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

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University of Southern California

Status

Completed

Conditions

Bladder Cancer

Treatments

Procedure: Studer Pouch orthotopic urinary diversion
Procedure: T-Pouch orthotopic urinary diversion

Study type

Interventional

Funder types

Other

Identifiers

NCT01008865
4B-01-2

Details and patient eligibility

About

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.

Enrollment

529 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

529 participants in 2 patient groups

Studer Pouch
Experimental group
Description:
Studer Pouch orthotopic urinary diversion
Treatment:
Procedure: Studer Pouch orthotopic urinary diversion
T-Pouch
Experimental group
Description:
T-Pouch orthotopic urinary diversion
Treatment:
Procedure: T-Pouch orthotopic urinary diversion

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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