Purpose of this Study
We are doing this study to keep tabs on the health status of people who have used, or who plan to use, a Medtronic® medical device to treat a urological or digestive disorder. This study is a registry, which means that it will allow us to compile information about how well these products work and how well they improve patients' quality of life.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Have a urological or digestive disorder (e.g., urinary incontinence or constipation) that is being treated, or that is planned to be treated, with a Medtronic® medical device</li>
<li>Are willing to be accessible to the study team</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: paige.green@duke.edu">paige.green@duke.edu.</a>
<li>Have a urological or digestive disorder (e.g., urinary incontinence or constipation) that is being treated, or that is planned to be treated, with a Medtronic® medical device</li>
<li>Are willing to be accessible to the study team</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: paige.green@duke.edu">paige.green@duke.edu.</a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you agree to participate in this registry, the registry staff will collect data about you and your health, together called "health information". You will be in the registry as long as you have a Medtronic® device, but you are able to withdraw at any point following your consent to join.
If you choose to join this study, it is important that you:<ul>
<li>Tell your doctor about your medical history</li>
<li>Attend all visits scheduled with your doctor, and reschedule any missed appointments as soon as possible</li>
<li>Report any injuries, hospitalizations, emergency room visits, symptoms, or complaints to your doctor as soon as possible</li></ul>
If you choose to join this study, it is important that you:<ul>
<li>Tell your doctor about your medical history</li>
<li>Attend all visits scheduled with your doctor, and reschedule any missed appointments as soon as possible</li>
<li>Report any injuries, hospitalizations, emergency room visits, symptoms, or complaints to your doctor as soon as possible</li></ul>
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Medtronic Post-Approval Network (PAN) Product Surveillance Registry
Principal Investigator
Nazema
Siddiqui
Protocol Number
PRO00043553
NCT ID
NCT01524276
Enrollment Status
Open to Enrollment