Clinical Trial of "Magic Gyno" Laser Device
Female Urogenital Diseases, Urinary Incontinence, Prolapse Genital
About this trial
This is an interventional supportive care trial for Female Urogenital Diseases focused on measuring Laser, Vaginal, Neodymium Laser, Laser Treatment, Nanosecond, Female Urogenital Diseases, Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
- Women from 18 years old in conditions caused by collagen deficiency in the treated area, women in premenopause and menopause;
- Participants who signed informed consent and fully informed about the purpose of the study;
Following disorders:
- Stress urinary incontinence,
- Mixed urinary incontinence with a predominance of the stress component,
- Genitourinary menopausal syndrome,
- Dystrophic and atrophic processes in the genital area,
- Scleroatrophic changes in the urogenital region,
- Prolapse of the genitals I-II degree,
- Vaginal relaxation syndrome,
- Postpartum recovery,
- Sexual dysfunctions,
- Restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- Preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Exclusion Criteria:
- Age up to 18 years;
- Inability or unwillingness to give informed consent to participate in a trial or to fulfill the requirements of a clinical trial;
- The presence of contraindications to the use of a medical device;
- Pregnancy;
- Bleeding disorders accompanied by a violation of blood clotting;
- Use of anticoagulant medicines (post-infarction and post-stroke conditions);
- Autoimmune diseases;
- Emerging infection diseases of any etiology;
- Damage to the skin (mucous membranes) in the area of laser treatment;
- Oncological diseases, cancer alertness;
- Decompensated diabetes;
- Photosensitizing drug administration;
- Decompensated somatic diseases;
- Decompensated cardiovascular disease, and other decompensated common diseases;
- Severe somatic diseases (heart failure, chronic renal failure, hepatitis, liver cirrhosis);
- Severe autoimmune diseases (including hemorrhagic vasculitis);
- Immunodeficiency (including HIV infection and AIDS);
- Severe mental and neurological disorders;
- Bedridden and immobile patients;
- COVID 19;
- Acute inflammatory diseases of the urogenital area;
- Acute purulent processes of the urogenital region;
- Bleeding of a natural nature (menstruation) and any other types of bleeding in the urogenital area;
- Postoperative scars up to 6 months;
- Lateral cysts of the vagina;
- Growing uterine fibroid;
- Fillers / suture in the area of laser exposure;
- The presence of varicose veins of the urogenital region and dilated capillary plexuses of the mucosa.
Sites / Locations
- Tver State Medical AcademyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Genitourinary disorder
Relaxation of vagina
Participants with: stress urinary incontinence, mixed urinary incontinence with a predominance of the stress component, genitourinary menopausal syndrome, dystrophic and atrophic processes in the genital area, scleroatrophic changes in the urogenital region. Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks. During the procedure, the following sequence of actions will be performed: st Stage - vaginal processing with a conical mirror handpiece, nd Stage - vaginal processing with a corner mirror handpiece, d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
Participants with: prolapse of the genitals I-II degree, vaginal relaxation syndrome, postpartum recovery, sexual dysfunctions, restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes), preoperative preparation for genital prolapse surgery and postoperative rehabilitation. Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks. During the procedure, the following sequence of actions will be performed: st Stage - vaginal processing with a conical mirror handpiece, nd Stage - vaginal processing with a corner mirror handpiece, d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.