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

NCT03536585 | Completed

• 1 other identifier: CS0716
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

Brief Summary

The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of vaginal looseness and for the treatment of the mons pubis and labia for skin tightening. All subjects will receive a total of three internal and three external treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.

Conditions

Vulvovaginal Atrophy; Menopause; Menopause Surgical

Outcome Measures

Primary Outcomes (1)

• Vaginal Laxity

  Self reported improvement in vaginal laxity defined as a score \> 4 on Vaginal Laxity Questionnaire (VLQ) where 1 = very loose, 2 = moderately loose, 3 = slightly loose, 4 = neither tight nor loose, 5 = slightly tight, 6 = moderately tight and 7 = very tight.

  Six months

Study Arms (2)

Vulvovaginal treatment

EXPERIMENTAL

Internal vaginal treatment monthly for 3 treatments; External mons pubis treatment monthly for 3 treatments; External labia treatment monthly for 3 treatments.

Device: Vulvovaginal treatment; Device: Baseline

Baseline

NO INTERVENTION

Subject's baseline photograph to act as their own control for the one-month and four-month post-treatment photograph of the mons pubis and labia.

Interventions

Vulvovaginal 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. * Radiofrequency and pulsed electro-magnetic fields treatment of the labia to maintain an external temperature of approximately 40 C - 45 C for 15 minutes. * Radiofrequency and pulsed electro-magnetic fields treatment of the mons pubis to maintain an external temperature of approximately 40 C - 47 C for 15 minutes.

Vulvovaginal treatment

Baseline DEVICE

Subject is acting as their own control. The baseline general appearance photograph will act as the comparator.

Vulvovaginal treatment

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: Eligible subjects must be post-menopausal or have undergone surgical menopause.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female subjects, ≥30 years of age who are post-menopausal, or women who have undergone surgically induced menopause and are not able to bear children.
• Requesting treatment for vaginal laxity with a score of ˂4 on the VLQ and are requesting treatment of the mons pubis and labia for skin laxity.
• Sexual activity (vaginal intercourse minimum twice per month) in a monogamous relationship.
• Negative Papanicolaou (Pap) Smear Cytology Test within 3 months prior to enrollment.

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 treated area.
• 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.
• Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.
• Skin piercing in the treatment area.
• Tattoos in the treatment area.
• Prior procedure in the treated area with laser or other device within 12 months of the initial treatment or during the course of treatment.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (3)

Southern Health Centre

White Rock, British Columbia, V4B 5C9, Canada

Location

Dr. George Arnold

Markham, Ontario, L6B 0T1, Canada

Location

Pearl MD Rejuvenation

Toronto, Ontario, M4T 2A2, Canada

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Paul Cardarelli

  Venus Concept

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent reviewer to identify the one-month and four-month post-treatment photograph of the mons pubis and labia.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: May 3, 2018
• Primary Completion: March 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

CA (3)