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

NCT02922868 | Completed Results FDA Device

• 1 other identifier: IRB00036203
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteriuria

Keywords

Cystoscopy; EndoSheath; Infection Control; Bacteriuria

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Post-Procedure Bacteriuria

  The primary endpoint will be the change in bacteriuria pre- and post-procedure between EndoSheath CST-5000 cystoscope and standard (non-sheathed) Olympus Visera Elite OTV-S190 cystoscope during the course of routine clinical use in a urology clinic. The pre-procedure measurement of bacteriuria will occur on the day of the procedure. The post-procedure measurement of bacteriuria will occur approximately two weeks (10-14 days) post-procedure. This will be assessed by urine culture exams.

  10-14 Days Post Procedure

Secondary Outcomes (6)

• Number of Cystoscopes With Positive Bioburden Post-procedure.

  Immediately after cystoscopy.

• Total Time to Reprocess a Cystoscope

  Beginning from the time a cystoscope is withdrawn from the urethral meatus at the end of a procedure until the completion of reprocessing, approximately 3,869 seconds

• Subject Assessment of Procedure.

  Approximately 2 min after the end of procedure.

• Staff Assessment of Cystoscope Reprocessing.

  At the end of day of each procedure during 6 months

• Total Cost of Cystoscopy Reprocessing

  6 months

Study Arms (2)

EndoSheath CST-5000 Scope

EXPERIMENTAL

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

Device: EndoSheath CST-5000 Scope

Olympus Visera Elite OTV-S190 Scope

ACTIVE COMPARATOR

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.

Device: Olympus Visera Elite OTV-S190 Scope

Interventions

EndoSheath CST-5000 Scope DEVICE

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

EndoSheath CST-5000 Scope

Olympus Visera Elite OTV-S190 Scope DEVICE

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

Olympus Visera Elite OTV-S190 Scope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Cogenix Medical Corporation: collaborator

Study Sites (1)

Wake Forest Baptist Health - Department of Urology

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Bacteriuria

Condition Hierarchy (Ancestors)

Urinary Tract Infections; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr Gopal Badlani
• Organization: Wake Forest

gbadlani@wakehealth.edu

3367165928

Study Officials

• Gopal H Badlani, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: October 4, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 12, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-08

Locations

US (1)