Evaluation of Implantable Tibial Neuromodulation Pivotal Study

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Implantable Tibial Neuromodulation Pivotal Study

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Device: Medtronic Implantable Tibial Neuromodulation (TNM) System


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Medtronic Implantable Tibial Neuromodulation (TNM) System|Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Objective | Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline. | 6 months | 
| Secondary Objective | Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline. | 6 months | 
| Secondary Objective | Change in urinary urgency assessed through the UPS at 6 months compared to baseline. | 6 months | 
| 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. | 6 months |