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

Not Applicable

Terminated

• Conditions: Fecal Incontinence; Overactive Bladder; Non-obstructive Urinary Retention
• Interventions: Device: InterStim Micro

• Registration Number: NCT04506866
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Study Start: 2020-08-25
• Primary Completion: 2022-12-19
• Study Completion: 2023-12-08
• Results First Submitted: 2023-12-11
• Results First Submitted QC: 2024-01-04
• Results First Posted: 2024-01-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Incontinence Cohort	InterStim Micro	Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.
Non-Obstructive Urinary Retention Cohort	InterStim Micro	Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
Overactive Bladder Cohort	InterStim Micro	Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.

Primary Outcome Measures

Name	Time	Method
Change From Baseline for HRQL Total Score	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	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	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.

Trial Locations

Locations (24)

East Coast Institute for Research; 🇺🇸 Jacksonville, Florida, United States

Florida Urology Partners; 🇺🇸 Tampa, Florida, United States

First Urology; 🇺🇸 Jeffersonville, Indiana, United States

Saint Elizabeth Healthcare; 🇺🇸 Edgewood, Kentucky, United States

Prisma Health; 🇺🇸 Greenville, South Carolina, United States

Centre Hospitalier Universitaire De Rennes; 🇫🇷 Rennes, France

Maastricht Universitair Medisch Centrum (MUMC); 🇳🇱 Maastricht, Netherlands

Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital; 🇬🇧 London, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Colon Surgeons of Charleston; 🇺🇸 Mount Pleasant, South Carolina, United States

Kantonsspital St.Gallen; 🇨🇭 Saint Gallen, Switzerland

CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States

Louisiana State University Health Sciences Center New Orleans; 🇺🇸 New Orleans, Louisiana, United States

Minnesota Urology (Woodbury); 🇺🇸 Woodbury, Minnesota, United States

Urology Partners of North Texas; 🇺🇸 Arlington, Texas, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University Urology Associates; 🇨🇦 Toronto, Ontario, Canada

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States