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

Study Overview
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Brief Summary
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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.

Official Title
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InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study

Conditions
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Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome

Intervention / Treatment
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* Device: InterStim Basic Evaluation lead and foramen needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 18 years of age or older Candidate for sacral neuromodulation in accordance with the InterStim System labeling Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol Willing and able to provide signed and dated informed consent Exclusion Criteria: Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) Have implantable pacemakers, or defibrillators Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component 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 Women who are pregnant or planning to become pregnant during participation in the study Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Basic evaluation<br>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<br>* Commercial devices within their intended use as described in approved Instructions for Use.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome