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

Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study

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.

Study Overview

• Status: Terminated
• Conditions: Overactive Bladder; Fecal Incontinence; Non-obstructive Urinary Retention
• Intervention / Treatment: Device: InterStim Micro

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1E2
      • University Urology Associates
• France
  • Nantes, France, 44000
    • CHU de Nantes - Hôtel Dieu
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes
• Netherlands
  • Maastricht, Netherlands
    • Maastricht Universitair Medisch Centrum (MUMC)
• Switzerland
  • Saint Gallen, Switzerland, 9007
    • Kantonsspital St.Gallen
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
• United States
  • Florida
    • Jacksonville, Florida, United States, 32258
      • East Coast Institute for Research
    • Tampa, Florida, United States, 33606
      • Florida Urology Partners
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology
  • Kentucky
    • Edgewood, Kentucky, United States, 41017-3403
      • Saint Elizabeth Healthcare
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center New Orleans
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Urology (Woodbury)
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health
    • Mount Pleasant, South Carolina, United States, 29464
      • Colon Surgeons of Charleston
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Arlington, Texas, United States, 76017
      • Urology Partners of North Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline for HRQL Total Score	The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL).8 Specifically, The OAB-q consists of an 8-item symptom bother scale and 25-item HRQL scale with 4 domains: coping (8 items), concern/worry (7 items), sleep (5 items) and social interaction (5 items). The score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. We are reporting the change from baseline for HRQL total score. If the change is positive, it means a better quality of life. The higher the positive change is, the better the quality of life is.	3 months
Change From Baseline in CCIS Score	The Cleveland Clinic Incontinence Score (Wexner Score) is an established 5-item questionnaire that was developed to assess the frequency and severity of fecal incontinence. CCIS-Wexner score ranges between 0 and 20. Higher scores indicate worse incontinence. We are reporting the change from baseline for CCIS Score. If the change is negative, the quality of life improved from baseline. The more negative the score is, the better the quality of life is.	3 months
Change From Baseline in the Number of CISC/Day	Subjects reported the clean intermittent self-catheterizations on voiding diaries for 7 consecutive days. We are reporting the change from baseline. If the change is negative, the quality of life is improved from baseline.	3 months

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Study Director: Mylene Champs, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Urinary Bladder Diseases; Urinary Bladder, Overactive; Urinary Retention; Fecal Incontinence
• Other Study ID Numbers: MDT19006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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