Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.
- Conditions
- Laser Burn
- Interventions
- Diagnostic Test: Vaginal Tactile Imaging
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
- Any woman undergoing vaginal Carbon Dioxide laser treatment.
- Women that are not in the age range.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Laser treatment Vaginal Tactile Imaging Female patients with either SUI of vaginal wall weakness and prolapse refered for an attempt at laser treatment.
- Primary Outcome Measures
Name Time Method Vaginal elasticity assessment up to 3 months from enrollment Vaginal elasticity as measured by the vaginal tactile imager
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rambam health care campus
🇮🇱Haifa, Israel