The Effect of Additional Laser Treatments.

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lax Vaginal Introitus
• Intervention / Treatment: Device: CO2 laser; Device: Sham laser

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Additional laser treatment; Women receiving a single laser treatment.	Device: CO2 laser; A single session of CO2 vaginal laser treatment
Sham Comparator: Sham laser treatment; Women receiving sham laser treatment.	Device: Sham laser; A single session of sham laser treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of effect	The duration of symptom improvement.	From the treatment session up to 6 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Sexual intercourse	Improvement in the monthly rate of sexual intercourse	From the treatment session up to 6 months post-treatment
Urinary distress index	Changes in the urinary distress index questionnaire score (range 0-15)	From the treatment session up to 6 months post-treatment

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): November 1, 2021
• Study Completion (Anticipated): January 28, 2023

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 0349-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No