Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

Inclusion criteria

• Age 21-80 years old, inclusive
• 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 for at least one episode on a 3-days diary.
• Reporting at least "moderate bother" on Item 2 on the UDI, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
• >8 micturitions and >3 urgency episodes per 24 hours on a 3-day bladder diary (see Appendix 2)
• 1 UUI episode on a 3-day bladder diary (see Appendix 2)
• Not currently taking anti-muscarinic or beta3 agonist therapy (after at least a 2-week wash-out period)
• Post-void residual (PVR) ≤ 100 ml NOTE: it may include Subjects with a single PVR of >100 ml followed by two consecutive PVR measurements of ≤100 ml in the study. We will record the final acceptable PVR measurement in the data.
• 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 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 AIDS and 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-English 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
• Subject with 24-hour total urine volume voided greater than 3,000 ml as measured at screening period.
• 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