"Clinical Trial of Magic Gyno Laser Device"

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

August 5, 2022

Primary Completion Date

January 22, 2024

Study Completion Date

January 22, 2024

Conditions
Female Urogenital DiseasesUrinary IncontinenceProlapse GenitalMenopausal SyndromePostmenopausal PeriodVaginal AtrophyVaginal ProlapsePostpartum PeriodSexual DysfunctionPreoperative CarePostoperative Care
Interventions
DEVICE

Laser treatment

"Laser radiation is emitted by a series of pulses following each other through a pause. The duration of one pulse is 20-200 ns, the pause between pulses is 30 us. The energy of one pulse is about 1 mJ.~General laser radiation parameters for 1st and 2nd stages are: beam with diameter of 4 millimeters (mm) scans treatment area by 4 circles with step of 2 mm (50 percentage (%) overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm, from 1 to 5 repetitions of total vagina treatment. General laser radiation parameters for 3d stage are: beam diameter of 6 mm, average power of 15-30 W, duration of ns-pulses packet of 50-100 milliseconds (ms), pause between packets of 50-100 ms, treatment duration up to 65 s, treatment in permanent motion with speed of 10-50 mm/s.~The procedure is performed without anesthesia. The doctor always focuses on the participant's feeling of warmth."

DIAGNOSTIC_TEST

Blood test

Taking blood from a vein for Wassermann reaction (WR), human immunodeficiency viruses (HIV), hepatitis B infection (HBsAg), hepatitis C infection (HCVAg) determination, glucose test (to include the participant in the study) and clinical blood analysis (to include the participant in the study and evaluate procedure efficiency)

DIAGNOSTIC_TEST

Clinical urine test

Urine sampling for Clinical urine test (to include the participant in the study).

DIAGNOSTIC_TEST

Vaginal smear

Vaginal smear for flora investigation (to include the participant in the study and evaluate procedure efficiency)

DIAGNOSTIC_TEST

Pelvic ultrasound

Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).

OTHER

Female Sexual Function Index

Female Sexual Function Index will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

OTHER

International Consultation on Incontinence Questionnaire - Short Form

International Consultation on Incontinence Questionnaire will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).

OTHER

The Short Form Health Survey

The Short Form Health Survey will be used to collect feedback on changes in the participants' life quality (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Vaginal Health Index

Vaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. Potential of hydrogen (pH) will be investigated by test-lines paper (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Vital signs determination

Vital signs determination (respiration rate, blood pressure, pulse rate, body temperature).

DIAGNOSTIC_TEST

pH of vagina determination

Potential of hydrogen (pH) of vagina will be investigated by test-lines paper (to evaluate procedure efficiency).

DIAGNOSTIC_TEST

Physical parameters determination

Physical parameters determination (body weight, age, height, body mass index).

Trial Locations (1)

170036

Tver State Medical Academy, Tver'

All Listed Sponsors
lead

MeLSyTech, Ltd

INDUSTRY