Clinical Study
Preliminary Evaluation of the UroStride™ Briefs and SoftGrip™ Patch System for Comfort and Usability
HAITEC Medical is conducting a research study to evaluate the fit, comfort, and usability of an investigational catheter support system called the UroStride™ Briefs and SoftGrip™ Patch System. The study is intended to gather participant feedback that may help improve future product design, sizing, instructions for use, and training materials.
The study device is investigational and is not approved by the U.S. Food and Drug Administration for the purposes being evaluated in this study.
CAUTION—Investigational Device. Limited by Federal law to investigational use.
Clinical Study Contact
Interested in learning about our upcoming clinical study?
If you are interested in learning more about the UroStride™ research study, complete the form below and a member of the study team will contact you with additional information Completing this form does not enroll you in the study and does not obligate you to participate. The information you provide will be used only so the study team can contact you with additional information about the study.
Who May Qualify
You may qualify for this study if you:
- Are male and 18 years of age or older
- Currently use an indwelling Foley catheter
- Are able to put on and remove underwear with little or no assistance
- Are willing to complete study questionnaires
Additional eligibility requirements may apply.
The study team will review these requirements with you before you decide whether to participate.
Participation
If you choose to participate, you may be asked to:
- Attend one study visit lasting approximately 45–60 minutes
- Review study instructions and educational materials
- Try on the investigational UroStride™ Briefs and SoftGrip™ Patch System
- Perform simple movements such as sitting, standing, walking, bending, and reaching
- Complete questionnaires about comfort, fit, and usability
You may also be given the option to wear the study product for the remainder of the day and complete a brief follow-up questionnaire.
Participants may receive up to $50 in gift cards for completing study-related activities.
Important Information
- Participation is entirely voluntary.
- Choosing not to participate will not affect your current or future medical care.
- You may or may not experience any direct benefit from participating.
- Information collected during the study will be kept confidential to the extent permitted by law.
- You may ask the study team questions before deciding whether to participate.
