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出境医 / 临床实验 / InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study (BASIC)

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

Study Description
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

Study Design
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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
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE November 28, 2019
Actual Primary Completion Date October 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
Official Title  ICMJE InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Overactive Bladder
  • Urinary Urge Incontinence
  • Urgency-frequency Syndrome
Intervention  ICMJE Device: InterStim Basic Evaluation lead and foramen needle
Commercial devices within their intended use as described in approved Instructions for Use.
Study Arms  ICMJE Basic evaluation
Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.
Intervention: Device: InterStim Basic Evaluation lead and foramen needle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2020) 		110
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		100
Actual Study Completion Date  ICMJE October 9, 2020
Actual Primary Completion Date October 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04016324
Other Study ID Numbers  ICMJE MDT19002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MedtronicNeuro
Study Sponsor  ICMJE MedtronicNeuro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: BASIC Clinical Research Study Team Medtronic
PRS Account MedtronicNeuro
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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