Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women
NCT ID: NCT05251220
Last Updated: 2022-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2018-01-01
2020-12-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
NCT04210583
Radiofrequency Female External Genital Region: a Clinical Trial
NCT02611791
Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
NCT03536585
Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
NCT03316950
The Use of Laser in the Treatment of Atrophic Vulvovaginitis
NCT04297319
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
10 women with objectively confirmed vulvovaginal atrophy
10 women with objectively confirmed vulvovaginal atrophy (genitourinary menopausal syndrome
No interventions assigned to this group
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
No interventions assigned to this group
7 with vaginal relaxation syndrome
7 with vaginal relaxation syndrome
No interventions assigned to this group
6 with vulvar lichen sclerosus
6 with vulvar lichen sclerosus
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* symptoms of genitourinary menopausal syndrome,
* vulvar lichen sclerosus
* pelvic floor muscle reduction
Exclusion Criteria
* oncological diseases
29 Years
72 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
1st Federal Budgetary Healthcare Institution Volga District Medical Center
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pauzina Olga Alexandrovna
Head of the Outpatient Department of the Volga District Medical Center of the FMBA of Russia, Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Federal Budgetary Healthcare Institution "Volga District Medical Center" of the Federal Medical and Biological Agency
Nizhny Novgorod, Russia,Nighegorodskaya Oblast', Russia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
29.10№14
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.