Status:
COMPLETED
Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Cervical Carcinoma
Dyspareunia
Eligibility:
FEMALE
Phase:
NA
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 C...
Detailed Description
PRIMARY OBJECTIVES: I. To conduct a pilot trial to estimate the proportion of gynecologic cancer patients with vaginal dryness or dyspareunia, who will have an improvement in their symptoms with vagi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03372720
Start Date
May 11 2018
End Date
April 12 2022
Last Update
April 22 2022
Active Locations (4)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58104
4
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210