Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies
2 other identifiers
interventional
19
1 country
4
Brief Summary
This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 14, 2017
CompletedStudy Start
First participant enrolled
May 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2022
CompletedApril 22, 2022
April 1, 2022
1.6 years
November 13, 2017
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in genitourinary syndrome of menopause (GSM) symptoms
Will be assessed by the Vaginal Assessment Scale (VAS). Will be summarized and compared between the treatment arms using a two-sample t-test or a Wilcoxon rank sum test, with a two-sided alternative for each. Will also analyze this endpoint graphically by plotting the VAS scores through time by treatment arm. Additionally, will correlate the scores from the VAS with other validated measures using a Spearman's correlation coefficient in an exploratory manner.
Baseline to 12 weeks
Secondary Outcomes (8)
Feasibility as measured by number of patients able to complete 3 study visitis
Up to 1 month
Improvement in objective findings of vaginal atrophy
Up to 1 month
Improvement in sexual function by FSFI
Up to 1 year
Improvement in sexual function FSDS
Up to 1 year
Improvement in urinary symptoms
Up to 1 month
- +3 more secondary outcomes
Study Arms (2)
Arm I (fractional CO2 laser therapy)
EXPERIMENTALPatients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
Arm II (sham laser therapy)
SHAM COMPARATORPatients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
Interventions
Undergo fractional CO2 laser therapy
Ancillary studies
Eligibility Criteria
You may qualify if:
- Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment \>= 6 months prior to enrollment
- Any form of hysterectomy, including radical hysterectomy permitted
- Must have no evidence of recurrent disease on pelvic exam within past 3 months
- Radiation therapy is permitted but not required
- Patient reported dyspareunia and/or vaginal dryness with severity of \>= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over \>= 4 weeks and/or the inability to be sexually active due to pain
You may not qualify if:
- Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer
- Pelvic organ prolapse stage II or higher
- Prior reconstructive pelvic surgery involving mesh
- Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58104, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Publications (2)
Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PMID: 40709601DERIVEDQuick AM, Dockter T, Le-Rademacher J, Salani R, Hudson C, Hundley A, Terstriep S, Streicher L, Faubion S, Loprinzi CL, Coleman JS, Wang KC, Lustberg M. Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors. Maturitas. 2021 Feb;144:37-44. doi: 10.1016/j.maturitas.2020.10.018. Epub 2020 Dec 2.
PMID: 33358206DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Quick, MD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 13, 2017
First Posted
December 14, 2017
Study Start
May 11, 2018
Primary Completion
December 18, 2019
Study Completion
April 12, 2022
Last Updated
April 22, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share