Overactive Bladder
Conditions
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 .
Interventions
DEVICETreatment with Morpheus
Radiofrequency device treatment
Sponsors
InMode MD Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-blinded non-comparative pilot trial in which a total of 20 subjects with OAB are included. Subjects may include individuals with overactive balder and contraindications to alternative first- and second-line treatments, OAB and do not desire pursuing alternative first- and second-line treatments, refractory overactive balder, and urge predominate mixed urinary incontinence. Subjects will undergo treatment with the Morpheus system every 4 weeks for a total of 3 treatments. Follow up will occur at 3- month and 6-month intervals after the subjects first treatment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
Yes
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 * Urethral obstruction * Urinary retention or prolonged catheter use * Less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months * Untreated symptomatic urinary tract infection * Unevaluated hematuria * Medical instability * Allergy to anesthetics used in the study * Not available for follow-up in 6 months * Participation in other research trials that could influence results of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms | 3 months | Measured by The Urogenital Distress Inventory-6 (UDI-6). The Urogenital Distress Inventory-6 (UDI-6) assesses the severity of urogenital symptoms through six questions addressing frequent urination, urgency-related leakage, leakage during physical activity, small amounts of leakage, difficulty emptying the bladder, and pain or discomfort in the lower abdomen or genital region. 0 = Not at all 1. = Slightly 2. = Moderately 3. = Greatly The scores for each item are summed to give a total score, which ranges from 0 to 18. Higher scores indicate greater distress and symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life | 6 months | Measured by The Urogenital Distress Inventory-6 (UDI-6). The Urogenital Distress Inventory-6 (UDI-6) assesses the severity of urogenital symptoms through six questions addressing frequent urination, urgency-related leakage, leakage during physical activity, small amounts of leakage, difficulty emptying the bladder, and pain or discomfort in the lower abdomen or genital region. 0 = Not at all 1. = Slightly 2. = Moderately 3. = Greatly The scores for each item are summed to give a total score, which ranges from 0 to 18. Higher scores indicate greater distress and symptom severity. |
| To assess the effectiveness of RF ablation assess on urgency and associated life impact | 6 months | Measured by the Medical, Epidemiologic, and Social Aspects of Aging (MESA ).The MESA questionnaire is consisted of 2 separate parts, with 6 questions concerning urgency urinary incontinence (UUI) and 9 concerning stress urinary incontinence (SUI). MESA SI (Stress Incontinence), theoretical scores ranged from 1 (mild) to 27 (severe). MESA UI (Urgency Incontinence), theoretical scores ranged from 1 (mild) to 18 (severe). Higher scores indicate more severe symptoms, |
Countries
United States
Outcome results
None listed