Clinical trial NCT06283498: Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder
Official title: Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Overactive Bladder Syndrome
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 32
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in urgency incontinence episodes after 3 month
timeFrame: 3 months
Secondary outcomes:
measure: Change in urgency incontinence episodes after 1 month
timeFrame: 1 month
measure: Change in urgency incontinence episodes
timeFrame: 6 months
measure: Change in urgency incontinence episodes
timeFrame: 12 months
measure: Analysis to assess the urinary frequency
timeFrame: 1 month
measure: Analysis to assess urinary frequency
timeFrame: 3 months
measure: Analysis to assess the urinary frequency.
timeFrame: 6 months
measure: Analysis to assess the urinary frequency.
timeFrame: 12 months
measure: Assessment of the impact of the treatment on Overactive Bladder symptoms
timeFrame: 1 month
measure: Assessment of the impact of the treatment on Overactive Bladder symptoms
timeFrame: 3 months
measure: Assessment of the impact of the treatment on Overactive Bladder symptoms
timeFrame: 6 months
measure: Assessment of the impact of the treatment on Overactive Bladder symptoms
timeFrame: 12 months
measure: Patient-reported Pain assessment
timeFrame: treatment procedure
measure: Patient-reported outcome measure
timeFrame: 1 month
measure: Patient-reported outcome measure
timeFrame: 3 months
measure: Patient-reported outcome measure
timeFrame: 6 months
measure: Patient-reported outcome measure
timeFrame: 12 months
Other outcomes:
Locations:
city: Corona Del Mar
country: United States
facility: Mickey Karram MD
state: California
city: Knoxville
country: United States
facility: Institute for Female Pelvic Medicine
state: Tennessee
city: Bogota,
country: Colombia
facility: The Hospital Infantil Universitario de San José (University Children's Hospital of San José)
Study officials:
affiliation: Not Affiliated
name: Mickey Karram, MD
role: PRINCIPAL_INVESTIGATOR
References: