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

Primary Purpose

Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
InterStim Basic Evaluation lead and foramen needle
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pinellas Urology
  • Florida Urology Partners
  • Minnesota Urology (Plymouth)
  • Urologic Research and Consulting
  • FirstHealth Urogynecology
  • Wright State Physicians
  • Prisma Health
  • Southern Urogynecology
  • Urology Partners of North Texas
  • Urology of Virginia
  • University Urology Associates
  • Radboud UMC
  • The Bristol Urological Institute
  • The Newcastle upon Tyne Hospitals
  • Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Basic evaluation

Arm Description

Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2019
Last Updated
November 22, 2021
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT04016324
Brief Title
InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
Acronym
BASIC
Official Title
InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
October 6, 2020 (Actual)
Study Completion Date
October 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome
Keywords
Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basic evaluation
Arm Type
Other
Arm Description
Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.
Intervention Type
Device
Intervention Name(s)
InterStim Basic Evaluation lead and foramen needle
Intervention Description
Commercial devices within their intended use as described in approved Instructions for Use.
Primary Outcome Measure Information:
Title
Motor or Sensory Response(s) During Lead Placement - by Subject
Description
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.
Time Frame
During lead implant procedure (approximately 20 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BASIC Clinical Research Study Team
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
Pinellas Urology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Minnesota Urology (Plymouth)
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Urologic Research and Consulting
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
FirstHealth Urogynecology
City
Hamlet
State/Province
North Carolina
ZIP/Postal Code
28345
Country
United States
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45234-2640
Country
United States
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605-4627
Country
United States
Facility Name
Southern Urogynecology
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169-3456
Country
United States
Facility Name
Urology Partners of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23642-1815
Country
United States
Facility Name
University Urology Associates
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Radboud UMC
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
The Bristol Urological Institute
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M68HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study

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