Genitourinary Syndrome of Menopause, Pelvic Floor Dysfunction, Vulvar Lichen Sclerosus
Conditions
Keywords
neodymium laser, GUMS, lichen sclerosus
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.
Interventions
None listed
Sponsors
1st Federal Budgetary Healthcare Institution Volga District Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
29 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* diseases of the urogenital tract * symptoms of genitourinary menopausal syndrome, * vulvar lichen sclerosus * pelvic floor muscle reduction
Exclusion criteria
* pregnancy * oncological diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vaginal dryness from baseline | 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. | 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). |
| Change in frequency of involuntary urination (urinary incontinence) from baseline | 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. | 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. |
| Change in frequency of involuntary urination during physical activities (stress 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. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in burning pain in the vagina from baseline | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in dyspareunia (discomfort during sexual intercourse) from baseline | 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. | 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. |
| Change in general health condition from baseline | 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. | 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. |
| Change in frequency of sexual activity sensations during sexual intercourse (sensitivity and arousal) from baseline | 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. | 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. |
| Change in satisfaction with sex life from baseline | 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. | 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. |
| Change in frequency of orgasms during sexual intercourse from baseline | 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. | 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. |
Countries
Russia
Outcome results
None listed