An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

Pelvic radiotherapy and vaginal brachytherapy play an integral role in managing gynecological
malignancies, including endometrial and cervical cancer. Radiation-induced vaginal stenosis
is a well recognized complication of radiation therapy and can result in painful, inadequate
pelvic exams and sexual dysfunction. Current recommendations to prevent and manage vaginal
stenosis include regular use of vaginal dilators, with our institutional recommendation being
three times weekly for 10 minutes. Compliance varies among studies but is generally perceived
to be low. Limited literature exists regarding ways to improve adherence and correct use of
vaginal dilators. The goal of this study is to enhance the standard vaginal dilator model to
improve patient outcomes. Eligibility includes women with endometrial or cervical cancer
treated with post-operative external beam radiation therapy with or without brachytherapy.
Patients will be randomized to either the standard vaginal dilator or an enhanced model. The
enhanced dilator model includes the addition of a silicone band placed at the desired depth
of vaginal dilator insertion, aimed to aide in correct insertion length. The primary aim of
the study is patient adherence to vaginal dilator use. Secondary aims include vaginal length,
CTCAE v5.0 grading scale for vaginal stricture, sexual function, self-reported comfort with
use, and discomfort during office pelvic exams. Outcomes will be obtained based on physician
reporting and patient surveys. All analyses will be completed by a biostatistician in the
Clinical Research Office using SAS version 9.4.

Inclusion Criteria:

- Diagnosis of endometrial or cervical cancer

- Undergoing external beam radiation therapy with or without brachytherapy

- English-speaking

Exclusion Criteria:

- History or current presence of fistula