Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation

Rambam Health Care Campus

Status: Completed

Conditions: Radiation Injuries

Treatments: Diagnostic Test: Vaginal Tactile Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT03667859

0398-18-RMB

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

25 participants in 2 patient groups

Women undergoing Brachytherapy

Description:

Women with either uterine or cervical malignancy treated primarily by brachytherapy.

Treatment:

Diagnostic Test: Vaginal Tactile Imaging

Women undergoing Pelvic Radiation

Description:

Women with either uterine or cervical malignancy treated primarily by pelvic radiation.

Treatment:

Diagnostic Test: Vaginal Tactile Imaging