Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

Not Applicable

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT05226286
• Lead Sponsor: MedtronicNeuro

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 available

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study Start: 2022-01-31
• Study First Posted: 2022-02-07
• Primary Completion: 2023-10-10
• Disposition First Posted: 2024-08-26
• Disposition First Submitted: 2024-09-16
• Study Completion: 2025-05-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Outcome	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

Name	Time	Method
Secondary Objective	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.

Trial Locations

Locations (29)

Urology Centers of Alabama; 🇺🇸 Homewood, Alabama, United States

Georgia Urology; 🇺🇸 Cartersville, Georgia, United States

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States

Providea Health Partners; 🇺🇸 Evergreen Park, Illinois, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Louisiana State University Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Chesapeake Urology Associates; 🇺🇸 Towson, Maryland, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Mercy Health Saint Mary's; 🇺🇸 Grand Rapids, Michigan, United States

Michigan Institute of Urology; 🇺🇸 Troy, Michigan, United States

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