinence and stricture formation was also greater in TURP than in TUNA cases with significantly fewer adverse events for TUNA than for TURP. CONCLUSIONS: The results of this study demonstrate stable treatment outcomes after 5 years of followup and suggest that TUNA is an attractive treatment option for men with LUTS due to BPH.

Aged↗

PubMed2002

Phase I trial of 1alpha-hydroxyvitamin d(2) in patients with hormone refractory prostate cancer.

This Phase I study of 1alpha-hydroxyvitamin D(2), an p.o. administered vitamin D analogue, in patients with advanced hormone-refractory prostate cancer was designed to assess the toxicity, pharmacokinetic and biological markers of drug activity, and lastly tumor response data to recommend a dose for Phase II studies. 1alpha-Hydroxyvitamin D(2) was administered daily at doses ranging from 5 to 15 microg/day. Patients were monitored for toxicity and tumor response, and blood and urine samples were collected for pharmacokinetics (1alpha,25-dihydroxyvitamin D(2) levels) and other parameters of biological activity (bone markers, parathyroid hormone, urine calcium, and serum phosphorus levels). Twenty-five patients were enrolled. Main toxicities were hypercalcemia with associated renal insufficiency. No other significant toxicity was seen. Pharmacokinetics showed an increase in the active metabolite 1alpha,25-dihydroxyvitamin D(2) that reached a plateau by week 4 despite continuous drug dosing. Elevation in daily urinary calcium excretion and serum phosphorus levels was seen, whereas a decrease in serum parathyroid hormone was evident. Two patients showed evidence of a partial response, whereas 5 others achieved disease stabilization for > or =6 months. 1alpha-Hydroxyvitamin D(2) was well tolerated with main toxicities being hypercalcemia and renal insufficiency. All of the toxicity was reversible with drug discontinuation. Evidence for drug activity was seen in surrogate markers, and pharmacokinetic analysis showed substantial increases in vitamin D metabolite levels among the various cohorts. Whereas the defined maximum tolerated dose was not reached, the recommended Phase II dose was 12.5 microg/day given continuously.

Adenocarcinoma↗

PubMedDate not supplied

Long-term complications associated with the Indiana pouch urinary diversion in patients with recurrent gynecologic cancers after high-dose radiation.

Few studies have assessed the long-term risks associated with the Indiana pouch continent urinary diversion after high-dose radiation therapy. A retrospective review of consecutive female patients who underwent cystectomy and Indiana pouch urinary diversion identified 12 with a history of high-dose pelvic irradiation (mean total 78.1 Gy). Long-term complications and outcomes in this group were compared to a synchronous group of patients (n = 14) with no history of radiation. Mean follow-up in the radiation therapy (RT) and nonirradiated comparison group (CG) were 48.5 and 40.8 months, respectively, with all patients having over 12 months of outcomes assessed. In the RT group, 83% of patients experienced a one or more complications (n = 29) while 57% of the CG did (n = 15; P = 0.2). Complications seen more commonly in the RT group included ureteral stricture/obstruction (5 vs. 2), renal insufficiency (3 vs. 1) and severe incontinence (3 vs. 0). Notably, 23 secondary operative procedures were required in the RT group versus CG (n = 11, P = 0.2). Percutaneous nephrostomy (6 vs. 1; P = 0.03) and ureteral reimplantation (4 vs. 0; P = 0.03) were seen significantly more commonly in the RT group than the CG. Long-term follow-up is critical to assess the complications associated with urinary diversions. We conclude that frequent complications and a significant increase in specific operative procedures are observed in heavily irradiated patients with recurrent gynecologic cancers receiving an Indiana Pouch urinary diversion. Given the risk of renal insufficiency, close monitoring of renal drainage and function is recommended. These considerable long-term complications should be considered when counseling patients contemplating Indiana Pouch urinary diversion after radiation therapy.

Adult↗