Title: Trans-venous occlusion of incompetent pelvic veins as a treatment for chronic pelvic pain in women: a randomised control trial
Funder: Department of Health and Social Care

Abstract: Background: Defined as continuous or intermittent lower abdominal or pelvic pain of at least six months duration, CPP is widely accepted as a major health problem with a worldwide prevalence of 24% in women.1310 Primarily affecting younger women, CPP is a leading cause for impaired quality of life, social isolation, marital discord and loss of employment.11 Pelvic vein incompetence (PVI) affects 15-20% women and its association with CPP is increasingly reported in the literature.1718 Remarkably, we know very little about PVI as the pelvic veins are emptied and not seen when women are tilted head-down during laparoscopy. Our systematic review included 13 studies evaluating trans-venous occlusion of PVI in 866 women with pelvic symptoms. Statistically significant improvements in pelvic pain were reported in nine of these 13 studies, with very few complications. These studies were all of poor quality (12 studies level 4 evidence, one study level 1b). As a result the NHS does not fund this treatment and there is no guidance from the RCOG or NICE on its management. Aims: to conduct a pragmatic RCT in women aged 18-54 with PVI and CPP to answer the following research questions: Primary Does treatment of PVI by trans-venous occlusion improve symptoms of CPP assessed using the validated Short-Form McGill Pain Questionnaire (SF-MPQ)? Secondary Does treatment of PVI by trans-venous occlusion improve symptoms of CPP assessed by a modified Short-Form McGill CPP Questionnaire (SF-MCPPQ) to focus on symptoms in CPP? Does treatment of PVI by trans-venous occlusion improve quality of life measured by the EuroQol (EQ-5d-3 level) in women with CPP? What are the NHS costs of treatment over six months in both treatment groups? What are the key drivers of the cost-effectiveness of coil occlusion compared with no treatment for women with PVI? Plan of investigation: Women aged 18-54 (inclusive) with CPP who have all other causes for their symptoms excluded by a gynaecologist will be recruited from the three largest women s health centres in the North West. Women meeting the inclusion criteria will undergo trans-vaginal ultrasound (TVU) to detect or exclude incompetence in the ovarian and internal iliac veins on both sides. 100 women with CPP and confirmed PVI will be randomised to either i) treatment by trans-venous occlusion plus best medical care, or ii) best medical care alone. All participants will complete the validated SF-MPQ, the modified SF-MCPPQ, and the EQ-5D-3 level (a measure of health status) before and at one week, three and six months after randomisation. Reflux venography and trans-venous occlusion: Trans-venous occlusion is performed under local anaesthesia and will be undertaken in an interventional radiology suite. The catheter is introduced through the right jugular vein and incompetence where present, will be confirmed by reflux venography stimulated by Valsalva and thigh compression and release. Incompetent veins will be treated with a distal and proximal occluding coil with foam sclerotherapy sandwiched in between. Patients can go home 2-3 hours following the procedure and usually do not require analgesia. Potential Benefit: This will be the first RCT on the effectiveness of trans-venous occlusion in women with PVI and CPP. If trans-venous occlusion reduces pain and improves quality of life, this study will have an immediate impact on the clinical care of women with PVI and CPP. It will also inform the design of a definitive multi-centre RCT. Even if our research shows that trans-venous occlusion is ineffective at relieving pelvic pain symptoms, women sufferers and healthcare providers would benefit from a more focused approach to diagnosis, and the abandonment of procedures used to treat PVI which are becoming increasingly frequent.

Lay abstract: Pain in the lower abdomen or pelvis for more than six months is known as chronic pelvic pain (CPP).1 CPP affects millions of women worldwide and accounts for 20-40% of all gynaecology outpatient appointments in the UK.2-4 Most women with CPP fail to achieve a diagnosis, and are subjected to repeated hospital admissions and invasive tests.5 Pelvic vein incompetence (PVI), where the valves within the pelvic veins fail as they do in varicose veins affects 15-20% of women and may cause CPP.6-9 Remarkably, we know little about PVI as the distended veins empty when women are tilted head down during laparoscopy, the usual investigation for CPP. The effectiveness of blocking the incompetent pelvic veins with small coils was reported in 13 studies which were all of poor quality with bias. As a result, The Royal College of Obstetrics and Gynaecology (RCOG), The National Institute of Clinical Excellence (NICE) and our NHS are understandably reluctant to support treatment for PVI even though all of these studies report that women benefited from treatment. The male equivalent, varicoceles caused by testicular vein incompetence, are treated by the NHS. Blocking incompetent pelvic veins with coils in women with PVI has never been tested in a well-designed clinical trial. We plan to recruit 100 women with CPP and PVI confirmed by trans-vaginal ultrasound from three women s health centres in the North West. Patients will be selected for trans-venous occlusion or best standard treatment at random to produce two equal groups. All participating women will complete detailed questionnaires on how the treatment has impacted their symptoms, quality of life and NHS costs of care. This study will report whether symptoms suffered by these women are improved by this treatment. We will also be able to report on changes in quality of life and NHS costs.

Research activity codes: 6.4 SURGERY
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;CARDIOVASCULAR