Enhanced vaginal dilator for reducing radiation-induced vaginal stenosis
An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial
This study is testing a new vaginal dilator designed to help women with endometrial or cervical cancer who have had radiation therapy avoid problems with vaginal tightness and discomfort.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Loyola University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Maywood, Illinois) |
| Trial ID | NCT03876860 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates an enhanced vaginal dilator designed to reduce radiation-induced vaginal stenosis in women with endometrial or cervical cancer who have undergone post-operative external beam radiation therapy with or without brachytherapy. Participants will be randomly assigned to use either the enhanced dilator, which includes a silicone band for improved insertion depth, or the standard dilator model. The study aims to assess patient adherence to dilator use, vaginal length, and overall comfort during pelvic exams. By comparing the two models, the trial seeks to determine if the enhanced dilator improves outcomes related to vaginal health and sexual function.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with endometrial or cervical cancer who are undergoing radiation therapy.
Not a fit: Patients with a history or current presence of fistula will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients by reducing complications associated with radiation therapy.
How similar studies have performed: While there is limited literature on enhancing vaginal dilator adherence, similar approaches in improving patient compliance with medical devices have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Maywood, Illinois
- Loyola University Medical Center — Maywood, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Margaret R Liotta, DO — Loyola University
- Study coordinator: Danielle M Krause, MD
- Email: dkrause@lumc.edu
- Phone: 7082164033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.