InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study (BASIC)

InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study

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 Overview

• Status: Completed
• Conditions: Overactive Bladder; Urgency-frequency Syndrome; Urinary Urge Incontinence
• Intervention / Treatment: Device: InterStim Basic Evaluation lead and foramen needle

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • University Urology Associates
• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • Radboud UMC
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • The Bristol Urological Institute
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospitals
  • Salford, United Kingdom, M68HD
    • Salford Royal NHS Foundation Trust
• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33710
      • Pinellas Urology
    • Tampa, Florida, United States, 33606
      • Florida Urology Partners
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Minnesota Urology (Plymouth)
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Urologic Research and Consulting
  • North Carolina
    • Hamlet, North Carolina, United States, 28345
      • FirstHealth Urogynecology
  • Ohio
    • Fairborn, Ohio, United States, 45234-2640
      • Wright State Physicians
  • South Carolina
    • Greenville, South Carolina, United States, 29605-4627
      • Prisma Health
    • West Columbia, South Carolina, United States, 29169-3456
      • Southern Urogynecology
  • Texas
    • Arlington, Texas, United States, 76017
      • Urology Partners of North Texas
  • Virginia
    • Virginia Beach, Virginia, United States, 23642-1815
      • Urology of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Basic evaluation; Subjects with overactive bladder will go through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit.	Device: InterStim Basic Evaluation lead and foramen needle; Commercial devices within their intended use as described in approved Instructions for Use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Study Director: BASIC Clinical Research Study Team, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2019
• Primary Completion (Actual): October 6, 2020
• Study Completion (Actual): October 9, 2020

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Overactive Bladder; Urgency-frequency Syndrome; Urinary Urge Incontinence
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: MDT19002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes