June 2013

High Frequency Treatment forNon-Invasive Non-Surgical Labia

Remodeling

Zuzana Fucíková, MD.Gynpoint, Prague, Czech Republic

I. Background and objectives

The main purpose of this study was to evaluatethe use of a novel high frequency device forthe indication of labia remodeling.

The basic principle of the device is toemit oscillating electrical current with forcedcollisions between charged molecules andions. These collisions are transformed intoheat. The main heat effect is to temporarilychange helical structure of the collagen, changestructure of elastin and stimulate groundsubstances. The result is micro-inflammatorystimulation of fibroblasts which produces newcollagen and new elastin, as well as othersubstances to enhance dermal structure.

II. Introduction

There are many women who suffer fromskin laxity around and on their labiaminora and labia majora. Many are

complaing about low sexual satisfaction andlow self-confidence. Until now they have onlyhad a choice of removing the unwanted skinby a surgical procedure (labioplasty). Thisprocedure is usually expensive, the healingcan take three weeks. The procedure can alsobe painful and has been associated with riskstypical of invasive procedures.

While a few laser devices have beenknown to treat vagina, consumers increasingly

demand non-invasive methods to treat vulva,particularly labia majora and labia minora.

III. Protégé Intima

The Protégé Intima is a new device designedto address labia remodeling. The systemcombines focused monopolar high frequencywith built-in safety features engineered for thisindication.

The device can reach temperature on theskin surface at around 40 to 42◦C. A patienttypically feels pleasant warming sensationat this temperature. One treatment takesaround 12 minutes, 6 minutes per one sideof vulva. The device has embedded safetysystem to prevent burns, sparking and arcing,and uses the proprietary Energy Flow Controlsafety system (EFC Elite). The EFC Eliteincludes visual contact confirmation (shouldthe applicator loose contact with the skin), dualground contact monitoring (to eliminate theburns), and the Impedance Intelligence system(to guarantee energy uniformity).

IV. Materials and methods

This preliminary study is a study on 10female patients treated with the device forlabia remodeling. The age of the patientswas between 21 to 55 years. The patientswere photographed before and after the 4th

Zuzana Fucíková, MD. : High Frequency Treatment for Non-Invasive Non-Surgical LabiaRemodeling, Page 1

June 2013

treatment. The change in the labia appearancewas recorded after the 4th treatment by thephysician, based on the photographs. Thepatients also filled a questionnaire about thechange in their sexual satisfaction. Theimprovement in the appearance was assessedby the physician as none [0], significant - mild[1], significant - moderate [2], and significant -excellent [3]. The changes in sexual satisfactionwere evaluated on the same 4-point scale (none[0], significant - mild [1], significant -moderate[2], and significant - excellent [3]). Further,the comfort of the treatment was evaluated bythe patients on the 4-point scale (intolerable[0], uncomfortable [1], comfortable [2], verycomfortable [3]).

Each patient was administered four (4)treatment sessions, with a period of 5 to8 days between each session. The initialtreatment parameters were set at the powerof 50 units and 80% duty cycle. A waterbased gel was applied to the skin. The initialpower was adjusted according to a patient’ssubjective level of temperature tolerance oruntil mild erythema appeared. A specialhygienic cover was applied to the tip of theapplicator. The applicator was moved in aslow linear fashion around the labia major andlabia minor region. One side of the vulva wastreated approximately 6 minutes. The surfacetemperature was in the range of 40 to 42◦C.

V. Results

All patients finished 4 labia remodelingtreatments in this preliminary study.The results were divided into 3 groups:An improvement in the appearance, animprovement in perceived sexual satisfaction,and rating of the treatment comfort.

The primary endpoint is an improvementof the shape and skin laxity of the vulva. Thegraphs show that 40% of the patients hadsignificant - excellent improvement of vulvaappearance, 40% of the patients had significant- moderate improvement of vulva appearance.

Figure 1: Improvement in appearance, subjects 101 to110

Figure 2: Percetange of improvement in appearance

The secondary endpoint of the labiaremodeling treatment is an improvement insexual satisfaction. Fourty percent of thepatients reported the improvement in sexualsatisfaction as significant - moderate and 40%reported their sexual satisfaction improvementas significant - mild.

Zuzana Fucíková, MD. : High Frequency Treatment for Non-Invasive Non-Surgical LabiaRemodeling, Page 2

June 2013

Figure 3: Sexual satisfaction, subjects 101 to 110

Figure 4: Percentage of sexual satisfaction

Fifty percent of the patients reported thetreatment with the device to be comfortable.

Fourty percent of the patients reported thetreatment to be very comfortable.

Figure 5: Percentage of comfort rating

VI. Conclusions

The results of this study show that the ProtégéIntima is a safe and effective device withindications for non-invasive non-surgical labiaremodeling. The use of the device leadsto the improvement of the appearance ofthe vulva and to the improvement of sexualsatisfaction. Eighty percent of the patients hadsignificant improvement in the appearance ofthe labia and in the improvement of sexualsatisfaction. Ninety percent of the patientsreported the treatment to be comfortable orvery comfortable.

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June 2013

Figure 6: Remodeling of labias. Labias are more firm

Figure 7: Labia shrinkage

Zuzana Fucíková, MD. : High Frequency Treatment for Non-Invasive Non-Surgical LabiaRemodeling, Page 4