Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation

Completed

• Conditions: Radiation Injuries
• Interventions: Diagnostic Test: Vaginal Tactile Imaging

• 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

Arm && Interventions

Group	Intervention	Description
Women undergoing Brachytherapy	Vaginal Tactile Imaging	Women with either uterine or cervical malignancy treated primarily by brachytherapy.
Women undergoing Pelvic Radiation	Vaginal Tactile Imaging	Women with either uterine or cervical malignancy treated primarily by pelvic radiation.

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