Clinical trial NCT05226286: Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)
Official title: Evaluation of Implantable Tibial Neuromodulation Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Outcome
timeFrame: 6 months
Secondary outcomes:
measure: Secondary Objective
timeFrame: 6 months
measure: Secondary Objective
timeFrame: 6 months
measure: Secondary Objective
timeFrame: 6 months
measure: Secondary Objective
timeFrame: 6 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Cartersville
country: United States
facility: Georgia Urology
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Evergreen Park
country: United States
facility: Providea Health Partners
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Towson
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Mercy Health Saint Mary's
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Plymouth
country: United States
facility: Minnesota Urology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Urology
state: Minnesota
city: Englewood
country: United States
facility: Summit Health Englewood
state: New Jersey
city: Voorhees
country: United States
facility: Summit Health Voorhees
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Hamlet
country: United States
facility: FirstHealth Urogynecology
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Urology Group
state: Ohio
city: Oklahoma City
country: United States
facility: Urology Surgeons of Oklahoma
state: Oklahoma
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
state: South Dakota
city: Arlington
country: United States
facility: Urology Partners of North Texas Research Institute
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Ascension Columbia St. Mary's
state: Wisconsin
Study officials:
affiliation: Medtronic
name: Katrina Lowell
role: STUDY_DIRECTOR
References: