NCT04228679

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 30 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sexual Dysfunction

Interventions

Type	Name	Description
DEVICE	Erbium laser	Erbium laser device
DEVICE	Sham Laser	Sham laser device

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-01-01
• Completion: 2022-03-31
• First posted: 2020-01-14
• Last updated: 2023-01-17

Locations

1 site across 1 country: Israel