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An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

Sponsor
Margaret Liotta (Other)
Overall Status
Unknown status
CT.gov ID
NCT03876860
Collaborator
(none)
118
Enrollment
1
Location
2
Arms
42.2
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Silicone Dilator
  • Device: Standard Dilator
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized control trial with two arms including control arm and experimental armRandomized control trial with two arms including control arm and experimental arm
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial
Actual Study Start Date :
Sep 24, 2018
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Dilator

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

Device: Standard Dilator
Standard vaginal dilator
Experimental: Silicone Dilator

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

Device: Silicone Dilator
Addition of silicone band to standard vaginal dilator

Outcome Measures

Primary Outcome Measures

  1. Participant Adherence [12 months]

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

Secondary Outcome Measures

  1. Vaginal Length [12 months]

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

  2. Vaginal stenosis grading scale [12 months]

    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.

  3. Change in female sexual function [12 months]

    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.

  4. Discomfort with pelvic exams [12 months]

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

  5. Discomfort with dilator use [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loyola University Medical Center Maywood Illinois United States 60153

Sponsors and Collaborators

  • Margaret Liotta

Investigators

  • Principal Investigator: Margaret R Liotta, DO, Loyola University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Margaret Liotta, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier:
NCT03876860
Other Study ID Numbers:
  • 211334
First Posted:
Mar 15, 2019
Last Update Posted:
Mar 15, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Margaret Liotta, Assistant Professor, Loyola University
Vaginal dilator
Vaginal stenosis
Additional relevant MeSH terms:
Endometrial Neoplasms
Constriction, Pathologic

Study Results

No Results Posted as of Mar 15, 2019