PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB

Study Overview
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Brief Summary
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To evaluate the NURO system for the treatment of OAB in drug naïve patients.

Detailed Description
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The purpose of this prospective, multicenter, single arm study is to evaluate the NURO system for the treatment of OAB in drug naïve patients. The study will assess change from baseline through 12 PTNM therapy sessions in UUI (urge urinary incontinence) episodes, voiding episodes, and patient reported outcomes. The study is expected to last approximately 14 weeks per subject following the enrollment visit. Subjects will be exited from the study after the final study visit is complete.

Official Title
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PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation (PTNM) System in Patients With OAB

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: NURO System PTNM Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Diagnosis of OAB and associated symptoms of UUI and qualify with at least 3 episodes of mild, moderate, or severe urgency demonstrated on a 3-day urinary voiding diary Experiencing UUI symptoms for at least 3 months No prior treatment with anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol Willing and able to provide signed and dated informed consent Exclusion Criteria: Have received anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB or advanced therapy treatment options for OAB (botulinum toxin injections, sacral neuromodulation, or percutaneous tibial nerve stimulation/neuromodulation) Primary stress incontinence or mixed incontinence where the stress component overrides the urge component Have implantable pacemakers or implantable defibrillators Use of transcutaneous electrical nerve stimulation (TENS) in pelvic region, back or legs 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 Nerve damage that could impact either tibial nerve or pelvic floor function. Subjects prone to excessive bleeding Inadequate skin integrity in the area of PTNM needle placement History of diabetes unless the diabetes is well-controlled through diet and/or medications Have symptomatic urinary tract infection (UTI) Participation in any research study involving or impacting gynecologic, urinary or renal function within the 4-week period prior to or plans to participate during study enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NURO System PTNM Therapy<br>Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system. | Device: NURO System PTNM Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline | Number of UUI episodes were collected at baseline and following the 12th PTNM therapy session. For each subject in the analysis, change in UUI episodes per day was calculated as UUI episodes per day after 12th PTNM session minus baseline. A negative change indicates the improvement in UUI symptom. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects | Number of voids were collected at baseline and following the 12th PTNM therapy session. For each UF subject in the analysis, a change in number of voids per day was calculated as number of voids per day after 12th PTNM session minus baseline. A negative change indicates improvement in UF symptoms. | 12 Weeks | 
| Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline | This objective was to assess the change after12 PTNM therapy sessions from baseline in quality of life as measured by the OABq Questionnaire. OABq consists of a symptom bother scale and four health related quality of life (HRQL) subscales (Coping, Concern, Sleep and Social interaction). The symptom bother scale and 4 HRQL subscales are measured as 0-100 using a range percentile transformation on the summed value from individual listed items. The HRQL score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from 4 subscales (Coping, Concern, Sleep and Social). A change was calculated as the score after 12th PTNM minus the score at baseline. A positive change in HRQL and its subscales (Coping, Concern, Sleep and Social) indicates improvement in QOL; a negative change in symptom bother score indicates improvement in QOL. | 12 Weeks |