Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

Launched by INMODE MD LTD. · Feb 21, 2024

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

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