Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy

NCT03725410 | Completed

• 1 other identifier: CS1017
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a multicenter, single-blind, randomized, sham-controlled study utilizing the Venus Fiore™ (MP)2, a table-top device designed to deliver multi-polar RF energy and pulsed electromagnetic fields for use in dermatological and general surgical procedures to temporarily improve blood circulation and to induce modification of collagen structure, neocollagenesis and angiogenesis for the treatment of symptoms associated with vulvovaginal atrophy.

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (6)

• Vaginal Health Index (VHI)

  Proportion of subjects in the active arm as compared to the proportion of the subjects in the sham arm assessed as having improvement in the Vaginal Health Index (VHI) score.

  Three months after initial treatment

• Vaginal Health Index (VHI)

  Proportion of subjects in the active arm as compared to the proportion of the subjects in the sham arm assessed as having improvement in the Vaginal Health Index (VHI) score.

  Six months after initial treatment

• Vaginal Mucus

  Report the microscopic changes in vaginal mucus in the study treatment group as compared to the sham treatment group.

  Three months after initial treatment

• Vaginal Mucus

  Report the microscopic changes in vaginal mucus in the study treatment group as compared to the sham treatment group.

  Six months after initial treatment

• Vaginal pH

  Report the microscopic changes in vaginal pH in the study treatment group as compared to the sham treatment group.

  Three months after initial treatment

• Vaginal pH

  Report the microscopic changes in vaginal pH in the study treatment group as compared to the sham treatment group.

  Six months after initial treatment

Study Arms (2)

Venus Fiore Study Treatment

ACTIVE COMPARATOR

Study treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes).

Device: Venus Fiore Study Treatment

Venus Fiore Sham Treatment

PLACEBO COMPARATOR

Sham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes).

Device: Venus Fiore Sham Treatment

Interventions

Venus Fiore Study Treatment DEVICE

Study treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes).

Venus Fiore Study Treatment

Venus Fiore Sham Treatment DEVICE

Sham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes).

Venus Fiore Sham Treatment

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Only human females have labia, a mons pubis and a vagina.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, female subjects, ≥ 19 years of age, requesting treatment of vulvovaginal tissue for improvement of symptoms associated with vulvovaginal atrophy
• Baseline FSFI score \<27.
• At least one full-term vaginal delivery (of more than 36 weeks gestation) completed at least one year before study enrollment.
• Able to read, understand and voluntarily provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• Sexually active in a monogamous relationship.
• Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
• Negative Papanicolaou (Pap) Smear Cytology Test within 3 months prior to 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 or bleeding of any sort on 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 (2)

IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Institute Palacios

Madrid, 28009, Spain

Location

Study Officials

• Matthew Gronski, PhD

  Venus Concept Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 31, 2018
• Study Start: September 25, 2018
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: June 2, 2023

Record last verified: 2022-02

Locations

ES (1); IT (1)