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

Completed

• Conditions: Laser Burn

• Registration Number: NCT03630406
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

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 Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-14
• Study Start: 2018-10-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Any woman undergoing vaginal Carbon Dioxide laser treatment.

Exclusion Criteria

• Women that are not in the age range.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal elasticity assessment	up to 3 months from enrollment	Vaginal elasticity as measured by the vaginal tactile imager

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel