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BMC Women's Health
Published in: BMC Women's Health 1/2011

Open Access 01-12-2011 | Study protocol

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

Authors: Renée J Detollenaere, Jan den Boon, Jelle Stekelenburg, Akeel HH Alhafidh, Robert A Hakvoort, Mark E Vierhout, Hugo WF van Eijndhoven

Published in: BMC Women's Health | Issue 1/2011

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Abstract

Background

Pelvic 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/design

The 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.

Discussion

The 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 registration

Netherlands Trial Register (NTR): NTR1866
Appendix
Available only for authorised users
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Metadata
Title
Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial)
Authors
Renée J Detollenaere
Jan den Boon
Jelle Stekelenburg
Akeel HH Alhafidh
Robert A Hakvoort
Mark E Vierhout
Hugo WF van Eijndhoven
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Women's Health / Issue 1/2011
Electronic ISSN: 1472-6874
DOI
https://doi.org/10.1186/1472-6874-11-4

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