NCT01008865

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

Completed NA Last updated 25 January 2019

What this trial tests

NA trial testing Studer Pouch orthotopic urinary diversion in Bladder Cancer in 529 participants. Completed in 14 June 2018.

Timeline

4 January 2002

Primary endpoint
14 June 2018

14 June 2018

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	529
Start date	4 January 2002
Primary completion	14 June 2018
Estimated completion	14 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Studer Pouch orthotopic urinary diversion
• T-Pouch orthotopic urinary diversion

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

University of Southern California

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.