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

NCT04506866 | Terminated Results FDA Device

• 1 other identifier: MDT19006
• Study Type: interventional
• Target: 148
• Locations: 6 countries
• Sites: 24

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.

Conditions

Overactive Bladder; Fecal Incontinence; Non-obstructive Urinary Retention

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Overactive Bladder Cohort

OTHER

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

Device: InterStim Micro

Fecal Incontinence Cohort

OTHER

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

Device: InterStim Micro

Non-Obstructive Urinary Retention Cohort

OTHER

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

Interventions

InterStim Micro DEVICE

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; Non-Obstructive Urinary Retention Cohort; Overactive Bladder Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (24)

East Coast Institute for Research

Jacksonville, Florida, 32258, United States

Location

Florida Urology Partners

Tampa, Florida, 33606, United States

Location

First Urology

Jeffersonville, Indiana, 47130, United States

Location

Saint Elizabeth Healthcare

Edgewood, Kentucky, 41017-3403, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Louisiana State University Health Sciences Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Minnesota Urology (Woodbury)

Woodbury, Minnesota, 55125, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Colon Surgeons of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Urology Partners of North Texas

Arlington, Texas, 76017, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

University Urology Associates

Toronto, Ontario, M5G 1E2, Canada

Location

CHU de Nantes - Hôtel Dieu

Nantes, 44000, France

Location

Centre Hospitalier Universitaire De Rennes

Rennes, 35033, France

Location

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, Netherlands

Location

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

• Elterman D, Murphy M, Krlin R, Levine R, Yaklic J, Michaels J, Bleier J, Paquette I, Farmer R, Xavier K, Papi B, Wu M, Siproudhis L. Post-Market Study Evaluating Performance of the Rechargeable InterStim Micro System in Fecal Incontinence Patients. Int Urogynecol J. 2025 Apr;36(4):913-921. doi: 10.1007/s00192-025-06127-9. Epub 2025 Apr 5.

  PMID: 40186665 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Fecal Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

Enrollment was closed earlier than planned.

Results Point of Contact

• Title: Mylène Champs
• Organization: Medtronic

mylene.champs@medtronic.com

612-433-0600

Study Officials

• Mylène Champs

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 10, 2020
• Study Start: August 25, 2020
• Primary Completion: December 19, 2022
• Study Completion: December 8, 2023
• Last Updated: December 27, 2024
• Results First Posted: January 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); FR (2); GB (2); US (17); CA (1); NL (1)