InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
BASIC
1 other identifier
interventional
110
4 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2019
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedStudy Start
First participant enrolled
November 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2020
CompletedResults Posted
Study results publicly available
November 23, 2021
CompletedNovember 23, 2021
November 1, 2021
10 months
July 9, 2019
October 5, 2021
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Motor or Sensory Response(s) During Lead Placement - by Subject
To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed.
During lead implant procedure (approximately 20 minutes)
Study Arms (1)
Basic evaluation
OTHERSubjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.
Interventions
Commercial devices within their intended use as described in approved Instructions for Use.
Eligibility Criteria
You may qualify if:
- Subjects 18 years of age or older
- Candidate for sacral neuromodulation in accordance with the InterStim System labeling
- Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary
- Willing and able to accurately complete study diaries, questionnaire, attend visits, 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 implantable pacemakers, or defibrillators
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- 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
- Women who are pregnant or planning to become pregnant during participation in the study
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (15)
Pinellas Urology
St. Petersburg, Florida, 33710, United States
Florida Urology Partners
Tampa, Florida, 33606, United States
Minnesota Urology (Plymouth)
Plymouth, Minnesota, 55441, United States
Urologic Research and Consulting
Englewood, New Jersey, 07631, United States
FirstHealth Urogynecology
Hamlet, North Carolina, 28345, United States
Wright State Physicians
Fairborn, Ohio, 45234-2640, United States
Prisma Health
Greenville, South Carolina, 29605-4627, United States
Southern Urogynecology
West Columbia, South Carolina, 29169-3456, United States
Urology Partners of North Texas
Arlington, Texas, 76017, United States
Urology of Virginia
Virginia Beach, Virginia, 23642-1815, United States
University Urology Associates
Toronto, Ontario, M5T 2S8, Canada
Radboud UMC
Nijmegen, 6525 GA, Netherlands
The Bristol Urological Institute
Bristol, BS10 5NB, United Kingdom
The Newcastle upon Tyne Hospitals
Newcastle upon Tyne, NE7 7DN, United Kingdom
Salford Royal NHS Foundation Trust
Salford, M68HD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rianna Rapson (Prin. Clinical Research Specialist)
- Organization
- Medtronic
Study Officials
- STUDY DIRECTOR
BASIC Clinical Research Study Team
Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 11, 2019
Study Start
November 28, 2019
Primary Completion
October 6, 2020
Study Completion
October 9, 2020
Last Updated
November 23, 2021
Results First Posted
November 23, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share