Contribution of innovative medical treatments

for female genital rejuvenation

Dr. Fabienne MARCHAND-LAMIRAUD

Gynaecological Surgeon and Aesthetic Gynaecologist.  drmarchand@polyclinique-atlantique.fr  Elsan Health - Atlantic Centre for Aesthetic Medicine. Avenue Claude Bernard Porte D, level 1. 44800 NANTES - SAINT HERBLAIN.

Abstract

Vulvo-vaginal rejuvenation is booming thanks to the recent innovative medical techniques which enrich the surgical methods of repair, generally reserved for the most advanced cases of alteration of the female genito-urinary system:

  • Hyaluronic acid (HA) specific to the intimate sphere for the treatment of vulvovaginal dryness and atrophy and for vulvar aesthetics,

  • The laser for the treatment of vaginal dryness,

  • Radiofrequency also improves the vulvo-vaginal tonicity and peri- clitoral vascularisation,

  • HIFU (High Intensity Focused Ultrasound) for the treatment of vaginal laxity and urogenital prolapse beginning to moderate,

  • LEDs (Light-Emitting Diode) for the treatment of genital irritations and pain.

Feeling good about one's body and intimate parts is not a luxury, as it contributes to self-esteem and enables a fulfilled sex life.

Keywords : Vulvovaginal dryness and atrophy, vulvar gap, dyspareunia, genital restoration, fulfilled sex life.

Introduction

Genital rejuvenation is a growing demand as women want to experience intimate comfort and improve their sexuality. 

Nevertheless, the subject is still taboo and few practitioners are responding to the demand.

Photo 1 and 2. Two examples of relaxation of the perineum with vulvar and vaginal gap.

Why such a demand for genital rejuvenation?

The genitals, like the rest of the body, undergo natural ageing and have been subjected to the changes associated with pregnancy and childbirth.

  • Hormonal changes in the vaginal mucous membrane can occur at any stage of life:

  1. in young women, because the pills are now minidosed, so the estrogen level is lower than the natural level,

  2. during anti-hormonal treatments, particularly in endometriosis for menstrual blockage,

  3. the menopause, when the ovaries no longer produce estrogen,

  4. during breast cancer treatment: by chemotherapy and hormone therapy.

  • Any aggressive local treatment is responsible for premature alteration of the genitals:

  1. Pelvic radiotherapy for cancer of the uterus, rectum and anus

  2. Vaginal brachytherapy in cervical cancer.

  3. Obstetrical traumas in particular

  4. In case of excess weight gain during pregnancy, multiple pregnancy

  5. Related to a long and difficult childbirth (large babies, large episiotomy...)

 Consequences of ageing of the genitals.

Ageing of the genitals is responsible of :

  1. Drought and vulvo-vaginal atrophy,

  2. Slackening of the perineum with vulvar gap

  3. Then a prolapse of the bladder, uterus, rectum, isolated or combined, to a greater or lesser degree.

These disorders are responsible for sexual dysfunction with dyspareunia.

 Genital rejuvenation: for whom?

  1. Any young woman who wishes to improve her genital aesthetics and/or sexuality.

  2. Any painful woman in the post partum.

  3. All menopausal women, in the aftermath of cancer treatments, in the aftermath of gynecological surgery, bariatric surgery with significant and rapid weight loss.

 An essential prerequisite: a gynaecological consultation before any genital rejuvenation operation.

  1. It diagnoses vulvovaginal atrophy or sagging.

  2. Cervical smears for screening should be normal,

  3. An absence of active gynaecological infection, especially herpes.

A therapeutic strategy will then be proposed, explained and written informative documents will be provided with a consent to be signed.

Methods  

A/ Medical treatments for genital rejuvenation

Recently, several innovative techniques of aesthetic medicine have appeared to help achieve a rejuvenation of the intimate genital sphere:

  1. The hyaluronic acid specific to the intimate sphere. 

  2. Lipofilling by reinjection of autologous fat.

  3. PRP by injection of platelet-rich plasma.

 1. Vulvo-vaginal hyaluronic acid: the Desirial

1A. The Desirial: This is a hyaluronic acid dedicated exclusively to the genital sphere, which has a high hydrating power.

It was developed by the French laboratory, VIVACY, which has obtained European authorisation for use in the genital sphere. 

It has an important hygroscopy since it can capture up to 1000 times its molecular weight. 

It is a combination of HA and mannitol, which is an antioxidant whose effect potentiates the action of HA [10].

The injection is given in the doctor's office. A 27 or 30G 1ml needle is injected under local anaesthesia at the perineal fourchette and the vestibule. 

The injection is done using the retrotractive or fan-shaped technique or in multiple points. 

The massage distributes the injected product correctly.

It is THE treatment for Intromission Dyspareunia due to dryness and atrophy. A reinjection is recommended at 6 months and then every year.

 1.B. Desirial Plus has a moisturizing but also volumizing effect. 

It will therefore be indicated in the aesthetics of the vulva in order to shape and plump the atrophied labia majora to regain the youthful appearance of the vulva.

More developed labia majora mask slightly enlarged labia minora.

This volumising effect also has a protective effect against vaginal infections.

  1. The injection is done with the cannula, by back-tracing, on a linear trajectory. 2ml is injected into each large lip.

  2. It can also be used on the anterior wall of the vagina to highlight the G spot to enhance vaginal pleasure and orgasm.

Technique: injection of hyaluronic acid in the vulvo-vaginal area with Desirial Plus.
Desirerial HA is a valuable innovation in the field of vulvo-vaginal rehydration. It is simple to use, provided rigorous training and respect for the elementary rules of asepsis.

 2. The repairing and volumising effect can be achieved by lipofilling associated or not with PRP (Platelet Rich Plasma) and growth factors

The injection is done :

  1. In the submucosal vaginal walls.

  2. In the vulvar region in particular:

    • To treat pain during penetration,

    • Filling retractile episiotomy scars,

    • Treat cracks in the perineal fork during sexual intercourse.

This technique requires a neuro-analgesia and hospitalization for a few hours.

B/ Physical treatments for genital rejuvenation

The physical treatments use the thermal effect which stimulates blood circulation and the fibroblasts which produce collagen, elastin and hyaluronic acid. 

In this way, the treated tissue regains thickness, suppleness and hydration.

Physical treatments restore the mucous membrane and normalize the pH and vaginal flora.

By creating neo-collagenesis tissue regenaration and shrinkgae is achieved.

 Several techniques can be used to obtain this result:

  1. The vaginal LASER,

  2. Vulvo-vaginal RADIO FREQUENCY,

  3. HIFU (High Intensity Focused Ultrasound).

  4. LED-BPM (with photo-bio-modulation).

These techniques use vaginal probes.

1/ The vaginal laser is CO2 or Erbium laser.

The delivered temperature is 80°C for CO2 and 60°C for Erbium.

This high heat causes micro-abrasions of the tissue (fractional emission) with an ABLATIVE action on the mucous membrane. 

It is the tissue repair that will bring the desired result.

 2/ The vulvo-vaginal RadioFrequency

It emits electromagnetic waves that deliver controlled heat at around 45°C and always < 50°C

 

It has no ablative action. 

It causes a stimulation of the vaginal mucosa and the muscles of the perineum, which leads to regeneration and REJUVENATION of the tissues. 

Vulvo-vaginal radio-frequency is a recent technique in Europe, introduced at the end of 2017. 

It allows the vaginal, vulva and clitoris to be restored (specific handpiece for the vulva necessary)

.

Effects obtained after Radio Frequency. 50 years old. After 3 sessions.

Intima® RF device with vaginal and vulvar probe

3/ Vaginal HIFU

It uses high-frequency focused ultrasound. The heat emitted in depth is 60°C maximum.

Depending on the probe used, the depth of action is different: 1.5mm - 3mm - 4.5mm.

By using the 4.5mm probe, the deep muscular layer of the mucosa is reached, thus obtaining a " tensor " effect used for the treatment of vulvar gap and beginning prolapse.

HIFU is not yet very developed in France.

The Food and Drug Administration (FDA) classifies the focused ultrasound stimulator system for aesthetic use as Class II (special controls).

The special controls that will apply to the device are the " Class II Special Controls Guidance Document ": " Focused Ultrasound Stimulator System for Aesthetic Use ".

The Agency shall classify the device in Class II (special controls) in order to provide reasonable assurance of the safety and effectiveness of the device.

System using the latest advances in ultrasound study, the energy released is accurate to the depth required.

The emission is circular at 360 degrees in the form of thermal energy in the vaginal mucosa and muscle, stimulating the appropriate blade and muscle fibres in cell regeneration.

Comparison with fractional CO2 laser. HIFU reaches deeper areas without damaging the surface skin and exerts a contraction effect

https://fr.dhgate.com/product/new-hifu-2-in-1-vaginal-tighten-high-intensity/446120637.html
https://fr.dhgate.com/product/new-hifu-2-in-1-vaginal-tighten-high-intensity/446120637.html

 4/ The PBM (photo-bio-modulation) by LEDs

It generates a biological reaction through light, the effect of which varies according to the wavelength.

The principle is based on the stimulation of intracellular mitochondria which release energy to promote cell renewal.

Indeed, light stimulates the cytochrome C-oxidase in the millions of mitochondria we have in our cells.

This results in the production of ATP (cellular energy). LEDs are cold light sources that act through non-thermal effects known as "photobiomodulation" at the cell level.

They deliver narrow bands of light from the " visible " and infrared spectrum of the sun: blue, violet, green, yellow, orange, red or infrared depending on the wavelength. 

Each color has an effect on certain types of cells and the dose used is also important.

Red light (630nm) or infrared light (830nm) has an anti-inflammatory and restorative cellular stimulation action.

The blue light (475nm) has an anti-infectious or antimycotic action.

The effects of the different colours can overlap and complement each other, hence the interest of colour combinations.

The mode of action is very different from that of lasers, which generally act by thermal action to destroy a target.

Depending on the protocols and parameters used (wavelengths, combinations of wavelengths, power, duration of irradiation, pulsed or non-pulsed mode, duration of the interpulses) preventive or therapeutic results can be obtained.

The skin, due to its surface position, is one of the most accessible organs for these treatments.

Penetration into the tissue varies according to the wavelength used.

Currently only a few bands of light are used in medicine, red (625-645 nm), blue (455-475 nm), and near infrared (815-835 nm).

Yellow is sometimes used, but the other colours have not (yet) been the subject of validated scientific studies.

There are never any side effects after a photobiomodulation session but only repercussions in the functioning of the target cells, generally dermal (skin) and/or hypodermal (fat tissue) depending on the wavelength used.

Vaginal probes and panels positioned in front of the vulva are used.

The use of LEDs in gynaecology is under development and is very promising, as the soothing and healing effect is quickly felt and LEDs potentiate the effects of thermal treatments such as laser and radio frequency.

   Results

A Literature review on the results of physical treatments 

for female genital rejuvenation

More than 50% of women will one day be affected by genital discomfort.

"EVES study" on > 1000 menopausal women indicates that:

  • 66% suffer from severe vaginal symptoms

  • 30% suffer from severe vulvar symptoms

  • 11% suffer from severe urinary symptoms

Most often these symptoms are associated with each other.

Thanks to the new medical treatments dedicated to female genital rejuvenation, a very clear improvement on clinical signs and sexuality is obtained from the first month and evolves up to 6 months. An annual maintenance treatment is recommended.                                                                          

https://surgerycongress.conferenceseries.com/ocm/2019/red-m-alinsod-the-alinsod-institute-of-aesthetic-vulvovaginal-surgery-usa

 1/ The effectiveness of HA treatment

 
  1. According to P. Sebban-Sarfati, the results of the first injection are significant.

  2. 15% of women were lost to follow-up at six months. At one month, 90% of patients were satisfied overall, 75% very satisfied, 15% moderately satisfied.

  3. However, this satisfaction rate dropped sharply at six months (45% dissatisfied). The very low failure rate is probably of multifactorial origin and more complex than a simple organic disorder.

  4. The six-month period of effectiveness coincides perfectly with the half-life of the molecule. This important observation could lead̀ to recommend that the injection be renewed as soon as possible, before the disorder reappears.

  5. No complications arose and only one session had to be interrupted due to the excessive pain felt by the patient.

  6. The sensation of well-being and local comfort associated with̀ the disappearance of burns and dryness is mostly expressed very quickly.

  7. Finally, an improvement in sexual health and the disappearance of dyspareunia allow the progressive restoration of sexual life. The testimonies are enthusiastic.

  8. This treatment is innovative because it is simple and safe as long as the recommendations are respected.

Results: Before and after injection of hyaluronic acid in vulvo-vaginal with the Desirial Plus.

 2/ Results of temperature-controlled transcutaneous 

radiofrequency for orgasmic dysfunction 

 In Red M. AlinsodMD, FACOG, FACS, ACGE 1   
Transcutaneous temperature-controlled radiofrequency for orgasmic dysfunction. 
Lasers Surg Med. 2016 Sep; 48(7): 641-645. 
Published online 2016 May 19. doi: 10.1002/lsm.22537

At follow-up, patients were given a questionnaire with eight questions about their treatment experience and perceived outcomes. 

All subjects completed the study; none were lost to follow-up and no side effects were reported in any of them.

 
 

 Two examples of relaxation of the perineum with vulvar and vaginal gap.

36 years old, after 2 pregnancies, vaginal relaxation and incontinence. Result after RF.

 Action of radiofrequency on the vulva

 

Of the 25 women registered :

  • 19 (76%) reported an average reduction in time to orgasm of at least 50%.

  • 23 (92%) reported an average reduction in the time to orgasm of at least 33%.

All patients also noted significant vaginal tightening effects, increased vaginal moisture and improved vulvar and clitoral sensitivity.

    • All anorgasmic patients (n = 10) reported regaining their ability to reach orgasm.

    • 2 patients reported minimal response.

The results of the questionnaire:

    • 23 of 25 subjects (92%) reported achieving orgasm after treatment with TTCRF ;

    • 16 reported no change in the intensity of orgasm,

    • While 9 subjects reported having more intense orgasms.

    • The time it took to reach orgasm was reduced by half or more in 19 of the 25 subjects.

  • All subjects reported a tightening of the vaginal canal.

  • An improvement in vaginal humidity was observed in 20 of the 25 patients.

  • All 25 patients said they were satisfied with the treatment and would recommend it to their family and friends. The complete results are presented in the table below:

https://surgerycongress.conferenceseries.com/ocm/2019/red-m-alinsod-the-alinsod-institute-of-aesthetic-vulvovaginal-surgery-usR

3/ Results of laser treatment for genito-urinary menopause syndrome (GUMS)

A systematic review and meta-analysis. (9)

The aim of this study was to identify and then synthesize all available data concerning the efficacy of laser therapy for postmenopausal women with genitourinary menopausal syndrome (GMS) with or without urinary incontinence (UI). 

PubMed, Scopus, Web of Science, Cochrane Library and ClinicalTrials.gov were accessed in October 2016.

 

The key words were: 

"laser genitourinary syndrome of menopause", "laser vulvovaginal atrophy", "laser vaginal atrophy" and "laser women incontinence".

The quality of the reports and the risk of bias in the included studies were assessed according to the STROBE and MINORs checklists, respectively. 

The quality of the totality of evidence was assessed according to the GRADE approach. 14 studies involving 542 participants were included in this systematic review and meta-analysis.   

 

Dryness / Dyspareunia/Itching/ Dysuria/Urgency/ Frequency : all symptoms of GMS and UI have been significantly and consistently reduced in all available publications.  

The average differences pooled for the different symptoms were as follows:

  • Drought: - 5.5 (95% CI: - 6.7, - 4.4; 7 studies; I2: 0%),

  • Dyspareunia - 5.6 (95% CI: - 6.8, - 4.5; 7 studies; I2: 0%),

  • Itching : - 4 (95% CI: - 5. 7, - 2.2; 6 studies; I2: 79%),

  • Burns: - 3.9 (95% CI: - 5.9, - 2; 6 studies; I2: 87%),

  • Dysuria: - 2.9 (95% CI: - 5.1, - 0.7; 4 studies; I2: 90%)

  • IU: - 4.9 (95% CI: - 6.4, - 3 ,4; 2 studies; I2: 0%).

As the urgency/frequency was assessed using different methodologies, the data could not be meta-analyzed.

In addition, KHQ, UDI-6, MCS12/PCS12, FSFI studies, overall sexual satisfaction and measurements of the effect of laser therapy on local pathophysiology improved significantly.

In conclusion, laser therapy for postmenopausal women with cell phones looks promising.

It could reduce the severity of symptoms, improve the quality of life of post-menopausal women and restore the vaginal mucosa to pre-menopausal status. However, the quality of the body of evidence is "poor" or "very poor" and therefore no evidence-based changes to current clinical practice can be suggested.

In (9) Pitsouni E1, Grigoriadis T1, Tsiveleka A2, Zacharakis D1, Salvatore S3, Athanasiou S4.

Microablative fractional CO2-laser therapy and the genitourinary syndrome of menopause: An observational study.  

Maturitas. 2016 Dec;94:131-136. doi:10.1016/d.maturitas.2016.09.012. Epub 2016 Sep 16.

 

SYMPTOMS IMPROVEMENT (%) AFTER 3 TREATMENTS WITH MONALISA TOUCH®.

      • BURNING: 84%

      • MANGING: 85%

      • DRYING: 76%

      • DYSPARENOUS 72%

      • LAXITY: 90%

Dr Stefano Salvatore - San Raffaele Hospital, Milan (Italy)

 

 Conclusion

Medical treatments for female genital rejuvenation using innovative physical methods have only recently appeared. 

They have totally changed the therapeutic approach to very frequent genital disorders due to ageing, such as dryness with vulvovaginal atrophy and vulvar gap. They allow to obtain a real vulvo-vaginal rejuvenation.

They are transforming the lives of women who suffer from it.

By regaining feminine comfort and a youthful appearance of her genitals, the woman regains the self-esteem and self-confidence necessary for a fulfilled sexuality and harmony of the couple. 

There is an urgent need for health professionals to inform their patients of the existence of these recent techniques and to refer them to centers that practice them safely. 

"The silence around this innovative treatment is due to its relative youth associated to the bibliographic weakness and the media silence" (P. Sebban Sarfati).  

Hope will come from the studies that will be launched: in particular, the randomised, double-blind investigation that is starting, conducted by the Vivacy laboratory, entitled "Treatment of vulvo-vaginal symptomatology suggesting an ostrogenic deficiency by injecting HA into the vaginal mucosa." ,

 

As well as the study announced as part of the DUMEG, by Dr Barbara Hersant, in the department of Pr Jean-Paul Meningaud, on "Comparative studies of different innovative treatments, lasers, HA and local treatments of the side effects of hormone therapy after breast cancer". 

If these studies scientifically demonstrate real effectiveness, which is likely, then a media buzz is very necessary.

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