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InterStim Micro Post Market Clinical Follow-up Study (ELITE)

Primary Purpose

Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
InterStim Micro
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

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

Overactive Bladder Cohort

Inclusion Criteria:

  1. Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with greater than or equal to 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
  2. Subjects 18 years of age or older
  3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
  4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging 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 primary stress incontinence or mixed incontinence where the stress component overrides the urge component
  3. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
  4. Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
  5. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
  6. Women who are pregnant or planning to become pregnant
  7. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  8. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Fecal Incontinence Cohort

Inclusion Criteria:

  1. Have a diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate or severe soiling)
  2. Subjects 18 years of age or older
  3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
  4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging 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. Uncorrected high grade internal rectal prolapse
  3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
  4. Women who are pregnant or planning to become pregnant
  5. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  6. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Non-Obstructive Urinary Retention Cohort

Inclusion Criteria:

  1. Have a diagnosis of non-obstructive urinary retention as demonstrated by a 7-day urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations
  2. Chronic non-obstructive urinary retention with an elevated post-void residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.
  3. Subjects 18 years of age or older
  4. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
  5. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
  6. 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. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
  3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy .
  4. Women who are pregnant or planning to become pregnant
  5. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  6. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Sites / Locations

  • East Coast Institute for Research
  • Florida Urology Partners
  • First Urology
  • Saint Elizabeth Healthcare
  • University of Louisville Hospital
  • Louisiana State University Health Sciences Center New Orleans
  • Ochsner Medical Center
  • Minnesota Urology (Woodbury)
  • Montefiore Medical Center
  • The Christ Hospital
  • University of Pennsylvania
  • Prisma Health
  • Colon Surgeons of Charleston
  • Vanderbilt University Medical Center
  • Urology Partners of North Texas
  • University of Texas Medical Branch
  • West Virginia University
  • University Urology Associates
  • CHU de Nantes - Hôtel Dieu
  • Centre Hospitalier Universitaire De Rennes
  • Maastricht Universitair Medisch Centrum (MUMC)
  • Kantonsspital St.Gallen
  • Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Overactive Bladder Cohort

Fecal Incontinence Cohort

Non-Obstructive Urinary Retention Cohort

Arm Description

Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.

Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.

Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.

Outcomes

Primary Outcome Measures

Overactive Bladder Cohort
To demonstrate an improvement in Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) total score at 3 months post-implant compared to baseline
Fecal Incontinence Cohort
To demonstrate an improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline
Non-Obstructive Urinary Retention Cohort
To demonstrate an improvement in number of clean intermittent self-catheterizations (CISC) per day at 3 months post-implant compared to baseline

Secondary Outcome Measures

Full Information

First Posted
August 3, 2020
Last Updated
July 20, 2023
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT04506866
Brief Title
InterStim Micro Post Market Clinical Follow-up Study
Acronym
ELITE
Official Title
Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
November 2024 (Anticipated)

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

5. Study Description

Brief Summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Overactive Bladder Cohort
Arm Type
Other
Arm Description
Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.
Arm Title
Fecal Incontinence Cohort
Arm Type
Other
Arm Description
Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.
Arm Title
Non-Obstructive Urinary Retention Cohort
Arm Type
Other
Arm Description
Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
Intervention Type
Device
Intervention Name(s)
InterStim Micro
Intervention Description
Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use
Primary Outcome Measure Information:
Title
Overactive Bladder Cohort
Description
To demonstrate an improvement in Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) total score at 3 months post-implant compared to baseline
Time Frame
3 months
Title
Fecal Incontinence Cohort
Description
To demonstrate an improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline
Time Frame
3 months
Title
Non-Obstructive Urinary Retention Cohort
Description
To demonstrate an improvement in number of clean intermittent self-catheterizations (CISC) per day at 3 months post-implant compared to baseline
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Overactive Bladder Cohort Inclusion Criteria: Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with greater than or equal to 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge incontinence in 72 hours Subjects 18 years of age or older Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging 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 primary stress incontinence or mixed incontinence where the stress component overrides the urge component Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy Women who are pregnant or planning to become pregnant 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. Fecal Incontinence Cohort Inclusion Criteria: Have a diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate or severe soiling) Subjects 18 years of age or older Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging 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) Uncorrected high grade internal rectal prolapse Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy Women who are pregnant or planning to become pregnant 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. Non-Obstructive Urinary Retention Cohort Inclusion Criteria: Have a diagnosis of non-obstructive urinary retention as demonstrated by a 7-day urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations Chronic non-obstructive urinary retention with an elevated post-void residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions. Subjects 18 years of age or older Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging 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) Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy . Women who are pregnant or planning to become pregnant 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
Mylène Champs
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
East Coast Institute for Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
First Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Saint Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017-3403
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University Health Sciences Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Minnesota Urology (Woodbury)
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Colon Surgeons of Charleston
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Urology Partners of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
University Urology Associates
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1E2
Country
Canada
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Hospitalier Universitaire De Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Maastricht Universitair Medisch Centrum (MUMC)
City
Maastricht
Country
Netherlands
Facility Name
Kantonsspital St.Gallen
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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InterStim Micro Post Market Clinical Follow-up Study

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