A guide to ThermiVa® treatment
  ​​
Introduction
 
It is considered a taboo subject, yet 76% of women are at risk of developing vaginal laxity at some point of their life. Vaginal laxity is one of the most common, yet overlooked health concern among women. Options to treat in the past have been limited. Now there are non­ surgical, non-invasive treatment options and everyone should know they are not alone and that they can get help.
Childbirth, and hormonal changes due to aging and menopause, may affect women intimate health. These physiologic changes may alter the laxity of the vaginal canal, damage the pelvic floor and devitalize the mucosal tone of the vaginal wall.

Vaginal laxity can lead to the development of conditions like:
 Diminished sexual satisfaction Orgasmic dysfunction
Stress urinary incontinence
 
In the past there were in general two opposite ways for treatment. Kegel exercises to strengthen the pelvic floor or invasive surgery at the other end. Now, vaginal laxity can be treated with non-invasive procedures without surgery or needles.
 
Vaginal laxity
 
76% of women are at risk of developing vaginal laxity at some point of their life. Yet vaginal laxity is an underreported problem .

In an international survey with 563 obstetrician gynecologists:
84% of respondents believed vaginal laxity is underreported by their patients
95% believed that vaginal laxity impacts their patients' sexual functioning
The impacts included altered sensation, decreased satisfaction, less confidence, and perceived inability to please a partner.
 
 
In another survey among women aged 25 to 55 who had at least 1 vaginal delivery:  
58% reported sex to be more of an effort than it was before children
48% reported that vaginal laxity was a concern
50% felt that vaginal tightening would have a positive effect on their partner relationship, sexual confidence, overall confidence, orgasmic experience, and sexual satisfaction
 
 
Aging, menopause, childbirth, obesity and many other factors can contribute to vaginal laxity. These changes can significantly impact quality of life, but women rarely discuss them, even with their physicians.
 
Vaginal laxity can lead to the development of conditions like:
Diminished sexual satisfaction
Orgasmic dysfunction
Stress urinary incontinence
  
The reasons why women seek female genital rejuvenation procedures are varied and can include but are not limited to: painful intercourse, pain with athletic activity, urinary incontinence, orgasmic dysfunction, vulvar irritation and discomfort with underwear/clothing
 
How does ThermiVa work?
 
ThermiVa treatments deliver controlled thermal energy to the desired areas- external (labia) and/ or internal (vagina). This treatment gently heats tissue to stimulate new collagen, improving vaginal laxity.The complete ThermiVa treatment includes three separate treatments over a period of three months. There is no downtime and no anesthesia required.

Which results can be expected? 
A recent clinical trial showed positive improvement following ThermiVa series of three treatments:
More than 93% of women treated had improvements of vaginal laxity
Statistically significant improvements in sexual functioning.
Retained improvement at one year follow-up.

Is it safe?
Study results show that the treatment is safe, tolerable, and effective for vaginal laxity. In a clinical study, transient mild erythema and mild edema were noted in 8% of patients. All occurrences of erythema and edema resolved on the same day as treatment without medical intervention.

Who is a candidate?
Changes which may affect feminine wellness:  childbirth and the natural aging process cause changes which may affect feminine health. A particularly strenuous vaginal childbirth, or multiple births, can cause  stretching of the vagina. The effects of menopause can also cause physical and functional changes. Any woman who is interested in restoring their vaginal area  is a candidate for ThermiVa.
It is also beneficial for women with mild to moderate prolapse and mild urinary stress incontinence.
 
 
 
 

Emission of energy to gently heat tissue, stimulating new collagen & elastin, improving vaginal laxity.

 
Designed for  conventient treatment  internally  and externally
 
 
 
 
References:
Berman JR, Berman LA, Werbin TJ, Goldstein I. Female Sexual Dysfunction: Anatomy Physiology, Evaluation and Treatment Options. Curr Opin Ural. 1999;9 :563-568 .
Pauls et al, Vaginal laxity. A poorly understood quality of life problem, survey of physicians member of the lnternaionl Urogynecology Assication, Internat UrogynJ,2012(23) 1435-1448.
Karcher et al, Vaginal rejuvenation using energy based devices, Internal journal of Women's dermatology 2 (2016), 85-88

ThermiRF for ThermiVa application is registered in Europe for electrocoagulation of soft tissues for vulvovaginal laxity
65 patient, multicenter study, Data on file
ThermiVa treatment guidelines. Data on file.
Vanaman et al, Emergingn trends in nonsurgical female genital rejuvenation. Dermatolog Surg 2016:0:1-11
Millheiser et al, cross-sectional survey of sexual health and vaginal laxity following vaginal delivery. J sex Med 2010:7 (suppl): 239


ThermiVa is certified, licensed and approved internationally by BSI EC for Europe, Health Canada and the FDA in the USA.
BSI EC -Certificate No. CE630665.
Health Canada  - Medical device Licence no. 67329 issued 7/2/2005.
FDA  - Device Certificate of equivalence- K130689