TCTR20230919003
Not yet recruiting
Phase 3
Efficacy of vaginal laser on genitourinary syndrome of menopause in breast cancer survivor: A randomized, double-blind, sham-controlled trial
Faculty of Medicine Khon Kaen University Research Fund0 sites122 target enrollmentSeptember 19, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- genitourinary syndrome of menopause in breast cancer survivor
- Sponsor
- Faculty of Medicine Khon Kaen University Research Fund
- Enrollment
- 122
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.The patient was diagnosed with breast cancer treated at Rukpathum Clinic, Srinagarind Hospital.
- •2\.Patients being treated for breast cancer Completed locoregional therapy and is following treatment at Rukpathum Clinic, Srinagarind Hospital.
- •3\.Patients with vaginal pain or vaginal dryness to a degree that interferes with daily life Evaluated from ICIQ\-VS Thai version, item 2 or item 9, at least 1 item. Give a score greater than or equal to 4 points.
- •4\.Patients older than or equal to 20 years old
Exclusion Criteria
- •1\. Breast cancer patients undergoing chemotherapy.
- •2\. Patients whose information and treatment history in their medical records are incomplete or missing.
- •3\. Patients who have previously received vaginal laser ablation treatment.
- •4\. Patients who have received treatment for vaginal and urinary tract symptoms before. within the period 6 months earlier
- •5\. Patients who cannot read or write Thai or communicate.
- •6\. Patients who are having vaginal or pelvic infections.
- •7\. Patients who are having a urinary tract infection.
- •8\. Patients who cannot undergo the procedure, such as having a narrowed vagina smaller than 2 cm. Unable to lithotomy.
Outcomes
Primary Outcomes
Not specified
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