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

Detollenaere, Renée J.; Boon, Jan den; Stekelenburg, Jelle; IntHout, Joanna; Vierhout, Mark E.; Kluivers, Kirsten B.; Eijndhoven, Hugo W F van

doi:10.1136/bmj.h3717

Cited by 144 publications

(141 citation statements)

References 34 publications

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“…First, we congratulate the authors on a well-conducted systematic review on this very pertinent topic. Broadly, the results are in agreement with those of other systematic reviews comparing uterus-preserving prolapse repair procedures with vaginal hysterectomy [2].We wonder why the authors did not include the large randomized controlled trial by Detollenaere et al of vaginal sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension [3]. This randomized controlled trial with over 100 women in each arm would meet the inclusion criteria of the current review and add strength to the evidence.…”

supporting

confidence: 74%

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Comment on “Hysteropreservation versus hysterectomy in the surgical treatment of uterine prolapse: systematic review and meta-analysis”

et al. 2017

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Sir, We read with great interest the review article by de Oliveira et al. entitled BHysteropreservation versus hysterectomy in the surgical treatment of uterine prolapse: systematic review and meta-analysis^ [1]. First, we congratulate the authors on a well-conducted systematic review on this very pertinent topic. Broadly, the results are in agreement with those of other systematic reviews comparing uterus-preserving prolapse repair procedures with vaginal hysterectomy [2].We wonder why the authors did not include the large randomized controlled trial by Detollenaere et al. of vaginal sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension [3]. This randomized controlled trial with over 100 women in each arm would meet the inclusion criteria of the current review and add strength to the evidence. Inclusion of data from this study in the current metaanalysis for the subgroup 'vaginal hysteropexy vs. vaginal hysterectomy -no mesh' would change the relative risk for recurrence from 3.70 (95% confidence interval 1.11-12.37) to 1.41 (95% confidence interval 0.21-9.30). This result, showing no difference in recurrence rates between the two procedure, would align with the results of our meta-analysis comparing sacrospinous hysteropexy and vaginal hysterectomy [4].

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supporting

confidence: 74%

“…We wonder why the authors did not include the large randomized controlled trial by Detollenaere et al of vaginal sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension [3]. This randomized controlled trial with over 100 women in each arm would meet the inclusion criteria of the current review and add strength to the evidence.…”

mentioning

confidence: 99%

Comment on “Hysteropreservation versus hysterectomy in the surgical treatment of uterine prolapse: systematic review and meta-analysis”

et al. 2017

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“…As well-observed by Kapoor et al in their letter to the editor, we acknowledge the non-inclusion of the trial by Detollenaere et al [2], even though the authors have evaluated surgical techniques that compared removing and preserving the uterus, the subject of our meta-analysis [1]. Here are some clarifications on this matter.…”

mentioning

confidence: 93%

“…One of their secondary outcomes involved similar criteria for failure as those standardized by us: point C >0 [2], data that could theoretically be used in our meta-analysis [1]. However, the interpretation of the failure rate could be biased considering the inclusion of a high number of women with less advanced POP.…”

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Hysteropreservation versus hysterectomy in the surgical treatment of uterine prolapse: systematic review and meta-analyses

2017

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Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse

Nager

Visco

Richter

et al. 2019

JAMA

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IMPORTANCE Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option. OBJECTIVE To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy. DESIGN, SETTING, PARTICIPANTS At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018. INTERVENTIONS Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension. MAIN OUTCOMES AND MEASURES The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate. RESULTS A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, −45.2 [95% CI, −57.7 to −32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%). CONCLUSIONS AND RELEVANCE Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.

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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

Abstract: trialregister.nl NTR1866.

Cited by 144 publications

References 34 publications

Comment on “Hysteropreservation versus hysterectomy in the surgical treatment of uterine prolapse: systematic review and meta-analysis”

Comment on “Hysteropreservation versus hysterectomy in the surgical treatment of uterine prolapse: systematic review and meta-analysis”

Hysteropreservation versus hysterectomy in the surgical treatment of uterine prolapse: systematic review and meta-analyses

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse

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