Use of a temporary ureteral drainage stent after uncomplicated ureteroscopy: results from a phase II clinical trial.
(Clinical Trial;Journal Article;Multicenter Study)
PURPOSE: An indwelling ureteral stent is commonly placed for 48 hours after uncomplicated ureteroscopy to maintain drainage and prevent postoperative complications. A propriety temporary ureteral drainage stent (TUDS, Boston Scientific/Microvasive, Natick, Massachusetts) was developed to satisfy this goal with the added advantages of biodegradability and spontaneous passage. We evaluated TUDS performance in a patient population. MATERIALS AND METHODS: A total of 88 patients at 6 centers were selected for TUDS placement. Device safety as well as effectiveness, defined as adequate intervention-free drainage for 48 hours with the maintenance of ureteral position, were the primary study end points. Secondary end points consisted of the time required to eliminate TUDS from the body, tolerability of device presence and passage, and overall patient satisfaction with the stent. RESULTS: A single patient was excluded from primary end point analysis because of inadequate day 2 evaluation, resulting in an overall stent effectiveness rate of 78.2% (68 of 87 patients). Primary end point failure occurred in the remaining 19 patients (21.8%) with early stent extrusion in 17 and intervention required in 2 others within 48 hours of stent placement (cystoscopy and intravenous analgesia in 1, and intravenous analgesia alone in 1). There were no adverse clinical sequelae in 16 patients who experienced early extrusion with only 1 requiring intravenous pain medication. Stent fragments were retained beyond 3 months in 3 patients, of whom 2 were treated in a minimally invasive manner with shock wave lithotripsy, while 1 required ureteroscopy and shock wave lithotripsy to clear the residual fragments. Median time to stent elimination from the ureter and from the body was 8 and 15 days, respectively. Overall 71 of the 80 patients (89%) reported satisfaction with TUDS. CONCLUSIONS: The concept of a self-degrading internal ureteral stent represents a new paradigm in ureteral drainage. TUDS combines adequate ureteral drainage and patient satisfaction after uncomplicated ureteroscopy, eliminating the need for stent removal.
Lingeman, JE; Preminger, GM; Berger, Y; Denstedt, JD; Goldstone, L; Segura, JW; Auge, BK; Watterson, JD; Kuo, RL
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