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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230919003

Enrollment

122

Registered

2023-09-19

Start date

2023-09-20

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

genitourinary syndrome of menopause in breast cancer survivor genitourinary syndrome of menopause, vaginal symptom, urinary symptom

Interventions

Fractional CO2 vaginal laser,sham group, faked vaginal laser intervention

Active Comparator Device,Sham Comparator No treatment

Laser,Sham

Eligibility

Sex/Gender

Female

Age

20 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
vaginal symptom at 12 weeks after end of the intervention ICIQ-VS score	—

Secondary

Measure	Time frame
urinary symptom at 12 weeks after end of the intervention UDI-6 score	—

Countries

Thailand

Contacts

Public ContactKamonphan Pinjaroen

Obstetrics and Gynecology Department Khon Kaen University

Kamonpi@kku.ac.th0933208907

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026