Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study)

Abstract

Background Pelvic 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. Methods The 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%. Discussion This 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 registration Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.

Practice pattern variation: treatment of pelvic organ prolapse in The Netherlands

“…The authors suggested that if there is no other indication for hysterectomy, VH should never be the first choice for surgical treatment of POP [12]. In the coming years, the results of an ongoing randomized controlled trial concerning two uteruspreserving surgical techniques for uterine descent (SSH and MF) will be published [26]. This will provide new scientific evidence on the role of these operative techniques that can contribute to further reduction of PPV.…”

Gynecologists’ perspectives on two types of uterus-preserving surgical repair of uterine descent; sacrospinous hysteropexy versus modified Manchester

“…However, little is known about what aspects of the operations patients consider to be important factors when making a decision. In 2018, a Dutch multicenter RCT was set up to compare the two uterus-preserving techniques: SSH versus MM (SAM study), as well as a study on patients’ preferences (SAM DCE study) [ 25 ]. The results of these two trials will contribute to better evidence-based counseling and to more shared decision making, and may reduce practice pattern variation after implementation of the results.…”

Patient's preference for sacrospinous hysteropexy or modified Manchester operation: A discrete choice experiment

“…SH: the posterior side of the cervix is attached to the right sacrospinous ligament with two non‐absorbable size 1 or 0 sutures at least 2 cm medial to the ischial spine. This procedure was performed open or using a suturing device 16 …”