Clinical verification of Catheasy

Important results from the project

The purpose of the clinical verification was that more clinics and more care personnel should have used the method on more patients. The goal of the project was to confirm that Catheay is a safe, user friendly, quick, easy to perform method with low pain perception. Another goal was that the clinics involved in the clinical verification will implement Catheasy in their daily routine. The project have fulfilled its purpose and objective, but in smaller scale, since the clinic that recruited patients report a very positive experience of Catheasy and may consider implementing the method.

Expected long term effects

The result of the clinical verification is that the care personnel that have used Catheasy confirm that it is a safe, user friendly, quick, easy to perform method with very low or no pain. A positive result from the clinical verification is that the personnel from the active clinic have become positive clinical references for Catheasy.

Approach and implementation

The plan was to in a few clinics with multiple users verify Catheasy on at least 50 patients. The recruitment of patients started during autumn 2017, but when the CRO did not succeed with the planned recruitment using social media it became evident that the clinical study could not be completed within the time frame and budget available and the study was prematurely stopped. It has proven that patients in need of urinary catheters is a difficult group of patients to recruit in a clinical study, probably because they are extensively distributed in the care system.