Transvaginal Radiofrequency Ablation for Overactive Bladder

InMode

Status: Completed

Conditions: Overactive Bladder

Treatments: Device: Treatment with Morpheus

Study type: Interventional

Funder types: Industry

Identifiers

NCT06458556

DO613705A

Details and patient eligibility

About

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 .

Enrollment: 17 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

Treatment with Morpheus

Experimental group

Treatment:

Device: Treatment with Morpheus