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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urgency-frequency Syndrome Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urinary Urge Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Urology Associates, Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

InterStim Basic Evaluation lead and foramen needle

Device

Commercial devices within their intended use as described in approved Instructions for Use.

Primary outcomes

Motor or Sensory Response(s) During Lead Placement - by Subject

Time frame: 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.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study

Acronym: BASIC

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jul 11, 2019
Registry last updated: Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed