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Procedure

Implantable Tibial Neuromodulation for Overactive Bladder (TITAN 2 Trial)

N/A
Waitlist Available
Research Sponsored by MedtronicNeuro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failed and/or are not a candidate for conservative therapies.
Failed and/or are not a candidate for conservative therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

TITAN 2 Trial Summary

This trial will test how safe and effective a new Medtronic device is for treating people with overactive bladder or urinary retention.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar neuromodulation treatments may cause discomfort at the stimulation site, skin irritation, or temporary nerve pain.

TITAN 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Standard treatments haven't worked for me or I can't use them.
Select...
Standard treatments haven't worked for me or I can't use them.

TITAN 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Secondary outcome measures
Secondary Objective

Find a Location

Who is running the clinical trial?

MedtronicNeuroLead Sponsor
69 Previous Clinical Trials
20,631 Total Patients Enrolled
Beth MichaudStudy DirectorMedtronic

Media Library

Tibial Neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05226286 — N/A
Overactive Bladder Research Study Groups:
Overactive Bladder Clinical Trial 2023: Tibial Neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system Highlights & Side Effects. Trial Name: NCT05226286 — N/A
Tibial Neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05226286 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible to enlist in this research endeavor at present?

"Correct. The online repository of clinicaltrials.gov demonstrates that this research is presently recruiting participants, with the initial post date on January 31st 2022 and most recent edit occurring November 11th 2022. At present, 170 patients need to be recruited from 23 medical sites."

Answered by AI

Could you enumerate the hospitals that are currently conducting this research endeavor in city?

"This research is currently being conducted in 23 distinct locations, with Charlotte, Iowa City and Milwaukee included among them. To lessen the burden of travel, it is advised to choose a trial site that lies closest to one's residence."

Answered by AI

How many individuals are partaking in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this current study is actively seeking participants and was first posted on January 31st 2022 with a most recent update taking place on November 11th 2022. 170 individuals must be recruited from 23 sites in order for the trial to progress."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Texas Medical Branch
Stony Brook University Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of Implantable Tibial Neuromodulation Pivotal Study
2022. "Evaluation of Implantable Tibial Neuromodulation Pivotal Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05226286.
All > Overactive Bladder
~59 spots leftby Apr 2025
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