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

Not Applicable

Completed

Conditions: Overactive Bladder
Urinary Urge Incontinence
Urgency-frequency Syndrome

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Basic evaluation	InterStim Basic Evaluation lead and foramen needle	Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method

Locations (15): Minnesota Urology (Plymouth)
🇺🇸
Plymouth, Minnesota, United States
FirstHealth Urogynecology
🇺🇸
Hamlet, North Carolina, United States
Radboud UMC
🇳🇱
Nijmegen, Netherlands
University Urology Associates
🇨🇦
Toronto, Ontario, Canada
The Newcastle upon Tyne Hospitals
🇬🇧
Newcastle Upon Tyne, United Kingdom
The Bristol Urological Institute
🇬🇧
Bristol, United Kingdom
Salford Royal NHS Foundation Trust
🇬🇧
Salford, United Kingdom
Pinellas Urology
🇺🇸
Saint Petersburg, Florida, United States
Florida Urology Partners
🇺🇸
Tampa, Florida, United States
Urologic Research and Consulting
🇺🇸
Englewood, New Jersey, United States
Urology Partners of North Texas
🇺🇸
Arlington, Texas, United States
Prisma Health
🇺🇸
Greenville, South Carolina, United States
Urology of Virginia
🇺🇸
Virginia Beach, Virginia, United States
Wright State Physicians
🇺🇸
Fairborn, Ohio, United States
Southern Urogynecology
🇺🇸
West Columbia, South Carolina, United States