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

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: NCT04506866
Recruitment Status : Active, not recruiting
First Posted : August 10, 2020
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Fecal Incontinence Non-obstructive Urinary Retention Device: InterStim Micro Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study
Actual Study Start Date : August 25, 2020
Actual Primary Completion Date : December 19, 2022
Estimated Study Completion Date : November 2024
Arms and Interventions
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Arm Intervention/treatment
Overactive Bladder Cohort
Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.
 Device: InterStim Micro
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
Fecal Incontinence Cohort
Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.
 Device: InterStim Micro
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
Non-Obstructive Urinary Retention Cohort
Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
 Device: InterStim Micro
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


Outcome Measures
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Primary Outcome Measures :
  1. Overactive Bladder Cohort [ Time Frame: 3 months ]
    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

  2. Fecal Incontinence Cohort [ Time Frame: 3 months ]
    To demonstrate an improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline

  3. Non-Obstructive Urinary Retention Cohort [ Time Frame: 3 months ]
    To demonstrate an improvement in number of clean intermittent self-catheterizations (CISC) per day at 3 months post-implant compared to baseline


Eligibility Criteria
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Information from the National Library of Medicine

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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

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.
Contacts and Locations
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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): NCT04506866


Locations
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Sponsors and Collaborators
MedtronicNeuro
Investigators
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Study Director: Mylène Champs Medtronic
More Information
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT04506866    
Other Study ID Numbers: MDT19006
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
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
Additional relevant MeSH terms:
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Fecal Incontinence
Urinary Bladder, Overactive
Urinary Retention
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urination Disorders