NCT03876860

An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

Official Title:

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

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

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

Disease(s) and\or Condition(s)

Endometrial Cancer

Cervical Cancer

Vaginal Stricture

Radiation Toxicity

Primary Purpose
  • PREVENTION
Intervention/Treatment
    • Type: DEVICE
    • Name: Silicone Dilator
    • Description: Addition of silicone band to standard vaginal dilator
    • Arm Group Labels: Silicone Dilator
    • Type: DEVICE
    • Name: Standard Dilator
    • Description: Standard vaginal dilator
    • Arm Group Labels: Standard Dilator
Sponsor
  • Margaret Liotta