Clinical Research Directory

Inclusion Criteria: * Women with minimum age of 18 years . * Documented clinical diagnosis of exclusive or predominant stress urinary incontinence. * Willingness to comply with study procedures and follow-up visits. * Signed informed consent to participate in the study. * BMI \</= 30. 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 * Impaired immune system due to immunosuppressive diseases such as AIDS and HIV 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 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 treatment study * Active urinary tract or vaginal infection * 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 * Untreated symptomatic urinary tract infection * Unevaluated hematuria * Not available for follow-up in 6 months * Participation in other research trials that could influence results of this study