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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Genitourinary Syndrome of Menopause, Pelvic Floor Dysfunction, Vulvar Lichen Sclerosus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diseases of the urogenital tract symptoms of genitourinary menopausal syndrome, vulvar lichen sclerosus pelvic floor muscle reduction Exclusion criteria: pregnancy oncological diseases

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 10 women with objectively confirmed vulvovaginal atrophy<br>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<br>37 women with 1-2 degree prolapse of the vaginal walls combined with stress urinary incontinence | |
| 7 with vaginal relaxation syndrome<br>7 with vaginal relaxation syndrome | |
| 6 with vulvar lichen sclerosus<br>6 with vulvar lichen sclerosus | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vaginal dryness from baseline | Efficacy was assessed by SF36 quality of life survey form means of the this is a non-specific questionnaire for assessing the patient's quality of life.When 1 point-is the highest result (best),5 points-this is the lowest result (worst). | 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. | 
| Change in frequency of involuntary urination (urinary incontinence) from baseline | The effectiveness was assessed using ICIQ-SF (International Urine Retention Index), a subjective indicator of the severity of urine loss and quality of life in patients with urinary incontinence, using the format of questions on a 5-point Likert scale to assess the presence, severity and concomitant symptoms. This is a subjective indicator designed to assess the level, impact and suspected cause of urinary incontinence on the quality of life.5 points-the highest score of the result,0 point- the lowest score of the result.The total amount of points for answering the questions where 0 points - a slight degree of urinary incontinence,19 - 21 - very severe urinary incontinence. | 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. | 
| Change in frequency of involuntary urination during physical activities (stress urinary incontinence). | Efficacy was assessed by means of the PISQ12 is a specific and reliable questionnaire consisting of three sections: behavioral and emotional characteristics, physical aspects and questions concerning the patient's relationship with a partner.Each item of the questionnaire contains five possible answers,which are evaluated in points.The result of the survey is expressed by the sum of points on all points.The maximum number of points is48,which is an indicator of the best sexual function. SF36 quality of life survey form means of the this is a non-specific questionnaire for assessing the patient's quality of life.When 1 point-is the highest result (best),5 points-this is the lowest result (worst) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in burning pain in the vagina from baseline | Efficacy was assessed by means of the Female Sexual Function Index (FSFI)- a self-controlled questionnaire survey, including 19 items,allows you to evaluate the features of desire,arousal,arousal,orgasm,achieving sexual satisfaction,and the presence of dyspareunia.With the help of this questionnaire,it is possible to conduct a differential assessment of clinical manifestations of sexual disorders.5 points-the highest score of the result,1 point- the lowest score of the result. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neodymium laser, GUMS, lichen sclerosus