Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.

Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.as Measured by Vaginal Tactile Imaging.

Female patients with either stress urinary incontinence (SUI) or vaginal wall weakness and prolapse will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after Carbon Dioxide laser treatment.

Study Overview

• Status: Completed
• Conditions: Laser Burn
• Intervention / Treatment: Diagnostic test: Vaginal Tactile Imaging

Detailed Description

Patients will be recruited and sign a consent form. The patients included are patients with SUI or vaginal wall weakness and prolapse. Each participant undergoes 3 laser treatments 4 weeks apart.

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

• Before the first treatment session (baseline).
• Before and after each treatment session.
• 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: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female patients with either SUI or vaginal wall weakness and prolapse.

Description

Inclusion Criteria:

• Any woman undergoing vaginal Carbon Dioxide laser treatment.

Exclusion Criteria:

• Women that are not in the age range.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laser treatment; Female patients with either SUI of vaginal wall weakness and prolapse refered for an attempt at laser treatment.	Diagnostic test: Vaginal Tactile Imaging; Vaginal Tactile Imaging

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 3 months from enrollment

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Roy Lauterbach, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 14, 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

• Other Study ID Numbers: 0022-18-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