CO2 Laser in the Treatment of the GSM - (Genitourinary Syndrome of Menopause) Genitourinary Syndrome of Menopause

NCT ID: NCT03939078

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2020-03-05

Brief Summary

Menopause is a woman's hormonal status one year after her ovulatory failure, when the decrease of circulating estrogen levels leads to a group of symptoms named Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, dysuria, epithelial fragility with recurrent bleedings, loss of genital elasticity and pH alterations causing recurrent infections. The CO2 laser is a fractional ablative source of light, capable of inducing neocollagenesis within the skin, reversing atrophies, increasing blood supply and reorganizing the architectural structure of the treated epithelium. Recent studies in the laser field show great improvement of the SGM, with satisfying results in female's sexual disfunction. Nevertheless, there is still a lack of studies that show, at the same time, the improvement in both patient's subjective reports and objective measurements, such as cytology, histology and immunohistochemistry. This study aims to thoroughly analyze the benefits of the CO2 laser in the treatment of the GMS, comparing the improvement found in questionnaires to the results of cytology, histology and immunohistochemistry for collagen I and III from vaginal biopsies before and after the laser treatment. Therefore, fourteen women after menopause complaining of symptoms of the GSM were selected from the ambulatory of the Hospital Universitário Antônio Pedro. The patients will be submitted to three CO2 intravaginal laser (Femilift®), with a 30-days interval between them. Biopsies of the vaginal wall will be taken one month before the start and one month after the end of the laser sessions, and material will be sent to histology, cytology and immunohistochemistry analysis. Results obtained will be compared to the patients' reports, in order to evaluate subjective and objective improvement due to the treatment.

Conditions

Menopause; Vaginal Atrophy; Urinary Incontinence

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Vaginal Laser Intervention

Patients will be submitted to vaginal biopsy before and after three laser sections, and therefore will be their own comparative group to see the improvement associated with the laser effects.

CO2 fractional ablative laser

Intervention Type: RADIATION

3 intravaginal fractional ablative CO2 laser sessions, with one month interval between them.

Interventions

CO2 fractional ablative laser

3 intravaginal fractional ablative CO2 laser sessions, with one month interval between them.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Women from 40 to 70 years old;
• Post- menopausa (at least one year after cessation of periods);
• Experimenting any symptom related to the Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, urinary incontinence, dysuria, recurrent urinary infections;
• Regular follow up in gynecologist, with recent normal pap smear.

Exclusion Criteria

• The volunteers must not be under any treatment for this syndrome;
• Volunteers cannot be using hormones or any vaginal treatment;
• Volunteers cannot have previous history of vaginal / uterine cancer;
• Volunteers cannot have previous surgery for urinary incontinence;
• Uterine prolapse;
• Recent altered pap smear.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alma Lasers

INDUSTRY

Sponsor Role: collaborator

Universidade Federal Fluminense

OTHER

Sponsor Role: lead

Responsible Party

Maria Claudia Almeida Issa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Antonio Pedro

Niterói, Rio de Janeiro, Brazil

Countries

Brazil

References

DiBonaventura M, Luo X, Moffatt M, Bushmakin AG, Kumar M, Bobula J. The Association Between Vulvovaginal Atrophy Symptoms and Quality of Life Among Postmenopausal Women in the United States and Western Europe. J Womens Health (Larchmt). 2015 Sep;24(9):713-22. doi: 10.1089/jwh.2014.5177. Epub 2015 Jul 22.

Reference Type: BACKGROUND

PMID: 26199981 (View on PubMed)

Keil K. Urogenital atrophy: diagnosis, sequelae, and management. Curr Womens Health Rep. 2002 Aug;2(4):305-11.

Reference Type: BACKGROUND

PMID: 12150759 (View on PubMed)

Palacios S, Castelo-Branco C, Currie H, Mijatovic V, Nappi RE, Simon J, Rees M. Update on management of genitourinary syndrome of menopause: A practical guide. Maturitas. 2015 Nov;82(3):308-13. doi: 10.1016/j.maturitas.2015.07.020. Epub 2015 Jul 26.

Reference Type: BACKGROUND

PMID: 26261035 (View on PubMed)

Zerbinati N, Serati M, Origoni M, Candiani M, Iannitti T, Salvatore S, Marotta F, Calligaro A. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci. 2015 Jan;30(1):429-36. doi: 10.1007/s10103-014-1677-2. Epub 2014 Nov 20.

Reference Type: BACKGROUND

PMID: 25410301 (View on PubMed)

Lindahl SH. Reviewing the options for local estrogen treatment of vaginal atrophy. Int J Womens Health. 2014 Mar 13;6:307-12. doi: 10.2147/IJWH.S52555. eCollection 2014.

Reference Type: BACKGROUND

PMID: 24648775 (View on PubMed)

Perino A, Calligaro A, Forlani F, Tiberio C, Cucinella G, Svelato A, Saitta S, Calagna G. Vulvo-vaginal atrophy: a new treatment modality using thermo-ablative fractional CO2 laser. Maturitas. 2015 Mar;80(3):296-301. doi: 10.1016/j.maturitas.2014.12.006. Epub 2014 Dec 25.

Reference Type: BACKGROUND

PMID: 25596815 (View on PubMed)

Hutchinson-Colas J, Segal S. Genitourinary syndrome of menopause and the use of laser therapy. Maturitas. 2015 Dec;82(4):342-5. doi: 10.1016/j.maturitas.2015.08.001. Epub 2015 Aug 12.

Reference Type: BACKGROUND

PMID: 26323234 (View on PubMed)

Bretas TLB, Issa MCA, Fialho SCAV, Villar EAG, Velarde LGC, Perez-Lopez FR. Vaginal collagen I and III changes after carbon dioxide laser application in postmenopausal women with the genitourinary syndrome: a pilot study. Climacteric. 2022 Apr;25(2):186-194. doi: 10.1080/13697137.2021.1941850. Epub 2021 Jul 22.

Reference Type: DERIVED

PMID: 34291703 (View on PubMed)

Other Identifiers

CO2 laser

Identifier Type: -

Identifier Source: org_study_id