NCT05251220

Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: 1st Federal Budgetary Healthcare Institution Volga District Medical Center · Other Government
• Sex: Female
• Age: 29 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar lichen sclerosus and pelvic floor muscle reduction.

Detailed description

Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar lichen sclerosus and pelvic floor muscle reduction. Materials and methods: 60 patients with diseases of the urogenital tract were enrolled into the study; they were treated with a neodymium (ND) laser: three 20-minute sessions every 28 ± 2 days. Efficacy was assessed by means of the Female Sexual Function Index (FSFI), ICIQ-SF, PISQ-12, SF36 survey forms, and a questionnaire to identify urinary disorders at the following time points: before treatment, one month after each session and 6 months after the last procedure.

Conditions

• Genitourinary Syndrome of Menopause
• Pelvic Floor Dysfunction
• Vulvar Lichen Sclerosus

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-12-24
• Completion: 2020-12-24
• First posted: 2022-02-22
• Last updated: 2022-02-22

Locations

1 site across 1 country: Russia