Trial Outcomes & Findings for InterStim Micro Post Market Clinical Follow-up Study (ELITE) (NCT NCT04506866)

Last Updated: 2024-12-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

148 participants

Primary outcome timeframe

3 months

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Overactive Bladder Cohort Subjects with overactive bladder were treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.	Fecal Incontinence Cohort Subjects with fecal incontinence were treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.	Non-Obstructive Urinary Retention Cohort Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
Overall Study STARTED	68	53	27
Overall Study COMPLETED	67	52	25
Overall Study NOT COMPLETED	1	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Number analyzed is different than overall because Race was not collected for sites in EMEA.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overactive Bladder Cohort n=68 Participants Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.	Fecal Incontinence Cohort n=53 Participants Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.	Non-Obstructive Urinary Retention Cohort n=27 Participants Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.	Total n=148 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 13.2 • n=68 Participants	58 years STANDARD_DEVIATION 11 • n=53 Participants	43 years STANDARD_DEVIATION 17.9 • n=27 Participants	57 years STANDARD_DEVIATION 15.1 • n=148 Participants
Sex: Female, Male Female	61 Participants n=68 Participants	48 Participants n=53 Participants	26 Participants n=27 Participants	135 Participants n=148 Participants
Sex: Female, Male Male	7 Participants n=68 Participants	5 Participants n=53 Participants	1 Participants n=27 Participants	13 Participants n=148 Participants
Race/Ethnicity, Customized White	54 Participants n=60 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	37 Participants n=44 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	9 Participants n=10 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	100 Participants n=114 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.
Race/Ethnicity, Customized Black	5 Participants n=60 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	4 Participants n=44 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	0 Participants n=10 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	9 Participants n=114 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.
Race/Ethnicity, Customized Hispanic	1 Participants n=60 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	2 Participants n=44 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	0 Participants n=10 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	3 Participants n=114 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.
Race/Ethnicity, Customized SPANISH/HISPANIC/LATINA	0 Participants n=60 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	1 Participants n=44 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	0 Participants n=10 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	1 Participants n=114 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.
Race/Ethnicity, Customized Asian	0 Participants n=60 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	0 Participants n=44 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	1 Participants n=10 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.	1 Participants n=114 Participants • Number analyzed is different than overall because Race was not collected for sites in EMEA.
Region of Enrollment Canada	4 participants n=68 Participants	12 participants n=53 Participants	3 participants n=27 Participants	19 participants n=148 Participants
Region of Enrollment Netherlands	0 participants n=68 Participants	0 participants n=53 Participants	1 participants n=27 Participants	1 participants n=148 Participants
Region of Enrollment United States	56 participants n=68 Participants	32 participants n=53 Participants	7 participants n=27 Participants	95 participants n=148 Participants
Region of Enrollment United Kingdom	0 participants n=68 Participants	0 participants n=53 Participants	10 participants n=27 Participants	10 participants n=148 Participants
Region of Enrollment France	8 participants n=68 Participants	7 participants n=53 Participants	6 participants n=27 Participants	21 participants n=148 Participants
Region of Enrollment Switzerland	0 participants n=68 Participants	2 participants n=53 Participants	0 participants n=27 Participants	2 participants n=148 Participants
Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL)	44 Total Score STANDARD_DEVIATION 21.7 • n=68 Participants • Number analyzed differs from overall because this score applies only to subjects enrolled in the OAB cohort and was not collected for subjects in the FI and the NOUR Cohorts.	—	—	44 Total Score STANDARD_DEVIATION 21.7 • n=68 Participants • Number analyzed differs from overall because this score applies only to subjects enrolled in the OAB cohort and was not collected for subjects in the FI and the NOUR Cohorts.
Cleveland Clinic Incontinence Score (CCIS)	—	14 Score STANDARD_DEVIATION 2.9 • n=53 Participants • Number analyzed differs from overall because this score applies only to subjects enrolled in the FI cohort and was not collected for subjects in the OAB and the NOUR Cohorts.	—	14 Score STANDARD_DEVIATION 2.9 • n=53 Participants • Number analyzed differs from overall because this score applies only to subjects enrolled in the FI cohort and was not collected for subjects in the OAB and the NOUR Cohorts.
Clean intermittent self-catheterizations (CISC) per day	—	—	5 Clean intermittent self-catheterizations STANDARD_DEVIATION 2.3 • n=27 Participants • Number analyzed differs from overall because this measure applies only to subjects enrolled in the NOUR cohort and was not collected for subjects in the OAB and the FI Cohorts.	5 Clean intermittent self-catheterizations STANDARD_DEVIATION 2.3 • n=27 Participants • Number analyzed differs from overall because this measure applies only to subjects enrolled in the NOUR cohort and was not collected for subjects in the OAB and the FI Cohorts.

PRIMARY outcome

Timeframe: 3 months

Population: This score is applicable only for the OAB cohort.

Outcome measures

Outcome measures
Measure	Overactive Bladder Cohort n=67 Participants Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.	Fecal Incontinence Cohort Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.	Non-Obstructive Urinary Retention Cohort Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
Change From Baseline for HRQL Total Score	33 Total score on a scale Standard Deviation 24.2	—	—

PRIMARY outcome

Timeframe: 3 months

Population: This score is only applicable for FI subjects.

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.

Outcome measures

Outcome measures
Measure	Overactive Bladder Cohort Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.	Fecal Incontinence Cohort n=52 Participants Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.	Non-Obstructive Urinary Retention Cohort Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
Change From Baseline in CCIS Score	—	-4.06 score on a scale Standard Deviation 3.696	—

PRIMARY outcome

Timeframe: 3 months

Population: This measure applies only to subjects in the NOUR Cohort.

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.

Outcome measures

Outcome measures
Measure	Overactive Bladder Cohort Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.	Fecal Incontinence Cohort Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.	Non-Obstructive Urinary Retention Cohort n=23 Participants Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
Change From Baseline in the Number of CISC/Day	—	—	-3.52 Number of CISC/Day Standard Deviation 2.901

Adverse Events

Overactive Bladder Cohort

Serious events: 3 serious events

Other events: 5 other events

Deaths: 1 deaths

Fecal Incontinence Cohort

Serious events: 8 serious events

Other events: 8 other events

Deaths: 0 deaths

Non-Obstructive Urinary Retention Cohort

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Overactive Bladder Cohort n=68 participants at risk Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.	Fecal Incontinence Cohort n=53 participants at risk Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.	Non-Obstructive Urinary Retention Cohort n=27 participants at risk Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
General disorders Medical device site discomfort	1.5% 1/68 • Number of events 1 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	3.8% 2/53 • Number of events 2 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	7.4% 2/27 • Number of events 2 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.
General disorders Implant site pain	2.9% 2/68 • Number of events 2 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	1.9% 1/53 • Number of events 1 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	14.8% 4/27 • Number of events 4 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.
General disorders Medical device site pain	0.00% 0/68 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	0.00% 0/53 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	11.1% 3/27 • Number of events 3 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.
Nervous system disorders Sciatica	0.00% 0/68 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	1.9% 1/53 • Number of events 1 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	7.4% 2/27 • Number of events 2 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/68 • Number of events 1 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	1.9% 1/53 • Number of events 1 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	11.1% 3/27 • Number of events 3 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.
Product Issues Device stimulation issue	1.5% 1/68 • Number of events 1 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	5.7% 3/53 • Number of events 3 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.	0.00% 0/27 • Adverse events were collected from consent. We are reporting here the adverse events that started between enrollment (=neurostimulator implant) and exit. Any adverse event meeting the definition of: serious adverse events and/or adverse device effects were considered reportable for this study.

Additional Information

Mylène Champs

Medtronic

Phone: 612-433-0600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place