Cited by 127Pelvic floor disorders treatmentsUterine Myomas and TreatmentsGynecological conditions and treatments

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

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Schulten, Sascha F M, Detollenaere, Renée J, Stekelenburg, Jelle, IntHout, Joanna, Kluivers, Kirsten B, van Eijndhoven, Hugo W F·2019·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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  1. [15]Schweitzer KJ de Jong M Milani AL Prolaps en seks: hoe meten we de relatie? Ned Tijdschr Obst Gyn 2008; 121: 79- 82.
  2. [28]Saripanidis S. Vaginal hysterectomies are cheaper long term [electronic response to Detollenaere RJ, et al. 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 [2019] https://www.bmj.com/content/351/bmj.h3717. PMC4512203 26206451

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Authors
Schulten, S. F. M., Detollenaere, R. J., Stekelenburg, J., IntHout, J., Kluivers, K. B., & van Eijndhoven, H. W. F.
Affiliations
  • Radboud University Medical Center (NL)
  • Isala (NL)
  • University Medical Center Groningen (NL)
Corresponding author
Detollenaere, Renée J
Venue
BMJ
Publisher
BMJ
Published
2019-09-10
Volume
366
Pages
l5149
ISSN
  • 1756-1833 (ISSN-L)
  • 0959-8138
OpenAlex
W2972634607
Cited by
127
References
28
Citations by year
2026: 16 · 2025: 14 · 2024: 20 · 2023: 16 · 2022: 26 · 2021: 18 · 2020: 14 · 2019: 1 · 2018: 1 · 2013: 1
FWCI
11.18
Type
journal article
Language
en
Open access
Locations
  • BMJ (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • HighWire Press Open Archive (submittedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by-nc)
  • Radboud Repository (Radboud University) (submittedVersion)
  • Radboud Repository (Radboud University) (submittedVersion, other-oa)
Topics
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
Keywords
vaginal hysterectomy, uterosacral ligament suspension, uterine prolapse, long-term surgical outcomes, reoperation, quality of life, sexual function, uterus-preserving surgery, pelvic floor surgery, pessary
MeSH terms
Adult, Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Hysterectomy, Vaginal, Ligaments, Middle Aged, Netherlands, Quality of Life, Recurrence, Reoperation, Severity of Illness Index, Suture Techniques, Uterine Prolapse, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Treatment Outcome

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