Vaginal Changes After CO2 Laser

NCT06691178 | Recruiting DMC

• 2 other identifiers: 20801R01EB030558-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Genitourinary syndrome of menopause (GSM) occurs due to a decline in estrogen levels as a woman approaches menopause. The syndrome negatively impacts women's quality of life and is characterized by vaginal dryness, burning, diminished lubrication, painful intercourse and urinary symptoms such as frequency and urgency. GSM is diagnosed by symptom assessment and physical exam, with current mainstay of treatment being vaginal estrogen. Women with a history of breast cancer, gynecologic cancer, or venous thromboembolism may not be candidates for hormonal therapy. Thus, there has been a quest for effective non-hormonal forms of treatment for GSM. The use of vaginal CO2 laser treatment for GSM has shown promising results. In this study, we aim to use long-wavelength optical coherence tomography/angiography/elastography (OCT/OCTA/OCE) to document changes that occur in the vaginal epithelium during menopause as well as after treatment for GSM. OCT is a well-studied technology and is widely used in Dermatology and Ophthalmology. In collaboration with the Beckman Laser Institute (BLI), we have developed a non-invasive vaginal probe (HS# 2017-3686). The probe has subsequently been used in previous studies to validate measurements in the vaginal epithelium (HS# 2019-5446). A previous RCT compared clinical response to laser therapy to a control group that received a low level of laser therapy. The study also did not examine histology. This will be a randomized controlled trial in which women will be enrolled into one group receiving laser therapy and compared to a true sham group that will not receive laser therapy at all. Response will be measured primarily by OCT device as well as optional vaginal biopsies. There will also be questionnaires and exam of the vaginal tissue using the VHI.

Conditions

Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (2)

• Vaginal epithelial thickness

  OCT measurement of vaginal epithelial thickness

  Measurements will be obtained once a month for the first three months. Measurements will be obtained at subsequent follow up visits every 3 months for 1 year.

• Blood vessel density

  OCT measurement of blood vessel density

  Measurements will be obtained once a month for the first three months. Measurements will be obtained at follow up visits every 3 months for 1 year.

Secondary Outcomes (5)

• Vulvovaginal symptoms questionnaire (VSQ)

  Questionnaire will be obtained at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).

• Vaginal health index (VHI)

  Physical exam will be performed at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).

• Vaginal Microbiome

  A vaginal swab will be obtained at baseline, during each treatment visit (once a month) and each follow up visit (every 3 months for 1 year).

• Patient Global Impression

  Questionnaire will be completed starting the second treatment visit (once a month) and each follow up visit (every 3 months for 1 year).

• Assessment of Quality of Life 6D

  Measurements will be obtained once a month for the first three months. Measurements will be obtained at subsequent follow up visits every 3 months for 1 year.

Study Arms (2)

CO2 Vaginal Laser treatment

EXPERIMENTAL

Laser treatment with a Fractional/Pixel CO2 laser (Femilift, Alma Lasers) will be performed with the following settings and procedure: single pulse; first pass 50-100 millijoules/pixel of energy, and 50-100 millijoules/pixel for the second pass. The energy level will be adjusted within the range based on the subject's comfort level. The same procedures will be followed for the sham group but no pulse will be generated.

Diagnostic Test: Optical coherence tomography (OCT)

Sham - no vaginal laser treatment

SHAM COMPARATOR

The vaginal laser probe will be placed as usual but no energy will be delivered to the tissue.

Diagnostic Test: Optical coherence tomography (OCT)

Interventions

Optical coherence tomography (OCT) DIAGNOSTIC_TEST

The OCT device with cover will be used to take measurements at four areas in the vaginal canal: the proximal posterior aspect, proximal anterior, distal anterior, and distal posterior. The proximal and distal points will be marked on the OCT cover during the first set of measurements. Markings will be used to guide measurements during subsequent visits.

CO2 Vaginal Laser treatment; Sham - no vaginal laser treatment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Birth sex: female
• Desire for vaginal laser therapy for GSM
• Age \>=18 years old
• Willingness to forego other treatments for GSM within the study period
• Diagnosed as postmenopausal (either by surgical removal of ovaries or natural progression defined as no periods in 1 year)

You may not qualify if:

• History of pelvic radiation
• On hormone replacement therapy in the prior 3 months
• Not able or willing to follow study instructions
• Current diagnosis of recurrent UTIs

Sponsors & Collaborators

• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• Alma Lasers: collaborator
• University of California, Irvine: lead

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, United States

RECRUITING

Related Publications (10)

• Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.

  PMID: 27472999 BACKGROUND

• Diedrich CM, Kastelein AW, Verri FM, Weber MA, Ince C, Roovers JWR. Effects of topical estrogen therapy on the vaginal microcirculation in women with vulvovaginal atrophy. Neurourol Urodyn. 2019 Jun;38(5):1298-1304. doi: 10.1002/nau.23977. Epub 2019 Apr 4.

  PMID: 30947367 BACKGROUND

• Santoro N, Komi J. Prevalence and impact of vaginal symptoms among postmenopausal women. J Sex Med. 2009 Aug;6(8):2133-42. doi: 10.1111/j.1743-6109.2009.01335.x. Epub 2009 Jun 1.

  PMID: 19493278 BACKGROUND

• Qiu S, Arthur A, Jiang Y, Miao Y, Li Y, Wang J, Tadir Y, Lane F, Chen Z. OCT angiography in the monitoring of vaginal health. APL Bioeng. 2023 Nov 7;7(4):046112. doi: 10.1063/5.0153461. eCollection 2023 Dec.

  PMID: 37946874 BACKGROUND

• Pitsouni E, Grigoriadis T, Falagas ME, Salvatore S, Athanasiou S. Laser therapy for the genitourinary syndrome of menopause. A systematic review and meta-analysis. Maturitas. 2017 Sep;103:78-88. doi: 10.1016/j.maturitas.2017.06.029. Epub 2017 Jun 27.

  PMID: 28778337 BACKGROUND

• Athanasiou S, Pitsouni E, Antonopoulou S, Zacharakis D, Salvatore S, Falagas ME, Grigoriadis T. The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women. Climacteric. 2016 Oct;19(5):512-8. doi: 10.1080/13697137.2016.1212006. Epub 2016 Aug 24.

  PMID: 27558459 BACKGROUND

• Tadir Y, Gaspar A, Lev-Sagie A, Alexiades M, Alinsod R, Bader A, Calligaro A, Elias JA, Gambaciani M, Gaviria JE, Iglesia CB, Selih-Martinec K, Mwesigwa PL, Ogrinc UB, Salvatore S, Scollo P, Zerbinati N, Nelson JS. Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies. Lasers Surg Med. 2017 Feb;49(2):137-159. doi: 10.1002/lsm.22637. Epub 2017 Feb 21.

  PMID: 28220946 BACKGROUND

• Li FG, Maheux-Lacroix S, Deans R, Nesbitt-Hawes E, Budden A, Nguyen K, Lim CY, Song S, McCormack L, Lyons SD, Segelov E, Abbott JA. Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial. JAMA. 2021 Oct 12;326(14):1381-1389. doi: 10.1001/jama.2021.14892.

  PMID: 34636862 BACKGROUND

• Li Y, Sudol NT, Miao Y, Jing JC, Zhu J, Lane F, Chen Z. 1.7 micron optical coherence tomography for vaginal tissue characterization in vivo. Lasers Surg Med. 2019 Feb;51(2):120-126. doi: 10.1002/lsm.23003. Epub 2018 Jul 30.

  PMID: 30058722 BACKGROUND

• Chang CH, Myers EM, Kennelly MJ, Fried NM. Optical clearing of vaginal tissues, ex vivo, for minimally invasive laser treatment of female stress urinary incontinence. J Biomed Opt. 2017 Jan 1;22(1):18002. doi: 10.1117/1.JBO.22.1.018002.

  PMID: 28301637 BACKGROUND

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Felicia Lane, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karla LORENTE, MD

CONTACT

714-798-9044; klorente@hs.uci.edu

Nicole Wakida

CONTACT

949.824.3295; nwakida@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director of Urogynecology

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: November 15, 2024
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)