An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial

Who is this study for? Adult patients with Endometrial or Cervical Cancer that are undergoing external beam radiotherapy with or without brachytherapy
What treatments are being studied? Silicone Vaginal Dilator
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of endometrial or cervical cancer

• Undergoing external beam radiation therapy with or without brachytherapy

• English-speaking

Locations
United States
Illinois
Loyola University Medical Center
RECRUITING
Maywood
Contact Information
Primary
Danielle M Krause, MD
dkrause@lumc.edu
7082164033
Backup
Margaret R Liotta, DO
mliotta@lumc.edu
7083272104
Time Frame
Start Date: 2018-09-24
Estimated Completion Date: 2024-04-01
Participants
Target number of participants: 118
Treatments
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
Sponsors
Leads: Margaret Liotta

This content was sourced from clinicaltrials.gov