NCT03876860

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Margaret Liotta · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer
• Cervical Cancer
• Vaginal Stricture
• Radiation Toxicity

Interventions

Type	Name	Description
DEVICE	Silicone Dilator	Addition of silicone band to standard vaginal dilator
DEVICE	Standard Dilator	Standard vaginal dilator

Timeline

• Start date: 2018-09-24
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2019-03-15
• Last updated: 2023-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study