Trial reportBMC women's health2011
Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial).
Trial report in BMC women's health, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Hysteropreservation versus hysterectomy in the surgical treatment of uterine prolapse: systematic review and meta-analysis.International urogynecology journal · 2017Pooled it
- Sacrospinous hysteropexy versus vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse stage 2 or higher: multicentre randomised non-inferiority trial.BMJ (Clinical research ed.) · 2015Trial
- Surgical Strategies for Apical Pelvic Organ Prolapse: A Systematic Review and Network Meta-Analysis.International urogynecology journal · 2026Review
- Sacrospinous Hysteropexy Versus Vaginal Hysterectomy in Women with Uterine Prolapse: 10-year Follow-up of a Randomised Controlled Trial.International urogynecology journal · 2026Article
- A Comparative Evaluation of Double Versus Loop Suture Techniques in Sacrospinous Ligament Fixation Over Two Years.International urogynecology journal · 2026Article
- Comparison of postoperative recovery and complications: laparoscopic sacrocolpopexy versus transvaginal sacrospinous ligament suspension.American journal of translational research · 2026Article
- Long-Term Outcomes (10 Years) of Sacrospinous Ligament Fixation for Pelvic Organ Prolapse Repair.Healthcare (Basel, Switzerland) · 2024Article
- Sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension in women with uterine prolapse stage 2 or higher: observational follow-up of a multicentre randomised trial.BMJ (Clinical research ed.) · 2019Observational
- Transvaginal Bilateral Sacrospinous Fixation after Second Recurrence of Vaginal Vault Prolapse: Efficacy and Impact on Quality of Life and Sexuality.BioMed research international · 2018Observational
- Unexpected premalignant gynecological lesions in women undergoing vaginal hysterectomy for utero-vaginal prolapse.Przeglad menopauzalny = Menopause review · 2015Article
- Surgical management of pelvic organ prolapse and uterine descent in the Netherlands.International urogynecology journal · 2013Article
- Concurrent Occurrence of Uterovaginal and Rectal Prolapse: An Uncommon Presentation.Annals of medical and health sciences researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. 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 registrationNetherlands Trial Register (NTR): NTR1866.
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