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 randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.

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
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • 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 randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.

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

Interventions

  • Device: Erbium laser
    • Erbium laser device
  • Device: Sham Laser
    • Sham laser device

Arms, Groups and Cohorts

  • Experimental: Erbium laser treatment
    • Women with vaginal laxity treated with real laser.
  • Sham Comparator: Sham laser treatment
    • Women with vaginal laxity treated with sham laser.

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. Minimal score is 2, maximal score is 36. Thee higher the score, the improved the sexual function is.
  • Pelvic floor disability index.
    • Time Frame: From recruitment up to 15 months.
    • Changes in the pelvic floor disability index scores pre- and post-treatment. Minimal score is 0, maximal score is 300. The higher the score, the improved the worse pelvic floor dysfunction is.
  • Vaginal laxity questionnaire.
    • Time Frame: From recruitment up to 15 months.
    • Changes in the vaginal laxity questionnaire scores pre- and post-treatment. Minimal score is 1, maximal score is 7. The lower the score, the worse vaginal laxity is.

Secondary Measures

  • Pelvic muscle strength.
    • Time Frame: From recruitment up to 15 months.
    • Changes in the pelvic muscle strength scores pre- and post-treatment. Minimal score is 0, maximal score is 15. The higher the score, the higher muscle strength is.
  • Patient global impression of improvement.
    • Time Frame: From recruitment up to 15 months.
    • Changes in the patient global impression of improvement scores pre- and post-treatment. Minimal score is 1, maximal score is 7. The higher the score, the higher the subjective improvement is.

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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