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Efficacy of vaginal dilator use on vaginal stenosis and quality of life in cervical cancer patients after treated with radiation therapy

Assessing the Effectiveness of Vaginal Dilator Therapy in Mitigating Vaginal Stenosis among Cervical Cancer Patients Post-Radiation Treatment

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250309001
Enrollment
67
Registered
2025-03-09
Start date
2020-12-07
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

females diagnosed with cervical cancer receiving radiation therapy Cervical cancer

Interventions

A vaginal dilator was developed and validated by radiation therapists using a 3D printer.
Active Comparator Device

Sponsors

Chulabhorn Royal Academy
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female patient aged 18 years or older. 2. Diagnosed with cervical cancer and treated with radiotherapy. 3. Able to communicate and understand the Thai language. 4. Willing to participate in the research study.

Exclusion criteria

Exclusion criteria: 1. Presence of lesions that prevent the use of a vaginal speculum. 2. Chronic or severe bleeding that makes speculum use impossible. 3. Emergency conditions or necessity for alternative treatment. 4. Patient is unable to attend follow-up appointments as per guidelines.

Design outcomes

Primary

MeasureTime frame
vaginal stenosis Vaginal measurements and physical exam will be recorded at baseline and 1, 3-, 6-, 9 and 12-months following CCRT Physician examinations

Secondary

MeasureTime frame
Quality of life baseline and 1, 3-, 6-, 9 and 12-months following CCRT questionaire

Countries

Thailand

Contacts

Public ContactSirikorn Kongwattanakul

Chulabhorn Royal Academy

sirikorn.roj@cra.ac.th0821426542

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026