Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy

NCT04607798 | Completed

• 1 other identifier: CS0416K
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of symptoms related to genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA). All subjects will receive a total of three internal treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.

Conditions

Genitourinary Syndrome of Menopause; Vulvovaginal Atrophy; Menopause

Keywords

Genitourinary Syndrome of Menopause; Menopause; Multi-polar Radio Frequency; Pulsed Electromagnetic Field; Sexual Dysfunction; Vaginal Laxity

Outcome Measures

Primary Outcomes (2)

• Vaginal Health Index

  Clinician assessed improvement in five vaginal parameters; (1) vaginal fluid volume, (2) moisture, (3) vaginal epithelial integrity, (4) elasticity and (5) vaginal pH. Assessed by the clinician at each visit with baseline comparison made at the one-month and four-month post-treatment assessments.

  Six months

• pH

  Clinician assessed improvement (reduction) in vaginal pH with baseline comparison made at the one-month and four-month post-treatment assessments.

  Six months

Secondary Outcomes (1)

• Female Sexual Function Index (FSFI)

  Six months

Study Arms (1)

Vulvovaginal treatment

EXPERIMENTAL

Internal vaginal treatment monthly for 3 treatments.

Device: Radiofrequency and pulsed electro-magnetic fields treatment

Interventions

Radiofrequency and pulsed electro-magnetic fields treatment DEVICE

Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.

Vulvovaginal treatment

Eligibility Criteria

• Age: 19 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female subjects, ≥19 years of age presenting with symptoms associated with GSM/VVA.
• Requesting treatment for vulvovaginal tissue for improvement of symptoms associated with GSM/VVA, with a score of ˂26.55 on the FSFI.
• Sexual activity (vaginal intercourse minimum twice per month) in a monogamous relationship.
• At least one full-term pregnancy (\>36 weeks gestation) with vaginal delivery completed at least one year before study enrollment.

You may not qualify if:

• Pregnant or intending to become pregnant during the course of study.
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• Having a permanent implant in the treated area (e.g. intrauterine device)
• Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treated area within 4-6 weeks of the initial treatment or during the course of the study.
• Use of retinoids such as oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
• Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
• Open laceration, abrasion, bleeding, infection or inflammation of any sort on or in the area to be treated.
• Active sexual transmitted disease (STD) (e.g. genital Herpes Simplex, condylomata) or vaginosis.
• Chronic vulvar pain or vulvar dystrophy.
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications, including corticosteroids, 6 months prior to and during the course of the study.
• Having any form of active cancer at the time of enrollment and during the course of the study.
• Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process.
• Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.
• Mentally incompetent or evidence of active substance or alcohol abuse.
• Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Cogerent Laser Clinics Group

Kyiv, 02002, Ukraine

Location

Related Publications (1)

• Kolodchenko Y. Nonablative, Noncoagulative Multipolar Radiofrequency and Pulsed Electromagnetic Field Treatment Improves Vaginal Laxity and Sexual Function. Womens Health Rep (New Rochelle). 2021 Jul 27;2(1):285-294. doi: 10.1089/whr.2021.0020. eCollection 2021.

  PMID: 34327510 DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Matthew Gronski, PhD

  Venus Concept

  STUDY DIRECTOR

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: October 22, 2020
• First Posted: October 29, 2020
• Study Start: October 3, 2017
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

UA (1)