Clinical trial NCT01008865: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 529
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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).
timeFrame: 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.
timeFrame: Within 30 days after surgery
measure: An additional secondary endpoint is cancer recurrence and overall survival, which will be recorded in each patient.
timeFrame: Yearly for the first 5 years, then every 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Siamak Daneshmand, MD
role: PRINCIPAL_INVESTIGATOR
References: