Follow up for PROSPECT Study

Around 1 in 10 women will need prolapse surgery at some point in their lives. Prolapse occurs when the pelvic organs (such as the bladder, bowel or womb) come down into, or out of, the vagina. This is caused either by weakness of the connective tissues which normally support these organs or by weak pelvic floor muscles. It is most common in women who have had children, although there has been surprisingly little research into its causes and treatment. There are many different operations for prolapse, depending on the type of prolapse, whether the woman is having their first or a secondary repair and the preference of the gynaecological surgeon. To date, there is a recurrence rate after surgery: three in ten women who have an operation may develop recurrent prolapse. To help improve failure rates, and because it had worked well for hernia repairs, surgeons started to use synthetic mesh (as an inlay or kit) and graft materials to reinforce the surgery. In 2009, the HTA funded the PROSPECT study to look at improvement of prolapse symptoms following surgery using these new mesh and graft techniques compared to standard surgery with no mesh. Between January 2010 and August 2013, 3,089 women joined the study from 35 hospitals across the UK. Women having their first repair were randomly allocated to receive either standard surgery (no mesh), prolapse surgery with a synthetic mesh inlay or prolapse surgery with graft material. Women having their second repair were randomly allocated to receive either standard surgery (no mesh), prolapse surgery with a synthetic mesh inlay or prolapse surgery with a synthetic mesh kit. Women could also choose which operation they wanted. For 6 years after the operation women completed questionnaires providing information on prolapse symptoms and the impact of prolapse surgery on their urinary, bowel and sexual function. They also told us if they needed further prolapse surgery or experienced any problems with the mesh or graft material. We would now like to ask the PROSPECT women to continue providing information up to 14 years after their prolapse surgery. This is because (1) on average, prolapse operations fail after about 12 years and therefore it is still too early to say whether the mesh or graft materials have improved failure rates and (2) there has been much public debate on the use of mesh and graft material and it is important to look at the long-term complications of their use. We therefore plan to continue sending the PROSPECT women questionnaires every two years (to 14 years) to collect information on prolapse symptoms and other related outcomes. Information on further prolapse treatments, or treatments for complications of the mesh and graft materials, will be collected from medical records and routine data sources. When complete, the long-term results of the PROSPECT study will provide information on what happens to women after prolapse surgery, with and without synthetic mesh or graft material. This information will help surgeons and women to better understand the benefits and risks of prolapse surgery and help women in the future make better-informed decisions about the benefits and risks of prolapse surgery.