N/A N=60 Randomized Triple-blind Supportive Care

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

Bacteriuria

Bottom Line

View on ClinicalTrials.gov: NCT02922868 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: Number of Participants Who Had Post-Procedure Bacteriuria — 0; 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EndoSheath CST-5000 Scope (Device); Olympus Visera Elite OTV-S190 Scope (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Had Post-Procedure Bacteriuria	0; 1	—
SECONDARY Number of Cystoscopes With Positive Bioburden Post-procedure.	0; 4; 0; 0	—
SECONDARY Total Time to Reprocess a Cystoscope	270.91; 3838.78	—
SECONDARY Subject Assessment of Procedure.	29.3; 26.5; 30.79; 29.2	—
SECONDARY Staff Assessment of Cystoscope Reprocessing.	4.27; 4.72; 4.13; 4.5; 3.9; 4.3	—
SECONDARY Total Cost of Cystoscopy Reprocessing	57,000.00; 32,000.00	—
SECONDARY Number of Procedures Per Day Per Scope.	5; 5	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02922868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.