Clinical trial NCT06458556: Transvaginal Radiofrequency Ablation for Overactive Bladder
Official title: Transvaginal Radiofrequency Ablation With Morpheus Device for Treatment of Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-13
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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 .


Eligibility criteria: 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

Primary outcomes:
measure: To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms
timeFrame: 3 months
measure: To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms
timeFrame: 3 months
Secondary outcomes:
measure: To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life
timeFrame: 6 months
measure: To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life
timeFrame: 6 months.
measure: To assess the effectiveness of RF ablation assess on urgency and associated life impact
timeFrame: 6 months
Other outcomes:
Locations:
city: Corona Del Mar
country: United States
facility: California Center for Pelvic Floor Disorders
state: California
Study officials:
affiliation: Not affiliated
name: Mickey Karram, MD
role: PRINCIPAL_INVESTIGATOR
References: