Grant: Operating Grant

Our study is a five year follow-up of 199 women who took part in a randomized clinical trial, comparing two surgical procedures for stress urinary incontinence. Both procedures involved placing a surgical mesh under the urethra, but used different surgical techniques. One group had the mesh passed through the obturator space in the pelvis (Trans-Obturator Tape, TOT group), the other group had the mesh put in place under the vagina (Tension-free Vaginal Tape, TVT group). We followed women at 12 months after surgery, at which time most outcomes did not differ between the groups, except that when women had a pelvic examination, the physician found that she could feel the surgical tape in more women in the TOT group than the TVT group. It is important that we continue to follow the women in our study to find out what happens to them. We intend to follow all the women in our original study at five years after surgery, to determine the safety, effectiveness and economics of the two types of surgical procedure. All study participants will be invited for a hospital clinic visit. Safety will be evaluated by repeating the pelvic examinations to find out if any further vaginal damage has occurred. Other adverse outcomes will also be collected. Effectiveness will be evaluated using a "pad test" in which women undertake a series of activities while wearing a pad to catch any leaking urine. The economics will be evaluated by collecting resource use over the five year period (for any hospital and outpatient treatments) and costs of those resources. These will be analysed incorporating results from a patient questionnaire that measures quality of life. The results of our study will help surgeons to decide which of the two surgical approaches is better at five years, and help them to discuss surgical options with patients. In addition, the study may allow us to contribute towards further understanding of the mechanism of surgical tape erosion of the vagin