InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
NCT ID: NCT04016324
Last Updated: 2021-11-23
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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COMPLETED
NA
110 participants
INTERVENTIONAL
2019-11-28
2020-10-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Basic evaluation
Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.
InterStim Basic Evaluation lead and foramen needle
Commercial devices within their intended use as described in approved Instructions for Use.
Interventions
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InterStim Basic Evaluation lead and foramen needle
Commercial devices within their intended use as described in approved Instructions for Use.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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BASIC Clinical Research Study Team
Role: STUDY_DIRECTOR
Medtronic
Locations
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Pinellas Urology
St. Petersburg, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Minnesota Urology (Plymouth)
Plymouth, Minnesota, United States
Urologic Research and Consulting
Englewood, New Jersey, United States
FirstHealth Urogynecology
Hamlet, North Carolina, United States
Wright State Physicians
Fairborn, Ohio, United States
Prisma Health
Greenville, South Carolina, United States
Southern Urogynecology
West Columbia, South Carolina, United States
Urology Partners of North Texas
Arlington, Texas, United States
Urology of Virginia
Virginia Beach, Virginia, United States
University Urology Associates
Toronto, Ontario, Canada
Radboud UMC
Nijmegen, , Netherlands
The Bristol Urological Institute
Bristol, , United Kingdom
The Newcastle upon Tyne Hospitals
Newcastle upon Tyne, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT19002
Identifier Type: -
Identifier Source: org_study_id