MULTICENTER TRIAL IN NORTH-AMERICA OF UROLUME URINARY SPHINCTER PROSTHESIS

We investigated the effectiveness and associated complications of trea tment with an endoluminal urethral sphincter prosthesis in 153 spinal cord injury men (mean age 36 years, range 16 to 74 years) with urodyna mically diagnosed detrusor-external sphincter dyssynergia. These patie nts were prospectively treated with a urethral sphincter stent at 15 c enters in North America. Followup ranged from 2 to 33 months. Voiding pressures averaged 76 +/- 28, 42 +/- 21, 44 +/- 38, 35 +/- 18 and 32 /- 20 cm. water, respectively, before prosthesis insertion in 153 pati ents, and at 3 months in 123, 6 months in 114, 12 months in 98 and 24 months in 22. A significant decrease in voiding pressure was noted in the 22 patients at 24 months compared with matched preoperative data ( 80 +/- 25 cm. water, p = 0.03). The residual urine decreased from 181 +/- 154 ml. before insertion to 82 +/- 93 ml. at 24 months (p = 0.01). Maximum cystometric capacity remained constant, with a mean of 195 +/ - 158 ml. before insertion to 248 +/- 122 ml. at 24 months (p = 0.17). No significant differences were apparent after 24 months of followup in any of the urodynamic parameters between 44 patients with and 109 w ithout previous external sphincterotomy. Hemorrhage requiring blood tr ansfusion, obstructive hyperplastic epithelial overgrowth and soft tis sue erosion did not occur. No deleterious effects were observed on ren al or erectile function. Of the patients 43 (28.1%) required 2 prosthe ses to bridge the external sphincter completely. Stent removal was req uired in 10 patients. Seven explantations were required for prosthesis migration, 1 for pain and urethral edema, 1 for inability to maintain a condom catheter, and 1 for nonepithelialization and secondary bladd er neck obstruction. A total of 13 patients (8.5%) required a subseque nt operation for bladder neck obstruction. Therefore, the sphincter pr osthesis is an attractive modality for the treatment of external sphin cter dyssynergia in patients with and without previous external sphinc terotomy because of its ease of deployment and minimal associated morb idity.