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

Genitourinary Syndrome of Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251220
• Other study ID #: 29.10?14
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 24, 2020

Study information

• Verified date: February 2022
• Source: 1st Federal Budgetary Healthcare Institution Volga District Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 24, 2020
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 29 Years to 72 Years

Eligibility

Inclusion Criteria:

• diseases of the urogenital tract

• symptoms of genitourinary menopausal syndrome,

• vulvar lichen sclerosus

• pelvic floor muscle reduction

Exclusion criteria:

• pregnancy

• oncological diseases

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause
• Lichen Sclerosus et Atrophicus
• Pelvic Floor Dysfunction
• Vulvar Lichen Sclerosus

Locations

Country	Name	City	State
Russian Federation	Federal Budgetary Healthcare Institution "Volga District Medical Center" of the Federal Medical and Biological Agency	Nizhny Novgorod	Russia,Nighegorodskaya Oblast'

Sponsors (1)

Lead Sponsor	Collaborator
1st Federal Budgetary Healthcare Institution Volga District Medical Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	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	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.
Other	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.
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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	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.