USE OF MESH IN WOMEN HAVING REPEATPROLAPSE SURGERY: RESULTS FROM PROSPECT, A RANDOMISED CONTROLLEDTRIAL
F. REID1, S. BREEMAN2, A. ELDERS 3, C. HEMMING 4, K.COOPER 5, R. M. FREEMAN 6, A. R. SMITH 7,S. HAGEN 8, A. MCDONALD 2, G. S. MACLENNAN 2,J. NORRIE 2, C. M. GLAZENER 9;
1TheWarrell Unit, Manchester, United Kingdom, 2Univ. ofAberdeen, Aberdeen, United Kingdom, 3Glasgow CaledonianUniv., Glasgow, United Kingdom, 4NHSG, Aberdeen, UnitedKingdom, 5Aberdeen Royal Infirmary, Aberdeen, UnitedKingdom, 6Plymouth Hosp. NHS Trust, Plymouth, UnitedKingdom, 7St Mary's Hosp., Manchester, United Kingdom,8NURSING, MIDWIFERY & ALLIED HEALTH PROFESSIONS RES,GLASGOW, United Kingdom, 9Health Services Research Unit,Univ. of Aberdeen, Aberdeen, United Kingdom.
Introduction: The use oftransvaginal synthetic mesh or mesh kits in women having repeatprolapse surgery has caused much controversy in recent years.PROSPECT, funded by the UK NIHR HTA programme, was designed toaddresses this controversy. It is a pragmatic randomised controlledtrial whose primary focus was on women’s symptoms ofprolapse.
Objective: To evaluate the results oftransvaginal synthetic mesh and mesh kits compared to repairs withnative tissue in women having repeat prolapse surgery.
Methods:Women undergoing anterior and/or posterior prolapse surgery for asecond/subsequent operation in the same compartment were randomisedfrom January 2010 to August 2013 in 35 centres in the UK. Women wererandomised to native tissue repair, non-absorbable synthetic meshinlay or a mesh kit using non-absorbable synthetic mesh. Womenundergoing concomitant uterine, vault or continence surgery were alsoeligible. All women provided informed written consent. Some surgeonsonly recruited to two arms of the trial. The primary outcome was thePelvic Organ Prolapse Symptom Score1 (POP-SS), a validatedprolapse questionnaire. Secondary patient reported outcomes includedquality of life (EQ-5D), bladder, bowel, and sexual function andserious adverse events (SAE). All of these outcomes were measured atone and two years. Anatomical outcome was measured using Pelvic OrganProlapse Quantification System2 (POP-Q) at one year byobservers blinded to treatment allocation and treatment receivedwhere possible. For women who had surgery, outcome data were analysedaccording to the group to which they were randomised. Treatmenteffect estimates are presented (with 95% confidence intervals) fromstatistical models that included prognostic variables.
Results:154 women were randomised; 56 to native tissue repair, 52 tosynthetic mesh inlay and 46 to a mesh kit. Baseline demographic andclinical characteristics were comparable across the groups. MeanPOP-SS was similar in each group at one and two years. There was noevidence of a difference in any secondary patient reported outcomesbetween the randomised groups at two years. There were no differencesin any of the serious non-mesh adverse events such as infection,pain, urinary retention and dyspareunia up to two years. There wasevidence of a difference in objective failure (leading edge >0cmbeyond hymen) in the native tissue versus mesh kit comparison, withwomen randomised to native tissue being more likely to have residualprolapse. Only one woman randomised to a mesh kit repair (1/39; 2.6%)required a new prolapse operation within the two years. Thecumulative mesh complication rate over two years were 7/52 (13.5%)for synthetic mesh inlay and 4/46 (8.7%) for mesh kits. Over the twoyear period six women required surgical correction of the meshexposure (four women in the synthetic mesh inlay group and two womenin the mesh kit group).
Table1: Native tissue repair versus Synthetic mesh inlay
POP-QLeading edge >0cm
Table2: Native tissue repair versus Mesh kit
POP-QLeading edge >0cm
Table3: New operations and complications: Outcomes over the first twoyears
Conclusions: We found noevidence of a difference in terms of prolapse symptoms from the useof synthetic mesh or mesh kit in women undergoing repeat prolapsesurgery. Evidence of a difference was observed in terms of objectivefailure and need for further prolapse surgery in the native tissueversus mesh kit comparison. However the sample size for allcomparisons was too small to be conclusive. We therefore encourageexisting and future trialists to report results for primary andrepeat prolapse surgery separately so that more information can beidentified for this group of women who are at even higher risk offailure than after their first repair.
References: 1. BJOG:an International Journal of Obstetrics & Gynaecology 116(1):25-31, 2009 2. American Journal of Obstetrics &Gynecology. 175 (1):10-17, 1996