Women who have surgery that uses stitches to lift and keep their prolapsed womb in place (called hysteropexy) are less likely to have recurrent symptoms after five years than those who have their womb removed (vaginal hysterectomy).
These results from a Dutch trial involving 204 women showed comparable outcomes for the two surgical options for other measures such as quality of life, repeat surgery and sexual functioning.
While vaginal hysterectomy is still widely seen as the first treatment choice for women with uterine (womb) prolapse, the use of surgery which preserves the uterus by using synthetic stitches to support the pelvic organs is becoming more common.
The results are noteworthy. They indicate that hysteropexy may be a safe, alternative option in skilled hands, but more convincing longer-term evidence is probably required to confirm the size of any difference if this exists.
Why was this study needed?
Uterine prolapse, where the uterus slips out of position and sags down, is increasingly common and can cause significant psychological and physical problems.
Around one in three women suffer from some form of pelvic organ prolapse, which costs the NHS £45 million per year to treat.
Vaginal hysterectomy, where the uterus is removed through the vagina, is the standard treatment for uterine prolapse. However, uterus preserving surgery is gaining popularity.
There have been few studies that directly compare vaginal hysterectomy with uterus preserving procedures, and there is a lack of long-term evidence. As a result, guidelines are somewhat ambiguous and treatment varies.
The SAVE U randomised controlled trial (RCT) compared uterus preservation with hysterectomy. Previously published results at one year after surgery showed similar outcomes for both procedures.
This publication looked at outcomes at five years after surgery.
What did this study do?
The SAVE U RCT involved 208 women who needed surgery for uterine prolapse, where the uterus had descended nearly to the opening of the vagina or below (stage 2 or higher). The trial took place in the Netherlands from 2009 to 2012.
The women were randomised to undergo sacrospinous hysteropexy (103 women) or vaginal hysterectomy with uterosacral ligament suspension (105 women). Women were excluded if they had previous pelvic floor surgery, or other pelvic symptoms. Surgeons were given a detailed guideline on the surgeries to ensure a uniform technique, although there was some variation in the type of stitches used.
For this follow-up study, 204 women were assessed five years after surgery.
There was some risk of bias because the trial could not be blinded.
What did it find?
- At five-year follow-up, apical (uterus or vaginal vault) prolapse stage 2 or higher or repeat surgery for apical prolapse occurred in 1% (1/102) after sacrospinous hysteropexy compared with 8% (8/102) after vaginal hysterectomy with uterosacral ligament suspension (difference ‑6.7%, 95% confidence interval [CI] -12.8% to -0.7%).
- A successful outcome, defined as no prolapse beyond the hymen, absence of bothersome bulge symptoms, and no repeat surgery or pessary use, was more likely with sacrospinous hysteropexy, occurring in 87% (89/102) compared with 76% (77/102) for vaginal hysterectomy (difference 11%, 95% CI 0.8% to 22.2%).
- Prolapse stage 2 or higher of the posterior vaginal wall (bulging of the rectum into the vagina) was less likely after sacrospinous hysteropexy, affecting 5% (5/102) compared with 18% (18/101) after vaginal hysterectomy (difference -12.7%, 95% CI -21.5% to -3.9%).
- Prolapse stage 2 or higher of the anterior vaginal wall (bulging of the bladder into the vagina) was common in both groups, affecting 40% (41/102) after sacrospinous hysteropexy and 36% (36/101) after vaginal hysterectomy (difference 4.5%, 95% CI ‑8.9% to 17.8%).
- There was no difference between the two groups in surgery for recurrent prolapse, time-to-event analysis (which calculates the cumulative events up to five years), quality of life, urinary or sexual function.
What does current guidance say on this issue?
The NICE 2019 guideline recommends that women considering surgery for uterine prolapse who have no wish to retain their uterus should be offered a choice of hysterectomy, vaginal sacrospinous hysteropexy or another surgery called Manchester repair.
NICE advises that its Patient Decision Aid should be used to help shared decision making. This booklet gives an overview of the evidence in this area. It states that in the studies NICE has looked at, 65% of women no longer had symptoms one year on from hysterectomy, compared with 55% for sacrospinous hysteropexy. The booklet stresses that evidence is too limited to be sure which surgery is better.
What are the implications?
Hysterectomy is most UK surgeons’ first-choice treatment for uterovaginal prolapse, but this and other studies do suggest that uterine preservation may be an effective alternative. Even when they do not want to preserve their fertility, women often prefer to keep their uterus and it can be challenging to balance such preferences against other risks such as long-term risk of cancer. Overall, the evidence is still uncertain as to which option is better.
In terms of cost to the NHS, hysteropexy typically requires a shorter hospital stay. If further studies confirm the reduced need for repeat surgery then it may also prove more cost-effective, but for now, we probably need more longer-term evidence.
Citation and Funding
Schulten S, Detollenaere R and Stekelenburg J. Sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension in women with uterine prolapse stage 2 or higher: observational follow-up of a multicentre randomised trial. BMJ: 2019;366:l5149.
This study was funded by the Isala research foundation.
Detollenaere R, den Boon J and Stekelenburg J. Sacrospinous hysteropexy versus vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse stage 2 or higher: multicentre randomised non-inferiority trial. BMJ: 2015;351:h3717.
NICE. Surgery for uterine prolapse: patient decision aid. London: National Institute for Health and Care Excellence; 2019.
NICE. Urinary incontinence and pelvic organ prolapse in women: management. NG123. London: National Institute for Health and Care Excellence; updated June 2019.
Produced by the University of Southampton and Bazian on behalf of NIHR through the NIHR Dissemination Centre