Clinical trial NCT04016324: InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
Official title: InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urinary Urge Incontinence
Urgency-frequency Syndrome
Keywords: Overactive Bladder
Urinary Urge Incontinence
Urgency-frequency Syndrome
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2019-07-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim Basic Evaluation Lead.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Motor or Sensory Response(s) During Lead Placement - by Subject
timeFrame: During lead implant procedure (approximately 20 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Pinellas Urology
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Plymouth
country: United States
facility: Minnesota Urology (Plymouth)
state: Minnesota
city: Englewood
country: United States
facility: Urologic Research and Consulting
state: New Jersey
city: Hamlet
country: United States
facility: FirstHealth Urogynecology
state: North Carolina
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: West Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
city: Arlington
country: United States
facility: Urology Partners of North Texas
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Toronto
country: Canada
facility: University Urology Associates
state: Ontario
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Bristol
country: United Kingdom
facility: The Bristol Urological Institute
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: Medtronic
name: BASIC Clinical Research Study Team
role: STUDY_DIRECTOR
References: