Erbium Laser for Treatment of Vaginal Laxity.

Overview

Patients with a primary complaint of vaginal laxity visiting a sexual dysfunction clinic at a tertiary medical center will undergo a series of 3 laser treatments and the affect of these treatments will be measure both by female sexual function index validated questionaires and by means of gynecological examination-the vaginal health index.

Full Title of Study: “The Affect of Erbium Laser Treatments on Vaginal Laxity in Female Pre-menopausal Female Individuals.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2021

Detailed Description

Patients suffering from vaginal laxity as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.

Patients will undergo a series of 3 laser treatments and the affect of these treatments will be measure both by female sexual function index validated questionaires and by means of gynecological examination-the vaginal health index.

Follow up after treatment cessation will be for 12 months post-treatment.

Interventions

  • Device: Erbium laser
    • Erbium laser device

Arms, Groups and Cohorts

  • Experimental: Erbium laser treatment
    • Women suffering from vaginal laxity undergoing laser treatments.

Clinical Trial Outcome Measures

Primary Measures

  • Female sexual function index.
    • Time Frame: From recruitment up to 15 months.
    • Changes in the female sexual function index scores pre- and post-treatment
  • Vaginal health index.
    • Time Frame: From recruitment up to 15 months.
    • Changes in the vaginal health index scores pre- and post-treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Premenopausal women.
  • Women with vaginal laxity as a primary complaint.

Exclusion Criteria

  • Vaginal bleeding of unknown source.
  • Repeated vaginal infections.
  • Known or suspected cervical pre-malignant neoplasia.

Gender Eligibility: Female

Female

Minimum Age: 30 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: ROY LAUTERBACH MD, Principal investigator – Rambam Health Care Campus
  • Overall Official(s)
    • Roy Lauterbach, MD, Principal Investigator, Rambam healthcare campus
  • Overall Contact(s)
    • Roy Lauterbach, MD, +972-52-9432416, r_lauterbach@rambam.health.gov.il

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