Use of a Temporary Ureteral Drainage Stent After Uncomplicated Ureteroscopy: Results From a Phase II Clinical Trial

No AccessJournal of UrologyCLINICAL UROLOGY: Original Articles1 May 2003Use of a Temporary Ureteral Drainage Stent After Uncomplicated Ureteroscopy: Results From a Phase II Clinical Trial JAMES E. LINGEMAN, GLENN M. PREMINGER, YITZHAK BERGER, JOHN D. DENSTEDT, LAWRENCE GOLDSTONE, JOSEPH W. SEGURA, BRIAN K. AUGE, JAMES D. WATTERSON, and RAMSAY L. KUO JAMES E. LINGEMANJAMES E. LINGEMAN , GLENN M. PREMINGERGLENN M. PREMINGER , YITZHAK BERGERYITZHAK BERGER , JOHN D. DENSTEDTJOHN D. DENSTEDT , LAWRENCE GOLDSTONELAWRENCE GOLDSTONE , JOSEPH W. SEGURAJOSEPH W. SEGURA , BRIAN K. AUGEBRIAN K. AUGE , JAMES D. WATTERSONJAMES D. WATTERSON , and RAMSAY L. KUORAMSAY L. KUO View All Author Informationhttps://doi.org/10.1097/01.ju.0000055600.18515.a1AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract 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. References 1 : Experience with indwelling ureteral stent catheters. J Urol1976; 115: 22. Link, Google Scholar 2 Lingeman, J.E., Schulsinger, D.A., Kuo, R.L.: A phase I trial of a temporary ureteral drainage device (TUDS). Unpublished data. Google Scholar 3 : The Gibbons indwelling silicone ureteral stent catheter. J Urol1977; 117: 33. 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Link, Google Scholar From the Clarian Health Partners, Methodist Hospital Institute for Kidney Stone Disease and Indiana University School of Medicine, Indianapolis, Indiana, Division of Urology, Department of Surgery, Duke University Medical Center, Durham, North Carolina, Division of Urology, University of Western Ontario, London, Ontario, Canada, Department of Urology, Mayo Clinic, Rochester, Minnesota, Associates in Urology, West Orange, New Jersey, and Georgia Urology, Atlanta, Georgia© 2003 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byChew B, Paterson R, Clinkscales K, Levine B, Shalaby S and Lange D (2018) In Vivo Evaluation of the Third Generation Biodegradable Stent: A Novel Approach to Avoiding the Forgotten Stent SyndromeJournal of Urology, VOL. 189, NO. 2, (719-725), Online publication date: 1-Feb-2013.Chew B, Lange D, Paterson R, Hendlin K, Monga M, Clinkscales K, Shalaby S and Hadaschik B (2018) Next Generation Biodegradable Ureteral Stent in a Yucatan Pig ModelJournal of Urology, VOL. 183, NO. 2, (765-771), Online publication date: 1-Feb-2010.Dellis A, Joshi H, Timoney A and Keeley F (2018) Relief of Stent Related Symptoms: Review of Engineering and Pharmacological SolutionsJournal of Urology, VOL. 184, NO. 4, (1267-1272), Online publication date: 1-Oct-2010.Hadaschik B, Paterson R, Fazli L, Clinkscales K, Shalaby S and Chew B (2018) Investigation of a Novel Degradable Ureteral Stent in a Porcine ModelJournal of Urology, VOL. 180, NO. 3, (1161-1166), Online publication date: 1-Sep-2008.Preminger G, Tiselius H, Assimos D, Alken P, Buck C, Gallucci M, Knoll T, Lingeman J, Nakada S, Pearle M, Sarica K, Türk C and Wolf J (2018) 2007 Guideline for the Management of Ureteral CalculiJournal of Urology, VOL. 178, NO. 6, (2418-2434), Online publication date: 1-Dec-2007.BEIKO D, KNUDSEN B, WATTERSON J, CADIEUX P, REID G and DENSTEDT J (2018) URINARY TRACT BIOMATERIALSJournal of Urology, VOL. 171, NO. 6 Part 1, (2438-2444), Online publication date: 1-Jun-2004. Volume 169Issue 5May 2003Page: 1682-1688 Advertisement Copyright & Permissions© 2003 by American Urological Association, Inc.KeywordsbiodegradationstentsureteroscopyureterdrainageMetricsAuthor Information JAMES E. LINGEMAN Financial interest and/or other relationship with Boston Scientific, Lumenis, TherMatrx and Olympus. More articles by this author GLENN M. PREMINGER Financial interest and/or other relationship with Microvasive, Olympus and Mission Pharma. More articles by this author YITZHAK BERGER Financial interest and/or other relationship with Pharmacia, Alza, Gynecare, Bioniche and Genyx. More articles by this author JOHN D. DENSTEDT Financial interest and/or other relationship with Boston Scientific. More articles by this author LAWRENCE GOLDSTONE More articles by this author JOSEPH W. SEGURA More articles by this author BRIAN K. AUGE More articles by this author JAMES D. WATTERSON More articles by this author RAMSAY L. 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