Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

• ClinicalTrials.gov Identifier: NCT05226286
• Recruitment Status: Active, not recruiting
• First Posted: February 7, 2022
• Last Update Posted: April 4, 2024
• Sponsor: MedtronicNeuro
• Information provided by (Responsible Party): MedtronicNeuro

Tracking Information

• First Submitted Date: January 26, 2022
• First Posted Date: February 7, 2022
• Last Update Posted Date: April 4, 2024
• Actual Study Start Date: January 31, 2022
• Actual Primary Completion Date: October 10, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2022)

Primary Outcome [ 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 4, 2022)

• Secondary Objective [ Time Frame: 6 months ]
  Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.
• Secondary Objective [ Time Frame: 6 months ]
  Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.
• Secondary Objective [ Time Frame: 6 months ]
  Change in urinary urgency assessed through the UPS at 6 months compared to baseline.
• Secondary Objective [ Time Frame: 6 months ]
  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.

Original Secondary Outcome Measures (submitted: January 26, 2022)

• Secondary Objective [ Time Frame: 6 months ]
  Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.
• Secondary Objective [ Time Frame: 6 months ]
  Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.
• Secondary Objective [ Time Frame: 6 months ]
  Change in urinary urgency assessed through the UPS at 6 months compared to baseline.
• Secondary Objective [ Time Frame: 6 months ]
  Change in OAB-q HRQL (health related quality of life) Total Score at 6 months compared to baseline.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Implantable Tibial Neuromodulation Pivotal Study
• Official Title: Evaluation of Implantable Tibial Neuromodulation Pivotal Study
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Overactive Bladder

Intervention

Device: Medtronic Implantable Tibial Neuromodulation (TNM) System

Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 2, 2023): 188
• Original Estimated Enrollment (submitted: January 26, 2022): 170
• Estimated Study Completion Date: April 2025
• Actual Primary Completion Date: October 10, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05226286
• Other Study ID Numbers: MDT20061
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: MedtronicNeuro
• Original Responsible Party: Same as current
• Current Study Sponsor: MedtronicNeuro
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Beth Michaud; Medtronic

• PRS Account: MedtronicNeuro
• Verification Date: January 2024