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 trialBMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5149 (Published 10 September 2019) Cite this as: BMJ 2019;366:l5149
- Sascha F M Schulten, resident and research fellow obstetrics and gynaecology12,
- Renée J Detollenaere, gynaecologist1,
- Jelle Stekelenburg, professor and gynaecologist34,
- Joanna IntHout, biostatistician2,
- Kirsten B Kluivers, urogynaecologist5,
- Hugo W F van Eijndhoven, urogynaecologist1
- 1Department of Obstetrics and Gynaecology, Isala Clinics, PO Box 10400, 8000 GK Zwolle, Netherlands
- 2Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, Netherlands
- 3Department of Obstetrics and Gynaecology, Medical Centre Leeuwarden, Leeuwarden, Netherlands
- 4Department of Health sciences, University Medical Center Groningen, Global health, Groningen, Netherlands
- 5Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, Netherlands
- Correspondence to: R J Detollenaere
- Accepted 22 July 2019
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.
Contributors: All authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. HWFvE and RJD conceived and designed the study, obtained funding, provided administrative, technical, or material support, and supervised the study. HWFvE and RJD are the guarantors. SFMS, JS, HWFvE, and RJD acquired the data. SFMS, JS, JIH, KBK, HWFvE, and RJD analysed and interpreted the data. SFMS, JS, JIH, KBK, HWFvE, and RJD drafted the manuscript. SFMS, JS, JIH, KBK, HWFvE, and RJD critically revised the manuscript for important intellectual content. SFMS, JIH, and RJD did the statistical analysis. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding: The SAVE U trial received an unrestricted grant from the Isala research foundation. The funder did not play any role in the design and conduct of the study; in the collection, management, analysis, or interpretation of the data; or in the preparation, review, or approval of the manuscript.
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.
Ethical approval: The study protocol was approved by the ethics committees of the four participating centres.
Data sharing: No additional data available.
The study guarantor (RJD) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; No important aspects of the study have been omitted and any discrepancies from the study as planned have been explained.
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