USC-STAR: Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder
USC-STAR was a single-center, unmasked randomized trial of the T-pouch, an orthotopic ileal neobladder with an antireflux mechanism, versus the Studer pouch in 484 patients with bladder cancer undergoing radical cystectomy, with the change in estimated glomerular filtration rate (eGFR) from baseline to 3 years as the primary endpoint. Among the 260 patients with 3-year renal data, eGFR fell by 6.6 mL/min/1.73 m² with the T-pouch and 6.4 mL/min/1.73 m² with the Studer pouch (p = 0.35).[1]
- Design and population
- Single-center, unmasked randomized superiority trial. Patients with clinically nonmetastatic bladder cancer scheduled for radical cystectomy with neobladder reconstruction.
- Arms
- T-pouch orthotopic ileal neobladder with an antireflux mechanism versus Studer orthotopic ileal neobladder
- Report and follow-up
- 2015 · 3 years (primary renal endpoint)
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| Change in CKD-EPI eGFR from baseline to 3 years (mL/min/1.73 m²); mean difference, T-pouch minus Studer | −6.6 vs −6.4 | difference -0.2; P 0.35 |
Harms: Urinary tract infection: Cumulative risk did not differ between the groups; the abstract gives no incidence figures.; Overall late complications: Cumulative risk did not differ between the groups; the abstract gives no incidence figures.; Diversion-related secondary surgical procedures: T-pouch was associated with an increased risk; the abstract gives no incidence figures.
Design
Patients with clinically nonmetastatic bladder cancer scheduled for radical cystectomy with a neobladder were randomized to a T-pouch or a Studer ileal orthotopic neobladder between February 2002 and November 2009: 237 to the T-pouch and 247 to the Studer pouch. Baseline characteristics did not differ between the groups. Renal function was calculated with the CKD-EPI equation.[1] The registered hypothesis was that the antireflux mechanism would reduce symptomatic urinary tract infection, upper-tract dilation and long-term loss of renal function.[2]
Results
Among the 260 patients with 3-year renal data, the mean eGFR decreased by 6.6 mL/min/1.73 m² with the T-pouch and 6.4 mL/min/1.73 m² with the Studer pouch between baseline and 3 years (p = 0.35). In multivariable analysis, neobladder type was not independently associated with 3-year renal function (p = 0.63); baseline eGFR, age and urinary tract obstruction were.[1]
A questionnaire mailed to men at least 12 months after surgery, drawn from the same randomized cohort, was answered by 68% (mean follow-up 4.5 years, range 1 to 8) and pooled both arms. Among the male respondents, 22.3% used no pads; 47% used at least 1 pad in the daytime, 32.2% used small or mini pads and 22.6% used diapers; 72% used pads at night, 14.7% used small or mini pads and 38.9% used diapers. Mucus leakage was reported by 62.5%, and 9.5% performed clean intermittent self-catheterization, 70.6% of whom started within the first year. Increasing age and diabetes mellitus predicted worse urinary function but did not affect pad use.[3]
Surgery and treatment delivery
Patients were assigned at radical cystectomy to a T-pouch, which includes an antireflux mechanism, or a Studer pouch. Treatment assignment was not masked.[1]
Adverse events
The cumulative risks of urinary tract infection and of overall late complications did not differ between the groups. The T-pouch was associated with an increased risk of diversion-related secondary surgical procedures.[1]
Limitations
The trial was conducted at one center, and assignment was not masked. The primary endpoint was renal function at 3 years, and both arms showed a moderate decline.[1] The questionnaire study includes men only and does not report results by arm.[3]
In conversation
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2012-11-15 | Men's functional questionnaire · pro | — | Response rate to a mailed questionnaire sent to men at least 12 months after surgery: 68%; T-pouch and Studer participants are pooled and the abstract gives no results by arm.; — Descriptive Respondents using no pads: 22.3% (arms pooled).; — Descriptive Respondents using at least 1 pad in the daytime: Among 179 male questionnaire respondents (T-pouch and Studer arms pooled), 84 (47%) used at least 1 daytime pad; among those 84 daytime pad users, 27 (32.2%) used mini/small pads and 19 (22.6%) used diapers.; — Descriptive Respondents using pads at night: Among 179 male questionnaire respondents (T-pouch and Studer arms pooled), 129 (72%) wore nighttime pads; among those 129 nighttime pad users, 19 (14.7%) used mini/small pads and 63 (48.9%) used diapers.; — Descriptive Respondents reporting mucus leakage: 62.5% (arms pooled).; — Descriptive Respondents performing clean intermittent self-catheterization: 9.5% (arms pooled); 70.6% of them started within the first year after surgery.; — Descriptive | Ahmadi H, Skinner EC, Simma-Chiang V, et al. "Urinary Functional Outcome Following Radical Cystoprostatectomy and Ileal Neobladder Reconstruction in Male Patients." *J Urol.* 2013;189(5):1782-1788. DOI |
| 2015-03-28 | 3-year renal outcome · primary | — | Change in CKD-EPI eGFR from baseline to 3 years (mL/min/1.73 m²); mean difference, T-pouch minus Studer: −6.6 vs −6.4; difference -0.2; P 0.35 Multivariable association of neobladder type with 3-year renal function: Baseline eGFR, age and urinary tract obstruction were independently associated with the 3-year decline in renal function.; P 0.63 | Skinner EC, Fairey AS, Groshen S, et al. "Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer." *J Urol.* 2015;194(2):433-439. DOI |
References
1. Skinner EC, Fairey AS, Groshen S, et al. "Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer." J Urol. 2015;194(2):433-439. doi:10.1016/j.juro.2015.03.101
2. ClinicalTrials.gov. "A Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients." Identifier NCT01008865. clinicaltrials.gov
3. Ahmadi H, Skinner EC, Simma-Chiang V, et al. "Urinary Functional Outcome Following Radical Cystoprostatectomy and Ileal Neobladder Reconstruction in Male Patients." J Urol. 2013;189(5):1782-1788. doi:10.1016/j.juro.2012.11.078