Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy

The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is
intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– patient with solitary ureteral stone ranging from 5mm to 15mm diameter

– able to tolerate general anesthesia

– clinical indication for treatment by ureteroscopic lithotripsy

– must be willing and able to participate in any follow-up visits

– provide informed consent

– have a CT scan demonstrating the stone

Exclusion Criteria:

– patients undergoing extracorporeal shock wave lithotripsy (ESWL) or any other
extracorporeal or percutaneous lithotripsy procedure as primary procedure

– any co-morbidity or condition that would necessitate exclusion of patient (physician
opinion)

– renal or ureteral anatomical abnormality

– multiple stones in the indicated ureter

– stones in the indicated kidney

– patient is immunocompromised

– multiple organ dysfunction syndrome

– has an absolute or relative solitary kidney mass

– >= Stage 3 chronic kidney disease

– bilateral ureteral obstructing stones

– staghorn calculi

– impaction of several stone fragments (Steinstrasse)

– uncorrected coagulopathy/thrombocytopenia

– urethral and/or ureteral stricture

– reconstructive urinary surgery

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

A Comparison of the Studer Pouch Versus 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.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

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.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.