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Red M. Alinsod, M.D., FACOG, FACS, ACGE 26
Articles
Applicati on Notes Volume 1 No. 1
Temperature Controlled Radiofrequency for
Vulvovaginal Laxity: A Pilot Study
Red M. Alinsod, M.D., FACOG, FACS, ACGE
South Coast Urogynecology, Laguna Beach, CA
Consultant for ThermiGyn
Chairman of the ThermiGyn Women’s Health Clinical Advisory Board
INTRODUCTION procedures have a temperature sensor located at the ti p; the ther-
mocouple measures ti ssue temperature and and impedance, which
The conditi on of vulvovaginal laxity and its relevance as a concern- provides feedback to the RF Generator; in turn the generator will
ing medical conditi on has recently become a discussion point be- adjust the power allowing the device to maintain a given set tem-
tween women and their physicians. The att enti on and discussions perature throughout the treatment. The benefi t is the physician can,
surrounding gynecological and urological issues that women face for the fi rst ti me, treat using precisely controlled RF energy at a pre-
may have historically gone by without any discussion, but thankfully selected temperature setti ng.
today women are openly sharing their concerns with their doctors.
In turn physicians are recognizing the clinical importance of vulvo- The RF electrode has a treatment
vaginal laxity and are looking for soluti ons for their pati ents. acti ve area of the size similar to
a postage stamp. This acti ve part
The term ‘vaginal rejuvenati on’ has received a lot of att enti on and of the electrode rests within one
scruti ny. According to an arti cle by Lauri Romanzi, M.D. (htt p:// side of the electrode close to the
www.urogynics.org/2010/06/20/vaginal-rejuvenation-defined/) ti p. The form of the electrode
public percepti on of the term seems to fall into any of three catego- ThermiVa Handpiece and locati on of the acti ve treat-
ries: correcti on of inconti nence and prolapse, improvement in the ment ti p allows for easy placement on targeted ti ssue. The TTCRF
appearance of vulvar structures, and enhancement of female sexual treatment electrode is about 8 inches long with a slight ‘S’ curve at
grati fi cati on. center, patt erned aft er the highly successful Hegar dilator that has
been in gynecologic use for decades. During TTCRF the RF electrode
Vulvovaginal laxity (as with vaginal laxity) is associated with advanc- is passed back and forth over the desired area unti l the ti ssue is
ing age and the trauma of childbirth. Treatment of vulvovaginal laxi- gradually heated to the therapeuti cally relevant level to induce col-
ty and related aspects in the past lay within a short spectrum heavily lagen, shrinkage and create an infl ammatory response which results
weighted at the ends. On one side stood non-invasive but minimally in neocollagenesis, and its eff ect of ti ssue ti ghtening. Pati ents report
eff ecti ve Kegel exercises to strengthen the pelvic fl oor, with risky, comfort during the procedure with no need for external cooling.
costly, and highly invasive surgery at the other end. Only recently
have alternati ves appeared to fi ll in the center of that range. The purpose of the study is to evaluate the safety, tolerability and
clinical effi cacy of TTCRF as well as anecdotally document possible
In response to this gap, modaliti es ancillary benefi cial eff ects of treatment, to promote further study.
harnessing laser or radiofrequency
(RF) energy and others for vaginal MATERIALS AND METHODS
use have emerged. Vulvovaginal
rejuvenati on with energy based Subjects (n=23; age range 21-65 years, mean 44; 5 menopausal, 5
devices, as is done in aestheti c der- perimenopausal) presented with self-described mild to moderate
ThermiVa Generator matology and plasti c surgery on the primary or secondary vulvovaginal laxity. Associated secondary con-
face, neck, and décolleté, is a fairly new concept with real potenti al diti ons (orgasmic dysfuncti on, stress inconti nence, atrophic vagini-
for success. Numerous studies in aestheti c medicine have demon- ti s, etc.) were present in most subjects. Exclusion criteria included
strated ti ssue contracti on and determined a therapeuti cally ideal pelvic surgery less than 5 years from the beginning of study, pres-
temperature range (40°C to 45°C) in which neocollagenesis (via the ence of major psychiatric conditi ons or related need for medicati on,
healing cascade) is sti mulated without causing unnecessary damage pregnancy or planned pregnancy within the study period, recent ab-
to the skin or integral ti ssue structures. normal Papnicolaou test result, presence of vulvar lesions or disease
(dermati ti s, human papillomavirus, herpes simplex, vulvar dystro-
Transcutaneous temperature controlled radiofrequency (TTCRF) phy, etc.), or the presence of any conditi on or circumstance that, in
brings with it numerous advantages to treatment. It is an estab- the opinion of the investi gati ng physician, may be unsafe or other-
lished modality for ti ssue ti ghtening via sti mulati on of neocolla- wise interfere with the study. Informed consent was obtained from
genesis, denaturati on of collagen, contracti on, acti vati on of the all subjects prior to commencement of the study. Pre-treatment
healing cascade. Unlike laser-based treatments skin type (color, or digital photography was performed at baseline along with physician
pigmentati on) is not an issue with RF energy, and while it is show- evaluati on of pati ents. Treatment was performed in a clinical offi ce
ing consitent positi ve results when used for surface skin on the face setti ng and no anesthesia was required. During treatment subjects
and other areas of the body, RF energy is even more eff ecti ve in were placed on a treatment table in the dorsal lithotomy positi on.
ti ssue that is naturally moist and well hydrated, as seen with vaginal A neutral return electrode pad was placed on the subject, with a
and labial ti ssue. The RF electrode used in temperature controlled coupling fl uid used as a lubricant for treatment with the ThermiVa
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