InterStim Micro Post Market Clinical Follow-up Study

Overactive Bladder Clinical Trial

— ELITE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04506866
• Other study ID #: MDT19006
• Status: Terminated
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: December 8, 2023

Study information

• Verified date: January 2024
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 148
• Est. completion date: December 8, 2023
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence
• Non-obstructive Urinary Retention
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Retention

Intervention

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

Locations

Country	Name	City	State
Canada	University Urology Associates	Toronto	Ontario
France	CHU de Nantes - Hôtel Dieu	Nantes
France	Centre Hospitalier Universitaire De Rennes	Rennes
Netherlands	Maastricht Universitair Medisch Centrum (MUMC)	Maastricht
Switzerland	Kantonsspital St.Gallen	Saint Gallen
United Kingdom	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 States	Urology Partners of North Texas	Arlington	Texas
United States	Montefiore Medical Center	Bronx	New York
United States	The Christ Hospital	Cincinnati	Ohio
United States	Saint Elizabeth Healthcare	Edgewood	Kentucky
United States	University of Texas Medical Branch	Galveston	Texas
United States	Prisma Health	Greenville	South Carolina
United States	East Coast Institute for Research	Jacksonville	Florida
United States	First Urology	Jeffersonville	Indiana
United States	University of Louisville Hospital	Louisville	Kentucky
United States	West Virginia University	Morgantown	West Virginia
United States	Colon Surgeons of Charleston	Mount Pleasant	South Carolina
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Louisiana State University Health Sciences Center New Orleans	New Orleans	Louisiana
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Florida Urology Partners	Tampa	Florida
United States	Minnesota Urology (Woodbury)	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Canada,  France,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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