Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial)

BMC Women's Health

Study Protocol

Hugo WF van Eijndhoven¹  Jan den Boon¹  Renée J Detollenaere²  Jelle Stekelenburg³  Mark E Vierhout⁴  Robert A Hakvoort⁵  Akeel HH Alhafidh⁶ 

[1] Dept. of Obstetrics and Gynaecology, Isala klinieken Zwolle, The Netherlands;Dept. of Obstetrics and Gynaecology, Isala klinieken Zwolle, The Netherlands;Dept. of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;Dept. of Obstetrics and Gynaecology, Medisch Centrum Leeuwarden, The Netherlands;Dept. of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;Dept. of Obstetrics and Gynaecology, Spaarne ziekenhuis Hoofddorp, The Netherlands;Dept. of Obstetrics and Gynaecology, Ziekenhuis Groep Twente Hengelo, The Netherlands;

关键词: Pelvic Organ Prolapse;    Vaginal Hysterectomy;    Pelvic Organ Prolapse Quantification;    Posterior Vaginal Wall;    Uterine Prolapse;   

DOI  :  10.1186/1472-6874-11-4

 received in 2010-11-19, accepted in 2011-02-15,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundPelvic organ prolapse is a common health problem, affecting up to 40% of parous women over 50 years old, with significant negative influence on quality of life. Vaginal hysterectomy is currently the leading treatment method for patients with symptomatic uterine prolapse. Several studies have shown that sacrospinous fixation in case of uterine prolapse is a safe and effective alternative to vaginal hysterectomy. However, no large randomized trials with long-term follow-up have been performed to compare efficacy and quality of life between both techniques.The SAVE U trial is designed to compare sacrospinous fixation with vaginal hysterectomy in the treatment of uterine prolapse stage 2 or higher in terms of prolapse recurrence, quality of life, complications, hospital stay, post-operative recovery and sexual functioning.Methods/designThe SAVE U trial is a randomized controlled multi-center non-inferiority trial. The study compares sacrospinous fixation with vaginal hysterectomy in women with uterine prolapse stage 2 or higher. The primary outcome measure is recurrence of uterine prolapse defined as: uterine descent stage 2 or more assessed by pelvic organ prolapse quantification examination and prolapse complaints and/or redo surgery at 12 months follow-up. Secondary outcomes are subjective improvement in quality of life measured by generic (Short Form 36 and Euroqol 5D) and disease-specific (Urogenital Distress Inventory, Defecatory Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments, complications following surgery, hospital stay, post-operative recovery and sexual functioning (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire). Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and considering an upper-limit of 7% to be non-inferior (beta 0.2 and one sided alpha 0.025), 104 patients are needed per group.DiscussionThe SAVE U trial is a randomized multicenter trial that will provide evidence whether the efficacy of sacrospinous fixation is similar to vaginal hysterectomy in women with uterine prolapse stage 2 or higher.Trial registrationNetherlands Trial Register (NTR): NTR1866

【 授权许可】

CC BY   
© Detollenaere et al; licensee BioMed Central Ltd. 2011