Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- MedtronicNeuro
- Enrollment
- 24
- Locations
- 7
- Primary Endpoint
- To characterize the TNM device implant procedure
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.
Detailed Description
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.)
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
To characterize the TNM device implant procedure
Time Frame: 14 days
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.
To characterize the TNM device initial system use
Time Frame: 14 days
This information will be collected through programming and device data at implant through the 14-day follow-up visit.