A Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | January 4, 2002 |
| End Date: | June 14, 2018 |
A Randomized Comparison of the Studer Pouch vs. the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients
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.
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.
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.
We found this trial at
1
site
1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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