Abstract
BackgroundPelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed.MethodsThe SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%.DiscussionThis study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed.Trial registrationDutch Trial Register (NTR 6978, http://www.trialregister.nl). Date of registration: 29 January 2018. Prospectively registered.
Highlights
Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life
The evidence will show whether the existing practice pattern variation (PPV) is detrimental and a de-implementation process regarding one of the operations is needed
Three types of vaginal operations for uterine descent are performed the most; the vaginal hysterectomy (VH), the modified Manchester operation (MM) and the sacrospinous hysteropexy (SSH), all combined with colporrhaphy when indicated
Summary
Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. According to the current guidelines, the first choice surgical treatment is a vaginal POP operation [5] When undergoing surgery these women have a 5–30% risk on re-operation due to recurrence [2, 6]. In the Netherlands choice of treatment is more or less divided between the three procedures for women with stage two uterine descent (varying from 25 to 34%) [7, 8]. This indicates a situation of maximal practice pattern variation. The lack of evidence makes it more difficult to come to a process of shared decision making between doctor and patient and individually tailored management in this field
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