Overview

This trial is active, not recruiting.

Condition bladder cancer
Treatments studer pouch orthotopic urinary diversion, t-pouch orthotopic urinary diversion
Sponsor University of Southern California
Start date January 2002
End date December 2015
Trial size 529 participants
Trial identifier NCT01008865, 4B-01-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Studer Pouch orthotopic urinary diversion
studer pouch orthotopic urinary diversion
(Experimental)
T-Pouch orthotopic urinary diversion
t-pouch orthotopic urinary diversion

Primary Outcomes

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).
time frame: 3 years after date of last patient enrolled

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Randomized Comparison of the Studer Pouch vs. the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
Principal investigator Siamak Daneshmand, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of Southern California.