Transvaginal Radiofrequency Ablation for Overactive Bladder

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Device: Treatment with Morpheus

• Registration Number: NCT06458556
• Lead Sponsor: InMode MD Ltd.

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-19
• Status Verified: 2024-05
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Morpheus	Treatment with Morpheus	-

Primary Outcome Measures

Name	Time	Method
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 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 Outcome Measures

Name	Time	Method
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,
To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life	6 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.

Trial Locations

Locations (1)

California Center for Pelvic Floor Disorders; 🇺🇸 Corona Del Mar, California, United States