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The Effect of Fractional CO2 Laser Compared with Platelet Rich Plasma (PRP) for The Treatment of Women with Stress Urinary Incontinence: An Assessor-Blinded Randomized Clinical Trial

The Effect of Fractional CO2 Laser Compared with Platelet Rich Plasma (PRP) for The Treatment of Women with Stress Urinary Incontinence: An Assessor-Blinded Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260215002
Enrollment
66
Registered
2026-02-15
Start date
2026-02-20
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

Mild to moderate stress urinary incontinence SUI, CO2 vaginal laser, PRP, PFMT

Interventions

Fractional CO2 laser group will have three laser sessions at 1 month interval of transvaginal fractional micro-ablative CO2 laser system (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy) using
CO2 laser combined PFMT,PRP combined PFMT,PFMT alone

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor
Astraco Medical Networks LTD.,DEKA Asia Pacific CO.,Ltd.
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age more than or equal 18 years old 2. SUI confirmed using 1-h PWT of at least 1 g 3. Mild to moderate SUI (score between 1 and 12 From ICIQ-UI SF) (Thai version of ICIQ-UI SF test-retest reliability was 0.98) 4. Positive cough test 5. Did not use any SUI treatment procedures including laser, PRP, or magnetic stimulation within prior 6 months 6. Did not use vaginal estrogen within prior 3 months 7. Never undergone anti-incontinence procedures

Exclusion criteria

Exclusion criteria: 1. Positive (score more than or equal 3) by OABSS score or the urgency score more than or equal 2 (from OABSS item 3) (Thai version of OABSS test-retest reliability was 0.88) 2. 1-h PWT > 50 g 3. Pelvic organ prolapses > stage II 4. Body mass index (BMI) > 30 kg/m2 5. Acute urinary tract infections 6. Voiding difficulty 7. Urinary retention 8. Overflow urinary incontinence with neurogenic causes 9. History of pelvic radiation 10. Undiagnosed abnormal vaginal bleeding 11. Active and untreated urogenital cancer 12. Active urogenital and pelvic infection (i.e., genital herpes, vaginitis, pelvic inflammatory disease) 13. Hematologic disorder (i.e., coagulopathy, thrombocytopenia, platelet dysfunction) 14. Concurrent use of anti-platelet or anti-coagulant medications 15. Pregnancy 16. Taking corticosteroid, or immunosuppressants 17. Any condition precluding informed consent

Design outcomes

Primary

MeasureTime frame
Decreasing of urine leakage 6 months 1 hour pad weight test

Secondary

MeasureTime frame
Efficacy of treatment by assessing subjective outcomes 6 months International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptoms Quality of Life ,Efficacy of treatment by assessing subjective outcomes 6 months International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms question 11,Efficacy of treatment by assessing subjective outcomes 6 months Patient Global Impression of Improvement score

Countries

Thailand

Contacts

Public ContactKamonwan Sansom

Ramathibodi Hospital

kamonwan.sansom@gmail.com0910641580

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026