NCT04506866: ELITE

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

Terminated NA Results posted Last updated 27 December 2024

What this trial tests

NA trial testing InterStim Micro in Overactive Bladder in 148 participants. Terminated before completion.

Timeline

25 August 2020

Primary endpoint
19 December 2022

8 December 2023

Quick facts

Lead sponsor	MedtronicNeuro
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	148
Start date	25 August 2020
Primary completion	19 December 2022
Estimated completion	8 December 2023
Sites	24 locations across France, Netherlands, United Kingdom, Canada, Switzerland, United States

Drugs / interventions tested

• InterStim Micro

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →
• Fecal Incontinence — all drugs for Fecal Incontinence →
• Non-obstructive Urinary Retention — all drugs for Non-obstructive Urinary Retention →

Sponsor

MedtronicNeuro — full company profile →

Who can join

18 and older, any sex, with Overactive Bladder or Fecal Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline for HRQL Total Score Primary · 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 ch

Group	Value	95% CI
Overactive Bladder Cohort	33	± 24.2

Change From Baseline in CCIS Score Primary · 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.

Group	Value	95% CI
Fecal Incontinence Cohort	-4.06	± 3.696

Change From Baseline in the Number of CISC/Day Primary · 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.

Group	Value	95% CI
Non-Obstructive Urinary Retention Cohort	-3.52	± 2.901

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Overactive Bladder Cohort

Serious: 3/68 (4%)

Deaths: 1/68

Fecal Incontinence Cohort

Serious: 8/53 (15%)

Deaths: 0/53

Non-Obstructive Urinary Retention Cohort

Serious: 4/27 (15%)

Deaths: 0/27

Serious adverse events (20 terms)

Reaction	System	Overactive Bladder Cohort	Fecal Incontinence Cohort	Non-Obstructive Urinary Re…
Abdominal pain	Gastrointestinal disorders	—	—	—
Implant site pain	General disorders	—	—	—
Sepsis	Infections and infestations	—	—	—
Superinfection	Infections and infestations	—	—	—
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	—	—	—
Cystitis	Infections and infestations	—	—	—
Pyelonephritis	Infections and infestations	—	—	—
Pancreatic carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Cerebellar infarction	Nervous system disorders	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—
Ileus	Gastrointestinal disorders	—	—	—
Cholangitis	Hepatobiliary disorders	—	—	—
Abscess limb	Infections and infestations	—	—	—
COVID-19	Infections and infestations	—	—	—
Craniocerebral injury	Injury, poisoning and procedural complications	—	—	—
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	—	—	—
Acute myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Overactive Bladder Cohort	Fecal Incontinence Cohort	Non-Obstructive Urinary Re…
Implant site pain	General disorders	—	—	—
Medical device site pain	General disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Device stimulation issue	Product Issues	—	—	—
Medical device site discomfort	General disorders	—	—	—
Sciatica	Nervous system disorders	—	—	—

Most-reported serious reactions: Abdominal pain, Implant site pain, Sepsis, Superinfection, Vascular pseudoaneurysm, Cystitis, Pyelonephritis, Pancreatic carcinoma stage IV.

Data from ClinicalTrials.gov NCT04506866 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Post-Market Study Evaluating Performance of the Rechargeable InterStim™ Micro System in Fecal Incontinence Patients.
   Elterman D, Murphy M, Krlin R, Levine R, et al · · 2025 · PMID 40186665 · DOI 10.1007/s00192-025-06127-9