Transvaginal Radiofrequency Ablation for Overactive Bladder

Transvaginal Radiofrequency Ablation With Morpheus Device for Treatment of Overactive Bladder.

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 .

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Treatment with Morpheus

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Corona Del Mar, California, United States, 92625
      • California Center for Pelvic Floor Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Morpheus	Device: Treatment with Morpheus; Radiofrequency device treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms	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; = Slightly; = Moderately; = 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.	3 months
To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life	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; = Slightly; = Moderately; = 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.	6 months
To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life	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.	6 months.
To assess the effectiveness of RF ablation assess on urgency and associated life impact	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,	6 months

Collaborators and Investigators

• Sponsor: InMode MD Ltd.
• Investigators: Principal Investigator: Mickey Karram, MD, not affiliated

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: DO613705A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No