Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.

Rambam Health Care Campus

Status

Completed

Conditions

Sexual Dysfunction

Treatments

Device: Sham Laser

Device: Erbium laser

Study type

Interventional

Funder types

Other

Identifiers

NCT04228679

0309-19-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

Female

Ages

30 to 55 years old

Volunteers

No Healthy Volunteers

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.