Trans-venous occlusion of pelvic vein incompetence
Research type
Research Study
Full title
TRANS-VENOUS OCCLUSION OF INCOMPETENT PELVIC VEINS AS A TREATMENT FOR CHRONIC PELVIC PAIN IN WOMEN: A RANDOMISED CONTROL TRIAL
IRAS ID
162622
Contact name
Jonathan Ghosh
Contact email
Sponsor organisation
University Hospital of South Manchester
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
Pain in the lower abdomen or pelvis for more than six months is known as chronic pelvic pain (CPP). CPP affects millions of women worldwide and accounts for 20-40% of all gynaecology outpatient appointments in the UK. Most women with CPP fail to achieve a diagnosis, and are subjected to repeated hospital admissions and invasive tests. 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. 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 consisted of case series and retrospective observational studies. 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 intervention (trans-venous occlusion) or non-intervention (reflux venography only) 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.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0360
Date of REC Opinion
1 Jun 2015
REC opinion
Favourable Opinion