Back to resultsA Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Studer Pouch orthotopic urinary diversion
T-Pouch orthotopic urinary diversion
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer
Eligibility 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.
Sites / Locations
- USC/Norris Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Studer Pouch
T-Pouch
Arm Description
Studer Pouch orthotopic urinary diversion
T-Pouch orthotopic urinary diversion
Outcomes
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).
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.
An additional secondary endpoint is cancer recurrence and overall survival, which will be recorded in each patient.
Full Information
NCT ID
NCT01008865
First Posted
November 4, 2009
Last Updated
January 23, 2019
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT01008865
Brief Title
A Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
Official Title
A Randomized Comparison of the Studer Pouch vs. the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2002 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
529 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Studer Pouch
Arm Type
Experimental
Arm Description
Studer Pouch orthotopic urinary diversion
Arm Title
T-Pouch
Arm Type
Experimental
Arm Description
T-Pouch orthotopic urinary diversion
Intervention Type
Procedure
Intervention Name(s)
Studer Pouch orthotopic urinary diversion
Intervention Type
Procedure
Intervention Name(s)
T-Pouch orthotopic urinary diversion
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siamak Daneshmand, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
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