Overactive BladderELITENCT04506866
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
A study testing InterStim Micro in people with Overactive Bladder and Fecal Incontinence, run by MedtronicNeuro at 24 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention
- What is being tested?
- InterStim Micro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 25 Aug 2020to 8 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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)
Show all 16Show fewer
- 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 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
Who cannot join
- 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
Show all 22Show fewer
- 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 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
- 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.
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
United States17 sites
Urology Partners of North Texas
Arlington, Texas, 76017
The Christ Hospital
Cincinnati, Ohio, 45219
Saint Elizabeth Healthcare
Edgewood, Kentucky, 41017-3403
University of Texas Medical Branch
Galveston, Texas, 77555
Prisma Health
Greenville, South Carolina, 29605
East Coast Institute for Research
Jacksonville, Florida, 32258
First Urology
Jeffersonville, Indiana, 47130
University of Louisville Hospital
Louisville, Kentucky, 40202
West Virginia University
Morgantown, West Virginia, 26506
Colon Surgeons of Charleston
Mt. Pleasant, South Carolina, 29464
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
Ochsner Medical Center
New Orleans, Louisiana, 70121
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Florida Urology Partners
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Minnesota Urology (Woodbury)
Woodbury, Minnesota, 55125
France2 sites
CHU de Nantes - Hôtel Dieu
Nantes, 44000
Centre Hospitalier Universitaire De Rennes
Rennes, 35033
United Kingdom2 sites
Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, SE1 7EH
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Netherlands1 site
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht
About this study
Official title: 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.
- Being tested
- InterStim Micro
- Medical subject headings
- Urinary Bladder, Overactive, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterStim MicroDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Overactive Bladder Cohort | Other | Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms. Receives: 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. Receives: 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. Receives: Device: InterStim Micro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start25 Aug 2020
- Primary completion19 Dec 2022
- Study completion8 Dec 2023
Why it stopped: Due to the extension of the clinical study duration and to avoid further delaying the reporting of results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mylène Champs, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506866
- Sponsor's protocol ID
- MDT19006
- Acronym
- ELITE
- Status last verified
- Dec 2024
- First submitted
- 3 Aug 2020
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40186665
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT04506866
- Acronym / sponsor ID
- ELITE / MDT19006
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the extension of the clinical study duration and to avoid further delaying the reporting of results.
- Enrolment
- 148 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overactive Bladder Cohort | Other | Device: InterStim MicroSubjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms. |
| Fecal Incontinence Cohort | Other | Device: InterStim MicroSubjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms. |
| Non-Obstructive Urinary Retention Cohort | Other | Device: InterStim MicroSubjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterStim MicroEligible 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 | Device | Fecal Incontinence Cohort, Non-Obstructive Urinary Retention Cohort, Overactive Bladder Cohort |
Primary outcome
Change From Baseline for HRQL Total Score
Time frame: 3 months
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.
Change From Baseline in CCIS Score
Time frame: 3 months
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.
Change From Baseline in the Number of CISC/Day
Time frame: 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40186665Elterman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mylène Champs study director
Medtronic
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterStim Micro in people with Overactive Bladder and Fecal Incontinence, run by MedtronicNeuro at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, France, United Kingdom, Canada, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline for HRQL Total Score (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04506866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.