Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Device: Device Morpheus8V

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogota,, Colombia
    • The Hospital Infantil Universitario de San José (University Children's Hospital of San José)
• United States
  • California
    • Corona Del Mar, California, United States, 92625
      • Mickey Karram MD
  • Tennessee
    • Knoxville, Tennessee, United States, 37932
      • Institute for Female Pelvic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)
• 1 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

Exclusion Criteria:

• 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
• Repair of pelvic organ prolapse or incontinence procedure in the previous 6 months
• Ongoing complications of prior anti-incontinence surgery
• Received intravesical botulinum injection within the previous 12 months
• History of an implanted nerve stimulator for incontinence
• History of prior sling or vaginal mesh placement,
• Previous diagnosis of interstitial cystitis, bladder cancer, or chronic pelvic pain
• Current participation in any other conflicting interventional or OAB treatment study
• Planning to become pregnant during the study period.
• Pelvic radiation, history of pelvic radiation
• Subject with 24-hour total urine volume voided greater than 3,000 ml as measured at screening period.
• Active urinary tract or vaginal infection
• Anatomical conditions that would prevent the introduction and use of the device, in such as significant pelvic organ prolapse,
• Current hydronephrosis or hydroureter
• Bladder outflow obstruction
• Active pelvic organ malignancy
• Urethral obstruction
• Urinary retention or prolonged catheter use
• Less than 12 months post-partum or currently pregnant or plan to become pregnant in the following 12 months.
• Untreated symptomatic urinary tract infection
• Unevaluated hematuria
• Medical instability
• Allergy to anesthetics as Benzocaine/Lidocaine/Tetracaine Cream (BLT Cream) used in the study
• Not available for follow-up in 6 months
• Participation in other research trials that could influence results of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Treatment; 20 female patients with overactive bladder symptoms, aged 21 to 80 years old, inclusive from two sites.	Device: Device Morpheus8V; Assigned to be treated using the modified Morpheus8V

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis to assess the urinary frequency	Change from baseline to the end of treatment in a 3-day diary analysis to assess the urinary frequency.	1 month
Analysis to assess urinary frequency	Change from baseline to the end of treatment in a 3-day diary analysis to assess urinary frequency.	3 months
Analysis to assess the urinary frequency.	Change from baseline to the end of treatment in a 3-day diary analysis to assess the urinary frequency. [Time Frame: 6 months]	6 months
Patient-reported Pain assessment	The subject will be asked to rate the severity from 0 to 10, with 0 equaling no symptoms and 10 equaling the worst possible symptoms. A number is obtained by measuring up to the point the subject has indicated.	treatment procedure
Change in urgency incontinence episodes after 1 month	Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes	1 month
Change in urgency incontinence episodes	Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes.	6 months
Change in urgency incontinence episodes	Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes.	12 months
Analysis to assess the urinary frequency.	Change from baseline to the end of treatment in a 3-day diary analysis to assess the urinary frequency.	12 months
Assessment of the impact of the treatment on Overactive Bladder symptoms	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.	1 month
Assessment of the impact of the treatment on Overactive Bladder symptoms	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 months
Assessment of the impact of the treatment on Overactive Bladder symptoms	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.	6 months
Assessment of the impact of the treatment on Overactive Bladder symptoms	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.	12 months
Patient-reported outcome measure	Patient perception of bladder condition and device acceptance measured by Patient Satisfaction Questionnaire. 6 points Likert scale, grading from 0 to 5. A lower score indicates a better outcome.	1 month
Patient-reported outcome measure	Patient perception of bladder condition and device acceptance measured by Patient Satisfaction Questionnaire. 6 points Likert scale, grading from 0 to 5. A lower score indicates a better outcome.	3 months
Patient-reported outcome measure	Patient perception of bladder condition and device acceptance measured by Patient Satisfaction Questionnaire. 6 points Likert scale, grading from 0 to 5. A lower score indicates a better outcome.	6 months
Patient-reported outcome measure	Patient perception of bladder condition and device acceptance measured by Patient Satisfaction Questionnaire. 6 points Likert scale, grading from 0 to 5. A lower score indicates a better outcome.	12 months

Collaborators and Investigators

• Sponsor: InMode MD Ltd.
• Investigators: Principal Investigator: Mickey Karram, MD, not affiliated

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): November 10, 2025
• Study Completion (Estimated): November 10, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: DO612574A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No