Sphincteric stent versus external sphincterotomy in spinal cord injured men: Prospective randomized multicenter trial

Purpose: In a prospective randomized multicenter trial we compared the trea tment results of conventional external sphincterotomy with those of UroLume sphincteric stent prosthesis placement in men with spinal cord injury and external detrusor-sphincter dyssynergia. Materials and Methods: We randomized 57 men with spinal cord injury in whom urodynamics verified external detrusor-sphincter dyssynergia into 2 groups to undergo either sphincter defeating procedure. We compared the primary u rodynamic parameter of maximum detrusor pressure, and secondary urodynamic parameters of bladder capacity and post-void residual urine volume in men w ho underwent sphincterotomy or sphincteric stent placement. Parameters were measured preoperatively, and 3, 6, 12 and 24 months postoperatively. Patie nts completed questionnaires regarding voiding sensation and quality of lif e issues at each followup visit. Results: Demographic data of the 26 patients treated with sphincterotomy an d the 31 treated with sphincteric stent placement were statistically simila r. Preoperatively mean maximum detrusor pressure plus or minus standard dev iation in sphincterotomy and stent cases was 98.3 +/- 27.6 and 95.7 +/- 27. 7 cm. water, respectively (p = 0.73). At 12 months mean maximum detrusor pr essure decreased to 48.9 +/- 16.4 and 52.6 +/- 31.6 cm. water in the sphinc terotomy and stent groups, respectively (p = 0). Preoperatively mean bladde r capacity in sphincterotomy and stent cases was 245 +/- 158 and 251 +/- 14 5 mi., respectively (p = 0.87). Bladder capacity did not change significant ly in either treatment group throughout followup. Preoperatively mean post- void residual urine volume in the sphincterotomy and stent groups was 212 /- 163 and 168 +/- 114 mi., respectively (p = 0.33). Residual urine volume decreased in each group at some but not all followup evaluations. The durat ion of hospitalization was greater for sphincterotomy than stenting (p = 0. 036). Six stents required explantation. Conclusions: The UroLume stent is as effective as conventional external sph incterotomy for treating external detrusor-sphincter dyssynergia. However, sphincteric stent placement is advantageous because it involves shorter hos pitalization and is potentially reversible.