Clinical Research Directory

Inclusion Criteria: * age\>18 years old * Subject is willing to provide Informed Consent, is geographically stable, understands the requirements for completing the bladder diary and is willing to comply with the required diary, follow-up visits, and testing schedules. * Urinary incontinence, predominant urgency incontinence, with moderate-severe overactive bladder, International Consultation on Incontinence Questionnaire - Overactibe Bladder Short Form (ICIQ-OABSS) score ≥6. * Ability and willingness to self-catheterize in case this is necessary. * With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly from screening until the last follow up Exclusion Criteria: * Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body. * Any permanent implant or an injected chemical substance in the treatment area. * Superficial areas that have been injected with hyaluronic acid (HA)/collagen/fat injections or other augmentation methods with bio-material during last 6 months. * Current or history of cancer, or current condition of any other type of cancer, or premalignant moles. * Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases. * Pregnancy, the intention of pregnancy and nursing. * Impaired immune system due to immunosuppressive diseases such as Acquired Immunodeficency Syndrome (AIDS) and Human Immunodeficency Virus (HIV), autoimmune disorders, or use of immunosuppressive medications. * Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen. * Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization. * Any active condition in the treatment area, such as sores, eczema, and rash. * History of vaginal disorders, keloids, abnormal wound healing. * History of bleeding coagulopathies or use of anticoagulants in the last 10 days, as per the practitioner's discretion. * Non-italian speakers * Severely impaired mobility or cognition * Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease * Repair of pelvic organ prolapse or incontinence procedure in the previous 6 months * Ongoing complications of prior anti-incontinence surgery * Received intravesical botulinum injection within the previous 12 months * History of an implanted nerve stimulator for incontinence * History of prior sling or vaginal mesh placement, * Previous diagnosis of interstitial cystitis, bladder cancer, or chronic pelvic pain * Current participation in any other conflicting interventional or OAB treatment study * Planning to become pregnant during the study period. * Pelvic radiation, history of pelvic radiation * Active urinary tract or vaginal infection * Anatomical conditions that would prevent the introduction and use of the device, in such as significant pelvic organ prolapse, * Current hydronephrosis or hydroureter * Bladder outflow obstruction * Active pelvic organ malignancy * Urethral obstruction * Urinary retention or prolonged catheter use * Less than 12 months post-partum or currently pregnant or plan to become pregnant in the following 12 months. * Untreated symptomatic urinary tract infection * Unevaluated hematuria * Medical instability * Allergy to anesthetics as Benzocaine/Lidocaine/Tetracaine Cream (BLT Cream) used in the study * Not available for follow-up in 6 months * Participation in other research trials that could influence results of this study