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Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

Primary Purpose

Overactive Bladder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medtronic Implantable Tibial Neuromodulation (TNM) System
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology Centers of Alabama
  • Georgia Urology
  • Northwestern Medicine
  • Providea Health Partners
  • University of Iowa Hospitals and Clinics
  • Louisiana State University Health Sciences Center
  • Chesapeake Urology Associates
  • Henry Ford Health System
  • Mercy Health Saint Mary's
  • Michigan Institute of Urology
  • Minnesota Urology
  • Mayo Clinic Urology
  • Summit Health Englewood
  • Summit Health Voorhees
  • Stony Brook University Hospital
  • Associated Medical Professionals
  • Atrium Health Carolinas Medical Center
  • Alliance Urology Specialists
  • FirstHealth Urogynecology
  • The Ohio State University Wexner Medical Center
  • Wright State Physicians
  • Central Ohio Urology Group
  • Urology Surgeons of Oklahoma
  • Prisma Health
  • Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
  • Urology Partners of North Texas
  • University of Texas Medical Branch
  • Virginia Mason Medical Center
  • Ascension Columbia St. Mary's

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Secondary Objective
Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.
Secondary Objective
Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.
Secondary Objective
Change in urinary urgency assessed through the UPS at 6 months compared to baseline.
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.

Full Information

First Posted
January 26, 2022
Last Updated
October 10, 2023
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT05226286
Brief Title
Evaluation of Implantable Tibial Neuromodulation Pivotal Study
Acronym
TITAN 2
Official Title
Evaluation of Implantable Tibial Neuromodulation Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Medtronic Implantable Tibial Neuromodulation (TNM) System
Intervention Description
Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.
Primary Outcome Measure Information:
Title
Primary Outcome
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary Objective
Description
Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.
Time Frame
6 months
Title
Secondary Objective
Description
Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.
Time Frame
6 months
Title
Secondary Objective
Description
Change in urinary urgency assessed through the UPS at 6 months compared to baseline.
Time Frame
6 months
Title
Secondary Objective
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Michaud
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Georgia Urology
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30120
Country
United States
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Providea Health Partners
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Chesapeake Urology Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mercy Health Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Minnesota Urology
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Mayo Clinic Urology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Summit Health Englewood
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Summit Health Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Associated Medical Professionals
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Atrium Health Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
FirstHealth Urogynecology
City
Hamlet
State/Province
North Carolina
ZIP/Postal Code
28345
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45234
Country
United States
Facility Name
Central Ohio Urology Group
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Urology Surgeons of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Urology Partners of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
46017
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Ascension Columbia St. Mary's
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Implantable Tibial Neuromodulation Pivotal Study

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