PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse.

Autor: Reid FM; Warrell Unit, St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Oxford Road Campus, Manchester, M13 0JH, UK. fiona.reid@mft.nhs.uk., Aucott L; Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Glazener CMA; Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Elders A; NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK., Hemming C; Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK., Cooper KG; Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK., Freeman RM; Department of Obstetrics and Gynaecology, Plymouth Hospitals NHS Trust, Plymouth, UK., Smith ARB; Warrell Unit, St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Oxford Road Campus, Manchester, M13 0JH, UK., Hagen S; NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK., Kilonzo M; Health Economics Research Unit, University of Aberdeen, Aberdeen, UK., Boyers D; Health Services Research Unit, University of Aberdeen, Aberdeen, UK.; Health Economics Research Unit, University of Aberdeen, Aberdeen, UK., MacLennan G; Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Norrie J; Edinburgh Clinical Trials Unit, Usher institute, University of Edinburgh, Edinburgh, UK., Breeman S; Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Jazyk: angličtina
Zdroj: International urogynecology journal [Int Urogynecol J] 2023 Jan; Vol. 34 (1), pp. 67-78. Date of Electronic Publication: 2022 Aug 26.
DOI: 10.1007/s00192-022-05308-0
Abstrakt: Introduction and Hypothesis: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse.
Methods: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures.
Results: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups.
Conclusions: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.
(© 2022. The Author(s).)
Databáze: MEDLINE