N/A
N=110
InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
Overactive Bladder · Urinary Urge Incontinence · Urgency-frequency Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04016324 ↗Enrolled (actual)
110
Serious AEs
0.8%
Results posted
Nov 2021
Primary outcome: Primary: Motor or Sensory Response(s) During Lead Placement - by Subject — 107; 109; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- InterStim Basic Evaluation lead and foramen needle (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedtronicNeuro
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Motor or Sensory Response(s) During Lead Placement - by Subject |
107; 109; 3; 1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04016324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.