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

Medtronic

Status: Completed

Conditions: Overactive Bladder

Treatments: Device: NURO System PTNM Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02857816

1679

Details and patient eligibility

About

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

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

154 participants in 1 patient group

NURO System PTNM Therapy

Other group

Description:

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

Treatment:

Device: NURO System PTNM Therapy