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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 women with objectively confirmed vulvovaginal atrophy | 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 | 37 women with 1-2 degree prolapse of the vaginal walls combined with stress urinary incontinence | ||
| 7 with vaginal relaxation syndrome | 7 with vaginal relaxation syndrome | ||
| 6 with vulvar lichen sclerosus | 6 with vulvar lichen sclerosus |
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| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dyspareunia (discomfort during sexual intercourse) 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. |
Inclusion Criteria:
Exclusion criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Budgetary Healthcare Institution "Volga District Medical Center" of the Federal Medical and Biological Agency | Nizhny Novgorod | Russia,Nighegorodskaya Oblast' | Russia |
Study Protocol,Statistical Analysis Plan (SAP).
The data can be viewed from the moment of registration of the clinical trial until December 2022.
We provide access to data on request via email
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| ID | Term |
|---|---|
| D007724 | Vulvar Lichen Sclerosus |
| D018459 | Lichen Sclerosus et Atrophicus |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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. |
| 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 sexual activity sensations during sexual intercourse (sensitivity and arousal) 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. |
| Change in satisfaction with sex life 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. |
| Change in frequency of orgasms during sexual intercourse 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. |
| Change in general health condition 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) Calculations were made using the Subjective assessment questionnaire on a 10-point scale. Which included questions from each questionnaire:Female Sexual Function Index (FSFI),ICIQ-SF (International Urinary Continence Index), PISQ-12 survey form, SF36 quality of life survey form. | 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. |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |