The Effect of Additional Laser Treatments.

Rambam Health Care Campus

Status: Unknown

Conditions: Lax Vaginal Introitus

Treatments: Device: CO2 laser; Device: Sham laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04111952

0349-19-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 253 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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253 participants in 2 patient groups

Additional laser treatment

Experimental group

Description:

Women receiving a single laser treatment.

Treatment:

Device: CO2 laser

Sham laser treatment

Sham Comparator group

Description:

Women receiving sham laser treatment.

Treatment:

Device: Sham laser