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Randomized Controlled Trial
. 2015 Jul 23:351:h3717.
doi: 10.1136/bmj.h3717.

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

Renée J Detollenaere  1 , Jan den Boon  2 , Jelle Stekelenburg  3 , Joanna IntHout  4 , Mark E Vierhout  5 , Kirsten B Kluivers  5 , Hugo W F van Eijndhoven  2
Affiliations
Randomized Controlled Trial

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

Renée J Detollenaere et al. BMJ. .

Abstract

Objective: To investigate whether uterus preserving vaginal sacrospinous hysteropexy is non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments in the surgical treatment of uterine prolapse.

Design: Multicentre randomised controlled non-blinded non-inferiority trial.

Setting: 4 non-university teaching hospitals, the Netherlands.

Participants: 208 healthy women with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery.

Interventions: Treatment with sacrospinous hysteropexy or vaginal hysterectomy with suspension of the uterosacral ligaments. The predefined non-inferiority margin was an increase in surgical failure rate of 7%.

Main outcome measures: Primary outcome was recurrent prolapse stage 2 or higher of the uterus or vaginal vault (apical compartment) evaluated by the pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse at 12 months' follow-up. Secondary outcomes were overall anatomical recurrences, including recurrent anterior compartment (bladder) and/or posterior compartment (bowel) prolapse, functional outcome, complications, hospital stay, postoperative recovery, and sexual functioning.

Results: Sacrospinous hysteropexy was non-inferior for anatomical recurrence of the apical compartment with bothersome bulge symptoms or repeat surgery (n=0, 0%) compared with vaginal hysterectomy with suspension of the uterosacral ligaments (n=4, 4.0%, difference -3.9%, 95% confidence interval for difference -8.6% to 0.7%). At 12 months, overall anatomical recurrences, functional outcome, quality of life, complications, hospital stay, measures on postoperative recovery, and sexual functioning did not differ between the two groups. Five serious adverse events were reported during hospital stay. None was considered to be related to the type of surgery.

Conclusions: Uterus preservation by sacrospinous hysteropexy was non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments for surgical failure of the apical compartment at 12 months' follow-up.

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 www.icmje.org/coi_disclosure.pdf and declare: JdB was a scientific medical advisor for Astellas and received consultancy fees, and has written an e-learning on incontinence for general practitioners. MEV is an advisory committee member for Astellas and receives consultancy fees. HWFvE receives training honorariums from Johnson & Johnson, AMS, and Bard Medical.

Figures

None
Flow of women through study. *Intention to treat: two patients allocated to vaginal hysterectomy (VH) received sacrospinous hysteropexy (SH) and were analysed in the VH group. Data at six and 12 month follow up were missing in one patient after SH and six patients after VH; one patient after VH had recurrent apical prolapse but pelvic organ prolapse quantification (POP-Q) score was missing, this patient was included in the intention to treat-last observation carried forward analysis. †Missed data imputed as failure. ‡Per protocol analysis: two patients did not receive intended treatment. Excluded per protocol analysis: lost for follow-up at 12 months (n=8), missing or incomplete POP-Q score (n=5), and major protocol deviations (n=9); two patients met two criteria to be excluded from per protocol analysis
See this image and copyright information in PMC

References

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