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

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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: Studer Pouch orthotopic urinary diversion; Procedure: T-Pouch orthotopic urinary diversion

• Study Type: Interventional
• Enrollment (Actual): 529
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	3 years after date of last patient enrolled

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Within 30 days after surgery
An additional secondary endpoint is cancer recurrence and overall survival, which will be recorded in each patient.	Yearly for the first 5 years, then every 2 years

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2002
• Primary Completion (ACTUAL): June 14, 2018
• Study Completion (ACTUAL): June 14, 2018

Study Registration Dates

• First Submitted: November 4, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (ESTIMATE): November 6, 2009

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 4B-01-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No