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

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 Overview

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

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion criteria:

• pregnancy
• oncological diseases

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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
7 with vaginal relaxation syndrome
6 with vulvar lichen sclerosus

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: 1st Federal Budgetary Healthcare Institution Volga District Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 24, 2020
• Study Completion (Actual): December 24, 2020

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: neodymium laser, GUMS, lichen sclerosus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: 29.10№14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study Protocol,Statistical Analysis Plan (SAP).
• IPD Sharing Time Frame: The data can be viewed from the moment of registration of the clinical trial until December 2022.
• IPD Sharing Access Criteria: We provide access to data on request via email
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No