Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer

No AccessJournal of UrologyAdult Urology1 Aug 2015Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer Eila C. Skinner, Adrian S. Fairey, Susan Groshen, Siamak Daneshmand, Jie Cai, Gus Miranda, and Donald G. Skinner Eila C. SkinnerEila C. Skinner Department of Urology, Stanford University, Stanford, California More articles by this author , Adrian S. FaireyAdrian S. Fairey Department of Urology, University of Alberta, Edmonton, Canada More articles by this author , Susan GroshenSusan Groshen USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author , Siamak DaneshmandSiamak Daneshmand USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author , Jie CaiJie Cai USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author , Gus MirandaGus Miranda USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author , and Donald G. SkinnerDonald G. Skinner USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.03.101AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: The need to prevent reflux in the construction of an orthotopic ileal neobladder is controversial. We designed the USC-STAR trial to determine whether the T-pouch neobladder that included an antireflux mechanism was superior to the Studer pouch in patients with bladder cancer undergoing radical cystectomy. Materials and Methods: This single center, randomized, controlled trial recruited patients with clinically nonmetastatic bladder cancer scheduled to undergo radical cystectomy with neobladder. Eligible patients were randomly assigned to undergo T-pouch or Studer ileal orthotopic neobladder. Treatment assignment was not masked. The primary end point was change in renal function from baseline to 3 years. The CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation was used to calculate the estimated glomerular filtration rate. Results: Between February 2002 and November 2009, 237 patients were randomly assigned to T-pouch ileal orthotopic neobladder and 247 to Studer ileal orthotopic neobladder. Baseline characteristics did not differ between the groups. Between baseline and 3 years the estimated glomerular filtration rate decreased by 6.4 ml/minute/1.73 m2 in the Studer group and 6.6 ml/minute/1.73 m2 in the T-pouch group (p=0.35). Multivariable analysis showed that type of ileal orthotopic neobladder was not independently associated with 3-year renal function (p=0.63). However, baseline estimated glomerular filtration rate, age and urinary tract obstruction were independently associated with 3-year decline in renal function. Cumulative risk of urinary tract infection and overall late complications were not different between the groups, but the T-pouch was associated with an increased risk of secondary diversion related surgeries. Conclusions: T-pouch ileal orthotopic neobladder with an antireflux mechanism did not prevent a moderate reduction in renal function observed at 3 years compared to the Studer pouch, but did result in an increase in diversion related secondary surgical procedures. References 1 : Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol2001; 19: 666. Google Scholar 2 : Long-term complications of conduit urinary diversion. J Urol2011; 185: 562. Link, Google Scholar 3 : Renal function up to 16 years after conduit (refluxing or anti-reflux anastomosis) or continent urinary diversion. 2. Renal scarring and location of bacteriuria. Br J Urol1995; 76: 546. 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Skinner Department of Urology, Stanford University, Stanford, California More articles by this author Adrian S. Fairey Department of Urology, University of Alberta, Edmonton, Canada More articles by this author Susan Groshen USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Siamak Daneshmand USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Jie Cai USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Gus Miranda USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Donald G. Skinner USC Institute of Urology, Keck Medical Center of USC, Los Angeles, California More articles by this author Expand All Advertisement PDF downloadLoading ...