Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228679
• Other study ID #: 0309-19-RMB
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2023
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 31, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sexual Dysfunction

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	Monthly sexual intercourse rate	Average monthly sexual intercourse rates.	From recruitment up to 15 months.