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Completed

NCT Number: NCT05226286

Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology Centers of Alabama, Homewood, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medtronic Implantable Tibial Neuromodulation (TNM) System

Device

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

Primary outcomes

  1. UUI Responder

    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 outcomes

  1. UUI Change From Baseline

    Time frame: 6 months

    Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.

  2. UF Change From Baseline

    Time frame: 6 months

    Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.

  3. UPS Change at 6 Months

    Time frame: 6 months

    Change in urinary urgency assessed through the UPS at 6 months compared to baseline.

    The UPS (Urgency Perception Scale) was developed to assess urgency associated with overactive bladder (OAB). The UPS is a single question assessed at each visit and has 3 options for responses: 1, 'I am usually not able to hold urine'; 2, 'I am usually able to hold urine until I reach the toilet if I go immediately'; and 3, 'I am usually able to finish what I am doing before going to the toilet'. Change from baseline is calculated by subtracting the baseline value from the follow-up value. Therefore, the change can range from -2 to 2 (with positive change indicating an improvement).

  4. OAB-q Change From Baseline

    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 A positive change in OAB-q HRQL score represents an improvement.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

Evaluation of Implantable Tibial Neuromodulation Pivotal Study

Acronym: TITAN 2

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Feb 7, 2022
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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