← Back to Search

Enhanced Vaginal Dilator for Vaginal Stenosis

N/A
Recruiting
Led By Margaret R Liotta, DO
Research Sponsored by Margaret Liotta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of endometrial or cervical cancer
Undergoing external beam radiation therapy with or without brachytherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial tests a new vaginal dilator model to reduce radiation-induced vaginal narrowing in cancer patients post-radiation therapy. It will compare it to a traditional model to see if it improves adherence and efficacy.

Who is the study for?
This trial is for English-speaking individuals diagnosed with endometrial or cervical cancer who are undergoing external beam radiation therapy, with or without brachytherapy. It's not suitable for those with a history or current presence of fistula.Check my eligibility
What is being tested?
The study tests an enhanced vaginal dilator against the standard model used in care. The new dilator includes a silicone band to help patients insert it correctly and potentially improve adherence and effectiveness.See study design
What are the potential side effects?
While specific side effects aren't mentioned, using any vaginal dilator may cause discomfort, slight bleeding, or infection if not used hygienically.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with endometrial or cervical cancer.
Select...
I am receiving external beam radiation, with or without seed implant therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participant Adherence
Secondary outcome measures
Change in female sexual function
Discomfort with dilator use
Discomfort with pelvic exams
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Silicone DilatorExperimental Treatment1 Intervention
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
Group II: Standard DilatorActive Control1 Intervention
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

Find a Location

Who is running the clinical trial?

Margaret LiottaLead Sponsor
Margaret R Liotta, DOPrincipal InvestigatorLoyola University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
Margaret Liotta 2018. "An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03876860.
~18 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top