Evaluation of the Use of the Renuvion APR System in the Labia

Labiaplasty is a procedure aimed at reducing lax or loose skin in the labia majora and/or minora due to childbirth, trauma, aging, genetics, or congenital disease.

Study Overview

• Status: Completed
• Conditions: Labia Enlarged; Labium; Hypertrophy
• Intervention / Treatment: Device: Renuvion APR System

Detailed Description

While traditional surgical procedures have been associated with complications such as dehiscence, hematoma, flap necrosis, narrowed introitus, and pain and asymmetry, correction with RF energy has shown minimal complication rates with high patient satisfaction. This study aims to evaluate the use of the Renuvion APR System for use as a minimally invasive alternative to surgical labiaplasty.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Allison Plastic Martinez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female subjects, ages 35 - 70 years old.
• ASA Physical Status Classification System Class I and Class II subjects.
• Labial protrusion Class II and Class III (MOTAKEF scale)12.
• Females who do not desire traditional invasive surgery.
• Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
• Absence of physical conditions unacceptable to the investigator.
• Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
• Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
• Willing to release rights for the use of study photos, including in publication.
• Able to read, understand, sign, and date the informed consent.

Exclusion Criteria:

• Labial protrusion Class I (MOTAKEF scale).
• Subjects presenting with ASA Physical Status Classification System Classes III or higher.
• Pregnant, lactating, or plans to become pregnant during study participation.
• Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
• Previous treatment in the study treatment area.
• Active systemic or local skin disease that may alter wound healing.
• Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
• Known susceptibility to keloid formation or hypertrophic scarring.
• Cancerous or pre-cancerous lesions in the area to be treated.
• Possesses a surgically implanted electronic device (i.e., pacemaker).
• Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
• Participation in any other investigational study within 30 days prior to consent and throughout study participation.
• Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Procedure with the Renuvion APR System in the labia; The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice.	Device: Renuvion APR System; The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Change Between Baseline and Follow-up Images as Determined by a Masked, Qualitative Assessment of Photographs at 90-days and 180-days Post-treatment Compared to Baseline.	Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days and 180-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the labia. Change was assessed as success with success being the correct identification of treated labia images by at least 2 of the 3 reviewers.	Day 90, Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Morphometric Labia Measurements at D180.	Analysis by anatomical measurements of the labia majora and minora at D180.	Day 180
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.	MOTAKEF scale of labia protrusion, Type I-A: Less than 2cm, Type II-A: From 2cm to 4cm, Type II-C: From 2cm to 4cm, Type II-AI: From 4cm to 6 cm, Type VI-A: Greater than 6 cm. The greater the class the greater area of protrusion of labia minora past the labia majora. An "A" is added for asymmetry and a "C" for involvement of the clitoral hood.	Day 30, Day 90, Day 180
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180	Hipertrofia de Ninfas scale of hypertrophy; Type I (Less than 2cm), Type II (2-4cm), Type III (4-6cm), Type IV (<6cm). The lower the type the better the outcome.	Day 30, Day 90, Day 180
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.	The subjects completed a Patient Satisfaction Questionnaire (PSQ) at the Day 180 follow-up visit. The subject completed this assessment while referring to baseline photos, current photos, and a hand mirror.	Day 180
During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).	During study treatment, the subject's pain levels were monitored using the 11-point Numeric Rating Scale (NRS). The average pain score for the entire region treated was recorded. Pain scores will be recorded at all follow-up visits. NRS 11-point Scale where 0 is no pain and 10 is most pain.	Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.	The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, completed a bilateral GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment. Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse	Day 30, Day 90, Day 180
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.	The subject completed a GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment. Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse	Day 30, Day 90, Day 180
The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia.	Female Sexual Function Index (FSFI) evaluation which measures desire, arousal, lubrication, orgasm, satisfaction, and pain, was administered at baseline, Day 90, and Day 180; 5 Answers available per question. The individual domain scores and full-scale score of the FSFI are derived by the computational formula. Response options for questions were: 0=no sexual activity, 5=almost always or always, 4=most times (more than half the time), 3=sometimes (about half the time), 2=a few times (less than half the time), 1=almost never or never. Individual domain scores are obtained by adding the scores of the individual items that comprise the domain and multiplying the sum by the specified domain factor. The full-scale score is obtained by adding the six domain scores with potential ranges from 2 to 36.	Baseline, Day 90, Day 180
The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits	The Genital Appearance Satisfaction (GAS) scale was used to assess the satisfaction of subjects with their genital appearance following treatment to the labia at baseline, Day 90, and Day 180. The higher the GAS score reveals the greater dissatisfaction. Response options for each section of questions were Never (score 3), Sometimes (score 2), Often (score 1), Always (score 0). Question response values were added together for a final score for each participant. The best response would be 0 (no dissatisfaction). The worse response would be 30 (dissatisfaction across all questions).	Baseline, Day 90, Day 180
Analysis of Days Until Subject Was Comfortable Returning to Sex.	Subjects report the number of days until they feel comfortable returning to sex.	Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of pre- and post-treatment genital (right and left labia majora and minora) vibratory perception measurements utilizing a biothesiometer. Readings may be conducted at each follow-up visit until measurements have returned to baseline.	Vibratory perception measurements utilizing a biothesiometer	Baseline, Day 30, 90, 180

Collaborators and Investigators

• Sponsor: Apyx Medical
• Investigators: Principal Investigator: Paul G Ruff, MD, West End Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Actual): April 23, 2024
• Study Completion (Actual): April 23, 2024

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hypertrophy
• Other Study ID Numbers: APX-22-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes