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InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study (BASIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016324
Recruitment Status : Completed
First Posted : July 11, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Brief Summary:
Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urinary Urge Incontinence Urgency-frequency Syndrome Device: InterStim Basic Evaluation lead and foramen needle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim Basic Evaluation Lead.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
Actual Study Start Date : November 28, 2019
Actual Primary Completion Date : October 6, 2020
Actual Study Completion Date : October 9, 2020

Arm Intervention/treatment
Basic evaluation
Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.
Device: InterStim Basic Evaluation lead and foramen needle
Commercial devices within their intended use as described in approved Instructions for Use.




Primary Outcome Measures :
  1. Motor or sensory response(s) during lead placement [ Time Frame: During lead implant ]
    To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016324


Locations
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United States, Florida
Pinellas Urology
Saint Petersburg, Florida, United States, 33710
Florida Urology Partners
Tampa, Florida, United States, 33606
United States, Minnesota
Minnesota Urology (Plymouth)
Plymouth, Minnesota, United States, 55441
United States, New Jersey
Urologic Research and Consulting
Englewood, New Jersey, United States, 07631
United States, North Carolina
FirstHealth Urogynecology
Hamlet, North Carolina, United States, 28345
United States, Ohio
Wright State Physicians
Fairborn, Ohio, United States, 45234-2640
United States, South Carolina
Prisma Health
Greenville, South Carolina, United States, 29605-4627
Southern Urogynecology
West Columbia, South Carolina, United States, 29169-3456
United States, Texas
Urology Partners of North Texas
Arlington, Texas, United States, 76017
United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23642-1815
Canada, Ontario
University Urology Associates
Toronto, Ontario, Canada, M5T 2S8
Netherlands
Radboud UMC
Nijmegen, Netherlands, 6525 GA
United Kingdom
The Bristol Urological Institute
Bristol, United Kingdom, BS10 5NB
The Newcastle upon Tyne Hospitals
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Salford Royal NHS Foundation Trust
Salford, United Kingdom, M68HD
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Study Director: BASIC Clinical Research Study Team Medtronic
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT04016324    
Other Study ID Numbers: MDT19002
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by MedtronicNeuro:
Overactive Bladder
Urinary Urge Incontinence
Urgency-frequency Syndrome
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Urinary Incontinence
Urination Disorders