Primary surgical repair of anterior vaginal prolapse BACKGROUND:  20-70% recurrences are reported after traditional anterior colporrhaphy  High anatomical success rates with synthetic polypropylene mesh usage are reported in observational studies  Little data on functional outcome exist  Concerns exist about the risk of complications with mesh usage such as mesh exposure or de novo dyspareunia OBJECTIVE: To compare anterior colporrhaphy with a trocar-guided transobturator mesh procedure (Avaulta ® anterior)

Methods  Randomised controlled trial  Three teaching hospitals  125 women with a symptomatic cystocele ≥ stage II requiring primary surgical repair were included  Primary outcome: the difference in anatomical cure (POPQ < stage II)  Secondary outcome: complications, functional outcome measured with validated questionnaires  Assessment at baseline and 1 year follow up

Results, anatomical outcome  Risk reduction 50,3% (95% CI 35,5-65,1) of anatomical failure in favour of the mesh  3 (5%) re-operations after anterior colporrhaphy vs 0% after mesh

Results, functional outcome Trocar-guided transobturator mesh Anterior Colporrhaphy Trocar-guided transobturator mesh Anterior Colporrhaphy n=58n=61 N=55 Urogenital Distress InventoryPre-operative 1 year follow up Genital prolapse 67 (33-67) 0 (0-0) Overactive bladder 22 (11-44)22 ( 0-44) 0 (0-11) 0 (0-22) Urinary Incontinence 17 ( 0-33) 0 (0-17) Obstructive micturation 17 ( 0-33) 0 (0-0) Discomfort/pain 33 ( 0-50)17 ( 0-50) 0 (0-17) Incontinence Impact Questionnaire Emotional functioning 11 ( 0-33)11 ( 0-22) 0 (0-11) Physical functioning 17 (0-33) 8 (0-33) 0 (0-4) 0 (0-0) Mobility 22 (11-33)22 ( 0-33)11 (0-22) 0 (0-11) Social functioning 11 ( 0-22) 0 (0-0) 0 (0-6) Embarrasment 0 ( 0-17) 0 (0-0) Data presented as median (p25-p75) No significant differences were observed between groups.

Conclusion  According to our definition of anatomical success the use of mesh provides a better outcome  However, functional outcome was similar between groups  Repeat surgery for a symptomatic cystocele recurrence after anterior colporrhaphy was low  Potential drawbacks of mesh implant surgery, like exposure were low (4%)

Implications for research and practice  From a patient’s perspective, the use of mesh in primary cystocele repair does not result in better functional outcome or a significant reduction in repeat surgery for symptomatic cystocele recurrence  Long term follow up is necessary to show:  if anatomical superiority persists in mesh usage  If complications increase or not in mesh usage  if the asymptomatic recurrences become symptomatic in the anterior colporrhaphy group