Trial Outcomes & Findings for InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study (NCT NCT04016324)
NCT ID: NCT04016324
Last Updated: 2021-11-23
Results Overview
To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed.
COMPLETED
NA
110 participants
During lead implant procedure (approximately 20 minutes)
2021-11-23
Participant Flow
Subjects were considered to be 'enrolled' in the study at the time of the BE Lead procedure.
Participant milestones
| Measure |
Basic Evaluation Subjects
Out of 134 overactive bladder consented subjects in the study, 110 underwent basic evaluation with the commercially approved foramen needle and basic evaluation kit, and 107 subjects completed the study.
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ethnicity was only collected for subjects in the US - was not collected for EU or Canada.
Baseline characteristics by cohort
| Measure |
Baseline
n=110 Participants
Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit
|
|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 14.67 • n=110 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=75 Participants • Ethnicity was only collected for subjects in the US - was not collected for EU or Canada.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=75 Participants • Ethnicity was only collected for subjects in the US - was not collected for EU or Canada.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=75 Participants • Ethnicity was only collected for subjects in the US - was not collected for EU or Canada.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=75 Participants • Race was only collected for subjects in the US - was not collected for EU or Canada.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=75 Participants • Race was only collected for subjects in the US - was not collected for EU or Canada.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=75 Participants • Race was only collected for subjects in the US - was not collected for EU or Canada.
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=75 Participants • Race was only collected for subjects in the US - was not collected for EU or Canada.
|
|
Race (NIH/OMB)
White
|
70 Participants
n=75 Participants • Race was only collected for subjects in the US - was not collected for EU or Canada.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=75 Participants • Race was only collected for subjects in the US - was not collected for EU or Canada.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=75 Participants • Race was only collected for subjects in the US - was not collected for EU or Canada.
|
PRIMARY outcome
Timeframe: During lead implant procedure (approximately 20 minutes)Population: Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit (110) were included.
To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed.
Outcome measures
| Measure |
Motor or Sensory Response of Lead
n=110 Participants
Response to Lead
|
Motor or Sensory Response of Needle
n=110 Participants
Response to Needle
|
|---|---|---|
|
Motor or Sensory Response(s) During Lead Placement - by Subject
Yes
|
107 Participants
|
109 Participants
|
|
Motor or Sensory Response(s) During Lead Placement - by Subject
No
|
3 Participants
|
1 Participants
|
Adverse Events
Basic Evaluation Subjects
Serious adverse events
| Measure |
Basic Evaluation Subjects
n=110 participants at risk；n=134 participants at risk
For the mortality and serious adverse events, all consented subjects (134) were included. Since non-serious events can only be device, therapy or stimulation related, only subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit (110) were included.
|
|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.75%
1/134 • Number of events 1 • From time of consent to one-week post lead placement
All serious, device related, procedure-related, and/or therapy-related adverse events were considered reportable for this study
|
Other adverse events
| Measure |
Basic Evaluation Subjects
n=110 participants at risk；n=134 participants at risk
For the mortality and serious adverse events, all consented subjects (134) were included. Since non-serious events can only be device, therapy or stimulation related, only subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit (110) were included.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.91%
1/110 • Number of events 1 • From time of consent to one-week post lead placement
All serious, device related, procedure-related, and/or therapy-related adverse events were considered reportable for this study
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.91%
1/110 • Number of events 1 • From time of consent to one-week post lead placement
All serious, device related, procedure-related, and/or therapy-related adverse events were considered reportable for this study
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.91%
1/110 • Number of events 1 • From time of consent to one-week post lead placement
All serious, device related, procedure-related, and/or therapy-related adverse events were considered reportable for this study
|
Additional Information
Rianna Rapson (Prin. Clinical Research Specialist)
Medtronic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place