Status:
COMPLETED
Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)
Lead Sponsor:
MedtronicNeuro
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
Eligibility Criteria
Inclusion
- Subjects 18 years of age or older
- Qualifying voiding diary
- Have a diagnosis of UUI for at least 6 months
- Failed and/or are not a candidate for conservative therapies.
- 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
- Have primary stress incontinence
- History of a prior implantable tibial neuromodulation system
- 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 during the course of 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.
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT05226286
Start Date
January 31 2022
End Date
May 30 2025
Last Update
November 21 2025
Active Locations (29)
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1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
2
Georgia Urology
Cartersville, Georgia, United States, 30120
3
Northwestern Medicine
Chicago, Illinois, United States, 60611
4
Providea Health Partners
Evergreen Park, Illinois, United States, 60805