CAUTION-Investigational Device. Limited by Federal or U.S. law to investigational use
PROTECT STUDY for OVERACTIVE BLADDER (OAB)
Actively Recruiting Patients
Protect PNS is being studied for the treatment of urgency urinary incontinence. OAB is characterized by symptoms including urgency, frequency, nocturia and often associated with a leakage of urine.
Eligibility
General Qualifications for Participation in the PROTECT Study:
(for a complete description, please speak to Clinical Study Investigator)
- ≥ 18 years of age
- Diagnosis of overactive bladder with urgency urinary incontinence or mixed incontinence (urge and stress) with predominate urge
- At least four incontinent episodes associated with urgency on a 3-day voiding diary
- At least 10-voids per day
- Self-reported bladder symptoms present > 6-months
- Documented failure of an adequate trial of first- and second-line therapy
Study Participation
As a participant in this clinical study you can expect the following:
(for a complete description, please speak to Clinical Study Investigator)
- Visit #1 will be to learn about study and confirm participation
- Visit #2 will focus on securing baseline health data
- Visit #3 is reserved for implantation of the device
- A total of 10 visits with your Urologist will be completed to assess progress during the trial period of 12 months
Study Locations
We are adding new sites around the country on a weekly basis. Please contact us below for more information for a study site near you.