Urinary Incontinence Clinical Trial
Official title:
Clinical Trial of the Safety and Efficacy of Medical Device "Laser Medical Device "Magic Gyno""
Verified date | March 2024 |
Source | MeLSyTech, Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | January 22, 2024 |
Est. primary completion date | January 22, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Tver State Medical Academy | Tver | Tver Oblast |
Lead Sponsor | Collaborator |
---|---|
MeLSyTech, Ltd |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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; S?ant, 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 | Mean Change from Baseline of "Desire" Score on the Female Sexual Function Index Questionnaire | Participants answer questions:
Q1. Over the past 4 weeks, how often did you feel sexual desire or interest? Answers = Points: almost always or always (5), most times (more than half the time) (4), sometimes (about half the time) (3), a few times (less than half the time) (2), almost never or never (1). Q2. Over the past 4 weeks, how would you rate your level (degree) of sexual desire or interest? Answers = Points: very high (5), high (4), moderate (3), low (2), very low or none at all (1) Score = (Score to Q1 + Score to Q2)x0.6 |
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 | Mean Change from Baseline of "Arousal" Score on the Female Sexual Function Index Questionnaire | Participants answer questions: Q3. Over the past 4 weeks, how often did you feel sexually aroused during sexual activity or intercourse? Q6. Over the past 4 weeks, how often have you been satisfied with your arousal (excitement) during sexual activity or intercourse? Answers = Points (Q3 and Q6): no sexual activity (0), almost always or always (5), most times (4), sometimes (3), a few times (2), almost never or never (1) Q4. Over the past 4 weeks, how would you rate your level of sexual arousal during sexual activity or intercourse? Answers = Points: no sexual activity (0), very high (5), high (4), moderate (3), low (2), very low or none at all (1) Q5. Over the past 4 weeks, how confident were you about becoming sexually aroused during sexual activity or intercourse? Answers=Points: no sexual activity (0), very high confidence (5), high confidence (4), moderate confidence (3), low confidence (2), very low or no confidence (1) Score=(Score to Q3+Score to Q4+Score to Q5+Score to Q6)x0.3 | 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 | Mean Change from Baseline of "Lubrication" Score on the Female Sexual Function Index Questionnaire | Participants answer questions:Q7. Over the past 4 weeks, how often did you become lubricated ("wet") during sexual activity or intercourse?Q9. Over the past 4 weeks, how often did you maintain your lubrication ("wetness") until completion of sexual activity or intercourse?Answers = Points: no sexual activity (0), almost always or always (5), most times (more than half the time) (4), sometimes (about half the time) (3), a few times (less than half the time) (2), almost never or never (1). Q8. Over the past 4 weeks, how difficult was it to become lubricated ("wet") during sexual activity or intercourse? Q10. Over the past 4 weeks, how difficult was it to maintain your lubrication ("wetness") until completion of sexual activity or intercourse? Answers = Points: no sexual activity (0), extremely difficult or impossible (1), very difficult (2), difficult (3), slightly difficult (4), not difficult (5). Score = (Score to Q7 + Score to Q8 + Score to Q9 + Score to Q10)x0.3 | 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 | Mean Change from Baseline of "Orgasm" Score on the Female Sexual Function Index Questionnaire | Participants answer questions:
Q11. Over the past 4 weeks, when you had sexual stimulation or intercourse, how often did you reach orgasm (climax)? Answers = Points: no sexual activity (0), almost always or always (5), most times (4), sometimes (3), a few times (2), almost never or never (1). Q12. Over the past 4 weeks, when you had sexual stimulation or intercourse, how difficult was it for you to reach orgasm (climax)? Answers = Points: no sexual activity (0), extremely difficult or impossible (1), very difficult (2), difficult (3), slightly difficult (4), not difficult (5). Q13. Over the past 4 weeks, how satisfied were you with your ability to reach orgasm (climax) during sexual activity or intercourse? Answers = Points: no sexual activity (0), very satisfied (5), moderately satisfied (4), about equally satisfied and dissatisfied (3), moderately dissatisfied (2), very dissatisfied (1). Score = (Score to Q11 + Score to Q12 + Score to Q13)x0.4 |
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 | Mean Change from Baseline of "Satisfaction" Score on the Female Sexual Function Index Questionnaire | Participants answer questions:
Q14. Over the past 4 weeks, how satisfied have you been with the amount of emotional closeness during sexual activity between you and your partner? Answers = Points: no sexual activity (0), very satisfied (5), moderately satisfied (4), about equally satisfied and dissatisfied (3), moderately dissatisfied (2), very dissatisfied (1). Q15. Over the past 4 weeks, how satisfied have you been with your sexual relationship with your partner? Answers = Points: no sexual activity (0), very satisfied (5), moderately satisfied (4), about equally satisfied and dissatisfied (3), moderately dissatisfied (2), very dissatisfied (1). Q16. Over the past 4 weeks, how satisfied have you been with your overall sexual life? Answers = Points: no sexual activity (0), very satisfied (5), moderately satisfied (4), about equally satisfied and dissatisfied (3), moderately dissatisfied (2), very dissatisfied (1). Score = (Score to Q14 + Score to Q15 + Score to Q16)x0.4 |
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 | Mean Change from Baseline of "Pain" Score on the Female Sexual Function Index Questionnaire | Participants answer questions:
Q17. Over the past 4 weeks, how often did you experience discomfort or pain during vaginal penetration? Answers = Points: did not attempt intercourse (0), almost always or always (1), most times (2), sometimes (3), a few times (4), almost never or never (5). Q18. Over the past 4 weeks, how often did you experience discomfort or pain following vaginal penetration? Answers = Points: did not attempt intercourse (0), almost always or always (1), most times (2), sometimes (3), a few times (4), almost never or never (5). Q19. Over the past 4 weeks, how would you rate your level (degree) of discomfort or pain during or following vaginal penetration? Answers = Points: did not attempt intercourse (0)very high (1)high (2)moderate (3)low (4)very low or none at all (5). Score = (Score to Q17 + Score to Q18 + Score to Q19)x0.4 |
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 | Mean Change from Baseline of Total Score on International Consultation on Incontinence Questionnaire - Short Form | Participants answer questions:
Q1 How often do you leak urine? Answers = Points: never (0), about once a week or less often (1), two or three times a week (2), about once a day (3), several times a day (4), all the time (5). Q2 How much urine do you usually leak? Answers = Points: none (0), a small amount (2), a moderate amount (4), a large amount (6) Q3 How much does leaking urine interfere with your everyday life? Answers = Visual Analogue Scale, where Not at all (0), A great deal (10). Total Score = Scores(Q1+Q2+Q3) |
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 | Mean Change from Baseline of "Physical Health Component Score" on The Short Form Health Survey | Participants fill out a survey form (SF-36 Health Survey Standard Scoring). Calculations of final scores (PCS and MCS) will be carried out using Mean and SD from US adult population (PCS-US and MCS-US respectively). | 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 | Mean Change from Baseline of "Mental Health Component Score" on The Short Form Health Survey | Participants fill out a survey form (SF-36 Health Survey Standard Scoring). Calculations of final scores (PCS and MCS) will be carried out using Mean and SD form US adult population (PCS-US and MCS-US respectively). | 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 | Mean Change from Baseline of pH of vagina | Potential of hydrogen (pH) will be investigated by test-lines paper. | 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 | Mean Change from Baseline of Lactobacilli quantity | Smear will be sampled from the posterior wall of vagina and stained according to Gram. Evaluation of the Lactobacilli quantity will be performed for each participant with light microscope in field of view. Score depends on the number of bacteria: low - 1, average - 2, normal - 3. | 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) |
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