N/A
N=10
Evaluation of the Use of the Renuvion APR System in the Labia
Labia Enlarged · Labium; Hypertrophy
Bottom Line
View on ClinicalTrials.gov: NCT05323630 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: 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. — 4; 4 Sets of B/A Images analyzed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Renuvion APR System (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Apyx Medical
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
4; 4 | — |
| SECONDARY Analysis of Morphometric Labia Measurements at D180. |
10.0; 10.5; 1.3; 1.3; 0.9; 0.9 | — |
| SECONDARY 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. |
0; 0; 6; 3; 1; 0 | — |
| SECONDARY Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 |
0; 0; 7; 3; 0; 0 | — |
| SECONDARY The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. |
7; 3; 6; 3; 6; 3 | — |
| SECONDARY During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). |
0.3; 0.0; 4.1; 2.3; 3.7; 4.0 | — |
| SECONDARY 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. |
0; 0; 2; 0; 5; 3 | — |
| SECONDARY The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. |
0; 0; 2; 1; 5; 2 | — |
| SECONDARY The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. |
24.45; 25.17; 24.45; 27.89; 29.49; 26.51 | — |
| SECONDARY The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits |
18.57; 22.33; 9.14; 12.33; 9.86; 10.67 | — |
| SECONDARY Analysis of Days Until Subject Was Comfortable Returning to Sex. |
35.7; 21.7 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05323630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.