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

Detollenaere RJ, den Boon J, Stekelenburg J, Alhafidh AH, Hakvoort RA, Vierhout ME, van Eijndhoven HW - BMC Womens Health (2011)

Bottom Line: 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.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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Dept. of Obstetrics and Gynaecology, Isala klinieken Zwolle, the Netherlands. r.j.detollenaere@isala.nl

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.

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Study design.
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Figure 1: Study design.

Mentions: The SAVE U trial is a prospective randomized non-blinded clinical trial conducted with the aim to determine non-inferiority of the primary endpoint between sacrospinous fixation and vaginal hysterectomy. The study will be an open label study, as it is impossible to blind the health care workers and patients involved for the surgical procedure to which the woman is allocated. Follow-up after one year, however, will be done by an independent physician. After inclusion, patients will be randomized centrally in 1:1 ratio stratified per centre and severity of prolapse. Patients are followed-up at 6 weeks, 6 months, 12 months and annually thereafter till 60 months follow-up. The design is presented in figure 1.


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

Detollenaere RJ, den Boon J, Stekelenburg J, Alhafidh AH, Hakvoort RA, Vierhout ME, van Eijndhoven HW - BMC Womens Health (2011)

Study design.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3045971&req=5

Figure 1: Study design.
Mentions: The SAVE U trial is a prospective randomized non-blinded clinical trial conducted with the aim to determine non-inferiority of the primary endpoint between sacrospinous fixation and vaginal hysterectomy. The study will be an open label study, as it is impossible to blind the health care workers and patients involved for the surgical procedure to which the woman is allocated. Follow-up after one year, however, will be done by an independent physician. After inclusion, patients will be randomized centrally in 1:1 ratio stratified per centre and severity of prolapse. Patients are followed-up at 6 weeks, 6 months, 12 months and annually thereafter till 60 months follow-up. The design is presented in figure 1.

Bottom Line: 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.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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Dept. of Obstetrics and Gynaecology, Isala klinieken Zwolle, the Netherlands. r.j.detollenaere@isala.nl

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.

Show MeSH
Related in: MedlinePlus