transvaginal detrusor nerve radiofrequency ablation for treatment of overactive bladder

Conditions: Overactive Bladder Syndrome

Summary: the goal of this safety and efficacy of transvaginal detrusor nerve ablation for treatment of overactive bladder symptoms, including refractory overactive bladder the main questions it aims to answer are: •change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[time frame: 3 months\] subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. if less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. if more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. investigators will have the ability to initiate a second and or third treatment on an individual basis. follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment.


Eligibility criteria:
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