drugset / Trial / NCT05050357
Effectiveness of Hormonal Intrauterine Device in Treating PCS Compared to Oral Progestin
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2022-12-31
- Completion
- 2023-02-01
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Robinson JC. Chronic pelvic pain. Curr Opin Obstet Gynecol. 1993 Dec;5(6):740-3.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Norethindrone | Unknown | — | Oral |