Clinical Trial of "Magic Gyno" Laser Device

NCT05463081 | Completed

• 1 other identifier: CTMGLD-2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Gyno" in accordance with the stated purpose. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: gynecology examination, vaginal health index, clinical blood test, vaginal flora examination, vaginal pH. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Female Sexual Function Index (FSFI) and The Short Form Health Survey (SF-36) will be used to collect feedback on changes in the participants life quality. Total up to 70 participants with pathology of pelvic organs will be involved in the study. Participants will be divided into two groups: group with genitourinary symptoms and group with vaginal relaxation symptoms, by 35 participants in each. The time intervals between tests will be the same for both groups. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the condition before treatment.

Conditions

Female Urogenital Diseases; Urinary Incontinence; Prolapse Genital; Menopausal Syndrome; Postmenopausal Period; Vaginal Atrophy; Vaginal Prolapse; Postpartum Period; Sexual Dysfunction; Preoperative Care; Postoperative Care

Keywords

Laser; Vaginal; Neodymium Laser; Laser Treatment; Nanosecond; Female Urogenital Diseases; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline of Vaginal Health Index Score

  Vaginal Health Index will be investigated by clinical examination for vagina: A. Vaginal elasticity (Characteristic=Points: None=1, Poor=2, Fair=3, Good=4, Excellent=5), B. Vaginal secretions (None=1; Sсant, thin yellow=2; Superficial, thin white=3; Moderate, thin white=4; Normal (white)=5), C. Epithelial mucous membrane (Petechiae noted before contact=1, Bleeding with light contact=2, Bleeds with scraping=3, Not friable thin epithelium=4, Normal=5), D. Vaginal hydration (None, surface inflamed=1, None, surface nod inflamed=2, Minimal=3, Moderate=4, Normal=5), E. pH will be investigated by test-lines paper (≥6.1=1, 5.6-6.0=2, 5.1-5.5=3, 4.7-5.0=4, ≤4.6=5). Score=A+B+C+D+E

  1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit)

Secondary Outcomes (11)

• Mean Change from Baseline of "Desire" Score on the Female Sexual Function Index Questionnaire

  1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit)

• Mean Change from Baseline of "Arousal" Score on the Female Sexual Function Index Questionnaire

  1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit)

• Mean Change from Baseline of "Lubrication" Score on the Female Sexual Function Index Questionnaire

  1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit)

• Mean Change from Baseline of "Orgasm" Score on the Female Sexual Function Index Questionnaire

  1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit)

• Mean Change from Baseline of "Satisfaction" Score on the Female Sexual Function Index Questionnaire

  1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit)

Study Arms (2)

Genitourinary disorder

EXPERIMENTAL

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: 1. st Stage - vaginal processing with a conical mirror handpiece, 2. nd Stage - vaginal processing with a corner mirror handpiece, 3. d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.

Device: Laser treatment; Diagnostic Test: Blood test; Diagnostic Test: Clinical urine test; Diagnostic Test: Vaginal smear; Diagnostic Test: Pelvic ultrasound; Other: Female Sexual Function Index; Other: International Consultation on Incontinence Questionnaire - Short Form; Other: The Short Form Health Survey; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Vital signs determination; Diagnostic Test: pH of vagina determination; Diagnostic Test: Physical parameters determination

Relaxation of vagina

EXPERIMENTAL

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: 1. st Stage - vaginal processing with a conical mirror handpiece, 2. nd Stage - vaginal processing with a corner mirror handpiece, 3. d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.

Device: Laser treatment; Diagnostic Test: Blood test; Diagnostic Test: Clinical urine test; Diagnostic Test: Vaginal smear; Diagnostic Test: Pelvic ultrasound; Other: Female Sexual Function Index; Other: International Consultation on Incontinence Questionnaire - Short Form; Other: The Short Form Health Survey; Diagnostic Test: Vaginal Health Index; Diagnostic Test: Vital signs determination; Diagnostic Test: pH of vagina determination; Diagnostic Test: Physical parameters determination

Interventions

Laser treatment DEVICE

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.

Genitourinary disorder; Relaxation of vagina

Blood test DIAGNOSTIC_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)

Genitourinary disorder; Relaxation of vagina

Clinical urine test DIAGNOSTIC_TEST

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

Genitourinary disorder; Relaxation of vagina

Vaginal smear DIAGNOSTIC_TEST

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

Genitourinary disorder; Relaxation of vagina

Pelvic ultrasound DIAGNOSTIC_TEST

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

Genitourinary disorder; Relaxation of vagina

Female Sexual Function Index OTHER

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

Genitourinary disorder; Relaxation of vagina

International Consultation on Incontinence Questionnaire - Short Form OTHER

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

Genitourinary disorder; Relaxation of vagina

The Short Form Health Survey OTHER

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

Genitourinary disorder; Relaxation of vagina

Vaginal Health Index DIAGNOSTIC_TEST

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).

Genitourinary disorder; Relaxation of vagina

Vital signs determination DIAGNOSTIC_TEST

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

Genitourinary disorder; Relaxation of vagina

pH of vagina determination DIAGNOSTIC_TEST

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

Genitourinary disorder; Relaxation of vagina

Physical parameters determination DIAGNOSTIC_TEST

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

Genitourinary disorder; Relaxation of vagina

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• MeLSyTech, Ltd: lead

Study Sites (1)

Tver State Medical Academy

Tver', Tver Oblast, 170036, Russia

Location

MeSH Terms

Conditions

Female Urogenital Diseases; Urinary Incontinence; Uterine Prolapse; Sexual Dysfunction, Physiological; Pelvic Organ Prolapse

Interventions

Laser Therapy; Hematologic Tests; Vaginal Smears

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urination Disorders; Urologic Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Prolapse; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Biopsy; Cytodiagnosis; Cytological Techniques; Specimen Handling; Diagnostic Techniques, Obstetrical and Gynecological

Study Officials

• Vladislav V Dubenskij, Ph.D.

  Tver State Medical Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: August 5, 2022
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: IPD can be shared with researchers starting 3 months after CSR or article publication for five years.
• Access Criteria: IPD can be shared with researchers only upon an official request from researcher's affiliation institution in the letter form on organization's letterhead paper signed by an authorized person. Official request must be directed by e-mail to the contact person (Ksenia Shatilova, shatilova@melsytech.com). The letter must contain the request purpose and statement of internal IPD use as confidential information only. IPD will be shared after approval by CEO of "MeLSyTech" Ltd according to the company internal rules. A requester will be notified of the decision by official letter. Depending on the decision, a requester will receive a link to the repository, or a justified rejection.

Locations

RU (1)