Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Constriction, Pathologic

Endometrial Neoplasms

Pathological Conditions, Anatomical

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants in control arm (active comparator) will receive standard vaginal dilator with standard set of instructions for dilator use, including both verbal and written instructions. Recommended dilator use is three-times weekly for ten minutes

Participants in experimental arm will receive standard vaginal dilator with addition of silicone ring with standard set of instructions for dilator use, including both verbal and written instructions. Recommended dilator use is three-times weekly for ten minutes

Addition of silicone band to standard vaginal dilator

Silicone Dilator

Standard Dilator

Danielle M Krause, MD

Margaret R Liotta, DO

Danielle Krause, MD

Margaret Liotta, DO

This is a randomized control trial aimed to decreased radiation-induced vaginal stenosis in patients with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. The intervention is an enhanced vaginal dilator model, including a silicone band placed at the desired depth of dilator insertion. The new model will be compared against the traditional vaginal dilator model used as our institutional standard of care. We hypothesize the enhanced model will improve adherence, correct use and efficacy of vaginal dilator use.

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.

Randomized control trial with two arms including control arm and experimental arm

An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial

There is no plan to make individual participant data available to other researchers

Number of participants who use the vaginal dilator at least three times per week

Vaginal length (in centimeters) measured using a POP-Q wooden stick

The vaginal stenosis grading scale is an ordinal scale ranging from 0 (no vaginal stenosis) to 3 (severe vaginal stenosis) as defined by the Common Terminology Criteria for Adverse Events Version 5.0 - vaginal stricture.

The female sexual function index (FSFI) is a measure of sexual functioning in women. Scores range from 2 to 36 with higher scores indicating greater functioning. The baseline FSFI score is subtracted from the 12-month follow-up FSFI score for each participant.

Discomfort with pelvic exams is measured using a visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

Discomfort with use of the dilator is measured using a visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

Spots Global Cancer Trial Database for silicone dilator