Implantable Tibial Neuromodulation for Overactive Bladder

(TITAN 2 Trial)

Recruiting at 31 trial locations

Overseen By Laura Giusto

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedtronicNeuro

Disqualifiers: Stress incontinence, Prior tibial implant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

188 Participants Needed

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.

Research Team

Anne Miller

Principal Investigator

Medtronic

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tibial neuromodulation using the Medtronic TNM system

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tibial Neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system

Trial Overview 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.

Who Is Running the Clinical Trial?

MedtronicNeuro

Lead Sponsor

Trials

72

Recruited

20,900+

Geoff Martha

MedtronicNeuro

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Eric Peterson

MedtronicNeuro

Chief Medical Officer since 2020

MD from University of Miami