Urogynaecology

 
 Prosecco
 EVA
 
 PEOPLE
 
 SAM
 
 MIRA
 PORTRET
 CUPIDO 1
 CUPIDO 2
 VUSIS-I
 VUSIS-II

 Avaulta
 CAMPUR
 CATH trial
 Compare
 Elevate Anterior
 Elevate Posterior
 Galapagoz
 HysNiche
 Kwaliteitsregistratie
 LigaSure
 MiniMo
 Misorest
 PARIS
 PERIGEE
 Pompoen
 SALTO
 > Save U
 TOAST
 TRUDIL
 TVT-O vs TVT-S
 Vesselseal
 VROUW
 WoMan trial
 

 

SAVE U

 

Sacrospinous fixation versus vaginal hysterectomy in treatment of uterine prolapse of stage 2 or higher

 

Go to the Save U website.

 

Background

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.

 

Objective
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.

 

Study design
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.

 

Study population
Women with uterine prolapse stage 2 requiring surgical treatment. Patients with co-existing anterior/ posterior defects or concomitant incontinence surgery can be included.

 

Intervention
Random allocation to sacrospinous fixation or vaginal hysterectomy.  

 

Outcome measures
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.


Power/data analysis
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%.


Time schedule
Start inclusion October 2009. Inclusion period 18 months. Follow up 60 months.

 

Methodology
H Klip, epidemiologist, Isala klinieken


Projectleaders

H.W.F van Eijndhoven, MD, Dept. of Gynaecology, Isala klinieken

J. den Boon, MD, Dept. Dept. of Gynaecology, Isala klinieken

 

Study Coordinator

R.J. Detollenaere, MD, researcher, Dept. of Gynaecology, Isala klinieken

 

Subsidy

None

 

Contact

R.J. Detollenaere, MD, researcher, Dept. of Gynaecology, Isala klinieken Zwolle

T: +31(0) 38 424 7415

E-mail: saveu@studies-obsgyn.nl

 

H. Hulsebos, research nurse, Dept. of Gynaecology, Isala klinieken Zwolle

T: +31(0) 38 424 7783

Email: h.j.m.hulsebos@isala.nl