Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

NCT06283498 | Enrolling By Invitation FDA Device

• 1 other identifier: DO612574A
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in urgency incontinence episodes after 3 month

  Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes.

  3 months

Secondary Outcomes (16)

• Change in urgency incontinence episodes after 1 month

  1 month

• Change in urgency incontinence episodes

  6 months

• Change in urgency incontinence episodes

  12 months

• Analysis to assess the urinary frequency

  1 month

• Analysis to assess urinary frequency

  3 months

Study Arms (1)

Device Treatment

EXPERIMENTAL

20 female patients with overactive bladder symptoms, aged 21 to 80 years old, inclusive from two sites.

Device: Device Morpheus8V

Interventions

Device Morpheus8V DEVICE

Assigned to be treated using the modified Morpheus8V

Device Treatment

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: 20 female patients with overactive bladder symptoms, aged 21 to 80 years old, inclusive from two sites .
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-80 years old, inclusive
• Subject is willing to provide Informed Consent, is geographically stable, understands the requirements for completing the bladder diary and is willing to comply with the required diary, follow-up visits, and testing schedules.
• Urinary incontinence, predominant urgency incontinence for at least one episode on a 3-days diary.
• Reporting at least "moderate bother" on Item 2 on the UDI, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
• \>8 micturitions and \>3 urgency episodes per 24 hours on a 3-day bladder diary (see Appendix 2)
• UUI episode on a 3-day bladder diary (see Appendix 2)
• Not currently taking anti-muscarinic or beta3 agonist therapy (after at least a 2-week wash-out period)
• Post-void residual (PVR) ≤ 100 ml NOTE: it may include Subjects with a single PVR of \>100 ml followed by two consecutive PVR measurements of ≤100 ml in the study. We will record the final acceptable PVR measurement in the data.
• Ability and willingness to self-catheterize in case this is necessary.
• With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly from screening until the last follow up

You may not qualify if:

• Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.
• Any permanent implant or an injected chemical substance in the treatment area.
• Superficial areas that have been injected with HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
• Current or history of cancer, or current condition of any other type of cancer, or premalignant moles.
• Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• Pregnancy, the intention of pregnancy and nursing.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, autoimmune disorders, or use of immunosuppressive medications.
• Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
• Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
• Any active condition in the treatment area, such as sores, eczema, and rash.
• History of vaginal disorders, keloids, abnormal wound healing.
• History of bleeding coagulopathies or use of anticoagulants in the last 10 days, as per the practitioner's discretion.
• Non-English speakers
• Severely impaired mobility or cognition
• Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (3)

Mickey Karram MD

Corona del Mar, California, 92625, United States

Location

Institute for Female Pelvic Medicine

Knoxville, Tennessee, 37932, United States

Location

The Hospital Infantil Universitario de San José (University Children's Hospital of San José)

Bogotá, Colombia

Location

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

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: November 10, 2023
• Primary Completion: November 10, 2025
• Study Completion (Estimated): November 10, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

CO (1); US (2)