NCT05002751

Quantifying Radiation Induced Vaginal Stenosis

Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements. In addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.

Detailed description

This single-arm pilot will enroll 12 subjects scheduled to receive radiotherapy or brachytherapy for gynecological cancers. The study will collect data from CT images, physical measurements, patient reported outcomes to develop a quantifiable generalizable metric for determining the severity of radiotherapy/brachytherapy induced vaginal stenosis. The data will be used to inform the development of a novel personalized device for the treatment of vaginal stenosis.

Conditions

• Vaginal Stricture
• Vaginal Stenosis

Interventions

Type	Name	Description
OTHER	UCSD Vaginal Dilator Questionnaire	14 question survey
OTHER	EORTC Sexual Health Questionnaire	22 question survey

Timeline

• Start date: 2022-10-06
• Primary completion: 2026-04-05
• Completion: 2027-02-28
• First posted: 2021-08-12
• Last updated: 2025-07-09

Locations

1 site across 1 country: United States