Implantable Tibial Neuromodulation for Overactive Bladder
(TITAN 2 Trial)

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: MedtronicNeuro

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for adults who've had an overactive bladder (UUI) for at least 6 months and haven't seen improvement with standard treatments. Participants must be able to follow the study's procedures, like filling out diaries and operating the device. Pregnant women, those planning pregnancy, or individuals with recent pelvic surgeries or certain anatomical issues can't join.

Inclusion Criteria

I have been diagnosed with urinary urgency incontinence for at least 6 months.

Keep a record of your bathroom visits.

Willing and able to provide signed and dated informed consent

+4 more

Exclusion Criteria

You have stress incontinence as your main urinary issue.

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

+4 more

Participant Groups

The study is testing a new system called Medtronic Tibial Neuromodulation (TNM) to see if it's safe and works well for treating overactive bladder. It involves placing a device that stimulates nerves in the leg connected to bladder control.