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

NCT03939078 | Completed FDA Device

• 1 other identifier: CO2 laser
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

menopause; vaginal atrophy; urinary incontinence; CO2 laser; fractional laser; dyspareunia; vaginal dryness; vaginal lubrication

Outcome Measures

Primary Outcomes (2)

• Reversion of vaginal atrophy

  Reversion of vaginal atrophy by the laser stimulation, with increasing layers of epithelial cells, increased collagen deposition and improvement in vascularization.

  1 month after the last (3rd) laser section

• Improvement in urinary incontinence

  Improvement in urine involuntary loss, the so called stress incontinence

  1 month after the third and last laser section

Study Arms (1)

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.

Radiation: CO2 fractional ablative laser

Interventions

CO2 fractional ablative laser RADIATION

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

Vaginal Laser Intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteer women from 40 to 70 years, healthy and with regular gynecologist follow up, not willing or not eligible to take hormones to treat the GSM, experimenting difficulties in their sexual life and their daily routine, due to vaginal atrophy and urinary incontinence.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead
• Alma Lasers: collaborator

Study Sites (1)

Hospital Universitario Antonio Pedro

Niterói, Rio de Janeiro, 24033-900, Brazil

Location

Related Publications (8)

• 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.

  PMID: 26199981 BACKGROUND

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

  PMID: 12150759 BACKGROUND

• 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.

  PMID: 26261035 BACKGROUND

• 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.

  PMID: 25410301 BACKGROUND

• 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.

  PMID: 24648775 BACKGROUND

• 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.

  PMID: 25596815 BACKGROUND

• 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.

  PMID: 26323234 BACKGROUND

• 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.

  PMID: 34291703 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Dyspareunia

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 6, 2019
• Study Start: April 5, 2018
• Primary Completion: October 5, 2019
• Study Completion: March 5, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

BR (1)