Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05112718
Status:
UNKNOWN
Last Update Posted:
2021-11-09
First Post:
2021-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Platelet Rich Plasma in Women With Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress urinary incontinence symptoms', 'timeFrame': '6-12 months', 'description': 'International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) Number of items: 12\n\nQuestion items:\n\nNocturia,Urgency, Bladder pain, Frequency, Hesitancy, Straining, Intermittency, Urge urinary incontinence, Frequency of urinary incontinence, Stress urinary incontinence, Unexplained urinary incontinence, Nocturnal enuresis\n\nCompletion time: 4-5 minutes\n\nScoring:\n\n0-16 filling symptoms subscale 0-12 voiding symptoms subscale 0-20 incontinence symptoms subscale 0-48 where all subscale scores are added. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient\n\nHigher scores indicate greater impact of individual symptoms for the patient.'}], 'secondaryOutcomes': [{'measure': 'Impact of urinary incontinence on the quality of life', 'timeFrame': '6-12 months', 'description': "King's Health Questionnaire (KHQ)\n\nDescription: The KHQ is an assessment of health-related quality of life related to a specific condition.\n\nFormat: 21 items about urinary tract symptoms yield scores in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy \\& severity of symptoms).\n\nScoring: Each item is rated using a 4 or 5 points likert scale. Domain scores range from 0 (best) to 100 (worst). There are 2 single-item domains (general health perceptions, and incontinence impact) and the severity of symptoms domain is scored using a scale from 0 (best) to 30 (worst)."}, {'measure': 'Assessment of urine loss (1-hr pad test)', 'timeFrame': '6-12 months', 'description': 'One-hour pad test standardized by International Continence Society (ICS):\n\n* started by putting one pre-weighted pad,\n* patient drinks 500 ml in \\<15 min- then sits or rests,\n* patient walks for 30 min,\n* patient performs the following activities: standing up from sitting, coughing vigorously, running on the spot for 1 min, bending to pick up an object from the floor, and washing hands in running water for 1min\n* the total amount of urine leaked is determined by weighing the pad.\n\nInterpretation:\n\nThe upper limit of weight increase for the 1-hr test in continent women is 1.4 grams.\n\nA weight gain of less than 1.4 g during 1-hr test could be a result of sweating or vaginal discharge.\n\nAn increase of 1-10 g is classified as representing mild incontinence, 11-50 g moderate and \\>50 g severe incontinence.'}, {'measure': 'Level of discomfort during injections (VAS score)', 'timeFrame': '6-12 months', 'description': 'The visual analog scale (VAS) is pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).'}, {'measure': 'Patient Global Impression of Improvement', 'timeFrame': '6-12 months', 'description': 'The Patient Global Impression of Improvement (PGI-I) is a validated generic tool for assessment of the over-all improvement or deterioration that the patient may experience following the treatment.\n\nThe PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.\n\nTherefore, lower values correlate with increased satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['incontinence', 'urinary incontinence', 'stress urinary incontinence', 'platelet rich plasma', 'PRP,', 'outpatient treatment', 'nonsurgical treatment'], 'conditions': ['Urinary Incontinence', 'Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '29984206', 'type': 'BACKGROUND', 'citation': 'Dawood AS, Salem HA. Current clinical applications of platelet-rich plasma in various gynecological disorders: An appraisal of theory and practice. Clin Exp Reprod Med. 2018 Jun;45(2):67-74. doi: 10.5653/cerm.2018.45.2.67. Epub 2018 Jun 29.'}, {'pmid': '29457008', 'type': 'BACKGROUND', 'citation': 'Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.'}, {'pmid': '28401541', 'type': 'BACKGROUND', 'citation': 'Schreiber Pedersen L, Lose G, Hoybye MT, Elsner S, Waldmann A, Rudnicki M. Prevalence of urinary incontinence among women and analysis of potential risk factors in Germany and Denmark. Acta Obstet Gynecol Scand. 2017 Aug;96(8):939-948. doi: 10.1111/aogs.13149. Epub 2017 May 20.'}, {'pmid': '32021973', 'type': 'BACKGROUND', 'citation': 'Behnia-Willison F, Nguyen TTT, Norbury AJ, Mohamadi B, Salvatore S, Lam A. Promising impact of platelet rich plasma and carbon dioxide laser for stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol X. 2019 Oct 22;5:100099. doi: 10.1016/j.eurox.2019.100099. eCollection 2020 Jan.'}, {'pmid': '37493287', 'type': 'DERIVED', 'citation': 'Grigoriadis T, Kalantzis C, Zacharakis D, Kathopoulis N, Prodromidou A, Xadzilia S, Athanasiou S. Platelet-Rich Plasma for the Treatment of Stress Urinary Incontinence-A Randomized Trial. Urogynecology (Phila). 2024 Jan 1;30(1):42-49. doi: 10.1097/SPV.0000000000001378. Epub 2023 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'Stress urinary incontinence (SUI) is defined as involuntary loss of urine on effort or physical exertion or on sneezing or coughing. Platelet-rich plasma (PRP) is an autologous solution of human plasma containing various growth factors witch enhance regeneration and healing process. The aim of this study is to evaluate the efficacy and safety of PRP in the treatment of the female SUI.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women with stress urinary incontinence\n\nExclusion Criteria:\n\n* pregnancy,\n* history of active malignant pathology,\n* mental disorders making them unable to give consent,\n* undiagnosed abnormal uterine bleeding,\n* genitourinary fistula,\n* anti-incontinence surgery,\n* pelvic organ prolapse stage \\> 2 according to POP-Q system'}, 'identificationModule': {'nctId': 'NCT05112718', 'briefTitle': 'Platelet Rich Plasma in Women With Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'The Use of Platelet Rich Plasma (PRP) as a Treatment of the Female Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': '420/20-09-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet Rich Plasma', 'description': 'The patients who receive PRP injections', 'interventionNames': ['Biological: Platelet Rich Plasma Injections']}, {'type': 'SHAM_COMPARATOR', 'label': 'Normal Saline', 'description': 'The patients who receive normal saline', 'interventionNames': ['Other: Normal Saline Injections']}], 'interventions': [{'name': 'Platelet Rich Plasma Injections', 'type': 'BIOLOGICAL', 'description': "PRP injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal).\n\nThe participants will receive 2 PRP injections at 4-6-week intervals. Xylocaine gel 2% is applied to the distal anterior vaginal wall 20 minutes before injections.", 'armGroupLabels': ['Platelet Rich Plasma']}, {'name': 'Normal Saline Injections', 'type': 'OTHER', 'description': "Normal saline injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal).\n\nThe participants will receive 2 injections at 4-6-week intervals.", 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Stavros Athanasiou, Prof.', 'role': 'CONTACT', 'email': 'stavros.athanasiou@gmail.com', 'phone': '+306944478555'}, {'name': 'Themos Grigoriadis, As. Prof.', 'role': 'CONTACT', 'email': 'tgregos@yahoo.com', 'phone': '+306948741306'}, {'name': 'Stavros Athanasiou, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Themos Grigoriadis, As. Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christos Kalantzis, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Urogynecological Unit of Alexandra Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Stavros Athanasiou, Professor', 'role': 'CONTACT', 'email': 'stavros.athanasiou@gmail.com', 'phone': '+306944478555'}], 'overallOfficials': [{'name': 'Stavros Athanasiou, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National and Kapodistrian University of Athens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Gynecology', 'investigatorFullName': 'Themos Grigoriadis', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}