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

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

To evaluate the NURO system for the treatment of OAB in drug naïve patients.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: NURO System PTNM Therapy

Detailed Description

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
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33710-1925
      • Pinellas Urology, Inc.
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Mount Auburn Hospital
  • Michigan
    • Dearborn, Michigan, United States, 48123
      • Advanced Urogynecology of Michigan, P.C.
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Metro Urology
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Urology Center Research Institute, LLC
  • New York
    • New York, New York, United States, 10016
      • NYU Urology Associates
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • Alliance Urology Specialists
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of University of Pennsylvania
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • SSM Health Dean Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years of age or older
2. 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
3. Experiencing UUI symptoms for at least 3 months
4. No prior treatment with anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB
5. Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol
6. Willing and able to provide signed and dated informed consent

Exclusion Criteria:

1. 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)
2. Primary stress incontinence or mixed incontinence where the stress component overrides the urge component
3. Have implantable pacemakers or implantable defibrillators
4. Use of transcutaneous electrical nerve stimulation (TENS) in pelvic region, back or legs
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
7. Nerve damage that could impact either tibial nerve or pelvic floor function.
8. Subjects prone to excessive bleeding
9. Inadequate skin integrity in the area of PTNM needle placement
10. History of diabetes unless the diabetes is well-controlled through diet and/or medications
11. Have symptomatic urinary tract infection (UTI)
12. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: NURO System PTNM Therapy; Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.	Device: NURO System PTNM Therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ACTUAL): November 21, 2017
• Study Completion (ACTUAL): November 21, 2017

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (ESTIMATE): August 5, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2019
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 1679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No