Skip to main content
OpenTrials
Completed

NCT Number: NCT03630406

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laser Burn

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Rambam health care campus

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any woman undergoing vaginal Carbon Dioxide laser treatment.

Exclusion criteria

  • Women that are not in the age range.

Treatment and study plan

Vaginal Tactile Imaging

Diagnostic Test

Vaginal Tactile Imaging

Primary outcomes

  1. Vaginal elasticity assessment

    Time frame: up to 3 months from enrollment

    Vaginal elasticity as measured by the vaginal tactile imager

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.