Research Reporting Standards for Endovascular Treatment of Pelvic Venous Insufficiency

Abstract

THIS document is the product of a co-operative effort by the Society of Inter-ventional Radiology (SIR) TechnologyAssessment Committee. Adoption ofcommon definitions, approaches to di-agnosis and treatment, and clinical out-comes assessment is expected to helpoptimize the care of patients withchronicpelvicpainresultingfrompelvicvenous insufficiency (PVI). The purposeofthisresearchreportingstandardsdoc-ument is to improve the quality andrelevance of PVI research by providingguidelines for the design and reportingof clinical trials.Chronic pelvic pain is a commonhealth problem among women and isdefined as noncyclic pelvic pain of morethan 6 months’ duration. The conditionis potentially debilitating, and afflictsmillions of women worldwide. It hasbeen reported that as many as 39% ofwomen experience chronic pelvic painat some time in their lives (1). Chronicpelvic pain presents a common chal-lenge for providers of women’s care, in-cluding obstetricians and gynecologists,family physicians, emergency roomphysicians, internists, surgeons, gastro-enterologists, and pain managementphysicians.Unfortunately, PVI is often over-looked in the differential diagnosis ofpelvic pain. The routine diagnosticworkup in as many as one third of allpatients who are evaluated for chronicpelvic pain will yield no obvious etiol-ogy. Of these patients in whom there isno apparent cause of pelvic pain, an es-timated 30% have PVI (2). PVI is ana-tomically analogous to the male varico-cele, but because the associated pelvicvaricosities are often not externally vis-ible or palpable, the diagnosis may beelusive. Pelvic congestion with pelvicvarices was first described in 1857 andthe first association of PVI with chronicpelvic pain was described in 1949 (3,4).Although an association of pelvic ve-nous congestion with a psychosocialcondition has been described (5,6), theanatomic hemodynamic mechanism re-sulting in physical symptoms has alsobeen well documented. Retrograde flowthrough incompetent gonadal and pel-vic veins may result in painful pelvicvaricosities(4,7).Becauseofthenegativepsychosocialassociationshistoricallyas-sociated with the traditional term of pel-vic congestion syndrome (PCS), PVI isnow the preferred term as it defines thepathophysiology of the condition. Thepsychological factors often describedwith PCS are likely the result of, ratherthan the cause of, symptoms related toPVI (8). In addition to psychotherapy,multiple approaches to the manage-ment of symptomatic pelvic venouscongestion have been described, includ-ing hormonal suppression, hysterec-tomyandoophorectomy,andtranscath-eter embolization.Hormonal suppression of ovarianfunction and hysterectomy with bilat-eral salpingo-oophorectomy are com-monly prescribed therapeutic optionsfor PVI. However, studies report onlyshort-term relief, with residual pain inas many as 33% of patients (9–12). In asmall pilot study (9), 22 women withpelvic congestion confirmed by venog-raphy were treated with medroxypro-gesterone acetate for 6 months. At theend of treatment, 18 women had a sig-