Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

Study Overview
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Brief Summary
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This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.

Detailed Description
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This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Official Title
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Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: Medtronic Implantable Tibial Neuromodulation (TNM) System


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Subjects 18 years of age or older Have a diagnosis for at least 6 months of OAB No OAB pharmacotherapy for 2 weeks prior to the baseline voiding diary Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system and comply with the study protocol Willing and able to provide signed and dated informed consent Primary Exclusion Criteria: Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury Severe uncontrolled diabetes History of urinary retention within the previous 6 months Current symptomatic urinary tract infection Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component Current urinary tract mechanical obstruction Have knowledge of planned magnetic resonance imaging (MRIs) or diathermy History of a prior implantable tibial neuromodulation system Skin lesions or compromised skin integrity at the implant site Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device Previous pelvic floor surgery in the last 6 months Women who are pregnant or planning to become pregnant Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. Any subject who is considered to be part of a vulnerable patient population. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.** **Subjects in concurrent studies can only be enrolled with permission from Medtronic. Contact Medtronic's study manager to determine if the subject can be enrolled in both studies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Medtronic Implantable Tibial Neuromodulation (TNM) System|Tibial neuromodulation (TNM) devices are implantable devices that provide stimulation to the tibial nerve.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the TNM device implant procedure | This information will be collected through a series of questions for participating investigators via a case report form at implant through the 14-day follow-up visit. | 14 days | 
| To characterize the TNM device initial system use | This information will be collected through programming and device data at implant through the 14-day follow-up visit. | 14 days |