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

18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

3 years after date of last patient enrolled

Safety Issue:


Principal Investigator

Siamak Daneshmand, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2002

Completion Date:

January 2015

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800