Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 6:11 PM
Study NCT ID:
NCT05050357
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Hormonal Intrauterine Device in Treating PCS Compared to Oral Progestin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effectiveness of hormonal IUD in reducing pain in patient with pelvic congestion syndrome in comparison to oral progestin', 'timeFrame': 'two years', 'description': 'The primary outcome measure is to compare the degree of pain reduction according to pain scale ( where the maximum for the scale will be 10 and means severe pain). The minimum of the score will be one and mean very mild pain to no pain ) in pelvic congestion syndrome cases taking hormonal IUD in comparison to those taking oral progestin.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic congestion syndrome', 'progestin', 'Hormonal intrauterine device', 'Intrauterine system'], 'conditions': ['Pelvic Congestion']}, 'referencesModule': {'references': [{'pmid': '26789334', 'type': 'BACKGROUND', 'citation': 'Champaneria R, Shah L, Moss J, Gupta JK, Birch J, Middleton LJ, Daniels JP. The relationship between pelvic vein incompetence and chronic pelvic pain in women: systematic reviews of diagnosis and treatment effectiveness. Health Technol Assess. 2016 Jan;20(5):1-108. doi: 10.3310/hta20050.'}, {'pmid': '14649734', 'type': 'BACKGROUND', 'citation': 'Chung MH, Huh CY. Comparison of treatments for pelvic congestion syndrome. Tohoku J Exp Med. 2003 Nov;201(3):131-8. doi: 10.1620/tjem.201.131.'}, {'pmid': '8519153', 'type': 'BACKGROUND', 'citation': 'Edwards RD, Robertson IR, MacLean AB, Hemingway AP. Case report: pelvic pain syndrome--successful treatment of a case by ovarian vein embolization. Clin Radiol. 1993 Jun;47(6):429-31. doi: 10.1016/s0009-9260(05)81067-0.'}, {'pmid': '21106807', 'type': 'BACKGROUND', 'citation': 'Freedman J, Ganeshan A, Crowe PM. Pelvic congestion syndrome: the role of interventional radiology in the treatment of chronic pelvic pain. Postgrad Med J. 2010 Dec;86(1022):704-10. doi: 10.1136/pgmj.2010.099473.'}, {'pmid': '17805925', 'type': 'BACKGROUND', 'citation': 'Ganeshan A, Upponi S, Hon LQ, Uthappa MC, Warakaulle DR, Uberoi R. Chronic pelvic pain due to pelvic congestion syndrome: the role of diagnostic and interventional radiology. Cardiovasc Intervent Radiol. 2007 Nov-Dec;30(6):1105-11. doi: 10.1007/s00270-007-9160-0. Epub 2007 Sep 6.'}, {'pmid': '21326577', 'type': 'BACKGROUND', 'citation': 'Ignacio EA, Dua R, Sarin S, Harper AS, Yim D, Mathur V, Venbrux AC. Pelvic congestion syndrome: diagnosis and treatment. Semin Intervent Radiol. 2008 Dec;25(4):361-8. doi: 10.1055/s-0028-1102998.'}, {'pmid': '14622683', 'type': 'BACKGROUND', 'citation': 'Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.'}, {'pmid': '16517774', 'type': 'BACKGROUND', 'citation': 'Kim HS, Malhotra AD, Rowe PC, Lee JM, Venbrux AC. Embolotherapy for pelvic congestion syndrome: long-term results. J Vasc Interv Radiol. 2006 Feb;17(2 Pt 1):289-97. doi: 10.1097/01.RVI.0000194870.11980.F8.'}, {'pmid': '10928522', 'type': 'BACKGROUND', 'citation': 'Maleux G, Stockx L, Wilms G, Marchal G. Ovarian vein embolization for the treatment of pelvic congestion syndrome: long-term technical and clinical results. J Vasc Interv Radiol. 2000 Jul-Aug;11(7):859-64. doi: 10.1016/s1051-0443(07)61801-6.'}, {'pmid': '14975970', 'type': 'BACKGROUND', 'citation': 'Park SJ, Lim JW, Ko YT, Lee DH, Yoon Y, Oh JH, Lee HK, Huh CY. Diagnosis of pelvic congestion syndrome using transabdominal and transvaginal sonography. AJR Am J Roentgenol. 2004 Mar;182(3):683-8. doi: 10.2214/ajr.182.3.1820683.'}, {'pmid': '8286684', 'type': 'BACKGROUND', 'citation': 'Robinson JC. Chronic pelvic pain. Curr Opin Obstet Gynecol. 1993 Dec;5(6):740-3.'}, {'pmid': '11331640', 'type': 'BACKGROUND', 'citation': 'Soysal ME, Soysal S, Vicdan K, Ozer S. A randomized controlled trial of goserelin and medroxyprogesterone acetate in the treatment of pelvic congestion. Hum Reprod. 2001 May;16(5):931-9. doi: 10.1093/humrep/16.5.931.'}, {'pmid': '11830623', 'type': 'BACKGROUND', 'citation': 'Venbrux AC, Chang AH, Kim HS, Montague BJ, Hebert JB, Arepally A, Rowe PC, Barron DF, Lambert D, Robinson JC. Pelvic congestion syndrome (pelvic venous incompetence): impact of ovarian and internal iliac vein embolotherapy on menstrual cycle and chronic pelvic pain. J Vasc Interv Radiol. 2002 Feb;13(2 Pt 1):171-8. doi: 10.1016/s1051-0443(07)61935-6.'}, {'pmid': '10498026', 'type': 'BACKGROUND', 'citation': 'Venbrux AC, Lambert DL. Embolization of the ovarian veins as a treatment for patients with chronic pelvic pain caused by pelvic venous incompetence (pelvic congestion syndrome). Curr Opin Obstet Gynecol. 1999 Aug;11(4):395-9. doi: 10.1097/00001703-199908000-00006.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effectiveness of hormonal intrauterine device (IUD) in treatment of pelvic congestion syndrome in comparison with oral progestins treatment.', 'detailedDescription': 'Pelvic congestion syndrome (PCS) is a poorly understood association between varicose or dilated pelvic veins and chronic pelvic pain (CPP). It is also called Pelvic venous syndrome, Pelvic venous insufficiency, Pelvic varices and Pelvic vascular dysfunction Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related to the pelvis of either men or women for more than 6 months according to The International Association for the Study of Pain (IASP). In other words, chronic pelvic pain with associated ovarian vein varicosities is termed pelvic congestion syndrome (PCS) and is an important but under-diagnosed condition.\n\nMillions of women worldwide\\\\e may suffer with chronic pelvic pain at some time in their life, and the occurrence may be as high as 39.1%. Chronic pelvic pain may account for 10 to 15% of outpatient gynecologic visits in the United States.The typical age of patients with this condition ranges from 20 to 45 years. It is unclear whether there is any genetic or ethnic predilection.\n\nThe etiology of pelvic congestion syndrome is reflux of blood in the ovarian veins due to the absence of functioning valves, resulting in retrograde blood flow and eventual venous dilatation. The cardinal presenting symptom of PCS is pelvic pain, usually described as a dull ache, without evidence of inflammatory disease. Clinical signs may include vulvar varicosities extending onto the medial thigh and long saphenous territory as well as tenderness on deep palpation at the ovarian point; however, such signs are not always present.\n\nFor many women with PCS, the road toward a definitive diagnosis has been long and laborious. Certainly the diagnosis of PCS continues to challenge all physicians involved. However, a heightened awareness and clinical suspicion for the specific symptomatology and associated findings may bring about a more rapid progression to the much anticipated treatment. Pelvic ultrasound (US) and/or computed tomography (CT) scan are usually the first imaging modalities in the evaluation of patients with chronic pelvic pain. Both provide excellent resolution of the uterus. Although a CT scan has greater sensitivity for showing varicosities throughout the lower pelvis, Two dimensional ultrasound with Doppler examination provides dynamic information about visualized venous blood flow.\n\nLaparoscopy is often used in patients with chronic pelvic pain in search of a specific diagnosis. This direct visualization is excellent for ruling out other etiologies distinct from PCS such as endometriosis. However, because the examination is done supine and requires insufflation of CO2 gas, there may be compression of varices if present, thereby masking the diagnosis of PCS.Certainly, the diagnostic venogram continues to provide physicians with a reliable minimally invasive gold standard tool in patients with PCS.The diagnostic venogram gives immediate dynamic flow information and measurements of ovarian and pelvic veins with the option of changing patient position.\n\nMany treatment modalities have been proposed. Medical management with hormone analogues and analgesics, surgical ligation of ovarian veins, hysterectomy with or without bilateral salpingo-oophorectomy and transcatheter embolization have been described in the literature as treatment options for patients with PCS today. Medical treatment of PCS includes psychotherapy, progestins, danazol, phlebotonics, gonadotropins receptor agonists (GnRH) with hormone replacement therapy (HRT), dihydroergotamine, and nonsteroidal antiinflammatory drugs (NSAIDS).\n\nTo improve clinical efficacy and reduce perioperative and postoperative morbidity, percutaneous pelvic vein embolization therapy has been utilized. Since its introduction in 1993 by Edwards et al, this modality has revolutionized the treatment of PCS. The procedure is usually performed at the time of diagnostic venography using a variety of embolic agents, including sclerosant foam and coils. In several published series in the 1990s, success rates for reduction of chronic pelvic pain ranged from 50 to 80%. With advancements in technique, clinical success is achieved in 70 to 85% of treated patients. It was found taht there was significant improvement in 83% of women in their overall pain perception levels with a mean of 45 months of long-term follow up.\n\nEmbolotherapy for PCS is an exciting therapy that has proven to be safer over the past two decades.Chung et al examined the effect of patient stress level on treatment efficacy, directly comparing hysterectomy with oophorectomy versus venous embolization for the treatment of PCS. Analysis of pain scores showed that venous embolization was more effective than hysterectomy, especially for patients who are "typically or moderately highly stressed. It was demonstrated that PCS patients who underwent ovarian and pelvic venous embolization have a more durable result in reduction of their pelvic pain.It was reported that there were no major complications and also did not find any significant changes in the basal follicle-stimulating hormone, luteinizing hormone, or estradiol levels.\n\nReported complications of embolotherapy are rare (\\< 4%) and include ovarian vein thrombophlebitis, recurrence of varices, migration of embolic material, and radiation exposure to ovaries. Long-term data shows no demonstrable negative effects on menstrual cycle or fertility from trans-catheter embolotherapy, It has proven to be a safe and effective nonsurgical approach in reducing chronic pelvic pain associated with pelvic venous incompetence.\n\nRegarding this study, investigators hypothesize that levonorgestrel-releasing intrauterine device is better than and more effective than oral progestin in treatment of PCS. Because levonorgestrel-releasing intrauterine device is local treatment and may cause little side effects than the oral treatment. In addition, it has better compliance than oral treatment. Lastly, it contains higher concentration than oral treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with clinical symptoms of pelvic congestion syndrome documented by Trans abdominal and/or transvaginal Doppler ultrasound (dilated ovarian veins with reversed caudal flow, presence of varices , dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary and variable duplex waveform during the Valsalva's maneuver).\n\nExclusion Criteria:\n\n* Endometriosis.\n* Uterine fibroids.\n* Previous pelvic operations.\n* Urological diseases.\n* Patient seeking pregnancy\n* Pelvic inflammatory diseases\n* Congenital uterine malformations"}, 'identificationModule': {'nctId': 'NCT05050357', 'briefTitle': 'Effectiveness of Hormonal Intrauterine Device in Treating PCS Compared to Oral Progestin', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effectiveness of Hormonal Intrauterine Device in Treating Pelvic Congestion Syndrome Compared to Oral Progestin', 'orgStudyIdInfo': {'id': 'HIUD vs progestin in PCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hormonal intrauterine device arm', 'interventionNames': ['Device: Hormonal intrauterine device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'progestin arm', 'interventionNames': ['Drug: Progestins Norethindrone']}], 'interventions': [{'name': 'Hormonal intrauterine device', 'type': 'DEVICE', 'description': 'insertion of hormonal IUD during menstrual period', 'armGroupLabels': ['hormonal intrauterine device arm']}, {'name': 'Progestins Norethindrone', 'type': 'DRUG', 'description': 'oral ethisteron twice daily for three months', 'armGroupLabels': ['progestin arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Abdelhamid Mohamed Abdelrahim AboDooh', 'investigatorAffiliation': 'Assiut University'}}}}