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Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy.
J Sex Med. 2022 05; 19(5):761-770.JS

Abstract

BACKGROUND

Among treatments for vulvo-vaginal atrophy (VVA), there is a new kind of energy-based device, the non-ablative CO2 laser.

AIM

This study aimed to assess the efficacy and safety of the non-ablative CO2 laser in menopausal women with VVA as a monotherapy or in association with vaginal estriol or moisturizer.

METHODS

Seventy-five women with VVA received laser treatment (Laser group), laser plus estriol gel (Laser+E) or laser plus moisturizers (Laser+M). The study protocol consisted of 3 monthly laser sessions (t0, t1, t2) and a gynecological examination at baseline and 1 month after last laser treatment (t3). Objective measures included VHI (Vaginal Health Index) and VuHI (Vulvar Health Index); subjective symptoms of VVA (Dryness, Burning, Itching, Dysuria) evaluated via visual analog scales, sexual function evaluated by FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Score) and MENQOL (Mopause-specific Quality Of Life). Adverse events and discomfort encountered during the procedure were also assessed.

OUTCOMES

Primary outcomes were the evaluation of VHI and VuHI and secondary outcomes were changes in VVA symptoms (VAS), sexual function (MENQOL, FSFI, FSDS) and discomfort during the procedure.

RESULTS

Seventy-five women (25 in Laser, 25 in Laser+E and 25 in Laser+M group) completed the study. At t3, mean VHI, VuHI, dryness, burning and itching VAS scores improved significantly with no differences between the groups. The lubrication domain of FSFI improved significantly only in the Laser+M group, while the pain domain improved significantly in all women with no differences between the groups. FSFI and FSDS overall scores and MENQOL sexual domain improved in all women with no significant difference between the groups. The mean score of the pain during the procedure was low at t0 and did not change throughout the study.

CLINICAL IMPLICATIONS

This study extends knowledge concerning the effectiveness of a new non-ablative CO2 laser in post-menopausal women with VVA.

STRENGTHS & LIMITATIONS

This is one of the first studies on this kind of laser and is the first to compare the effectiveness of laser treatment alone or in combination with vaginal estriol or moisturizers. Parameters of VVA and sexual function were evaluated using validated tools. Study limitations include short follow-up time, the limited number of participants and the absence of a sham-controlled group.

CONCLUSION

Non-ablative CO2 laser seems to be an effective treatment for VVA in menopausal women. Our preliminary data shows that it can be effective as monotherapy or with adjuvant treatments. Alvisi S, Lami A, Baldassarre M, et al. Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med 2022;19:761-770.

Authors+Show Affiliations

Gynecology and Physiopathology of Human Reproduction, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.Gynecology and Physiopathology of Human Reproduction, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy; Center for Applied Biomedical Research, Department of Surgical and Medical Sciences, S. Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.Gynecology and Physiopathology of Human Reproduction, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.Gynecology and Physiopathology of Human Reproduction, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.Gynecology and Physiopathology of Human Reproduction, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy; Center for Applied Biomedical Research, Department of Surgical and Medical Sciences, S. Orsola-Malpighi University Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy. Electronic address: cristina.meriggiola@unibo.it.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

35370104

Citation

Alvisi, Stefania, et al. "Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or With Estriol or Moisturizers in Postmenopausal Women With Vulvovaginal Atrophy." The Journal of Sexual Medicine, vol. 19, no. 5, 2022, pp. 761-770.
Alvisi S, Lami A, Baldassarre M, et al. Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2022;19(5):761-770.
Alvisi, S., Lami, A., Baldassarre, M., Lenzi, J., Mancini, I., Seracchioli, R., & Meriggiola, M. C. (2022). Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy. The Journal of Sexual Medicine, 19(5), 761-770. https://doi.org/10.1016/j.jsxm.2022.02.027
Alvisi S, et al. Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or With Estriol or Moisturizers in Postmenopausal Women With Vulvovaginal Atrophy. J Sex Med. 2022;19(5):761-770. PubMed PMID: 35370104.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy. AU - Alvisi,Stefania, AU - Lami,Alessandra, AU - Baldassarre,Maurizio, AU - Lenzi,Jacopo, AU - Mancini,Ilaria, AU - Seracchioli,Renato, AU - Meriggiola,Maria Cristina, Y1 - 2022/03/31/ PY - 2021/11/12/received PY - 2022/01/27/revised PY - 2022/02/26/accepted PY - 2022/4/5/pubmed PY - 2022/5/6/medline PY - 2022/4/4/entrez KW - Dyspareunia KW - Energy-Based Devices KW - Genitourinary Syndrome KW - Laser Therapy KW - Non-Ablative Laser KW - Sexual Function KW - Vaginal Health Index KW - Vulvo-Vaginal Atrophy SP - 761 EP - 770 JF - The journal of sexual medicine JO - J Sex Med VL - 19 IS - 5 N2 - BACKGROUND: Among treatments for vulvo-vaginal atrophy (VVA), there is a new kind of energy-based device, the non-ablative CO2 laser. AIM: This study aimed to assess the efficacy and safety of the non-ablative CO2 laser in menopausal women with VVA as a monotherapy or in association with vaginal estriol or moisturizer. METHODS: Seventy-five women with VVA received laser treatment (Laser group), laser plus estriol gel (Laser+E) or laser plus moisturizers (Laser+M). The study protocol consisted of 3 monthly laser sessions (t0, t1, t2) and a gynecological examination at baseline and 1 month after last laser treatment (t3). Objective measures included VHI (Vaginal Health Index) and VuHI (Vulvar Health Index); subjective symptoms of VVA (Dryness, Burning, Itching, Dysuria) evaluated via visual analog scales, sexual function evaluated by FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Score) and MENQOL (Mopause-specific Quality Of Life). Adverse events and discomfort encountered during the procedure were also assessed. OUTCOMES: Primary outcomes were the evaluation of VHI and VuHI and secondary outcomes were changes in VVA symptoms (VAS), sexual function (MENQOL, FSFI, FSDS) and discomfort during the procedure. RESULTS: Seventy-five women (25 in Laser, 25 in Laser+E and 25 in Laser+M group) completed the study. At t3, mean VHI, VuHI, dryness, burning and itching VAS scores improved significantly with no differences between the groups. The lubrication domain of FSFI improved significantly only in the Laser+M group, while the pain domain improved significantly in all women with no differences between the groups. FSFI and FSDS overall scores and MENQOL sexual domain improved in all women with no significant difference between the groups. The mean score of the pain during the procedure was low at t0 and did not change throughout the study. CLINICAL IMPLICATIONS: This study extends knowledge concerning the effectiveness of a new non-ablative CO2 laser in post-menopausal women with VVA. STRENGTHS & LIMITATIONS: This is one of the first studies on this kind of laser and is the first to compare the effectiveness of laser treatment alone or in combination with vaginal estriol or moisturizers. Parameters of VVA and sexual function were evaluated using validated tools. Study limitations include short follow-up time, the limited number of participants and the absence of a sham-controlled group. CONCLUSION: Non-ablative CO2 laser seems to be an effective treatment for VVA in menopausal women. Our preliminary data shows that it can be effective as monotherapy or with adjuvant treatments. Alvisi S, Lami A, Baldassarre M, et al. Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med 2022;19:761-770. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/35370104/Short_Term_Efficacy_and_Safety_of_Non_Ablative_Laser_Treatment_Alone_or_with_Estriol_or_Moisturizers_in_Postmenopausal_Women_with_Vulvovaginal_Atrophy_ DB - PRIME DP - Unbound Medicine ER -