Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2) (TITAN 2)

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Medtronic Implantable Tibial Neuromodulation (TNM) System

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UUI Change From Baseline	Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.	6 months
UF Change From Baseline	Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.	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).	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.	6 months

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Study Director: Mylene Champs, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive; Therapeutics; Diagnosis; Drug Therapy; Prognosis; Drug Delivery Systems; Neoplasm Staging
• Other Study ID Numbers: MDT20061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No