{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T02:51:27Z","timestamp":1790218287009,"version":"4.1.0"},"reference-count":122,"publisher":"National Institute for Health and Care Research","issue":"13","license":[{"start":{"date-parts":[[2020,3,1]],"date-time":"2020-03-01T00:00:00Z","timestamp":1583020800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["15\/141\/06"],"award-info":[{"award-number":["15\/141\/06"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>New surgical approaches for apical prolapse have gradually been introduced, with few prospective randomised controlled trial data to evaluate their safety and efficacy compared with traditional methods.<\/jats:p><\/jats:sec>Objective<\/jats:title>To compare surgical uterine preservation with vaginal hysterectomy in women with uterine prolapse and abdominal procedures with vaginal procedures in women with vault prolapse in terms of clinical effectiveness, adverse events, quality of life and cost-effectiveness.<\/jats:p><\/jats:sec>Design<\/jats:title>Two parallel randomised controlled trials (i.e. Uterine and Vault). Allocation was by remote web-based randomisation (1\u2009:\u20091 ratio), minimised on the need for concomitant anterior and\/or posterior procedure, concomitant incontinence procedure, age and surgeon.<\/jats:p><\/jats:sec>Setting<\/jats:title>UK hospitals.<\/jats:p><\/jats:sec>Participants<\/jats:title>Uterine trial \u2013 563 out of 565 randomised women had uterine prolapse surgery. Vault trial \u2013 208 out of 209 randomised women had vault prolapse surgery.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Uterine trial \u2013 uterine preservation or vaginal hysterectomy. Vault trial \u2013 abdominal or vaginal vault suspension.<\/jats:p><\/jats:sec>Main outcome measures<\/jats:title>The primary outcome measures were women\u2019s prolapse symptoms (as measured using the Pelvic Organ Prolapse Symptom Score), prolapse-specific quality of life and cost-effectiveness (as assessed by incremental cost per quality-adjusted life-year).<\/jats:p><\/jats:sec>Results<\/jats:title>Uterine trial \u2013 adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for uterine preservation was 4.2 (standard deviation 4.9) versus vaginal hysterectomy with a Pelvic Organ Prolapse Symptom Score of 4.2 (standard deviation 5.3) (mean difference \u20130.05, 95% confidence interval \u20130.91 to 0.81). Serious adverse event rates were similar between the groups (uterine preservation 5.4% vs. vaginal hysterectomy 5.9%; risk ratio 0.82, 95% confidence interval 0.38 to 1.75). There was no difference in overall prolapse stage. Significantly more women would recommend vaginal hysterectomy to a friend (odds ratio 0.39, 95% confidence interval 0.18 to 0.83). Uterine preservation was \u00a3235 (95% confidence interval \u00a36 to \u00a3464) more expensive than vaginal hysterectomy and generated non-significantly fewer quality-adjusted life-years (mean difference \u20130.004, 95% confidence interval \u20130.026 to 0.019). Vault trial \u2013 adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for an abdominal procedure was 5.6 (standard deviation 5.4) versus vaginal procedure with a Pelvic Organ Prolapse Symptom Score of 5.9 (standard deviation 5.4) (mean difference \u20130.61, 95% confidence interval \u20132.08 to 0.86). The serious adverse event rates were similar between the groups (abdominal 5.9% vs. vaginal 6.0%; risk ratio 0.97, 95% confidence interval 0.27 to 3.44). The objective anterior prolapse stage 2b or more was higher in the vaginal group than in the abdominal group (odds ratio 0.38, 95% confidence interval 0.18 to 0.79). There was no difference in the overall prolapse stage. An abdominal procedure was \u00a3570 (95% confidence interval \u00a3459 to \u00a3682) more expensive than a vaginal procedure and generated non-significantly more quality-adjusted life-years (mean difference 0.004, 95% confidence interval \u20130.031 to 0.041).<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Uterine trial \u2013 in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between uterine preservation and vaginal hysterectomy. Vault trial \u2013 in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between an abdominal and a vaginal approach.<\/jats:p><\/jats:sec>Future work<\/jats:title>Long-term follow-up for at least 6 years is ongoing to identify recurrence rates, need for further prolapse surgery, adverse events and cost-effectiveness.<\/jats:p><\/jats:sec>Trial registration<\/jats:title>Current Controlled Trials ISRCTN86784244.<\/jats:p><\/jats:sec>Funding<\/jats:title>This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment<\/jats:italic>; Vol. 24, No. 13. See the National Institute for Health Research Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta24130","type":"journal-article","created":{"date-parts":[[2020,3,6]],"date-time":"2020-03-06T10:03:43Z","timestamp":1583489023000},"page":"1-220","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":27,"title":["Surgical interventions for uterine prolapse and for vault prolapse: the two VUE RCTs"],"prefix":"10.3310","volume":"24","clinical-trial-number":[{"clinical-trial-number":"isrctn86784244","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0075-9036","authenticated-orcid":true,"given":"Christine","family":"Hemming","sequence":"first","affiliation":[{"name":"Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, 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Transvaginal Mesh Implants Independent Review: Final Report. Edinburgh: Scottish Government; 2017. URL: www.gov.scot\/Publications\/2017\/03\/3336\/0 (accessed 1 February 2018)."},{"key":"key20200306100039326_ref1-bib42","unstructured":"NHS England. Mesh Oversight Group Report. London: NHS England; 2017. URL: www.england.nhs.uk\/wp-content\/uploads\/2017\/07\/mesh-oversight-group-report.pdf (accessed 1 February 2018)."},{"key":"key20200306100039326_ref1-bib43","volume-title":"British National Formulary","author":"Joint Formulary Committee"},{"key":"key20200306100039326_ref1-bib44","unstructured":"Information Services Division Scotland. Specialty Costs \u2013 Detailed Tables. Edinburgh: Information Services Division Scotland. URL: www.isdscotland.org\/Health-topics\/Finance\/Costs\/Detailed-Tables\/Speciality-Costs\/index.asp (accessed 6 February 2018)."},{"key":"key20200306100039326_ref1-bib45","unstructured":"Department of Health and Social Care. NHS Reference Costs 2015\u201316. 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Newcastle upon Tyne: NHS Business Services Authority. URL: www.nhsbsa.nhs.uk\/pharmacies-gp-practices-and-appliance-contractors\/drug-tariff (accessed 1 October 2018)."},{"key":"key20200306100039326_ref1-bib50","unstructured":"Information Services Division Scotland. Costs: File Listings. Edinburgh: Information Services Division Scotland. URL: www.isdscotland.org\/Health-Topics\/Finance\/Costs\/File-Listings-2016.asp (accessed 11 January 2017)."},{"key":"key20200306100039326_ref1-bib51","unstructured":"Warrington Clinical Commissioning Group. Continence and Catheter Care Formulary. Warrington: Warrington Clinical Commissioning Group; 2014. URL: www.warringtonccg.nhs.uk\/Page%20Images\/public-info\/Catheter%20Care%20Formulary%20Revised%20February%202014%20revised.pdf (accessed February 2019)."},{"key":"key20200306100039326_ref1-bib52","unstructured":"Office for National Statistics. Annual Survey of Hours and Earnings: 2016 Provisional Results. Newport: Office for National Statistics; 2016. 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