The North American experience with the UroLume endoprosthesis as a treatment for XXXX : long-term results. The North American UroLume Study Group.

@entity1 @entity1067
OBJECTIVES: To determine the efficacy and safety of the UroLume endoprosthesis as a treatment for obstructive @entity1067 in healthy @entity1 . METHODS: One hundred twenty-six @entity1 were enrolled prospectively in a multicenter North American Clinical Trial. Ninety-five @entity1 (mean age 68 +/- 7 years) had moderate or severe prostatism, whereas 31 @entity1 (mean age 76 +/- 8 years) were in urinary retention. Voiding function for all @entity1 was assessed prior to stent placement and in follow-up at 1, 3, 6, 12, and 24 months with the Madsen-Iversen symptom questionnaire, peak urinary flow rate, postvoid residual urine volume, and cystoscopic examination. RESULTS: For the nonretention cohort at 24-month follow-up, the results were as follows: (1) total symptom score decreased from 14.3 +/- 0.5 preinsertion to 5.4 +/- 0.5 (p < 0.001); (2) peak urinary flow rate increased from 9.1 +/- 0.5 mL/s preinsertion to 13.1 +/- 0.7 mL/s (p < 0.001); and (3) postvoid residual urine volume decreased from 85 +/- 9 mL to 47 +/- 8 mL (p = 0.02). For the retention group, the total symptom score, peak urinary flow rate, and postvoid residual urine volume at 24 months were 4.1 +/- 0.5, 11.4 +/- 1.0 mL/s and 46 +/- 7 mL, respectively. By 12-month follow-up, most endoprostheses were completely covered with urothelium. Although significant long-term complications were minimal, 17 endoprostheses have been explanted for an overall removal rate of 13%. All devices were removed transurethrally without subsequent sequelae to the external urinary sphincter or urethra. CONCLUSIONS: The long-term results from this North American Clinical Trial suggest that the UroLume endoprosthesis can be an effective and safe treatment for properly selected healthy @entity1 with obstructive @entity1067 . Randomized clinical trials comparing this minimally invasive procedure with transurethral resection of the prostate are now underway to document further its efficacy and safety.
