The effectiveness of a 3-dimensional printed vaginal dilator in mitigating radiation-induced vaginal stenosis for patients with cervical cancer.

Abstract

Objective: Vaginal stenosis (VS) is a common adverse effect of pelvic radiotherapy. Current guidelines recommend vaginal dilation to maintain tissue elasticity and prevent VS. Previously, patients were instructed to self-dilate using own fingers. The current study assessed the effectiveness of using a 3-dimensional (3D) printed vaginal dilator (VD) for mitigating vaginal narrowing and shortening in cervical cancer patients within 1 year after radiotherapy.

Methods: VDs were developed and validated by radiation therapists using a 3D printer. We enrolled 67 female patients diagnosed with cervical cancer at Chulabhorn Hospital to test the dilators. As a baseline, vaginal diameter and length were measured using the dilator before intracavitary radiotherapy. The patients were instructed on the use of VDs and provided with information guides and logbooks. Physical examinations were conducted at intervals of 1, 3, 6, 9, and 12 months post-radiotherapy.

Results: The patients' average age was 51.75 years (standard deviation=13.23). 57% of all patients were diagnosed with stage III squamous cell carcinoma, and 66% underwent concurrent chemoradiation therapy. With the use of dilators, patients exhibited shortened and narrowed vaginal canals at 9 months and 1 month after receiving radiotherapy treatment. Most patients went on to develop VS. However, in most cases patients exhibited grade 1 VS according to the Late Effects in Normal Tissues-Subjective, Objective, Management and Analytic classification, with only 15.79% of patients exhibiting grade 2 VS.

Conclusion: The use of a VD could potentially lessen the severity of VS induced by radiotherapy/brachytherapy.

Trial registration: Thai Clinical Trial Registry Identifier: TCTR20250309001.