Advertisement
Research Article| Volume 135, P34-39, May 2020

Safety evaluation of fractional CO2 laser treatment in post-menopausal women with vaginal atrophy: A prospective observational study

      Highlights

      • Fractional CO2 laser treatment for vulvovaginal atrophy in well selected patients is a safe and effective procedure.
      • Overall, patients were highly satisfied and would repeat laser treatment or would recommend it.
      • No severe complicationsare associated with Fractional CO2 laser for treatment of VVA.
      • A minority of patients reported mild complications, but these resolved without the need for treatment.
      • Most discomfort was related to probe introduction and rotation.

      Abstract

      Objectives

      To evaluate the safety of and patient satisfaction with fractional CO2 laser for the treatment of vulvo-vaginal atrophy (VVA) in postmenopausal patients.

      Study design

      Patients affected by VVA were considered for the study. All women were treated using a Lumenis AcuPulse DUO (Lumenis, Yokneam, Israel) in fractionated mode with a 28 mm probe, FemTouch™. Pain during different steps of the procedure (introduction, rotation and extraction of probe and laser impulse transmission) was evaluated on a 7-point Likert scale. The occurrence of side-effects was evaluated at the end of the procedure, and in the three-month follow-up (after the last treatment) complications were classified as ‘early’ (occurring within 30 days) or late (after 30 days). Participant satisfaction was measured on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). The institutional review board approved the study protocol.

      Results

      Fifty-three women were enrolled in the study. No severe complications occurred after a median follow-up of six months. One patient (1.9 %) reported dizziness immediately after treatment, which completely resolved within 15 min. A minor bleeding occurred related to tip introduction and rotation. One patient (1.9 %) aborted the procedure because of discomfort on probe introduction but decided to repeat the procedure after two weeks. Two patients (3.7 %) reported symptoms of dysuria within 7 days of the procedure. The mean overall pain score at first treatment, evaluated on the 7-point Likert scale, was 3.57 ± 1.50. The mean pain scores related to probe introduction and rotation were 3.13 ± 1.37 and 2.32 ± 1.08, whereas pain scores for extraction and laser impulse transmission were 1.23 ± 0.27 and 1.13 ± 0.37 respectively. Mean overall pain score (1.27; CI 95 % 0.83–1.71, p < 0.001) and pain scores related to probe introduction (0.54; CI 95 % 0.18–0.90, p = 0.001) and probe rotation (0.46; CI 95 % 0.12–0.90, p = 0.003) all statistically significantly decreased between the first and third treatment (Fig. 1). Mean pain scores related to laser activation (0.01; CI 95 % −0.06 – 0.20, p = 0.07) and extraction (0.08; CI 95 % −0.04–0.19, p = 0.31) did not change over the course of treatment.
      Overall, patient satisfaction with the procedure was high: 89.7 % of patients would highly (value 5–7) recommend the procedure and 94.9 % would be ready to repeat the procedure to maintain results. Discomfort related to treatment was lower than expected for 41 % of patients (value 5–7) and as expected for 48.7 % (value 3–4).

      Conclusion

      Fractional CO2 laser for treatment of VVA seems a safe therapeutic option. No severe complications occurred. A minority of patients reported mild complications, but these resolved without the need for treatment. Most discomfort was related to probe introduction and rotation. Overall, patients were highly satisfied, and they would repeat laser treatment.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Maturitas
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Calleja-Agius J.
        • Brincat M.P.
        Urogenital atrophy.
        Climacteric. 2009; 12: 279-285
        • Sokol Eric R.
        • Karram Mickey M.
        Use of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause: 1-year outcomes.
        Menopause. 2017; 24: 810-814
        • Kingberg S.A.
        • Wysocki S.
        • Magnus L.
        • Krychman M.L.
        Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (Real Women’s Views of Treatment Options for Menopausal Vaginal Changes) survey.
        J. Sex. Med. 2013; 10: 1790-1799
        • Sokol E.R.
        • Karram M.M.
        An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy.
        Menopause. 2016; 23: 1102-1107
        • Perino A.
        • Calligaro A.
        • Forlani F.
        • et al.
        Vulvo-vaginal atrophy: a new treatment modality using thermo-ablative fractional CO2 laser.
        Maturitas. 2015; 80: 296-301
        • Salvatore S.
        • Nappi R.E.
        • Zerbinati N.
        • et al.
        A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study.
        Climacteric. 2014; 17: 363-369
        • Zerbinati N.
        • Serati M.
        • Origoni M.
        • Candiani M.
        • Iannitti T.
        • Salvatore S.
        • et al.
        Microscopic and ultrastructural modifications of post-menopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment.
        Lasers Med. Sci. 2014; 30: 429-436
        • Perino A.
        • Calligaro A.
        • Forlani F.
        • et al.
        Vulvo-vaginal atrophy: a new treatment modality using thermo-ablative fractional CO2 laser.
        Maturitas. 2015; 80: 296-301
        • Salvatore S.
        • Nappi R.E.
        • Parma M.
        • et al.
        Sexual function after fractional microablative CO2 laser in women with vulvovaginal atrophy.
        Climacteric. 2015; 18: 219-225
        • Strasberg Steven M.
        • Linehan David C.
        • Hawkins William G.
        The accordion severity grading system of surgical complications.
        Ann. Surg. 2009; 250: 177-186
      1. https://www.jwatch.org/fw114423/2018/08/01/fda-warns-against-using-lasers-vaginal-rejuvenation 1 august 2018.

        • Eder S.E.
        Early effect of fractional CO2 laser treatment in Post-menopausal women with vaginal atrophy.
        Laser Ther. 2018; 27: 41-47
        • Arroyo C.
        Fractional CO2 laser treatment for vulvovaginal atrophy symptoms and vaginal rejuvenation in perimenopausal women.
        Int. J. Womens Health. 2017; 9: 591-595
        • Behnia-Willison F.
        • Sarraf S.
        • Miller J.
        • Mohamadi B.
        • Care A.S.
        • Lam A.
        • Willison N.
        • Behnia L.
        • Salvatore S.
        Safety and long-term efficacy of fractional CO2 laser treatment in women suffering from genitourinary syndrome of menopause.
        Eur. J. Obstet. Gynecol. Reprod. Biol. 2017; 213: 39-44
        • Martin R.C.G.
        • Brennan M.F.
        • Jaques D.P.
        Quality of complication reporting in the surgical literature.
        Ann. Surg. 2002; 235: 803-812
        • Di Donato V.
        • et al.
        Ospemifene for the treatment of vulvar and vaginal atrophy: a meta-analysis of randomized trials. Part I: evaluation of efficacy.
        Maturitas. 2019; 121: 86-92
        • Di Donato V.
        • et al.
        Ospemifene for the treatment of vulvar and vaginal atrophy: a meta-analysis of randomized trials. Part I: evaluation of efficacy.
        Maturitas. 2019; 121: 86-92
        • Briki M.
        • et al.
        Sexual dysfunction and depression: validity of a French version of the ASEX scale.
        Encephale. 2014; 40: 114-122
        • Maseroli E.
        • Fanni E.
        • Fambrini M.
        • Ragghianti B.
        • Limoncin E.
        • Mannucci E.
        • Maggi M.
        • Vignozzi L.
        Bringing the body of the iceberg to the surface: the Female Sexual Dysfunction Index-6 (FSDI-6) in the screening of female sexual dysfunction.
        J. Endocrinol. Invest. 2016; 39: 401-409