Transvaginal Radiofrequency Ablation for Overactive Bladder

NCT06458556 | Completed FDA Device

• 1 other identifier: DO613705A
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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 .

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• 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 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.

  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 Outcomes (3)

• To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life

  6 months

• To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life

  6 months.

• To assess the effectiveness of RF ablation assess on urgency and associated life impact

  6 months

Study Arms (1)

Treatment with Morpheus

EXPERIMENTAL

Device: Treatment with Morpheus

Interventions

Treatment with Morpheus DEVICE

Radiofrequency device treatment

Treatment with Morpheus

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Women with overactive bladder
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (1)

California Center for Pelvic Floor Disorders

Corona del Mar, California, 92625, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mickey Karram, MD

  Not affiliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 13, 2024
• Study Start: June 19, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)