Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

Part of paid clinical trials in Corona del Mar, California.

Sponsor
InMode MD Ltd.
Study ID
NCT06283498
Status
Enrolling By Invitation

Conditions

  • Overactive Bladder Syndrome

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Device Morpheus8V — DEVICE
    Assigned to be treated using the modified Morpheus8V

Study Details

The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder The main questions it aims to answer are: •Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[Time Frame: 3 months\] Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis. Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment.

Key Dates

Start date
Nov 10, 2023
Status verified
Mar 2025
Primary completion
Nov 10, 2025
Completion
Nov 10, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Device Treatment
    20 female patients with overactive bladder symptoms, aged 21 to 80 years old, inclusive from two sites.

Primary Outcome Measure

Change in urgency incontinence episodes after 3 month [ Time Frame: 3 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mickey Karram MDCorona del MarCalifornia92625-
Institute for Female Pelvic MedicineKnoxvilleTennessee37932-

Find similar trials in Corona del Mar, CA

By research site
Mickey Karram MD· Corona del Mar, CAInstitute for Female Pelvic Medicine· Knoxville, TN

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