A clinical trial is a voluntary research study conducted with patients to evaluate the safety or effectiveness of a new or existing medical treatment, drug, or device. The goal of a clinical trial is to find new or improved methods of treating, preventing, or diagnosing different medical conditions.
The goal of the ELITE study is to better understand how living with Medtronic’s InterStim™ Micro system impacts bladder or bowel control symptoms, and everyday life. The InterStim™ Micro system has already been FDA-approved and is commercially available for patients with bladder and bowel control issues.
Some of the symptoms, or changes that will be measured/tracked during this study include:
For a full description of the ELITE study, visit clinicaltrials.gov
The InterStim™ Micro system is an implantable system that targets the sacral nerves of the lower back to help the bladder or bowel function normally again. This treatment is also known as sacral neuromodulation (SNM). The InterStim™ Micro system has already been FDA-approved and is commercially available to treat bladder and bowel control issues such as overactive bladder, urinary retention, and fecal incontinence.
If you participate in the study, all the risks of getting the InterStim™ Micro System implanted and SNM therapy are the same whether you are in the study or not.
Your study physician will assess if you are eligible for the ELITE study based on certain criteria.
The ELITE study may last for up to two years. Below is a high-level summary of what you can expect if you participate in the study.
Note: As a volunteer participant, you can exit the study at any time.
Before enrolling in the study, you will meet with a physician at one of our ELITE study locations. During this meeting, your physician will screen you to determine if you are eligible for the study. If your physician determines you are a good candidate to enroll, you will be asked to sign a consent form to participate.
Once the study begins, you will be asked to track your symptoms related to bladder or bowel control for 3 to 7 days. If you are eligible after this initial tracking period, you will be scheduled for an InterStim™ evaluation. This lead will allow you to “try out” the treatment for 3 to 14 days before moving forward with long-term therapy.
If you achieve success during your evaluation, your doctor may decide to move forward with long-term therapy. Long-term therapy includes receiving the implanted InterStim™ Micro device and tracking your symptoms over the course of a two-year period. You will be scheduled for regular appointments with your study physician throughout this phase of the study.
Note: Long-term therapy is completely adjustable, reversible, and full-body MRI eligible.*
You will be paid for your time spent keeping a detailed diary, completion of questionnaires and other documentation, for your hours missed from work or other normal activities, transportation, and other related costs that may be incurred for your study participation and visits.
To participate in the study, you will need to sign a consent form and the Authorization to Use and Disclose Health Information. If you decide to participate in the study, Medtronic (including, its agents and contractors) and others who work with the study will see health information about you.
Medtronic will keep your health information confidential in accordance with all applicable laws and regulations. Any reports or publications about the study or any other research will not include your name or a description of you. Information received during the study will not be used to market to you; your name will not be placed on any mailing lists or sold to anyone for marketing purposes.
Under certain conditions. See approved labeling for details. Patients with InterStim™ SureScan MRI leads only.