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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01008865
First received: November 4, 2009
Last updated: April 29, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Bladder Cancer Procedure: Studer Pouch orthotopic urinary diversion Procedure: T-Pouch orthotopic urinary diversion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Randomized Comparison of the Studer Pouch vs. the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 529
Actual Study Start Date: January 4, 2002
Estimated Study Completion Date: June 4, 2018
Estimated Primary Completion Date: December 8, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008865

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Siamak Daneshmand, MD University of Southern California
  More Information

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01008865     History of Changes
Other Study ID Numbers: 4B-01-2
Study First Received: November 4, 2009
Last Updated: April 29, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 28, 2017