RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity

NCT04210583 | Completed

• 1 other identifier: FE1019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity. The study will enroll up to 50 subjects who completed the Venus Fiore CS0716 study for the treatment of vaginal laxity and treatment of the mons pubis and labia for improvement in skin laxity. Subjects will be followed up at least six and twelve months post-treatment. Analysis will be performed on all subjects who complete the six-month and twelve month follow-up visits.

Conditions

Vulvovaginal Atrophy; Menopause; Menopause Surgical

Outcome Measures

Primary Outcomes (1)

• Long term safety (Follow-up for any AEs) of the Venus Fiore Fiore™ (MP)2 system in vaginal laxity and skin laxity of the mons pubis and labia.

  AE assessment VLQ, FSFI, GRAS and GAIS (optional) Vaginal pH and vaginal smear (optional) Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided)

  6 months

Secondary Outcomes (1)

• long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia.

  12 months

Study Arms (1)

Vulvovaginal Treatment

EXPERIMENTAL

At visit 1 -(6 months post treatment in the CS0716 study): AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional), At Visit 2 (6 months post treatment in the CS0716 study): AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional), Administer study treatment (optional: internal, mons pubis and/or labia treatment). Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided) Final AE follow-up 30 days post Visit 2 Treatment (if applicable): AE assessment (applicable only if treatment provided at Visit 2 in the FE1019 study).

Device: Vulvovaginal Treatment

Interventions

Vulvovaginal Treatment DEVICE

Device model(s) - Venus Fiore™ Device settings and programming internal applicator - 42°C - 45°C Temperature output via automatic temperature control (ATC) (optional treatment). Duration of exposure and frequency of exposure with internal applicator - one treatment for 12-15 minutes at 12 months (optional treatment). Device settings and programming external mons pubis and labia applicators - 10-35% output (optional treatment). Duration of exposure and frequency of exposure external applicators - one treament for 15 minutes for the mons pubis, 10 minutes for labia at 12 months (optional treatment).

Vulvovaginal Treatment

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: Eligible Females that have completed at least two treatments in the Venus Fiore™ CS0716 study and are at least 6 months post Fiore™ treatment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have completed at least two treatments in the Venus Fiore™ CS0716 study and are at least 6 months post Fiore™ treatment.
• Able to read, understand and voluntarily provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• Sexual active and in a monogamous relationship

You may not qualify if:

• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
• Having a permanent implant in the treatment area.
• Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treatment areaduring the course of the study.
• Use of retinoids such as oral Isotretinoin (Accutane®) 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 areas to be treated.
• Active sexual transmitted disease (STD) (e.g. genital Herpes Simplex, condylomata) or vaginosis.
• Chronic vulvar pain or vulvar dystrophy.
• Use of immunosuppressive medications, including corticosteroids, 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 study, 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.
• 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.
• Unstable dosages of medications such as antihypertensives or use of psychotropics that are known to affect sexuality.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Dr. George Arnold

Markham, Ontario, L6B 0T1, Canada

Location

Study Officials

• Mathew Gronski

  Venus Concept

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 1. Long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia. * Subject's assessment of discomfort and pain as measured by a 10 cm visual analog scale (VAS) at 12 months if treatment (optional) is provided. * Subjects experiencing a treatment-related adverse event (AE) at six-months and twelve-months post-treatment. 2. Long term efficacy of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia. * Improvement in vaginal laxity at six-months and twelve-months post-treatment compared to baseline as defined as a score \>4 on the VLQ. * Improvement in FSFI mean score at six-months and twelve-months post-treatment compared to baseline.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1. Long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia. * Subject's assessment of discomfort and pain as measured by a 10 cm visual analog scale (VAS) at 12 months if treatment (optional) is provided. * Subjects experiencing a treatment-related adverse event (AE) at six-months and twelve-months post-treatment. 2. Long term efficacy of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia. * Improvement in vaginal laxity at six-months and twelve-months post-treatment compared to baseline as defined as a score \>4 on the VLQ. * Improvement in FSFI mean score at six-months and twelve-months post-treatment compared to baseline.

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 24, 2019
• Study Start: September 4, 2019
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

CA (1)