Evaluation of Implantable Tibial Neuromodulation Pivotal Study

Overactive Bladder Clinical Trial

— TITAN 2  

Official title:

Evaluation of Implantable Tibial Neuromodulation Pivotal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05226286
• Other study ID #: MDT20061
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: April 2025
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• Medtronic Implantable Tibial Neuromodulation (TNM) System
Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.

Locations

Country	Name	City	State
United States	Urology Partners of North Texas Research Institute	Arlington	Texas
United States	Georgia Urology	Cartersville	Georgia
United States	Atrium Health Carolinas Medical Center	Charlotte	North Carolina
United States	Northwestern Medicine	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Summit Health Englewood	Englewood	New Jersey
United States	Providea Health Partners	Evergreen Park	Illinois
United States	Wright State Physicians	Fairborn	Ohio
United States	Central Ohio Urology Group	Gahanna	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	Mercy Health Saint Mary's	Grand Rapids	Michigan
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	Prisma Health	Greenville	South Carolina
United States	FirstHealth Urogynecology	Hamlet	North Carolina
United States	Urology Centers of Alabama	Homewood	Alabama
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Ascension Columbia St. Mary's	Milwaukee	Wisconsin
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	Urology Surgeons of Oklahoma	Oklahoma City	Oklahoma
United States	Minnesota Urology	Plymouth	Minnesota
United States	Mayo Clinic Urology	Rochester	Minnesota
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic	Sioux Falls	South Dakota
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Associated Medical Professionals	Syracuse	New York
United States	Chesapeake Urology Associates	Towson	Maryland
United States	Michigan Institute of Urology	Troy	Michigan
United States	Summit Health Voorhees	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	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	Secondary Objective	Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.	6 months
Secondary	Secondary Objective	Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.	6 months
Secondary	Secondary Objective	Change in urinary urgency assessed through the UPS at 6 months compared to baseline.	6 months
Secondary	Secondary Objective	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; The outcome is worse the higher the value of the total score.	6 months