To evaluate the NURO system for the treatment of OAB in drug naïve patients.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Pinellas Urology, Inc.
St. Petersburg, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Mount Auburn Hospital
Cambridge, Massachusetts, United States
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.
Time frame: 12 Weeks
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.
Time frame: 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.
Time frame: 12 Weeks
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Advanced Urogynecology of Michigan, P.C.
Dearborn, Michigan, United States
Metro Urology
Woodbury, Minnesota, United States
Urology Center Research Institute, LLC
Englewood, New Jersey, United States
NYU Urology Associates
New York, New York, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States
Virginia Mason Medical Center
Seattle, Washington, United States
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