Studies
| Study First Submitted Date | 2022-10-04 |
| Study First Posted Date | 2022-10-07 |
| Last Update Posted Date | 2023-03-09 |
| Start Month Year | November 1, 2023 |
| Primary Completion Month Year | November 1, 2023 |
| Verification Month Year | October 2022 |
| Verification Date | 2022-10-31 |
| Last Update Posted Date | 2023-03-09 |
Detailed Descriptions
| Sequence: | 20771449 |
| Description | PRIMARY OBJECTIVE: To determine the safety and feasibility of using platelet-rich plasma (PRP) treatment in menopausal patients with genitourinary syndrome SECONDARY OBJECTIVE: To determine the preliminary efficacy in the treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms VSQ, Vaginal health index, Vaginal maturation index, and Day-to-Day Impact of Vaginal Aging score will be used for assessments. OUTLINE: Patients receive platelet-rich plasma via injection into the vaginal area after obtaining plasma into PRP tubes After 3 sessions of PRP treatment, patients are followed up for 6 months. |
Facilities
| Sequence: | 200522398 |
| Status | Recruiting |
| Name | Kanuni Sultan Suleyman Training and Research Hospital |
| City | İstanbul |
| Zip | 34307 |
| Country | Turkey |
Facility Contacts
| Sequence: | 28167158 |
| Facility Id | 200522398 |
| Contact Type | primary |
| Name | Ozan Karadeniz |
| dr.ozankrdnz@gmail.com | |
| Phone | +905333663003 |
Browse Interventions
| Sequence: | 96254042 | Sequence: | 96254043 | Sequence: | 96254044 | Sequence: | 96254045 | Sequence: | 96254046 | Sequence: | 96254047 |
| Mesh Term | Hyaluronic Acid | Mesh Term | Adjuvants, Immunologic | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs | Mesh Term | Viscosupplements | Mesh Term | Protective Agents |
| Downcase Mesh Term | hyaluronic acid | Downcase Mesh Term | adjuvants, immunologic | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | viscosupplements | Downcase Mesh Term | protective agents |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52298903 |
| Name | Genitourinary Syndrome of Menopause |
| Downcase Name | genitourinary syndrome of menopause |
Id Information
| Sequence: | 40250523 |
| Id Source | org_study_id |
| Id Value | KanuniSSEAH3 |
Countries
| Sequence: | 42669195 |
| Name | Turkey |
| Removed | False |
Design Groups
| Sequence: | 55735891 | Sequence: | 55735892 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | Menopause patients having genitourinary syndrome (PRP) | Title | vaginal hyluronic acid supplement for GSM |
| Description | Preparation of PRP sample from the patient's own blood and then the volume immediately above the erythrocyte layer was collected. Calcium gluconate in conc. 1:9 will be used as an activator. After activation, in a period of less than 2 min, approximately 4 ml of the PRP will be injected into the vaginal wall. ( at 3,6 and 9 o clock)It will be repeated once a month for 3 times. | Description | Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months. |
Interventions
| Sequence: | 52610796 | Sequence: | 52610797 |
| Intervention Type | Biological | Intervention Type | Drug |
| Name | Platelet Rich Plasma treatment | Name | Vaginal Hyaluronic Acid supplement |
| Description | Patients receive platelet-rich plasma via injection into the vaginal area. | Description | Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months. |
Keywords
| Sequence: | 80048167 | Sequence: | 80048168 | Sequence: | 80048169 | Sequence: | 80048170 |
| Name | genitourinary syndrome | Name | menopause | Name | platelet rich plasma | Name | vaginal atrophy |
| Downcase Name | genitourinary syndrome | Downcase Name | menopause | Downcase Name | platelet rich plasma | Downcase Name | vaginal atrophy |
Design Outcomes
| Sequence: | 177848457 | Sequence: | 177848458 | Sequence: | 177848459 | Sequence: | 177848460 | Sequence: | 177848461 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Vaginal health index score (VHIS) | Measure | The Vulvovaginal Symptom Questionnaire (VSQ) | Measure | Day-to-Day Impact of Vaginal Aging Questionnaire | Measure | vaginal maturation index | Measure | vaginal health index |
| Time Frame | [ Time Frame: 6 months after intervention ] | Time Frame | [ Time Frame: 6 months after intervention ] | Time Frame | [ Time Frame: 6 months after intervention ] | Time Frame | [ Time Frame: 6 months after intervention ] | Time Frame | [ Time Frame: 6 months after intervention ] |
| Description | evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration | Description | symptoms, emotions, life-impact, and sexual impact of vulvovaginal symptoms. | Description | Measure of the Impact of Vaginal Symptoms on Functioning and Well-being in Postmenopausal Women | Description | objective, qualitative assessment of vaginal response to hormones as well as overall hormonal environment. | Description | clinical tool that, by evaluating 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration) |
Browse Conditions
| Sequence: | 193975115 | Sequence: | 193975116 | Sequence: | 193975117 |
| Mesh Term | Syndrome | Mesh Term | Disease | Mesh Term | Pathologic Processes |
| Downcase Mesh Term | syndrome | Downcase Mesh Term | disease | Downcase Mesh Term | pathologic processes |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48439133 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Kanuni Sultan Suleyman Training and Research Hospital |
Central Contacts
| Sequence: | 12039851 |
| Contact Type | primary |
| Name | Ozan Karadeniz, MD |
| Phone | +905333663003 |
| dr.ozankrdnz@gmail.com | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68321358 | Sequence: | 68321359 |
| Design Group Id | 55735891 | Design Group Id | 55735892 |
| Intervention Id | 52610796 | Intervention Id | 52610797 |
Eligibilities
| Sequence: | 30839626 |
| Gender | Female |
| Minimum Age | 45 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria: Women with menopause Patients with symptoms of genitourinary syndrome of menopause Exclusion Criteria: Genitourinary bleeding or infection without a definitive diagnosis Coagulopathy Allergy to medication or therapy related to the treatment Chronic disease that might influence the outcome Using medication that might influence the outcome in 30 days Using hormone or steroid within 8 weeks Personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus, vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent urinary tract infection, genital infection, history of vaginal or pelvic radiation Chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity Pelvic organ prolapse greater than stage II Pelvic surgery within 6 months Known allergy to lidocaine or prilocaine Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of therapy Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254169467 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 45 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 5 |
Designs
| Sequence: | 30585516 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Single |
| Subject Masked | True |
Responsible Parties
| Sequence: | 28951933 |
| Responsible Party Type | Principal Investigator |
| Name | Ozan Karadeniz |
| Title | Principal investigator |
| Affiliation | Kanuni Sultan Suleyman Training and Research Hospital |