Recruiting

Vaginal Dilator

Sponsor:

Margaret Liotta

Code:

NCT03876860

Conditions

Endometrial Cancer

Cervical Cancer

Vaginal Stricture

Radiation Toxicity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Silicone Dilator

Standard Dilator

Study Details

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.

Conditions

Endometrial Cancer

Cervical Cancer

Vaginal Stricture

Radiation Toxicity

Study ID

NCT03876860

Start date

Sep 24, 2018

Status verified date

Oct, 2023

Completion date

Apr 1, 2024

Anticipated

Primary completion date

Apr 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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

Interventions

Silicone Dilator

Addition of silicone band to standard vaginal dilator

Standard Dilator

Standard vaginal dilator

Primary outcome measure

  • Participant Adherence [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Danielle M Krause, MD

7082164033dkrause@lumc.edu

Margaret R Liotta, DO

7083272104mliotta@lumc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Margaret Liotta, DO

7083272104mliotta@lumc.edu

Principal Investigator:

Margaret Liotta, DO

More Information

Sponsor

Margaret Liotta

Last update posted

Oct 5, 2023

Last verified

Oct, 2023

Keywords

  • Vaginal dilator
  • Vaginal stenosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Margaret Liotta on 2023-10-05.