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

NCT ID: NCT01008865

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 529 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-04
• Study Completion Date: 2018-06-14

Brief Summary

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Studer Pouch

Studer Pouch orthotopic urinary diversion

Group Type: EXPERIMENTAL

Studer Pouch orthotopic urinary diversion

Intervention Type: PROCEDURE

T-Pouch

T-Pouch orthotopic urinary diversion

Group Type: EXPERIMENTAL

T-Pouch orthotopic urinary diversion

Intervention Type: PROCEDURE

Interventions

Studer Pouch orthotopic urinary diversion

Intervention Type: PROCEDURE

T-Pouch orthotopic urinary diversion

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siamak Daneshmand, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

4B-01-2

Identifier Type: -

Identifier Source: org_study_id