Clinical trial NCT05251220: Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women
Official title: Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genitourinary Syndrome of Menopause
Pelvic Floor Dysfunction
Vulvar Lichen Sclerosus
Keywords: neodymium laser, GUMS, lichen sclerosus
Lead sponsor: 1st Federal Budgetary Healthcare Institution Volga District Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-02-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 29
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with diseases of the urogenital tract were enrolled into the study;women with symptoms of genitourinary menopausal syndrome, vulvar lichen sclerosus and pelvic floor muscle reduction

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion criteria:

* pregnancy
* oncological diseases

Primary outcomes:
measure: Change in vaginal dryness from baseline
timeFrame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
measure: Change in frequency of involuntary urination (urinary incontinence) from baseline
timeFrame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
measure: Change in frequency of involuntary urination during physical activities (stress urinary incontinence).
timeFrame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
Secondary outcomes:
measure: Change in burning pain in the vagina from baseline
timeFrame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
Other outcomes:
measure: Change in dyspareunia (discomfort during sexual intercourse) from baseline
timeFrame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
measure: Change in frequency of sexual activity sensations during sexual intercourse (sensitivity and arousal) from baseline
timeFrame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
measure: Change in satisfaction with sex life from baseline
timeFrame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
measure: Change in frequency of orgasms during sexual intercourse from baseline
timeFrame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
measure: Change in general health condition from baseline
timeFrame: Questioning was conducted at the following time points: before laser treatment, one month after each laser treatment session, and 6 months after the last procedure.
Locations:
city: Nizhny Novgorod
country: Russian Federation
facility: Federal Budgetary Healthcare Institution "Volga District Medical Center" of the Federal Medical and Biological Agency
state: Russia,Nighegorodskaya Oblast'
Study officials:
References: