Table 1 The VUE RCTs: two parallel RCTs evaluating the surgical options for upper compartment pelvic organ prolapse
Design and comparisons | Condition | No. of participants recruited at the time of suspension | Mesh in use within the trial | Implications of suspension | |
|---|---|---|---|---|---|
Uterine trial | Vaginal hysterectomy compared to uterine suspension | Uterine prolapse | 224 | Uterine suspension procedure dependant on the surgeon’s normal practice (as such, patients may have no mesh, abdominal mesh* or transvaginal mesh) | Recruitment Temporary suspension in Scottish sites only (suspending recruitment of new participants and randomisation of consented participants). No change to the rest of the UK. Intervention Sites advised to follow local NHS governance on the use of TV synthetic mesh for participants awaiting surgery. This may have deviated from the randomised intervention. Follow-up Continued as per protocol |
Vault trial | Abdominal vault suspension compared to a vaginal vault suspension | Vault prolapse | 87 | Abdominal procedure requires the use of abdominal mesh*; vaginal vault procedure dependant on the surgeon’s normal practice (as such, patients may have no mesh or may have transvaginal mesh) |