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

Completed

• Conditions: Vulvar Lichen Sclerosus; Genitourinary Syndrome of Menopause; Pelvic Floor Dysfunction

• Registration Number: NCT05251220
• Lead Sponsor: 1st Federal Budgetary Healthcare Institution Volga District Medical Center

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-24
• Study Completion: 2020-12-24
• Study First Submitted: 2021-12-12
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion criteria:

• pregnancy
• oncological diseases

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Federal Budgetary Healthcare Institution "Volga District Medical Center" of the Federal Medical and Biological Agency; 🇷🇺 Nizhny Novgorod, Russia,Nighegorodskaya Oblast', Russian Federation