An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

Description

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.

Conditions

Endometrial Cancer, Cervical Cancer, Vaginal Stricture, Radiation Toxicity

Study Overview

Study Details

Study overview

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.

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

An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Maywood

Loyola University Medical Center, Maywood, Illinois, United States, 60153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of endometrial or cervical cancer
  • * Undergoing external beam radiation therapy with or without brachytherapy
  • * English-speaking
  • * History or current presence of fistula

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Margaret Liotta,

Margaret R Liotta, DO, PRINCIPAL_INVESTIGATOR, Loyola University

Study Record Dates

2024-04-01