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



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:September 2016
End Date:November 21, 2017

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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.

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.

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
We found this trial at
11
sites
Evanston, Illinois 60201
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Phone: 215-615-3780
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Cambridge, Massachusetts 02144
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Cambridge, MA
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Dearborn, Michigan 48124
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Dearborn, MI
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Englewood, New Jersey 07631
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Englewood, NJ
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Greensboro, North Carolina
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Greensboro, NC
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Madison, Wisconsin 53715
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Madison, WI
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New York, New York 10016
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New York, NY
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Saint Petersburg, Florida 33710
Phone: 727-341-1583
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Saint Petersburg, FL
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Seattle, WA
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Woodbury, Minnesota 55125
Phone: 651-999-6846
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Woodbury, MN
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