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

Completed · Not applicable

Conditions studied: Overactive Bladder

In brief

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

Key facts

Study ID

NCT02857816

Run by

MedtronicNeuro

People needed

154

Starts

2016-09-01

Expected to finish

2017-11-21

Last updated by the study team

2019-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• Pinellas Urology, Inc. — St. Petersburg, Florida, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Mount Auburn Hospital — Cambridge, Massachusetts, United States
• 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
• SSM Health Dean Medical Group — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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