Welcome to the ELITONE-UUI Clinical Study
Congratulations on enrolling in our clinical research study of urge urinary incontinence. (If you haven’t signed the consent form, sign here.) This page outlines four important next steps.
(Now) Complete a pre-study questionnaire. This helps us understand how bothered you are by your incontinence. This should take approximately 10 minutes.
(Now) Complete the $50 deposit using our secure payment system. The deposit will be returned when you complete the study.*
(Now) Record your leaks, bathroom visits, and pad use for seven days. Download and print the 7-day Baseline Log to keep track. At the end of the study we will make comparisons to this baseline data to see if you improved.**
(In 7 Days) Enter the data from your Baseline Log into an online form. This speeds up the review process and helps us get you started with the treatments.
What Happens Next?
After you complete those four steps we will review your baseline data and mail you the study device. The package will include detailed instructions on how to apply and operate the device, as well as how to keep track of your treatments and leaks. As a reminder, you will need to:
- Use the device 20 minutes a day, 5x per week, for 6 weeks.
- Keep track of leaks, bathroom visits, and pad use EVERY DAY for six weeks.
- After six week of use, complete a post-study survey and return all the study materials.
Still Have Questions?
If you have questions now, or at any time during the study, you can email email@example.com. During business hours (9-5 Eastern) you can call 978-435-4324. Outside of business hours you can call 781-985-0563. Below are responses to a few common questions.
*Why do I have to pay to participate?
The payment is just a deposit. It is very important that all participants complete the clinical study. In our past research, participants have ‘disappeared’ after receiving the device. This compromises the results and diminishes the effort put in by those women who completed all the necessary steps. By taking a deposit we hope to encourage all participants to complete the study. If you need to drop out partway through, you will still get your deposit back once you return the materials.
I can’t afford the deposit. Can you waive it?
We may to waive the deposit for a limited number of participants with financial need. Please email firstname.lastname@example.org if you feel you qualify. You will be placed on a waiting list and contacted if a position opens up.
**What if my baseline data doesn’t meet the inclusion criteria?
It is important that you track your leaks, bathroom visits, and pad use accurately. We will review your 7-day baseline data, and if you leak too much or too little we may decide to exclude you from the study. We will let you know right away and refund your deposit immediately.