InterStim Micro Post Market Clinical Follow-up Study (ELITE)

Stopped early · Not applicable

Conditions studied: Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention

In brief

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.

Key facts

Study ID

NCT04506866

Run by

MedtronicNeuro

People needed

148

Starts

2020-08-25

Expected to finish

2023-12-08

Last updated by the study team

2024-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Exclusion Criteria:
• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
• Uncorrected high grade internal rectal prolapse
• 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.
• Non-Obstructive Urinary Retention Cohort
• Inclusion Criteria:
• Have a diagnosis of non-obstructive urinary retention as demonstrated by a 7-day urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations

Where it is running

• East Coast Institute for Research — Jacksonville, Florida, United States
• Florida Urology Partners — Tampa, Florida, United States
• First Urology — Jeffersonville, Indiana, United States
• Saint Elizabeth Healthcare — Edgewood, Kentucky, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Louisiana State University Health Sciences Center New Orleans — New Orleans, Louisiana, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Minnesota Urology (Woodbury) — Woodbury, Minnesota, United States
• Montefiore Medical Center — The Bronx, New York, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Prisma Health — Greenville, South Carolina, United States
• Colon Surgeons of Charleston — Mt. Pleasant, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Urology Partners of North Texas — Arlington, Texas, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• West Virginia University — Morgantown, West Virginia, United States
• University Urology Associates — Toronto, Ontario, Canada
• CHU de Nantes - Hôtel Dieu — Nantes, France
• Centre Hospitalier Universitaire De Rennes — Rennes, France
• Maastricht Universitair Medisch Centrum (MUMC) — Maastricht, Netherlands
• Kantonsspital St.Gallen — Sankt Gallen, Switzerland
• Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital — London, United Kingdom
• The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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