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

Completed · Not applicable

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT01008865

Run by

University of Southern California

People needed

529

Starts

2002-01-04

Expected to finish

2018-06-14

Last updated by the study team

2019-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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