Effect of vaginal mesh hysteropexy vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: A randomized clinical trial

Charles W. Nager, Anthony G. Visco, Holly E. Richter, Charles R. Rardin, Rebecca G. Rogers, Heidi S. Harvie, Halina M. Zyczynski, Marie Fidela R. Paraiso, Donna Mazloomdoost, Scott Grey, Amaanti Sridhar, Dennis Wallace

Research output: Contribution to journalArticle

Abstract

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. Trial Registration: ClinicalTrials.gov Identifier: NCT01802281.

Original languageEnglish (US)
Pages (from-to)1054-1065
Number of pages12
JournalJAMA - Journal of the American Medical Association
Volume322
Issue number11
DOIs
StatePublished - Sep 17 2019

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Vaginal Hysterectomy
Prolapse
Treatment Failure
Ligaments
Suspensions
Randomized Controlled Trials
Hysterectomy
Sutures
Pelvic Floor Disorders
Hymen
Uterine Prolapse
Granulation Tissue
Operative Time
Outcome Assessment (Health Care)
Survival
Incidence
Research

ASJC Scopus subject areas

  • Medicine(all)

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Effect of vaginal mesh hysteropexy vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse : A randomized clinical trial. / Nager, Charles W.; Visco, Anthony G.; Richter, Holly E.; Rardin, Charles R.; Rogers, Rebecca G.; Harvie, Heidi S.; Zyczynski, Halina M.; Paraiso, Marie Fidela R.; Mazloomdoost, Donna; Grey, Scott; Sridhar, Amaanti; Wallace, Dennis.

In: JAMA - Journal of the American Medical Association, Vol. 322, No. 11, 17.09.2019, p. 1054-1065.

Research output: Contribution to journalArticle

Nager, Charles W. ; Visco, Anthony G. ; Richter, Holly E. ; Rardin, Charles R. ; Rogers, Rebecca G. ; Harvie, Heidi S. ; Zyczynski, Halina M. ; Paraiso, Marie Fidela R. ; Mazloomdoost, Donna ; Grey, Scott ; Sridhar, Amaanti ; Wallace, Dennis. / Effect of vaginal mesh hysteropexy vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse : A randomized clinical trial. In: JAMA - Journal of the American Medical Association. 2019 ; Vol. 322, No. 11. pp. 1054-1065.
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abstract = "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. Trial Registration: ClinicalTrials.gov Identifier: NCT01802281.",
author = "Nager, {Charles W.} and Visco, {Anthony G.} and Richter, {Holly E.} and Rardin, {Charles R.} and Rogers, {Rebecca G.} and Harvie, {Heidi S.} and Zyczynski, {Halina M.} and Paraiso, {Marie Fidela R.} and Donna Mazloomdoost and Scott Grey and Amaanti Sridhar and Dennis Wallace",
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T1 - Effect of vaginal mesh hysteropexy vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse

T2 - A randomized clinical trial

AU - Nager, Charles W.

AU - Visco, Anthony G.

AU - Richter, Holly E.

AU - Rardin, Charles R.

AU - Rogers, Rebecca G.

AU - Harvie, Heidi S.

AU - Zyczynski, Halina M.

AU - Paraiso, Marie Fidela R.

AU - Mazloomdoost, Donna

AU - Grey, Scott

AU - Sridhar, Amaanti

AU - Wallace, Dennis

PY - 2019/9/17

Y1 - 2019/9/17

N2 - 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. Trial Registration: ClinicalTrials.gov Identifier: NCT01802281.

AB - 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. Trial Registration: ClinicalTrials.gov Identifier: NCT01802281.

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