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Prospective randomized trial comparing Endosheath with Visera Elite System for clinical use & improved cost-effectiveness

Login to Access Video or Poster Abstract: MP52-11
Sources of Funding: Cogentix Medical

Introduction

Flexible cystoscopy is routinely performed by urologists as an outpatient procedure. The use of a disposable sheath can increase the cystoscope lifespan and reduce costs related to reprocessing. The aim of this study was to compare the Endosheath Technology with the Visera Elite System for the following parameters: urinart tract infection (UTI), patient satisfaction, physician assessment and cost-effectiveness. _x000D_ _x000D_

Methods

This is a prospective, randomized, single center clinical trial (IRB#00036203) performed in patients referred for cystoscopy. Patients with UTI, chronic pelvic pain, urethral strictures were excluded. Urinalysis/culture were collected before and 14 days after cystoscopy using Visera Elite System (Olympus) or Endosheath System (Cogentix). After cystoscopy they filled a Visual Analog Scale (VAS) for pain/discomfort. Physicians filled 5-point Likert scales for the following elements: ease of insertion, manipulation, optical quality and overall use. The reprocessing time, cost analysis, which means staff-cost associated with reprocessing & retail-price per system, were compared._x000D_

Results

Out of 74 patients enrolled, 40 completed the 2-weeks study; 20 underwent cystoscopy with Visera Elite System and 20 with Endosheath. There were 2 positive cultures at 14 days follow up in the Visera System. VAS, physicians assessment and reprocessing time data are shown in Table 1. The cost analysis are presented in Tables 2 and 3._x000D_ _x000D_

Conclusions

There was no increase in the risk of infection using the Endosheath System. It has a lower cost and reprocessing time. Regarding patient VAS and physician subjective assessment there was no difference in a comparative analysis. _x000D_ _x000D_

Funding

Cogentix Medical

Authors
Thomas Watkins
Joao Zambon
Ashok Hemal
Robert Evans
Ryan Terlecki
Jorge Gutierrez
Majid Mirzazadeh
Gopal Badlani
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