Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedtronicNeuro
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Subjects 18 years of age or older
2. Candidate for sacral neuromodulation in accordance with the InterStim System labeling
3. Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary
4. Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol
5. Willing and able to provide signed and dated informed consent
You may not be if
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
2. Have implantable pacemakers, or defibrillators
3. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
4. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the InterStim System labeling
5. Women who are pregnant or planning to become pregnant during participation in the study
6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements
7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
