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416 - PROSPECTIVE NON-COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF A PIXEL CO2 LASER SYSTEM IN THE TREATMENT OF VULVOVAGINAL ATROPHY: INTERIM ANALYSIS

416

PROSPECTIVE NON-COMPARATIVE STUDY TOASSESS THE EFFECTIVENESS OF A PIXEL CO2LASER SYSTEM IN THE TREATMENT OF VULVOVAGINAL ATROPHY: INTERIMANALYSIS

J. S. SCHACHAR1, H.DEVAKUMAR 2, L. MARTIN 2, E. A. HURTADO 2,G. DAVILA 2;
1Female Pelvic Medicine andReconstructive Surgery, Cleveland Clinic Florida, Weston, FL,2Cleveland Clinic Florida, Weston, FL.

Introduction: GenitourinarySyndrome of Menopause (GSM) or Vulvovaginal atrophy (VVA) involveshistological, morphological, and clinical changes that can lead togenito-urinary symptoms that greatly impact a woman’s quality oflife. GSM is primarily treated with local estrogen, however othernon-hormonal therapies have been used. Recently fractional CO2 lasertherapy has been used by dermatologists and plastic surgeons forvarious indications, including remodeling of atrophic skin. Ex-vivoand in-vivo studies have demonstrated the safety of laser therapy ingynecologic patients.
Objective: The study objective was toassess the efficacy of the CO2 laser in the treatment ofvulvovaginal atrophy (GSM-VVA).
Methods: Subjects withsymptomatic GSM completed pre-treatment evaluations and were enrolledin the study. Pre-treatment evaluation included: pelvic exam, vaginalpH, Vaginal Atrophy Bother Questionnaire (VABQ), Symptoms of AtrophicVaginitis Questionnaire (SAVQ), Vulvovaginal Atrophy SymptomQuestionnaire (VASQ), Pelvic Organ Prolapse/Urinary IncontinenceSexual Questionnaire (PISQ-12), Bachmann Vaginal Health Index (BVHI),Vaginal Health Grade (VHG), and Urinary Distress Inventory (UDI-6).Subjects then underwent three treatment sessions during an eight weekperiod. The treatments were standardized for all patients andincluded three 360-degree passes at 80-100mJ/pixel with the pixelatedCO2 laser (Alma Lasers FemiLift; Illinois, USA). Subjects wereinstructed against the use of any medications on the treatment areaand to comply with all study restrictions at each visit. Two weeksafter each treatment, subjects completed the same panel ofassessments as at baseline. Subjects were also scheduled to returnfor additional follow-up at 1 year after the initial treatment. Ap-value of less than 0.05 was considered statisticallysignificant.
Results: Fifteen subjects were recruited forthis trial with an average age of 58.3 years. Comparisons were madebetween subject’s pre and post-treatment evaluations. Subjects hadsignificant improvements on all four of the subjective assessments ofGSM and the associated symptoms, which included the VABQ, SAVQ, VASQ,and PISQ-12 (p=0.0001, p=0.0001, p=0.0002, and 0.0045, respectively).Subjects also had significant improvement on the two objectiveindices of GSM, BVHI and VHG (p=0.0005 and p=0.0001, respectively).Subjects did not have significant improvement on the UDI-6(p=0.2519).
Conclusions: On short-term follow-up, subjectsthat received pixelated CO2 laser therapy had significantimprovement in vulvovaginal atrophy and the associated symptoms.Subjects did not demonstrate improvement of urinarysymptoms.
References: (1) Sokol ER, Karram MM. Anassessment of the safety and efficacy of a fractional CO2 lasersystem for the treatment of vulvovaginal atrophy. Menopause 2016Oct;23(10):1102-1107. (2) Salvatore S, Nappi RE, Zerbinati N,Calligaro A, Ferrero S, Origoni M, et al. A 12-week treatment withfractional CO2 laser for vulvovaginal atrophy: a pilot study.Climacteric 2014 Aug;17(4):363-369. (3) Salvatore S, Leone RobertiMaggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, et al.Histological study on the effects of microablative fractional CO2laser on atrophic vaginal tissue: an ex vivo study. Menopause 2015Aug;22(8):845-849.


VulvovaginalAtrophy Assessment


Pre-TreatmentAverage Score

Post-Treatment Average Score

p-Value

VaginalAtrophy Bother Questionnaire

6.43±2.65

1.64±1.78

0.0001

Symptomsof Atrophic Vaginitis Questionnaire

7.38±3.28

2.10±2.01

0.0001

VulvovaginalAtrophy Symptom Questionnaire

19.33±7.70

8.21±6.23

0.0002

PISQ-12

16.46±4.41

11.00±4.02

0.0045

BachmannVaginal Health Index

13.66±3.16

18.98±3.88

0.0005

VaginalHealth Grade

8.43±2.10

3.21±2.49

0.0001

UDI-6

16.03±16.30

9.82±10.02

0.2519