The Effect of Additional Laser Treatments.

Not Applicable

• Conditions: Lax Vaginal Introitus
• Interventions: Device: CO2 laser; Device: Sham laser

• Registration Number: NCT04111952
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

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 Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Primary Completion: 2021-11-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20
• Study Completion: 2023-01-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 253

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional laser treatment	CO2 laser	Women receiving a single laser treatment.
Sham laser treatment	Sham laser	Women receiving sham laser treatment.

Primary Outcome Measures

Name	Time	Method
Length of effect	From the treatment session up to 6 months post-treatment	The duration of symptom improvement.

Secondary Outcome Measures

Name	Time	Method
Female sexual function index	From the treatment session up to 6 months post-treatment	Changes in the female sexual function index questionnaire score (range 0-35)
Sexual intercourse	From the treatment session up to 6 months post-treatment	Improvement in the monthly rate of sexual intercourse
Urinary distress index	From the treatment session up to 6 months post-treatment	Changes in the urinary distress index questionnaire score (range 0-15)

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel