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Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05226286
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : March 6, 2023
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Device: Medtronic Implantable Tibial Neuromodulation (TNM) System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Implantable Tibial Neuromodulation Pivotal Study
Actual Study Start Date : January 31, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : January 2025
Arms and Interventions
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Intervention Details:
  • Device: Medtronic Implantable Tibial Neuromodulation (TNM) System
    Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Secondary Objective [ Time Frame: 6 months ]
    Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.

  2. Secondary Objective [ Time Frame: 6 months ]
    Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.

  3. Secondary Objective [ Time Frame: 6 months ]
    Change in urinary urgency assessed through the UPS at 6 months compared to baseline.

  4. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05226286


Contacts
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Contact: Beth Michaud 7635268102 beth.m.michaud@medtronic.com
Contact: Anne Miller anne.e.miller@medtronic.com

Locations
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Sponsors and Collaborators
MedtronicNeuro
Investigators
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Study Director: Beth Michaud Medtronic
More Information
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT05226286    
Other Study ID Numbers: MDT20061
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: March 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations