Sacrospinous fixation versus vaginal hysterectomy in treatment of uterine prolapse of stage 2 or higher
Go to the Save U website.
Uterovaginal prolapse is a common health problem, affecting up to 40% of parous women over 50 years old, with significant influence on quality of life. In the Netherlands vaginal hysterectomy is currently the leading treatment method for patients with symptomatic uterovaginal prolapse. Several studies have shown that sacrospinous fixation in case of uterine or vaginal vault prolapse is a safe and effective alternative to vaginal hysterectomy. However to date no large randomised 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.
A multi-center, prospective, randomised, non-blinded clinical trial. Evaluation will take place in every center pre-operatively, after 6 weeks, 6 months, 12 months and annually thereafter till 60 months follow-up.
Women with uterine prolapse stage ¡Ý 2 requiring surgical treatment. Patients with co-existing anterior/ posterior defects or concomitant incontinence surgery can be included.
Random allocation to sacrospinous fixation or vaginal hysterectomy.
Primary outcome: anatomical outcome and recurrence rate assessed by a POP-Q-test. Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery and sexual functioning.
The analysis will be by intention to treat. Based on the literature, we presume that both interventions are equivalent regarding anatomical outcome. The aim is to show that in the sacrospinous fixation arm, anatomical result is comparable to the vaginal hysterectomy group or at least better. A total of 208 patients will be included to yield a 80% power for a non-inferiority margin of 7%, assuming a relapse rate of 3%.
Start inclusion October 2009. Inclusion period 18 months. Follow up 60 months.
H Klip, epidemiologist, Isala klinieken
H.W.F van Eijndhoven, MD, Dept. of Gynaecology, Isala klinieken
J. den Boon, MD, Dept. Dept. of Gynaecology, Isala klinieken
R.J. Detollenaere, MD, researcher, Dept. of Gynaecology, Isala klinieken
R.J. Detollenaere, MD, researcher, Dept. of Gynaecology, Isala klinieken Zwolle
T: +31(0) 38 424 7415
H. Hulsebos, research nurse, Dept. of Gynaecology, Isala klinieken Zwolle
T: +31(0) 38 424 7783