Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

Not Applicable

Completed

• Conditions: Sexual Dysfunction
• Interventions: Device: Erbium laser; Device: Sham Laser

• Registration Number: NCT04228679
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-01-12
• Study First Submitted QC: 2020-01-12
• Study First Posted: 2020-01-14
• Study Start: 2020-04-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erbium laser treatment	Erbium laser	Women with vaginal looseness and sexual dysfunction treated with real laser.
Sham laser treatment	Sham Laser	Women with vaginal looseness and sexual dysfunction treated with sham laser.

Primary Outcome Measures

Name	Time	Method
Female sexual function index.	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 Outcome Measures

Name	Time	Method
Vaginal health index	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.	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.
Monthly sexual intercourse rate	From recruitment up to 15 months.	Average monthly sexual intercourse rates.
Vaginal laxity questionnaire.	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.

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel