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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04111952

Enrollment

253

Registered

2019-10-02

Start date

2019-06-01

Completion date

2023-01-28

Last updated

2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lax Vaginal Introitus

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.

Interventions

DEVICECO2 laser

A single session of CO2 vaginal laser treatment

DEVICESham laser

A single session of sham laser treatment.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026