Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Cystoscopy

The increasing costs in health care and enhanced infection control requirements necessitate
the efficient and reliable use of frequently used techniques like cystoscopy. The health
economics of cystoscopy are dependent on maintaining low levels of post-cystoscopy sequelae
like urinary tract infection (UTI) and its potential precursors, significant asymptomatic
bacteriuria and leukocytosis. Another key component of the economics and efficiency of
cystoscopy is the time and cost related to the reprocessing of these devices in preparation
for re-use. The use of disposable endoscope sheaths may limit the need for high level
disinfection (HLD) between procedures and reduce reprocessing time and potentially prolong
the cystoscope lifespan. The rationale for this study is to determine if a sheathed
cystoscopy system would provide the desired cost and efficiency advantages compared to
procedures done with non-sheathed cystoscopes. This is a prospective, randomized, parallel
group, single center clinical trial to assess the clinical outcomes, practice efficiency and
health economics of the use of sheathed cystoscopes (EndoSheath® System) compared to using
standard (non-sheathed) cystoscopes. The study will evaluate the infection control (via the
change in bacteriuria), clinical practice efficiency and costs of the EndoSheath technology
with CST 5000 scope compared to standard cystoscopy with Olympus Visera Elite OTV-S190
digital flexible scope. There will be 30 subjects in the control group undergoing cystoscopy
with the standard scope at the clinic, the Olympus Visera Elite, and 30 subjects in the study
group undergoing cystoscopy with the EndoSheath system. The study is designed as a
prospective, randomized controlled trial. There will be no active blinding of clinicians or
subjects; however, it is anticipated that most subjects will be unaware of differences in the
cystoscopy equipment that will be utilized in their routine procedures.

Inclusion Criteria:

- Males and females, at least 18 years of age or older

- Patients undergoing de novo or follow up diagnostic or therapeutic cystoscopy
procedures in a Urology clinic setting

- Antibiotic-free for at least 7 days prior to cystoscopy procedure

- Patients willing to return to the clinic at approximately two weeks (10 -14 days)
post-procedure for a urine test

Exclusion Criteria:

- Patients with significant lower urinary tract obstruction, gross hematuria

- Patients having an acute pelvic inflammatory disease or symptomatic UTI

- Patients with urethral strictures

- Patients with chronic pain conditions

- Patients unwilling to return to the clinic at approximately two weeks (10 -14 days)
for a urine test