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

NCT05251220 | Completed

• 1 other identifier: 29.10№14
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Syndrome of Menopause; Pelvic Floor Dysfunction; Vulvar Lichen Sclerosus

Keywords

neodymium laser, GUMS, lichen sclerosus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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.

Other Outcomes (5)

• 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.

• 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.

• 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.

Study Arms (4)

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

Eligibility Criteria

• Age: 29 Years - 72 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• pregnancy
• oncological diseases

Sponsors & Collaborators

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

Study Sites (1)

Federal Budgetary Healthcare Institution "Volga District Medical Center" of the Federal Medical and Biological Agency

Nizhny Novgorod, Russia,Nighegorodskaya Oblast', Russia

Location

MeSH Terms

Conditions

Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Outpatient Department of the Volga District Medical Center of the FMBA of Russia, Principal Investigator

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: February 22, 2022
• Study Start: January 1, 2018
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data can be viewed from the moment of registration of the clinical trial until December 2022.
• Access Criteria: We provide access to data on request via email

Locations

RU (1)