An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

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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 Start (Actual) 24 September 2018

🗓️ Primary Completion (Estimated) 1 April 2024

✅ Study Completion (Estimated) 1 April 2024

👥 Enrollment (Estimated) 118

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Maywood, Illinois, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 27 February 2019
First Submitted that Met QC Criteria 13 March 2019
First Posted 15 March 2019

Study Record Updates

Last Update Submitted that Met QC Criteria 3 October 2023
Last Update Posted 5 October 2023
Last Verified October 2023