InterStim Micro Post Market Clinical Follow-up Study (ELITE)
NCT ID: NCT04506866
Last Updated: 2024-12-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
148 participants
INTERVENTIONAL
2020-08-25
2023-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Overactive Bladder Cohort
Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.
InterStim Micro
Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use
Fecal Incontinence Cohort
Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.
InterStim Micro
Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use
Non-Obstructive Urinary Retention Cohort
Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
InterStim Micro
Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use
Interventions
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InterStim Micro
Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use
Eligibility Criteria
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Inclusion Criteria
2. Subjects 18 years of age or older
3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
5. Willing and able to provide signed and dated informed consent
1. 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)
2. Subjects 18 years of age or older
3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
5. Willing and able to provide signed and dated informed consent
1. 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
2. Chronic non-obstructive urinary retention with an elevated post-void residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.
3. Subjects 18 years of age or older
4. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
5. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
6. Willing and able to provide signed and dated informed consent
Exclusion Criteria
2. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
3. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
4. Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
5. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
6. Women who are pregnant or planning to become pregnant
7. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
8. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
Fecal Incontinence Cohort
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
2. Uncorrected high grade internal rectal prolapse
3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
4. Women who are pregnant or planning to become pregnant
5. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
6. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
Non-Obstructive Urinary Retention Cohort
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy .
4. Women who are pregnant or planning to become pregnant
5. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
6. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Mylène Champs
Role: STUDY_DIRECTOR
Medtronic
Locations
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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
Countries
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References
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Elterman D, Murphy M, Krlin R, Levine R, Yaklic J, Michaels J, Bleier J, Paquette I, Farmer R, Xavier K, Papi B, Wu M, Siproudhis L. Post-Market Study Evaluating Performance of the Rechargeable InterStim Micro System in Fecal Incontinence Patients. Int Urogynecol J. 2025 Apr;36(4):913-921. doi: 10.1007/s00192-025-06127-9. Epub 2025 Apr 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT19006
Identifier Type: -
Identifier Source: org_study_id