Clinical trial NCT02857816: PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB
Official title: PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation (PTNM) System in Patients With OAB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects
timeFrame: 12 Weeks
measure: Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Pinellas Urology, Inc.
state: Florida
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Cambridge
country: United States
facility: Mount Auburn Hospital
state: Massachusetts
city: Dearborn
country: United States
facility: Advanced Urogynecology of Michigan, P.C.
state: Michigan
city: Woodbury
country: United States
facility: Metro Urology
state: Minnesota
city: Englewood
country: United States
facility: Urology Center Research Institute, LLC
state: New Jersey
city: New York
country: United States
facility: NYU Urology Associates
state: New York
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of University of Pennsylvania
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Madison
country: United States
facility: SSM Health Dean Medical Group
state: Wisconsin
Study officials:
References: