Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation

Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation as Measured by Vaginal Tactile Imaging

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

Study Overview

• Status: Completed
• Conditions: Radiation Injuries
• Intervention / Treatment: Diagnostic test: Vaginal Tactile Imaging

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women undergoing Brachytherapy; Women with either uterine or cervical malignancy treated primarily by brachytherapy.	Diagnostic test: Vaginal Tactile Imaging; Vaginal elasticity measurements using the Vaginal Tactile Imaging system.
Women undergoing Pelvic Radiation; Women with either uterine or cervical malignancy treated primarily by pelvic radiation.	Diagnostic test: Vaginal Tactile Imaging; Vaginal elasticity measurements using the Vaginal Tactile Imaging system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal elasticity assessment	Vaginal elasticity as measured by the vaginal tactile imager.	up to 6 months from enrollment

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 12, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Radiation Injuries
• Other Study ID Numbers: 0398-18-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No