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

Not Applicable

Completed

• Conditions: Overactive Bladder; Urinary Urge Incontinence; Urgency-frequency Syndrome

• Registration Number: NCT04016324
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-11
• Study Start: 2019-11-28
• Primary Completion: 2020-10-06
• Study Completion: 2020-10-09
• Results First Submitted: 2021-10-05
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Results First Posted: 2021-11-23
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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.

Trial Locations

Locations (15)

Pinellas Urology; 🇺🇸 Saint Petersburg, Florida, United States

Florida Urology Partners; 🇺🇸 Tampa, Florida, United States

Minnesota Urology (Plymouth); 🇺🇸 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

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