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A Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Southern California Identifier:
First received: November 4, 2009
Last updated: April 29, 2017
Last verified: April 2017
This is a prospective, randomized study of two types of continent ileal neobladder construction in patients undergoing cystectomy for primary bladder cancer. Patients will be randomly assigned to have either a T-pouch or a Studer pouch constructed at the time of their surgery. They will be followed long-term to determine the relative advantages and disadvantages of the two types of diversion. The investigators' hypothesis is that the inclusion of an antireflux mechanism in the T-pouch will result in significantly fewer episodes of symptomatic urinary tract infection, and will have a lower incidence of upper tract dilation and loss of renal function over the long term.

Condition Intervention
Bladder Cancer Procedure: Studer Pouch orthotopic urinary diversion Procedure: T-Pouch orthotopic urinary diversion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of the Studer Pouch vs. the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients

Resource links provided by NLM:

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • The primary endpoint is the long-term outcome (> 3 years) as it pertains to renal function, anatomy of the upper urinary tracts, and the requirement for medical or surgical intervention (ie for symptomatic urinary tract infections). [ Time Frame: 3 years after date of last patient enrolled ]

Secondary Outcome Measures:
  • A secondary endpoint is the length of surgery and the incidence of early postoperative complications (<30 days from surgery) believed to be related to the type of urinary diversion. [ Time Frame: Within 30 days after surgery ]
  • An additional secondary endpoint is cancer recurrence and overall survival, which will be recorded in each patient. [ Time Frame: Yearly for the first 5 years, then every 2 years ]

Enrollment: 529
Actual Study Start Date: January 4, 2002
Estimated Study Completion Date: June 4, 2018
Estimated Primary Completion Date: December 8, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Studer Pouch
Studer Pouch orthotopic urinary diversion
Procedure: Studer Pouch orthotopic urinary diversion
Experimental: T-Pouch
T-Pouch orthotopic urinary diversion
Procedure: T-Pouch orthotopic urinary diversion


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients undergoing radical cystectomy for bladder cancer who are considered candidates for a neobladder reconstruction are eligible for enrollment.
  • Diagnosed with primary bladder cancer (any histology).
  • Scheduled to undergo a radical cystectomy (cystoprostatectomy in men and anterior exenteration in women).
  • Felt by the treating physician to be a candidate for an orthotopic neobladder urinary diversion.
  • Be competent and willing to sign the informed consent.
  • Patients may have received previous radiation therapy or intravesical or systemic chemotherapy. Patients with documented metastatic disease are not excluded as long as they are felt to be candidates for a continent neobladder urinary diversion.

Exclusion Criteria:

  • Patients undergoing radical cystectomy for any malignancy other than primary bladder cancer (for example prostate cancer or colon cancer invading the bladder,or a gynecologic malignancy), or non-malignant disease (such as a neurogenic bladder or radiation cystitis).
  • Unwilling or unable to sign the informed consent.
  • Not eligible for an orthotopic neobladder reconstruction.
  • A history of other malignancy (except for stage I cancer treated with curative intent without evidence of recurrence, clinically localized prostate cancer either untreated or treated with prostatectomy or radiation therapy or hormone therapy,or non-melanoma skin cancer) within the previous 5 years.
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Please refer to this study by its identifier: NCT01008865

United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: Siamak Daneshmand, MD University of Southern California
  More Information

Responsible Party: University of Southern California Identifier: NCT01008865     History of Changes
Other Study ID Numbers: 4B-01-2
Study First Received: November 4, 2009
Last Updated: April 29, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases processed this record on August 23, 2017