The Effect of Additional Laser Treatments.

NCT ID: NCT04111952

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-01-28

Brief Summary

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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

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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.

Conditions

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Lax Vaginal Introitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Additional laser treatment

Women receiving a single laser treatment.

Group Type EXPERIMENTAL

CO2 laser

Intervention Type DEVICE

A single session of CO2 vaginal laser treatment

Sham laser treatment

Women receiving sham laser treatment.

Group Type SHAM_COMPARATOR

Sham laser

Intervention Type DEVICE

A single session of sham laser treatment.

Interventions

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CO2 laser

A single session of CO2 vaginal laser treatment

Intervention Type DEVICE

Sham laser

A single session of sham laser treatment.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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ROY LAUTERBACH MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roy Lauterbach, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam health care campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0349-19-RMB

Identifier Type: -

Identifier Source: org_study_id

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