PATIENTS AND METHODS: Over a one-year period, we randomly assigned patients with an indication for surgery for BPH and who met inclusion criteria to treatment with either PKRP or TURP. We measured prostate volume by transrectal ultrasound, relief of bladder outlet obstruction, operative time, decline in serum sodium and hemoglobin, weight of resected prostatic chips, duration of catheterization and hospital stay. Patients were evaluated one month after discharge for obstructive symptoms. Complications were also recorded.
RESULTS: Of 102 patients enrolled, 51 underwent PKRP and 51 underwent TURP. Relief of obstructive symptoms and mean operative time showed no statistically significant difference. The PKRP group had a smaller decline in hemoglobin than the TURP group (0.6 g/dL vs 1.8 g/dL, P=.01), a lower reduction in serum sodium levels (1.03 mmol/L vs 5.01 mmol/L, P=.01), a shorter catheterization time (37.2 hours versus 57.7 hours, P=.03) and a shorter hospital stay (1.5 days versus 2.6 days, P=.02). One patient in the bipolar PKRP group needed recatheterization versus four patients in the TURP group.
CONCLUSION: PKRP reduces morbidity with an outcome similar to conventional monopolar TURP in the treatment of BPH.
DESIGN: This multicenter, parallel group, randomized controlled trial involved 363 prevalent CAPD patients from 8 centers. The primary endpoint was peritonitis rate; secondary endpoints were technique failure and technical problems encountered. The duration of the evaluation was 1 year.
RESULTS: The risk of peritonitis on Carex varied between the centers. We found a significant treatment-center interaction effect (likelihood ratio test: p = 0.03). The incidence rate ratio (IRR) of peritonitis on Carex as compared with Ultra ranged from 0.4 to 7.2. In two centers, Carex was inferior to Ultra with regard to peritonitis; but, in five centers, the results were inconclusive. Equivalence was not demonstrated in any center. The overall rate of peritonitis in the Carex group was twice that in the Ultra group [IRR: 2.18; 95% confidence interval (CI): 1.51 to 3.14]. Technique failure and technical problems were more common with the Carex system. Technique failure rate at 1 year was 44% in the Carex group and 22% in the Ultra group.
CONCLUSIONS: Equivalence between the Carex disconnect system and the Ultra disconnect system could not be demonstrated. The risk of peritonitis on Carex varied significantly between centers.