Transvaginal Radiofrequency Ablation for Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06458556
• Other study ID #: DO613705A
• Status: Completed
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: InMode MD Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• Treatment with Morpheus
Radiofrequency device treatment

Locations

Country	Name	City	State
United States	California Center for Pelvic Floor Disorders	Corona Del Mar	California

Sponsors (1)

Lead Sponsor	Collaborator
InMode MD Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.
Secondary	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