BASIC: InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study

• Sponsor: MedtronicNeuro (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04016324
• Collaborator: (none)
• Enrollment: 110
• Locations: 15
• Arm: 1
• Actual Duration (Months): 10.4
• Patients Per Site: 7.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder; Urinary Urge Incontinence; Urgency-frequency Syndrome	Device: InterStim Basic Evaluation lead and foramen needle	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim Basic Evaluation Lead.To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim Basic Evaluation Lead.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
• Actual Study Start Date: Nov 28, 2019
• Actual Primary Completion Date: Oct 6, 2020
• Actual Study Completion Date: Oct 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Basic evaluation Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.	Device: InterStim Basic Evaluation lead and foramen needle; Commercial devices within their intended use as described in approved Instructions for Use.

Outcome Measures

Primary Outcome Measures

1. Motor or Sensory Response(s) During Lead Placement - by Subject [During lead implant procedure (approximately 20 minutes)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects 18 years of age or older

2. Candidate for sacral neuromodulation in accordance with the InterStim System labeling

3. Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary

4. Willing and able to accurately complete study diaries, questionnaire, attend visits, 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 implantable pacemakers, or defibrillators

3. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component

4. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the InterStim System labeling

5. Women who are pregnant or planning to become pregnant during participation in the study

6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements

7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinellas Urology	Saint Petersburg	Florida	United States	33710
2	Florida Urology Partners	Tampa	Florida	United States	33606
3	Minnesota Urology (Plymouth)	Plymouth	Minnesota	United States	55441
4	Urologic Research and Consulting	Englewood	New Jersey	United States	07631
5	FirstHealth Urogynecology	Hamlet	North Carolina	United States	28345
6	Wright State Physicians	Fairborn	Ohio	United States	45234-2640
7	Prisma Health	Greenville	South Carolina	United States	29605-4627
8	Southern Urogynecology	West Columbia	South Carolina	United States	29169-3456
9	Urology Partners of North Texas	Arlington	Texas	United States	76017
10	Urology of Virginia	Virginia Beach	Virginia	United States	23642-1815
11	University Urology Associates	Toronto	Ontario	Canada	M5T 2S8
12	Radboud UMC	Nijmegen		Netherlands	6525 GA
13	The Bristol Urological Institute	Bristol		United Kingdom	BS10 5NB
14	The Newcastle upon Tyne Hospitals	Newcastle Upon Tyne		United Kingdom	NE7 7DN
15	Salford Royal NHS Foundation Trust	Salford		United Kingdom	M68HD

Sponsors and Collaborators

• MedtronicNeuro

Investigators

• Study Director: BASIC Clinical Research Study Team, Medtronic

Study Documents (Full-Text)

• Study Protocol - Jun 10, 2019
• Statistical Analysis Plan - Sep 14, 2020

More Information

Publications

None provided.

• Responsible Party: MedtronicNeuro
• ClinicalTrials.gov Identifier: NCT04016324
• Other Study ID Numbers: MDT19002
• First Posted: Jul 11, 2019
• Last Update Posted: Nov 23, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by MedtronicNeuro: Overactive Bladder; Urinary Urge Incontinence; Urgency-frequency Syndrome
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence, Urge

Study Results

Participant Flow

Pre-assignment Detail	Subjects were considered to be 'enrolled' in the study at the time of the BE Lead procedure.

Arm/Group Title	Basic Evaluation Subjects
Arm/Group Description	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.
Period Title: Overall Study
STARTED	110
COMPLETED	107
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Baseline
Arm/Group Description	Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit
Overall Participants	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.6 (14.67)
Sex: Female, Male (Count of Participants)
Female	93 84.5%
Male	17 15.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 6.4%
Not Hispanic or Latino	68 61.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.9%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 3.6%
White	70 63.6%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Motor or Sensory Response(s) During Lead Placement - by Subject
Description	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.
Time Frame	During lead implant procedure (approximately 20 minutes)

Outcome Measure Data

Analysis Population Description

Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit (110) were included.

Arm/Group Title	Motor or Sensory Response of Lead	Motor or Sensory Response of Needle
Arm/Group Description	Response to Lead	Response to Needle
Measure Participants	110	110
Yes	107 97.3%	109 NaN
No	3 2.7%	1 NaN

Adverse Events

Time Frame	From time of consent to one-week post lead placement
Adverse Event Reporting Description	All serious, device related, procedure-related, and/or therapy-related adverse events were considered reportable for this study
Arm/Group Title	Basic Evaluation Subjects
Arm/Group Description	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.
All Cause Mortality
	Basic Evaluation Subjects
	Affected / at Risk (%)	# Events
Total	0/134 (0%)
Serious Adverse Events
	Basic Evaluation Subjects
	Affected / at Risk (%)	# Events
Total	1/134 (0.7%)
Gastrointestinal disorders
Gastritis	1/134 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Basic Evaluation Subjects
	Affected / at Risk (%)	# Events
Total	3/110 (2.7%)
Injury, poisoning and procedural complications
Incision site haemorrhage	1/110 (0.9%)	1
Skin and subcutaneous tissue disorders
Dermatitis contact	1/110 (0.9%)	1
Skin irritation	1/110 (0.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.