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

Overactive Bladder Clinical Trial

— BASIC  

Official title:

InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016324
• Other study ID #: MDT19002
• Status: Completed
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: October 9, 2020

Study information

• Verified date: November 2021
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 9, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urgency-frequency Syndrome
• Urinary Bladder, Overactive
• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Intervention

Device:
• InterStim Basic Evaluation lead and foramen needle
Commercial devices within their intended use as described in approved Instructions for Use.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During lead implant procedure (approximately 20 minutes)