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Efficacy of vaginal laser on genitourinary syndrome of menopause in breast cancer survivor: A randomized, double-blind, sham-controlled trial

Phase 3
Conditions
genitourinary syndrome of menopause in breast cancer survivor
genitourinary syndrome of menopause, vaginal symptom, urinary symptom
Registration Number
TCTR20230919003
Lead Sponsor
Faculty of Medicine Khon Kaen University Research Fund
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
Female
Target Recruitment
122
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
vaginal symptom at 12 weeks after end of the intervention ICIQ-VS score
Secondary Outcome Measures
NameTimeMethod
urinary symptom at 12 weeks after end of the intervention UDI-6 score
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