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

NCT01008865 | Completed DMC

• 1 other identifier: 4B-01-2
• Study Type: interventional
• Target: 529
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  3 years after date of last patient enrolled

Secondary Outcomes (2)

• 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.

  Within 30 days after surgery

• An additional secondary endpoint is cancer recurrence and overall survival, which will be recorded in each patient.

  Yearly for the first 5 years, then every 2 years

Study Arms (2)

Studer Pouch

EXPERIMENTAL

Studer Pouch orthotopic urinary diversion

Procedure: Studer Pouch orthotopic urinary diversion

T-Pouch

EXPERIMENTAL

T-Pouch orthotopic urinary diversion

Procedure: T-Pouch orthotopic urinary diversion

Interventions

Studer Pouch orthotopic urinary diversion PROCEDURE

Studer Pouch

T-Pouch orthotopic urinary diversion PROCEDURE

T-Pouch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Siamak Daneshmand, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 6, 2009
• Study Start: January 4, 2002
• Primary Completion: June 14, 2018
• Study Completion: June 14, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

US (1)