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Randomized Controlled Trial
. 2019 Sep 10:366:l5149.
doi: 10.1136/bmj.l5149.

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

Sascha F M Schulten  1   2 , Renée J Detollenaere  3 , Jelle Stekelenburg  4   5 , Joanna IntHout  2 , Kirsten B Kluivers  6 , Hugo W F van Eijndhoven  1
Affiliations
Randomized Controlled Trial

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

Sascha F M Schulten et al. BMJ. .

Abstract

Objective: To evaluate the effectiveness and success of uterus preserving sacrospinous hysteropexy as an alternative to vaginal hysterectomy with uterosacral ligament suspension in the surgical treatment of uterine prolapse five years after surgery.

Design: Observational follow-up of SAVE U (sacrospinous fixation versus vaginal hysterectomy in treatment of uterine prolapse ≥2) randomised controlled trial.

Setting: Four non-university teaching hospitals, the Netherlands.

Participants: 204 of 208 healthy women in the initial trial (2009-12) with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery who had been randomised to sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension. The women were followed annually for five years after surgery. This extended trial reports the results at five years.

Main outcome measures: Prespecified primary outcome evaluated at five year follow-up was recurrent prolapse of the uterus or vaginal vault (apical compartment) stage 2 or higher evaluated by pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse. Secondary outcomes were overall anatomical failure (recurrent prolapse stage 2 or higher in apical, anterior, or posterior compartment), composite outcome of success (defined as no prolapse beyond the hymen, no bothersome bulge symptoms, and no repeat surgery or pessary use for recurrent prolapse), functional outcome, quality of life, repeat surgery, and sexual functioning.

Results: At five years, surgical failure of the apical compartment with bothersome bulge symptoms or repeat surgery occurred in one woman (1%) after sacrospinous hysteropexy compared with eight women (7.8%) after vaginal hysterectomy with uterosacral ligament suspension (difference-6.7%, 95% confidence interval -12.8% to-0.7%). A statistically significant difference was found in composite outcome of success between sacrospinous hysteropexy and vaginal hysterectomy (89/102 (87%) v 77/102 (76%). The other secondary outcomes did not differ. Time-to-event analysis at five years showed no differences between the interventions.

Conclusions: At five year follow-up significantly less anatomical recurrences of the apical compartment with bothersome bulge symptoms or repeat surgery were found after sacrospinous hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension. After hysteropexy a higher proportion of women had a composite outcome of success. Time-to-event analysis showed no differences in outcomes between the procedures.

Trial registration: trialregister.nl NTR1866.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work. HWFvE receives honorariums as trainer for Coloplast and BARD outside the submitted work.

Figures

Fig 1
Fig 1
Flow of women through study. *Intention to treat: two women allocated to vaginal hysterectomy received sacrospinous hysteropexy and were analysed in the vaginal hysterectomy group. One woman after vaginal hysterectomy had recurrent apical prolapse, but pelvic organ prolapse quantification (POP-Q) score was missing; this woman was included in the intention-to-treat last observation carried forward analysis. †Missed data imputed as failure. ‡Per protocol analysis: two women did not receive intended treatment. Excluded from per protocol analysis: discontinued follow-up at five year (n=22), missing or incomplete POP-Q score (n=18), and major protocol deviations (n=9); seven patients met two criteria for exclusion from per protocol analysis
Fig 2
Fig 2
Survival analysis to estimate the cumulative incidence of surgical failure of the apical compartment, overall anatomical failure, composite outcome of success and repeat surgery in any compartment at five year follow-up after sacrospinous hysteropexy and vaginal hysterectomy with uterosacral ligament suspension. *Cumulative incidence was number of events (%) that occurred during five year follow-up. Hazard ratios and 95% confidence intervals were calculated using Cox regression. (Top left) Recurrent apical prolapse stage ≥2 with bothersome symptoms or repeat surgery for apical prolapse. (Top right) Pelvic organ prolapse quantification (POP-Q) stage ≥2 in any compartment. (Bottom left) No prolapse beyond the hymen, no bothersome bulge symptoms and no repeat surgery or pessary use for recurrent prolapse. (Bottom right) Repeat surgery in any compartment
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