Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

Overview

Patients with a primary complaint of vaginal looseness and sexual dysfunction, 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 Looseness and Sexual Dysfunction in 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: January 1, 2022

Detailed Description

Patients suffering from vaginal looseness and sexual dysfunction, 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 looseness and sexual dysfunction treated with real laser.
  • Sham Comparator: Sham laser treatment
    • Women with vaginal looseness and sexual dysfunction treated with sham laser.

Clinical Trial Outcome Measures

Primary Measures

  • Female sexual function index.
    • Time Frame: From recruitment up to 15 months.
    • 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.

Secondary Measures

  • Vaginal health index
    • Time Frame: From recruitment up to 15 months.
    • Vaginal health index score. The total VHI scores range between 5 and 25. A higher score indicates increased vaginal health.
  • 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.
  • Monthly sexual intercourse rate
    • Time Frame: From recruitment up to 15 months.
    • Average monthly sexual intercourse rates.

Participating in This Clinical Trial

Inclusion Criteria

  • Premenopausal women. – Women with vaginal looseness and sexual dysfunction as a primary complaint. Exclusion Criteria:

  • Vaginal bleeding of unknown source. – Repeated vaginal infections. – Known or suspected cervical pre-malignant neoplasia. – Previous treatment with vaginal laser or other forms of energy-based treatment modalities. – Pregnancy. – Current pelvic inflammatory disease or urinary tract infection. – Vaginal surgery during the year preceding study participation. – Treatment with systemic or vaginal hormone replacement therapy. – Current pelvic floor physiotherapy.

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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.