Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sexual Dysfunction

Intervention / Treatment
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* Device: Erbium laser
* Device: Sham Laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erbium laser treatment<br>Women with vaginal looseness and sexual dysfunction treated with real laser. | Device: Erbium laser<br>* Erbium laser device<br>|
| Sham Comparator: Sham laser treatment<br>Women with vaginal looseness and sexual dysfunction treated with sham laser. | Device: Sham Laser<br>* Sham laser device<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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. | 
| 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. | 
| Monthly sexual intercourse rate | Average monthly sexual intercourse rates. | From recruitment up to 15 months. |