Overactive BladderTITAN 2NCT05226286

Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

A study testing Medtronic Implantable Tibial Neuromodulation (TNM) System in people with Overactive Bladder, run by MedtronicNeuro at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder
What is being tested?: Medtronic Implantable Tibial Neuromodulation (TNM) System
Type of treatment: Medical device
How many people: 188 participants
Where: 29 sitesUnited States
Study dates: 31 Jan 2022to 30 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 sites

Urology Partners of North Texas Research Institute
Arlington, Texas, 46017
Georgia Urology
Cartersville, Georgia, 30120
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
Northwestern Medicine
Chicago, Illinois, 60611
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Henry Ford Health System
Detroit, Michigan, 48202
Summit Health Englewood
Englewood, New Jersey, 07631
Providea Health Partners
Evergreen Park, Illinois, 60805
Wright State Physicians
Fairborn, Ohio, 45234
Central Ohio Urology Group
Gahanna, Ohio, 43230
University of Texas Medical Branch
Galveston, Texas, 77555
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
Alliance Urology Specialists
Greensboro, North Carolina, 27403
Prisma Health
Greenville, South Carolina, 29605
FirstHealth Urogynecology
Hamlet, North Carolina, 28345
Urology Centers of Alabama
Homewood, Alabama, 35209
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Ascension Columbia St. Mary's
Milwaukee, Wisconsin, 53211
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70006
Urology Surgeons of Oklahoma
Oklahoma City, Oklahoma, 73120
Minnesota Urology
Plymouth, Minnesota, 55441
Mayo Clinic Urology
Rochester, Minnesota, 55905
Virginia Mason Medical Center
Seattle, Washington, 98101
Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105
Stony Brook University Hospital
Stony Brook, New York, 11794
Associated Medical Professionals
Syracuse, New York, 13210
Chesapeake Urology Associates
Towson, Maryland, 21204
Michigan Institute of Urology
Troy, Michigan, 48084
Summit Health Voorhees
Voorhees Township, New Jersey, 08043

Other trials in United States

About this study

Official title: Evaluation of Implantable Tibial Neuromodulation Pivotal Study

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

Conditions: Overactive Bladder
Being tested: Medtronic Implantable Tibial Neuromodulation (TNM) System
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medtronic Implantable Tibial Neuromodulation (TNM) SystemDevice
Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.

What is being measured

The primary outcome is the main question the study is designed to answer.

UUI Responder
Proportion of TNM subjects experiencing a reduction of 50% or more in daily urinary urge incontinence (UUI) episodes (UUI responder rate) at 6 months after device implant.
Measured: 6 months

Secondary outcomes (4)

UUI Change From Baseline
Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.
Measured: 6 months
UF Change From Baseline
Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.
Measured: 6 months
UPS Change at 6 Months
Change in urinary urgency assessed through the UPS at 6 months compared to baseline.
The UPS (Urgency Perception Scale) was developed to assess urgency associated with overactive bladder (OAB). The UPS is a single question assessed at each visit and has 3 options for responses: 1, 'I am usually not able to hold urine'; 2, 'I am usually able to hold urine until I reach the toilet if I go immediately'; and 3, 'I am usually able to finish what I am doing before going to the toilet'. Change from baseline is calculated by subtracting the baseline value from the follow-up value. Therefore, the change can range from -2 to 2 (with positive change indicating an improvement).
Measured: 6 months
OAB-q Change From Baseline
Change in Overactive Bladder Quality of Life Questionnaire (OAB-q) health related quality of life (HRQL) Total Score at 6 months compared to baseline.
Details related to OAB-Q HRQL:
OAB-q HRQL minimum value total score: 33 OAB-q HRQL maximum value total score:198 A positive change in OAB-q HRQL score represents an improvement.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 202230 May 2025

First posted7 Feb 2022
Study start31 Jan 2022
Primary completion10 Oct 2023
Study completion30 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overactive BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05226286
Sponsor's protocol ID: MDT20061
Acronym: TITAN 2
Status last verified: Nov 2025
First submitted: 26 Jan 2022
Last updated: 21 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive

All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Implantable Tibial Neuromodulation Pivotal Study
ClinicalTrials.gov ID: NCT05226286
Acronym / sponsor ID: TITAN 2 / MDT20061
Conditions: Overactive Bladder
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: 31 Jan 2022 (actual)
Primary completion: 10 Oct 2023 (actual)
Study completion: 30 May 2025 (actual)
First posted: 7 Feb 2022 (actual)
Results: Posted 21 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtronic Implantable Tibial Neuromodulation (TNM) SystemStimulation of the tibial nerve using Medtronic's tibial neuromodulation device.	Device	–

Primary outcome

UUI Responder
Time frame: 6 months
Proportion of TNM subjects experiencing a reduction of 50% or more in daily urinary urge incontinence (UUI) episodes (UUI responder rate) at 6 months after device implant.

4 secondary outcomes

UUI Change From Baseline
Time frame: 6 months
UF Change From Baseline
Time frame: 6 months
UPS Change at 6 Months
Time frame: 6 months
OAB-q Change From Baseline
Time frame: 6 months

Results and safety

Results posted to the registry on 21 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enrolled Subjects	188	104

Primary outcome: UUI Responder

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Implanted Subjects n = 123
Value	72

Population analysed: Includes subjects who were implanted and had data available at baseline and 6 months

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected throughout the study once the informed consent form was signed. This results section is showing the AEs that happened at or after implant through 24-month follow-up visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implanted Subjects	35 of 126 (27.8%)	81 of 126 (64.3%)	1 of 126

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Overactive Bladder

Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mylene Champs study director

Medtronic

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Implantable Tibial Neuromodulation (TNM) System in people with Overactive Bladder, run by MedtronicNeuro at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

UUI Responder (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05226286.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.