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

Laser Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630406
• Other study ID #: 0022-18-RMB
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Any woman undergoing vaginal Carbon Dioxide laser treatment.

Exclusion Criteria:

• Women that are not in the age range.

Related Conditions & MeSH terms

• Laser Burn

Intervention

Diagnostic Test:
• Vaginal Tactile Imaging
Vaginal Tactile Imaging

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal elasticity assessment	Vaginal elasticity as measured by the vaginal tactile imager	up to 3 months from enrollment