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

• ClinicalTrials.gov Identifier: NCT02857816
• Recruitment Status: Completed
• First Posted: August 5, 2016
• Results First Posted: December 12, 2018
• Last Update Posted: January 14, 2019
• Sponsor: MedtronicNeuro
• Information provided by (Responsible Party): MedtronicNeuro

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Overactive Bladder	Device: NURO System PTNM Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 154 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation (PTNM) System in Patients With OAB
• Study Start Date: September 2016
• Actual Primary Completion Date: November 21, 2017
• Actual Study Completion Date: November 21, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline [ Time Frame: 12 Weeks ]
   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.

Secondary Outcome Measures :

1. Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects [ Time Frame: 12 Weeks ]
   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.
2. Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline [ Time Frame: 12 Weeks ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

Pinellas Urology, Inc.

Saint Petersburg, Florida, United States, 33710-1925

United States, Illinois

NorthShore University Health System

Evanston, Illinois, United States, 60201

United States, Massachusetts

Mount Auburn Hospital

Cambridge, Massachusetts, United States, 02138

United States, Michigan

Advanced Urogynecology of Michigan, P.C.

Dearborn, Michigan, United States, 48123

United States, Minnesota

Metro Urology

Woodbury, Minnesota, United States, 55125

United States, New Jersey

Urology Center Research Institute, LLC

Englewood, New Jersey, United States, 07631

United States, New York

NYU Urology Associates

New York, New York, United States, 10016

United States, North Carolina

Alliance Urology Specialists

Greensboro, North Carolina, United States, 27403

United States, Pennsylvania

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Washington

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

United States, Wisconsin

SSM Health Dean Medical Group

Madison, Wisconsin, United States, 53715

Sponsors and Collaborators

MedtronicNeuro

  Study Documents (Full-Text)

Documents provided by MedtronicNeuro:

Study Protocol  [PDF] June 3, 2016

Statistical Analysis Plan  [PDF] August 21, 2017

More Information

• Responsible Party: MedtronicNeuro
• ClinicalTrials.gov Identifier: NCT02857816
• Other Study ID Numbers: 1679
• First Posted: August 5, 2016
• Results First Posted: December 12, 2018
• Last Update Posted: January 14, 2019
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• 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

Additional relevant MeSH terms:

Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations