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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Commercial devices within their intended use as described in approved Instructions for Use.
Pinellas Urology
St. Petersburg, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Minnesota Urology (Plymouth)
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.
Time frame: During lead implant procedure (approximately 20 minutes)
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Plymouth, Minnesota, United States
Urologic Research and Consulting
Englewood, New Jersey, United States
FirstHealth Urogynecology
Hamlet, North Carolina, United States
Wright State Physicians
Fairborn, Ohio, United States
Prisma Health
Greenville, South Carolina, United States
Southern Urogynecology
West Columbia, South Carolina, United States
Urology Partners of North Texas
Arlington, Texas, United States
Urology of Virginia
Virginia Beach, Virginia, United States
...and 5 more locations