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

Urinary Incontinence Clinical Trial

Official title:

Fractional Ablative CO2 Laser in the Treatment of the Genitourinary Syndrome of Menopause

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939078
• Other study ID #: CO2 laser
• Status: Completed
• Start date: April 5, 2018
• Est. completion date: March 5, 2020

Study information

• Verified date: September 2020
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 5, 2020
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Enuresis
• Menopause
• Urinary Incontinence
• Vaginal Atrophy

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Universitario Antonio Pedro	Niteroi	Rio De Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal Fluminense	Alma Lasers

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Improvement in urinary incontinence	Improvement in urine involuntary loss, the so called stress incontinence	1 month after the third and last laser section