Extrait

Background and study aims: One in ten women will need an operation for prolapse. Prolapse occurs when the pelvic organs (such as the bladder, the bowel or the womb) come down into, or out of, the vagina. This is caused either by weakness of the tissues which usually support these organs or by weak pelvic floor muscles. It is most common in women who have had children, although there has been little research into its causes and treatment. Within the next 10 years, an extra 1 million women will reach the age when they are most likely to need prolapse surgery. This study will show which prolapse operations are the safest and most effective for all women. There are many different operations for prolapse: the VUE study only concerns women with a uterine (womb) prolapse or a vault prolapse (top of the vagina, in a woman who has had her womb removed previously). All the types of prolapse surgery in the VUE study are in common use in the NHS. The aim of this study is to answer one main question for each type of prolapse: that is, which of the operations gives the best results and is safest. Therefore, once we have the results of VUE, doctors in the future should be able to choose the prolapse surgery that has the best results with the fewest problems. This will mean fewer repeat operations, better health and quality of life for women, and better use of NHS facilities. Who can participate? Women who are going to have prolapse surgery for vault or uterine prolapse. What does the study involve? Women having surgery for uterine or vault prolapse will go into one of two trials: 1. Uterine trial: vaginal hysterectomy compared with an operation to suspend the uterus without removing it, and 2. Vault trial: suspending the vault from below (the vaginal route) compared with suspending it via the abdomen (tummy). Women will not have to undergo any tests or procedures that are not part of routine care for prolapse. Women will have a routine physical examination before surgery and complete a questionnaire before their operation. The women will be examined and reviewed as outpatients at 12 months after surgery. What are the possible benefits and risks of participating? There may be no direct benefit to women who take part, but they will be helping with this research enabling doctors to assess which operation is best and safest. Where is the study run from? University of Aberdeen in collaboration with NHS Grampian When is the study starting and how long is it expected to run for? Recruitment will start in February 2013 and participants will be enrolled for 12 months. The study may extend beyond this as we intend to look at participants’ health with long term follow up. Who is funding the study? NHS National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Health Technology Assessment programme (NETSCC HTA). Who is the main contact? Prof. Cathryn Glazener [email protected]

Critère d'inclusion

• Vaginal wall prolapse

Liens

• isrctn
• ictrp