Transvaginal Radiofrequency Ablation With Morpheus Device for Treatment of Overactive Bladder.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- InMode MD Ltd.
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
To assess the effectiveness of transvaginal radiofrequency oblation by the Morpheus device at varying depths of penetration for improving urge predominate and urinary incontinence symptoms in women with overactive bladder .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-85 years old
- •Urinary incontinence for ≥ 3 months
- •Reporting at least "moderate bother" on Item 2 on the Urinary Distress Inventor questioner, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
- •If mixed urinary incontinence, urge is reported predominant symptom on MESA score.
- •\>10 micturition per 24 hours and \>3 urgency episodes on 3-ay bladder diary
- •\> 1 UUI episode on 3-day bladder diary
- •Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2-week wash-out period)
Exclusion Criteria
- •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 in the previous 6 months
- •Received intravesical botulinum injection within the previous 12 months
- •History of implanted nerve stimulator for incontinence
- •History of prior sling or vaginal mesh placement, UNLESS onset of UUI was completely unrelated to placement and severity was unaffected by mesh placement.
- •Previous diagnosis of Interstitial cystitis
- •Active pelvic organ malignancy
- •History of pelvic radiation
Outcomes
Primary Outcomes
To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms
Time Frame: 3 months
Measured by the Incontinence Impact Questionnaire Total Score. Normative values for a general population, 10% of whom scored above 4.8 on IIQ-7. Values obtained from patients with severe incontinence indicate that a score \> 70 on the IIQ signifies a poor QOL. Lower scores on IIQ-7 may identify more females who are bothered by urinary incontinence. 7 items are divided into four domains (physical activity, travel, social relationships, emotional health). Item-level scores are rated on a four-point Likert scale (where 0=not at all and 3=greatly), determined by the self-reported impact of symptoms related to urinary incontinence. The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.
Secondary Outcomes
- To assess the effectiveness of RF ablation assess on urgency and associated life impact(6 months)
- To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life(6 months.)