GentleCath Air for Men Sleeve Study

You are invited to participate in the GentleCath Air for Men Sleeve Study. The goal of this study is to obtain your thoughts regarding 2 different modifications to the sleeve of the product.

This study is being conducted by Convatec with the assistance of 180 Medical.

The purpose of your participation in this research is to help Convatec determine concepts to develop further based on your experience as a catheter user. You were selected as a possible participant in this study because you have been using a catheter for longer than 3 months.

Participation in this study is voluntary. If you agree to participate in this study, you would be interviewed for about 60 minutes. We will ask a brief summary of your background (10 min) as it relates to intermittent catheters, your first impressions of the prototypes, usability observations, and detailed comparisons around wetting, unpacking, simulated insertion, emptying the bag, and disposal (45 min). Finally, a wrap- up (5 min).

Participating in this study may not benefit you directly, but it will help us learn. You may find answering some of the questions uncomfortable, embarrassed, and/or inconvenienced. You may skip any questions you don’t want to answer and you may end the interview at any time.

The records from this study will be kept as confidential as possible. No individual identities will be used in any reports or publications resulting from the study. The recording will be stored on a secure server and will be given codes and stored separately from any names or other direct identification of participants. Research information will be kept in locked files at all times. Only research personnel will have access to the files and only those with an essential need to see names or other identifying information will have access to that particular file. After the study is completed, an anonymous report will be generated and the recording will be permanently deleted from the secure server after 30 days.

Your decision whether or not to participate in this study is voluntary and will not affect your relationship with 180 Medical. If you choose not to participate in this study, you can withdraw your consent and discontinue participation at any time without prejudice.

If you have any questions about the study, please contact Morgan Ledford by emailing MorganLedford@180Medical.com

I have read and I understand the provided information, and have received answers to any questions I asked. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. I understand that I will be given a copy of this consent form. I am at least 18 years old, and voluntarily agree to take part in this study.