Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

Medtronic

Status: Active, not recruiting

Conditions: Overactive Bladder

Treatments: Device: Medtronic Implantable Tibial Neuromodulation (TNM) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05226286

MDT20061

Details and patient eligibility

About

The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects 18 years of age or older
2. Qualifying voiding diary
3. Have a diagnosis of UUI for at least 6 months
4. Failed and/or are not a candidate for conservative therapies.
5. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol
6. Willing and able to provide signed and dated informed consent

Exclusion criteria

1. Have primary stress incontinence
2. History of a prior implantable tibial neuromodulation system
3. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
4. Previous pelvic floor surgery in the last 6 months
5. Women who are pregnant or planning to become pregnant during the course of the study
6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)