Clinical trial NCT04705571: Clinical Evaluation of Fractional Bi-Polar RF for Symptoms of SUI and Vulvovaginal Atrophy
Official title: Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Vulvovaginal Signs and Symptoms
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-12
Enrollment: 41
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Eligible subjects will receive 1 treatment with the MorpheusV Applicator according to the study protocol.
Primary purpose: TREATMENT

Brief summary: Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy

Detailed description: The objective of this trial is to evaluate the safety and efficacy of the MorpheusV Applicator for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy

Eligibility criteria: Inclusion Criteria:

* Signed informed consent to participate in the study.

  * Female subjects, 35 and 75 years of age at the time of enrolment with primary and moderate to severe symptoms of SUI, who had scored at least 6 out of 12 according to severity index developed by Sandvik
  * She has produced a leak during the bladder "cough" stress test.
  * 18 out of 27 for the Stress Incontinence Questions and were confirmed as having predominant SUI on the Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment.
  * General good health confirmed by medical history and skin examination of the treated area.
  * The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.

Exclusion Criteria:

* - Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane.
* Current or history of cancer, or premalignant condition in the treatment area.
* Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* Pregnancy and nursing.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
* Patients with 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.
* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
* Any surgery in treated area within 3 months prior to treatment.
* Simultaneous participation in another investigator drug or device study or completion of the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
* Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area.
* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient

Primary outcomes:
measure: An objective change as measured by standardized cough stress test
timeFrame: Day 0, Month 6
measure: An objective evaluation of vaginal atrophy/estrogenization
timeFrame: Day 0, month 6
measure: The effect of the treatment on urinary symptoms and quality of life by means of the Incontinence Quality of Life (IQOL) Questionnaire
timeFrame: Day 0, month 6
measure: The effect of the treatment on urinary symptoms by means of Urogenital Distress Inventory 6 Questionnaire
timeFrame: day 0, month 6
measure: The effect of the treatment on urinary symptoms by means of Bladder voiding diary after the treatment
timeFrame: Day 0, month 6
measure: The effect of the treatment on urinary symptoms by means of Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire
timeFrame: Day 0, month 6
measure: Evaluation of histological changes to vaginal canal tissue
timeFrame: Day 0, month 3
Secondary outcomes:
measure: Occurrence of expected post treatment immediate response
timeFrame: day 0, through study completion, on average 6 months
measure: Discomfort scale
timeFrame: day 0
measure: Adverse Events
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Alpharetta
country: United States
facility: Miklos and Moore Urogynecology
state: Georgia
city: Bluffton
country: United States
facility: Advanced Women's Care of the Lowcountry, PC
state: South Carolina
Study officials:
affiliation: Advanced Women's Care of the Lowcountry, PC
name: Tracy Blusewicz, MD
role: PRINCIPAL_INVESTIGATOR
References: