Status:
COMPLETED
Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Primary
- 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
- 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.
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04873271
Start Date
May 11 2021
End Date
July 8 2022
Last Update
July 13 2022
Active Locations (7)
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1
Georgia Urology
Marietta, Georgia, United States, 30060
2
Urologic Research and Consulting
Englewood, New Jersey, United States, 07631
3
FirstHealth Urogynecology
Hamlet, North Carolina, United States, 28345
4
Prisma Health
Greenville, South Carolina, United States, 29605