Brief Title
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
Official Title
An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial
Brief Summary
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.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Participant Adherence
Secondary Outcome
Vaginal Length
Condition
Endometrial Cancer
Intervention
Silicone Dilator
Study Arms / Comparison Groups
Standard Dilator
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
118
Start Date
September 24, 2018
Completion Date
April 1, 2022
Primary Completion Date
April 1, 2021
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Margaret R Liotta, DO, 7082164033, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03876860
Organization ID
211334
Responsible Party
Sponsor-Investigator
Study Sponsor
Margaret Liotta
Study Sponsor
Margaret R Liotta, DO, Principal Investigator, Loyola University
Verification Date
March 2019