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Completed

NCT Number: NCT06458556

Transvaginal Radiofrequency Ablation for 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 .

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

California Center for Pelvic Floor Disorders

Corona del Mar, California, 92625, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment with Morpheus

Device

Radiofrequency device treatment

Primary outcomes

  1. To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms

    Time frame: 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

    • = 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.

  2. To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms

    Time frame: 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 outcomes

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

    Time frame: 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

    • = 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.

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

    Time frame: 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.

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

    Time frame: 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,

Sponsors and collaborators

Lead sponsor

InMode MD Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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