Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

The Affect of Erbium Laser Treatments on Vaginal Looseness and Sexual Dysfunction in Pre-menopausal Female Individuals.

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction
• Intervention / Treatment: Device: Erbium laser; Device: Sham Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erbium laser treatment; Women with vaginal looseness and sexual dysfunction treated with real laser.	Device: Erbium laser; Erbium laser device
Sham Comparator: Sham laser treatment; Women with vaginal looseness and sexual dysfunction treated with sham laser.	Device: Sham Laser; Sham laser device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female sexual function index.	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.	From recruitment up to 15 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor disability index.	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.	From recruitment up to 15 months.
Vaginal laxity questionnaire.	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.	From recruitment up to 15 months.
Vaginal health index	Vaginal health index score. The total VHI scores range between 5 and 25. A higher score indicates increased vaginal health.	From recruitment up to 15 months.
Monthly sexual intercourse rate	Average monthly sexual intercourse rates.	From recruitment up to 15 months.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: January 12, 2020
• First Submitted That Met QC Criteria: January 12, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0309-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No