Posted on May 14, 2017 by Cogentix Medical

New EndoSheath Study Presented at Major Urology Conference

Breaking NewsOver the past two decades, the EndoSheath® Protective Barrier has been the subject of 30+ studies which reinforce its role as a safe, proven and cost-effective option for endoscopic procedures. Now, a recent study presented at the 2017 American Urological Association Annual Meeting in Boston, demonstrates that PrimeSight™ Cystoscopes using the EndoSheath Barrier continue to offer advantages that are meaningful to the changing landscape of flexible cystoscopy and medical device reprocessing.

Comparable Performance to Olympus Visera® System

A prospective randomized trial comparing EndoSheath with Visera Elite System for clinical use & improved cost-effectiveness, from a group of researchers at Wake Forest University, discussed the microbial safety, overall time savings and cost-effectiveness of using a PrimeSight Cystoscope with EndoSheath Barrier when compared to the use and reprocessing of the Olympus Visera system. The researchers confirmed that using EndoSheath is at least as safe as standard reprocessing, and that the system is essentially comparable in terms of ease of insertion, ease of manipulation, ease of use and patient pain and discomfort. Only a slight difference was noted in optical quality, which was scored slightly better in the Olympus system. In addition, the study highlighted EndoSheath product advantages such as its ability to act as a viral barrier, cost effectiveness, and much lower reprocessing time.

Acts as a Viral Barrier During Cystoscopy

The group of researchers from Wake Forest evaluated microbial safety in cystoscopy for the two systems by comparing colony forming units (CFU) and rate of urinary tract infection (UTI) post-cystoscopy. They based their methods for identifying bacteria on the scope on a previous study performed by Alvarado, which also supports the use of EndoSheath in replacement of reprocessing with high level disinfection. The results of this study were found to be very similar to those found previously by Baker and by McCombine; that is, EndoSheath acts as a viral barrier versus bacteria and there is no higher rate of UTI with the use of EndoSheath than with standard cystoscopes. Within this study, there were no incidences of bacterial growth on the scope shaft or control body found in the EndoSheath group, while four scopes in the standard group were identified to have staphylococcus coagulase negative. This provides further evidence that EndoSheath prevents microbes from colonizing on the enclosed PrimeSight cystoscope when the system is introduced into a patient. Secondarily to that, all patients were tested for UTI two weeks after undergoing cystoscopy. Two patients from the standard cystoscopy group showed positive cultures at that time, while no patients from the EndoSheath group were found to be positive for a UTI. This level of safety, when coupled with increased efficiency and greater cost-effectiveness make EndoSheath a game-changer for many urology practices.

Drastic Improvements in Reprocessing Time

The Wake Study researchers also recorded total time required to prepare the system for a procedure, perform the procedure, and reprocess the scope in preparation for the next procedure. They confirmed what other studies have already found: reprocessing time is significantly shorter when using the EndoSheath. With the conventional system, total reprocessing time was 62.1 (± 12.8) minutes while endoscope reprocessing following use of the EndoSheath barrier took 4.2 (± 1.3) minutes. This finding is consistent with previous studies performed involving EndoSheath, as well as the sentiments of the staff at Affiliated Urologists in the video below.

Potential impact on practice finances

The Wake Forest group used the recorded time spent and analyzed the staff cost for that time spent for three different medical professionals: Registered Nurse (RA), Licensed Practical Nurse (LPN), and Certified Nursing Assistant (CNA). This staff hourly cost was added to other components, including cost of disposables (sheaths, gloves, gels), cost of reprocessing chemicals, and other capital purchases for the cystoscopy system. The drastic reduction in reprocessing time was the key contributor to lower per-procedure cost as staff hourly pay was applied to each. Total cost per procedure for the Visera system ranged from $19.88 for a CNA and $35.19 for a RN, while the total cost per procedure for the EndoSheath system ranged from $1.66 for a CNA to $6.30 for a RN.  Cost savings was also a benefit recognized by Affiliated Urologists in this second video.

For more information about the research studies performed on EndoSheath, view the clinical abstracts available on the Cogentix Medical website.

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