The Effect of Additional Laser Treatments.

Lax Vaginal Introitus Clinical Trial

Official title:

The Efficacy and Safety of an Additional Vaginal Laser Treatment in Women Previously Treated With Laser for Gynecological Indications.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04111952
• Other study ID #: 0349-19-RMB
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: January 28, 2023

Study information

• Verified date: April 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.

Description:

The following study is intended to evaluate the efficacy and safety of an additional laser treatment for women previously treated for gynecological indications with laser treatments. Women will be randomized to one of 2 groups: 1. Study group-additional single laser treatment. 2. Control group-single sham laser treatment. All women will fill out validated questionnaires regarding sexual function, urinary stress incontinence and satisfaction after treatment. All women will be followed for an additional 6 months to evaluate the length of effect.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 253
• Est. completion date: January 28, 2023
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Previously treated with 3 laser treatments.

• Clear PAP test from the last 3 years.

Exclusion Criteria:

• Vaginal bleeding of unknown source.

• Vaginal surgery in the past 9 months.

Related Conditions & MeSH terms

• Lax Vaginal Introitus

Intervention

Device:
• CO2 laser
A single session of CO2 vaginal laser treatment
• Sham laser
A single session of sham laser treatment.

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	Length of effect	The duration of symptom improvement.	From the treatment session up to 6 months post-treatment
Secondary	Female sexual function index	Changes in the female sexual function index questionnaire score (range 0-35)	From the treatment session up to 6 months post-treatment
Secondary	Sexual intercourse	Improvement in the monthly rate of sexual intercourse	From the treatment session up to 6 months post-treatment
Secondary	Urinary distress index	Changes in the urinary distress index questionnaire score (range 0-15)	From the treatment session up to 6 months post-treatment