Status:
TERMINATED
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Lead Sponsor:
MedtronicNeuro
Conditions:
Overactive Bladder
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
Eligibility Criteria
Inclusion
- Overactive Bladder Cohort
- Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with greater than or equal to 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
- Subjects 18 years of age or older
- Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
- Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
- Willing and able to provide signed and dated informed consent
Exclusion
- Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
- Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
- Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
- Women who are pregnant or planning to become pregnant
- Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
- Fecal Incontinence Cohort
- Inclusion Criteria:
- Have a diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate or severe soiling)
- Subjects 18 years of age or older
- Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
- Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
- Willing and able to provide signed and dated informed consent
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2023
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04506866
Start Date
August 25 2020
End Date
December 8 2023
Last Update
December 27 2024
Active Locations (24)
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1
East Coast Institute for Research
Jacksonville, Florida, United States, 32258
2
Florida Urology Partners
Tampa, Florida, United States, 33606
3
First Urology
Jeffersonville, Indiana, United States, 47130
4
Saint Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017-3403