N/A
Completed N=188
Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)
Source: ClinicalTrials.gov NCT05226286 ↗Enrolled (actual)
188
Serious AEs
27.8%
Results posted
Nov 2025
Primary outcomePrimary: UUI Responder — 72 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY UUI Responder |
72 | — |
| SECONDARY UUI Change From Baseline |
-2.8 | — |
| SECONDARY UF Change From Baseline |
-2.6 | — |
| SECONDARY UPS Change at 6 Months |
0.4 | — |
| SECONDARY OAB-q Change From Baseline |
27.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05226286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.