Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation

Completed

• Conditions: Radiation Injuries

• Registration Number: NCT03667859
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Female patients with either uterine/cervical malignancies will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after radiation treatment.

Detailed Description

Patients will be recruited and sign a consent form. The patients included are patients with either uterine/cervical malignancies. Each participant undergoes radiation treatment either as primary or complementary treatment.

Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:

* Before the first treatment session (baseline).

* After the last session of laser treatment.

* 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Study Start: 2018-11-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Any woman undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.

Exclusion Criteria

• Women that are not in the age range.
• Women with massive vaginal bleeding.
• Women after pelvic exenteration.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal elasticity assessment	up to 6 months from enrollment	Vaginal elasticity as measured by the vaginal tactile imager.

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel