Title: Clinical and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a Comprehensive Cohort Study
Funder: Chief Scientist Office, Scotland

Abstract: Around 1 in 10 women will need prolapse surgery at some point in their lives. There is insufficient information to identify which operation is best. New techniques have been introduced which use mesh to reinforce the surgery, but these have not been properly evaluated, especially in terms of how well they improve prolapse symptoms. The study will be carried out in at least 15 hospitals in the UK. We will randomise women having anterior and/or posterior vaginal wall prolapse surgery to one of two trials: (1) Women having a first repair operation may be randomised to one of: a) a standard anterior or posterior prolapse repair, b) a standard repair with a biological graft inlay; or c) a standard repair with a non-absorbable mesh inlay. (2) Women having a second or subsequent repair may be randomised to: d) a standard anterior or posterior prolapse repair, e) a standard repair with a non-absorbable mesh inlay to support the stitches, or f) a new mesh repair using an introducer (mesh kit). Mesh kits will only be used for women having a secondary operation for prolapse as it is thought that it is more invasive than the other options and so should be reserved for such women, because they have a higher risk of failure. All women having prolapse operations will be eligible for our study. They will be given information about the study before they are admitted to hospital. After discussion with their gynaecologist, women will be able to choose whether or not they are willing to be randomised to one of the specified operations if the doctor is also willing to randomise her. Those women who do not wish to be randomised to a particular procedure but are happy for their outcomes to be monitored will be examined and will complete the questionnaires in the same way as the randomised groups as part of a Comprehensive Cohort. All women will have a routine gynaecological examination before surgery and they will complete questionnaires both before and after their operation. Further symptom questionnaires will also be completed 6, 12 and 24 months later. The women in the randomised trials will also be examined and reviewed in outpatients at 12 months after surgery. Our primary outcome is the cure or improvement of prolapse symptoms, as reported by the women themselves.

Lay abstract: Around 1 in 10 women will need prolapse surgery at some point in their lives. There is not enough evidence from research to identify which operation is best. New techniques have been introduced which use mesh to reinforce the surgery, but these have not been properly evaluated, especially in terms of how well they improve prolapse symptoms. In particular, a recent review by NICE (the National Institute for Clinical Excellence) has found that there is insufficient information on the efficacy and safety of mesh used in prolapse surgery in women. The study will be carried out in at least 15 hospitals in the UK. We will randomise women having an anterior and/or posterior vaginal wall prolapse operation to one of two trials: 1.A woman who is having her first repair operation will be randomised to one of: a) a standard anterior or posterior prolapse repair, b) a standard repair with a biological graft inlay to support the stitches; or c) a standard repair with a non-absorbable mesh inlay to support the stitches. 2.A woman who is having a second or subsequent repair will be randomised to: d) a standard anterior or posterior prolapse repair, e) a standard repair with a non-absorbable mesh inlay to support the stitches, or f) a new mesh repair using an introducer (mesh kit). This last option will only be available for women having a secondary operation for prolapse as it is thought that it is more invasive than the other options and so should be reserved for such women, because they have a higher risk of failure. All women having prolapse operations will be eligible for our study. They will be given information about the study before they are admitted to hospital. After discussion with their gynaecologist, women will be able to choose whether or not they are willing to be randomised to one of the specified operations. Those women who do not wish to be randomised to a particular procedure but are happy for their outcomes to be monitored, will be examined and will complete the questionnaires in the same way as the randomised groups as part of a Comprehensive Cohort. Women will have a routine gynaecological examination before surgery and they will complete questionnaires both before and after their operation. Further symptom questionnaires will also be filled in 6, 12 and 24 months later. The women will be examined and reviewed in outpatients at 4 to 6 months after surgery. Our primary outcome is the cure or improvement of prolapse symptoms, as reported by the women themselves.

Research activity codes: 6.4 SURGERY
Health categories: RENAL AND UROGENITAL