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

NCT02857816 | Completed Results FDA Device

• 1 other identifier: 1679
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects

  12 Weeks

• Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline

  12 Weeks

Study Arms (1)

NURO System PTNM Therapy

OTHER

Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.

Device: NURO System PTNM Therapy

Interventions

NURO System PTNM Therapy DEVICE

NURO System PTNM Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (11)

Pinellas Urology, Inc.

St. Petersburg, Florida, 33710-1925, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Mount Auburn Hospital

Cambridge, Massachusetts, 02138, United States

Location

Advanced Urogynecology of Michigan, P.C.

Dearborn, Michigan, 48123, United States

Location

Metro Urology

Woodbury, Minnesota, 55125, United States

Location

Urology Center Research Institute, LLC

Englewood, New Jersey, 07631, United States

Location

NYU Urology Associates

New York, New York, 10016, United States

Location

Alliance Urology Specialists

Greensboro, North Carolina, 27403, United States

Location

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

SSM Health Dean Medical Group

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study had a single arm with all subjects treated with PTNM Therapy.

Results Point of Contact

• Title: Beth Michaud / Sr. Principal Clinical Research Specialist
• Organization: Medtronic Pelvic Health & Gastric Therapies

beth.m.michaud@medtronic.com

763.526.8102

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 5, 2016
• Study Start: September 1, 2016
• Primary Completion: November 21, 2017
• Study Completion: November 21, 2017
• Last Updated: January 14, 2019
• Results First Posted: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

US (11)