Labia Enlarged, Labium; Hypertrophy
Conditions
Brief 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.
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.
Interventions
DEVICERenuvion 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.
Sponsors
Apyx Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-center, single arm, evaluator-blinded study of the subjects undergoing a procedure with the Renuvion APR System in the labia. Follow-up visits will occur 1D Contact, 14D, 30D, 90D, and 180D post-procedure. Images will be captured at baseline and all follow-up visits. Three experienced, independent blinded photographic reviewers will perform a qualitative analysis/review of pre-treatment and post-treatment sets of images for each subject. Images will be provided in a blinded and randomized order. Each blinded reviewer will choose which is the before image and which is the after. Success will be correct identification of before and after by at least 2 of the 3 reviewers.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 90, Day 180 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 30, Day 90, Day 180 | 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. |
| Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 30, Day 90, Day 180 | 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. |
| The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Day 180 | 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. |
| During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180 | 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. |
| Analysis of Morphometric Labia Measurements at D180. | Day 180 | Analysis by anatomical measurements of the labia majora and minora at D180. |
| The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 30, Day 90, Day 180 | 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 |
| The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. | Baseline, Day 90, Day 180 | 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. |
| The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits | Baseline, Day 90, Day 180 | 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). |
| Analysis of Days Until Subject Was Comfortable Returning to Sex. | Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180 | Subjects report the number of days until they feel comfortable returning to sex. |
| 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. | Day 30, Day 90, Day 180 | 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 |
Countries
United States
Participant flow
Pre-assignment details
There were no pre-assignments, but 7 subjects were treated with the APR-15-TP Handpiece and 3 of the subjects were treated with the Micro Handpiece launched after the study began.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| Procedure With the Renuvion Micro System in the Labia The labia procedure utilizing the Renuvion Micro system will be performed per the investigator's standard clinical practice. | 3 |
| Total | 10 |
Baseline characteristics
| Characteristic | Total | Procedure With the Renuvion APR System in the Labia | Procedure With the Renuvion Micro System in the Labia |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 7 Participants | 3 Participants |
| Age, Continuous | 41 Years STANDARD_DEVIATION 5.1 | 41 Years STANDARD_DEVIATION 4 | 41 Years STANDARD_DEVIATION 8.5 |
| BMI | 25.704 kg/m2 | 25.246 kg/m2 | 26.773 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 10 participants | 7 participants | 3 participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 3 |
| other Total, other adverse events | 7 / 7 | 3 / 3 |
| serious Total, serious adverse events | 0 / 7 | 0 / 3 |
Outcome results
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.
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.
Time frame: Day 90, Day 180
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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 Sets of B/A Images analyzed |
| Procedure with the Renuvion APR System in the labia (Micro) | 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 Sets of B/A Images analyzed |
Secondary
Analysis of Days Until Subject Was Comfortable Returning to Sex.
Subjects report the number of days until they feel comfortable returning to sex.
Time frame: Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Days Until Subject Was Comfortable Returning to Sex. | 35.7 Days | Standard Deviation 26 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Days Until Subject Was Comfortable Returning to Sex. | 21.7 Days | Standard Deviation 8.02 |
Secondary
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.
Time frame: Day 30, Day 90, Day 180
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Baseline | Type VI: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 30 | Type II: From 2cm to 4cm | 4 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Baseline | Type I: Less than 2cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Baseline | Type II: From 2cm to 4cm | 7 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Baseline | Type III: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 30 | Type I: Less than 2cm | 3 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 30 | Type III: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 30 | Type VI: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 90 | Type I: Less than 2cm | 2 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 90 | Type II: From 2cm to 4cm | 5 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 90 | Type III: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 90 | Type VI: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 180 | Type I: Less than 2cm | 5 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 180 | Type II: From 2cm to 4cm | 2 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 180 | Type III: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 180 | Type VI: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 180 | Type VI: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Baseline | Type VI: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 30 | Type I: Less than 2cm | 2 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 90 | Type I: Less than 2cm | 2 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 180 | Type I: Less than 2cm | 2 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Baseline | Type I: Less than 2cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 90 | Type II: From 2cm to 4cm | 1 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Baseline | Type II: From 2cm to 4cm | 3 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 180 | Type III: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Baseline | Type III: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 90 | Type III: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 30 | Type II: From 2cm to 4cm | 1 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 180 | Type II: From 2cm to 4cm | 1 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 30 | Type III: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 90 | Type VI: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180 | Day 30 | Type VI: Greater than 6 cm | 0 Participants |
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.
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.
Time frame: Day 30, Day 90, Day 180
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Baseline | Type VI-A: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 90 | Type II-C: From 2cm to 4cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 30 | Type II-C: From 2cm to 4cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 90 | Type II-AI: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Baseline | Type II-AI: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 90 | Type VI-A: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 30 | Type II-AI: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 180 | Type I-A: Less than 2cm | 5 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 30 | Type I-A: Less than 2cm | 3 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 180 | Type II-A: From 2cm to 4cm | 2 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 30 | Type VI-A: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 180 | Type II-C: From 2cm to 4cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Baseline | Type II-C: From 2cm to 4cm | 1 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 180 | Type II-AI: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 90 | Type I-A: Less than 2cm | 3 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 180 | Type VI-A: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 30 | Type II-A: From 2cm to 4cm | 4 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Baseline | Type I-A: Less than 2cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 90 | Type II-A: From 2cm to 4cm | 4 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Baseline | Type II-A: From 2cm to 4cm | 6 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 90 | Type II-A: From 2cm to 4cm | 1 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Baseline | Type II-C: From 2cm to 4cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Baseline | Type II-AI: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Baseline | Type VI-A: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 30 | Type I-A: Less than 2cm | 2 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 30 | Type II-A: From 2cm to 4cm | 1 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 30 | Type II-C: From 2cm to 4cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 30 | Type II-AI: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 30 | Type VI-A: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 90 | Type I-A: Less than 2cm | 2 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Baseline | Type II-A: From 2cm to 4cm | 3 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 90 | Type II-C: From 2cm to 4cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 90 | Type II-AI: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 90 | Type VI-A: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 180 | Type I-A: Less than 2cm | 2 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 180 | Type II-A: From 2cm to 4cm | 1 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 180 | Type II-C: From 2cm to 4cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 180 | Type II-AI: From 4cm to 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 180 | Type VI-A: Greater than 6 cm | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Baseline | Type I-A: Less than 2cm | 0 Participants |
Secondary
Analysis of Morphometric Labia Measurements at D180.
Analysis by anatomical measurements of the labia majora and minora at D180.
Time frame: Day 180
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Morphometric Labia Measurements at D180. | Introital Opening to Most Anterior Projecting Edge of the Labia Minora Day 180 | 1.3 cm | Standard Deviation 0.6 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Morphometric Labia Measurements at D180. | Maximum Projection of the Labia Minora Day 180 | 1.8 cm | Standard Deviation 0.8 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Morphometric Labia Measurements at D180. | Inter-Labial Sulcus Length Day 180 | 9.0 cm | Standard Deviation 1 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Morphometric Labia Measurements at D180. | Maximum Projection of Labia Majora Day 180 | 1.3 cm | Standard Deviation 0.3 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Morphometric Labia Measurements at D180. | Posterior Border of the Sulcus to the Fornix Day 180 | 0.9 cm | Standard Deviation 0.2 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Morphometric Labia Measurements at D180. | Arch of Labia Minora Day 180 | 8.7 cm | Standard Deviation 1.8 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Morphometric Labia Measurements at D180. | Resting Projection of Labia Minora Beyond Labia Majora Day 180 | 0.7 cm | Standard Deviation 0.5 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Morphometric Labia Measurements at D180. | Arch of Labia Majora Day 180 | 10.8 cm | Standard Deviation 1.5 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | Analysis of Morphometric Labia Measurements at D180. | Sulcus Length of Labia Majora (Posterior to Anterior Margins) Day 180 | 10.0 cm | Standard Deviation 0.6 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Morphometric Labia Measurements at D180. | Arch of Labia Majora Day 180 | 10.5 cm | Standard Deviation 0.9 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Morphometric Labia Measurements at D180. | Sulcus Length of Labia Majora (Posterior to Anterior Margins) Day 180 | 10.5 cm | Standard Deviation 0.7 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Morphometric Labia Measurements at D180. | Introital Opening to Most Anterior Projecting Edge of the Labia Minora Day 180 | 1.3 cm | Standard Deviation 0.8 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Morphometric Labia Measurements at D180. | Posterior Border of the Sulcus to the Fornix Day 180 | 0.9 cm | Standard Deviation 0.1 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Morphometric Labia Measurements at D180. | Inter-Labial Sulcus Length Day 180 | 7.6 cm | Standard Deviation 1.5 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Morphometric Labia Measurements at D180. | Resting Projection of Labia Minora Beyond Labia Majora Day 180 | 0.8 cm | Standard Deviation 0.5 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Morphometric Labia Measurements at D180. | Maximum Projection of the Labia Minora Day 180 | 1.8 cm | Standard Deviation 0.7 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Morphometric Labia Measurements at D180. | Maximum Projection of Labia Majora Day 180 | 0.9 cm | Standard Deviation 0.3 |
| Procedure with the Renuvion APR System in the labia (Micro) | Analysis of Morphometric Labia Measurements at D180. | Arch of Labia Minora Day 180 | 9.5 cm | Standard Deviation 1 |
Secondary
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.
Time frame: Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 180 | 0.0 Score on a Scale | Standard Deviation 0 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Baseline | 0.3 Score on a Scale | Standard Deviation 0.8 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 1 | 4.1 Score on a Scale | Standard Deviation 2.5 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 14 | 3.7 Score on a Scale | Standard Deviation 3.4 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 30 | 1.6 Score on a Scale | Standard Deviation 1.8 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 90 | 0.1 Score on a Scale | Standard Deviation 0.4 |
| Procedure with the Renuvion APR System in the labia (Micro) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 30 | 2.0 Score on a Scale | Standard Deviation 0 |
| Procedure with the Renuvion APR System in the labia (Micro) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 180 | 0.0 Score on a Scale | Standard Deviation 0 |
| Procedure with the Renuvion APR System in the labia (Micro) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 14 | 4.0 Score on a Scale | Standard Deviation 1 |
| Procedure with the Renuvion APR System in the labia (Micro) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Baseline | 0.0 Score on a Scale | Standard Deviation 0 |
| Procedure with the Renuvion APR System in the labia (Micro) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 90 | 0.0 Score on a Scale | Standard Deviation 0 |
| Procedure with the Renuvion APR System in the labia (Micro) | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | Day 1 | 2.3 Score on a Scale | Standard Deviation 2.1 |
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.
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
Time frame: Day 30, Day 90, Day 180
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 30 | No Change | 2 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 90 | No Change | 1 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 30 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 180 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 30 | Improved, Much Improved, Very Much Improved | 5 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 180 | No Change | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 90 | Improved, Much Improved, Very Much Improved | 6 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 180 | Improved, Much Improved, Very Much Improved | 7 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | 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. | Day 90 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 180 | Improved, Much Improved, Very Much Improved | 3 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 30 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 30 | No Change | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 30 | Improved, Much Improved, Very Much Improved | 3 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 90 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 90 | Improved, Much Improved, Very Much Improved | 3 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 180 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 180 | No Change | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | 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. | Day 90 | No Change | 0 Participants |
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.
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.
Time frame: Baseline, Day 90, Day 180
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. | FSFI Day 180 | 29.49 Score on FSFI Scale (Range 2 - 36) | Standard Deviation 0.8 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. | FSFI Baseline | 24.45 Score on FSFI Scale (Range 2 - 36) | Standard Deviation 1.1 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. | FSFI Day 90 | 24.45 Score on FSFI Scale (Range 2 - 36) | Standard Deviation 1.1 |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. | FSFI Baseline | 25.17 Score on FSFI Scale (Range 2 - 36) | Standard Deviation 0.5 |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. | FSFI Day 90 | 27.89 Score on FSFI Scale (Range 2 - 36) | Standard Deviation 1.3 |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. | FSFI Day 180 | 26.51 Score on FSFI Scale (Range 2 - 36) | Standard Deviation 1.6 |
Secondary
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
Time frame: Day 30, Day 90, Day 180
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 180 | No Change | 1 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 180 | Improved, Much Improved, Very Much Improved | 6 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 30 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 30 | No Change | 2 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 30 | Improved, Much Improved, Very Much Improved | 5 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 90 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 90 | No Change | 0 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 90 | Improved, Much Improved, Very Much Improved | 7 Participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 180 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 90 | Improved, Much Improved, Very Much Improved | 2 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 90 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 180 | Improved, Much Improved, Very Much Improved | 3 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 180 | No Change | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 30 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 90 | No Change | 1 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 30 | No Change | 1 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 180 | Worse | 0 Participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | Day 30 | Improved, Much Improved, Very Much Improved | 2 Participants |
Secondary
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).
Time frame: Baseline, Day 90, Day 180
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits | Genital Appearance Satisfaction Baseline | 18.57 Score on GAS Scale (0 -30 Range) | Standard Deviation 0.6 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits | Genital Appearance Satisfaction Day 90 | 9.14 Score on GAS Scale (0 -30 Range) | Standard Deviation 0.5 |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits | Genital Appearance Satisfaction Day 180 | 9.86 Score on GAS Scale (0 -30 Range) | Standard Deviation 0.6 |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits | Genital Appearance Satisfaction Baseline | 22.33 Score on GAS Scale (0 -30 Range) | Standard Deviation 0.5 |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits | Genital Appearance Satisfaction Day 90 | 12.33 Score on GAS Scale (0 -30 Range) | Standard Deviation 0.4 |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits | Genital Appearance Satisfaction Day 180 | 10.67 Score on GAS Scale (0 -30 Range) | Standard Deviation 0.5 |
Secondary
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.
Time frame: Day 180
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Do you notice improvement in how your labia look? : Yes | 7 participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Characterize Satisfaction With Procedure - Satisfied (Very, Satisfied, or Slightly) | 6 participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Recommend Procedure To Friends and Family Members - Yes | 6 participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Closer together | 1 participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Improvement in loose skin | 4 participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Less sagging skin | 3 participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Majora seem smaller-Right Minora seems same or only slight improvement | 1 participants |
| Procedure with the Renuvion APR System in the labia (APR-15-TP) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Smoother skin texture | 2 participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Smoother skin texture | 1 participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Do you notice improvement in how your labia look? : Yes | 3 participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Improvement in loose skin | 3 participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Characterize Satisfaction With Procedure - Satisfied (Very, Satisfied, or Slightly) | 3 participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Majora seem smaller-Right Minora seems same or only slight improvement | 1 participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Recommend Procedure To Friends and Family Members - Yes | 3 participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Less sagging skin | 3 participants |
| Procedure with the Renuvion APR System in the labia (Micro) | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | Improvement noticed - Closer together | 1 participants |