Characteristics associated with composite surgical failure over 5 years of women in a randomized trial of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension - 22/12/22
, Amaanti Sridhar, MS b, Charles W. Nager, MD c, Yuko M. Komesu, MD d, Heidi S. Harvie, MD e, Halina M. Zyczynski, MD f, Charles Rardin, MD g, Anthony Visco, MD h, Donna Mazloomdoost, MD i, Sonia Thomas, DrPH bOn behalf of the
Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network
Abstract |
Background |
Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years.
Objective |
This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse.
Study Design |
This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤1 year, >1 year, and no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate P<.2, additional clinically important variables, apical repair, and clinical site. Backward selection determined final retained risk factors (P<.1) with statistical significance evaluated by Bonferroni correction (P<.005). Final factors were assessed for interaction with type of apical repair at P<.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors.
Results |
In the final multivariable model, body mass index (increase of 5 kg/m2: adjusted hazard ratio, 1.7; 95% confidence interval, 1.3–2.2; P<.001) and duration of prolapse symptoms (increase of 1 year: adjusted hazard ratio, 1.1; 95% confidence interval, 1.0–1.1; P<.005) were associated with composite surgical failure, where rates of failure were 2.9 and 1.8 times higher in women with obesity and women who are overweight than women who have normal weight and women who are underweight (95% confidence intervals, 1.5–5.8 and 0.9–3.5) and 3.0 times higher in women experiencing >5 years prolapse symptoms than women experiencing ≤5 years prolapse symptoms (95% confidence interval, 1.8–5.0). Sacrospinous hysteropexy with graft had a lower rate of failure than hysterectomy with uterosacral suspension (adjusted hazard ratio, 0.6; 95% confidence interval, 0.4–1.0; P=.05). The interaction between symptom duration and apical repair (P=.07) indicated that failure was less likely after hysteropexy than hysterectomy for those with ≤5 years symptom duration (adjusted hazard ratio, 0.5; 95% confidence interval, 0.2–0.9), but not for those with >5 years symptom duration (adjusted hazard ratio, 1.0; 95% confidence interval 0.5–2.1).
Conclusion |
Obesity and duration of prolapse symptoms have been determined as risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse.
Le texte complet de cet article est disponible en PDF.Key words : sacrospinous hysteropexy with graft, surgical repair, transvaginal mesh hysteropexy, transvaginal prolapse repair, uterosacral ligament suspension, uterovaginal prolapse, vaginal hysterectomy
Plan
| This study was conducted and funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network (grant numbers U10 HD054214, U10 HD041267, U10 HD041261, U10 HD069013, U10 HD069025, U10 HD069010, U10 HD069006, U10 HD054215, and U01HD069031). Partial support was provided by the Boston Scientific Corporation through an unrestricted grant to the Data Coordinating Center, RTI International. Boston Scientific Corporation had no role in the study design, data collection, data management, data analysis, data interpretation, writing of the report, or decision to submit this manuscript. |
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| H.E.R. receives institutional research support from Renovia, Allergan, the National Institute on Aging, the National Institute of Diabetes and Digestive and Kidney Diseases, and the NICHD and receives royalties from UpToDate. |
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| C.R. receives institutional research support from the NICHD, the Foundation for Female Health Awareness, Solace Therapeutics, Reia Inc, the Institutional Resident Education Support, and Boston Scientific Corporation. |
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| The authors report no conflict of interest. |
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| This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institutes of Health Office of Research on Women’s Health |
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| This study was registered on ClinicalTrials.gov (trial identification: NCT01802281; www.clinicaltrials.gov) on April 2, 2013. The date of initial participant enrollment was on April 22, 2013. |
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| This study was presented orally at the Pelvic Floor Disorders Week, Phoenix, AZ, October 12–16, 2021. |
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| This study received an award for best clinical paper. |
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| Nonpersonally identifying individual participant data along with a data dictionary and explanation of deidentification methodology is available for use. |
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| A total of 27 datasets are available for use, in both SAS and CSV format. Data includes information, such as patient demographics, medical history, Pelvic Organ Prolapse Quantification assessments, and quality of life measures. |
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| The study protocol, annotated case report forms and annotated quality of life forms, data dictionary, and deidentification methodology are available. |
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| Data became available on March 28, 2022 and are available indefinitely. |
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| Data can be requested for use via the NICHD Data and Specimen Hub (DASH; 417076. There is no data use limitation. |
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| Cite this article as: Richter HE, Sridhar A, Nager CW, e al. Characteristics associated with composite surgical failure over 5 years of women in a randomized trial of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension. Am J Obstet Gynecol 2023;228:63.e1-16. |
Vol 228 - N° 1
P. 63.e1-63.e16 - janvier 2023 Retour au numéro
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