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

NCT ID: NCT02922868

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of this research study is to compare the effectiveness and efficiency of using a sterile sheath (EndoSheath®) during cystoscopy versus a standard scope.

Detailed Description

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.

Conditions

Bacteriuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

EndoSheath CST-5000 Scope

Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.

Group Type: EXPERIMENTAL

EndoSheath CST-5000 Scope

Intervention Type: DEVICE

Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.

Olympus Visera Elite OTV-S190 Scope

Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.

Group Type: ACTIVE_COMPARATOR

Olympus Visera Elite OTV-S190 Scope

Intervention Type: DEVICE

Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope

Interventions

EndoSheath CST-5000 Scope

Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.

Intervention Type: DEVICE

Olympus Visera Elite OTV-S190 Scope

Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cogenix Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gopal H Badlani, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Health - Department of Urology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00036203

Identifier Type: -

Identifier Source: org_study_id