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

1st Federal Budgetary Healthcare Institution Volga District Medical Center

Status: Completed

Conditions: Vulvar Lichen Sclerosus; Pelvic Floor Dysfunction; Genitourinary Syndrome of Menopause

Study type: Observational

Funder types: Other

Identifiers

NCT05251220

29.10№14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 29 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diseases of the urogenital tract
• symptoms of genitourinary menopausal syndrome,
• vulvar lichen sclerosus
• pelvic floor muscle reduction

Exclusion criteria

• pregnancy
• oncological diseases

Trial design

60 participants in 4 patient groups

10 women with objectively confirmed vulvovaginal atrophy

Description:

10 women with objectively confirmed vulvovaginal atrophy (genitourinary menopausal syndrome

37 women with 1-2 degree prolapse of the vaginal walls combined with stress urinary incontinence

Description:

37 women with 1-2 degree prolapse of the vaginal walls combined with stress urinary incontinence

7 with vaginal relaxation syndrome

Description:

7 with vaginal relaxation syndrome

6 with vulvar lichen sclerosus

Description:

6 with vulvar lichen sclerosus