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Red M. Alinsod, M.D., FACOG, FACS, ACGE  26


                                              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
              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
       ©2019 Alinsod Institute for Aesthetic VulvoVaginal Surgery | Physician Brochure
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