Original Research
Gynecology
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

https://doi.org/10.1016/j.ajog.2022.07.048Get rights and content

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.

Introduction

The apex of the vagina (either the cervix or the vaginal cuff) is thought to be the keystone of pelvic organ support. Loss of apical support is usually present in women with prolapse that extends beyond the hymen, when prolapse symptoms tend to occur.1,2 At least half of the observed variation in anterior compartment support may be explained by apical support.3 Adequate support for the vaginal apex is thought to be an essential component of a durable surgical repair for women with advanced prolapse.4,5 Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the vaginal hysterectomy with uterosacral ligament suspension (USLS) vs sacrospinous hysteropexy with graft suspension (Study for Uterine Prolapse Procedures Randomized Trial [SUPeR]) trial, sacrospinous hysteropexy with graft resulted in a lower composite surgical failure rate than vaginal hysterectomy with USLS over 5 years after the randomized surgical intervention (adjusted hazard ratio [aHR], 0.58; 95% confidence interval [CI], 0.36–0.94; P=.03).6 Beyond comparison of various surgical procedures, there is interest in identifying modifiable risk factors to reduce the risk of pelvic organ prolapse (POP) recurrence.

AJOG at a Glance

This study aimed to identify baseline clinical and demographic characteristics associated with time to composite surgical failure developing over 5 years in women with uterovaginal prolapse participating in a randomized trial.

Higher body mass index and longer duration of prolapse symptoms were associated with composite surgical failure. The interaction between symptom duration and apical repair indicated that failure was less likely after hysteropexy vs hysterectomy for those with ≤5 years symptom duration, but not for those with >5 years symptom duration.

This robust study showed that obesity and duration of prolapse symptoms are risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of mesh augmented hysteropexy or vaginal hysterectomy approaches. These modifiable risk factors should be considered with women presenting with prolapse symptoms and when discussing treatment plans for bothersome prolapse.

A recent secondary analysis of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) and Extended Follow-Up of Patients Enrolled in OPTIMAL (E-OPTIMAL) trials noted that risk factors found to be associated with composite surgical failure 5 years after native tissue vaginal prolapse repair included Hispanic ethnicity, larger preoperative perineal body, and higher pretreatment Pelvic Organ Prolapse Distress Inventory (POPDI) scores.7 Other risk factors for prolapse recurrence have been found to include levator avulsion, preoperative Pelvic Organ Prolapse Quantification System (POP-Q) stage 3 to 4, and family history.8,9

This planned secondary analysis aimed to identify characteristics associated with time to composite surgical failure developing over 5 years, including baseline clinical characteristics and demographics and operative and early postoperative factors. We hypothesized that clinical, demographic, and perioperative covariates associated with surgical treatment failure over 5 years would be identified that could be the focus of future intervention trials.

Section snippets

Materials and Methods

At 9 clinical sites in the Pelvic Floor Disorders Network, all women participating in this randomized trial provided written informed consent (NCT01802281). Participants were randomized 1:1 in the operating room to sacrospinous hysteropexy with graft (polypropylene mesh) or vaginal hysterectomy with USLS within each clinical site and remained masked to the type of surgery for 5 years of biannual follow-up.6 All eligible participants that were treated as randomized were included in the analysis

Results

The potential risk factors by surgical failure category are shown in Table 1. The median time of the failure events was 18 months. In unadjusted bivariate analysis, risk factors (P<.20) associated with composite surgical failure included higher education after high school (P=.02), vaginal parity (P=.11), body mass index (BMI; P<.001), baseline estrogen use (P=.13), history of smoking (P=.16), duration of prolapse symptoms (P=.002), POP-Q point Ba (P=.06), Incontinence Severity Index score (P

Principal findings

Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery randomized to sacrospinous hysteropexy with graft or vaginal hysterectomy with bilateral uterosacral ligament suspension, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years (aHR, 0.58; 95% CI, 0.36–0.94; P=.03).6 In this planned secondary analysis, risk factors associated with time to composite surgical failure over 5 years from surgical

Results in the context of what is known

Higher BMI was independently associated with surgical failure for both vaginal prolapse procedures; women with obesity (BMI ≥30 kg/m2) were 2.9 times more likely to experience surgical failure than women with normal weight and women who are underweight, and women who are overweight were 1.8 times more likely than women with normal weight and women who are underweight women to have failure. BMI has inconsistently been associated with failure after prolapse surgery. In a systematic review, higher

Acknowledgments

We would like to thank the following for making this study possible:

References (13)

There are more references available in the full text version of this article.

Cited by (2)

  • Nationwide assessment of practice variability in the utilization of hysteropexy at laparoscopic apical suspension for uterine prolapse

    2024, AJOG Global Reports

  • THE PLACE OF VAGINAL SACROSPINAL FIXATION IN THE SURGICAL TREATMENT OF GENITAL PROLAPSE

    2023, Akusherstvo i Ginekologiya (Russian Federation)

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.

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.

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.

The authors report no conflict of interest.

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

This study was registered on ClinicalTrials.gov (trial identification: NCT01802281; http://www.clinicaltrials.gov) on April 2, 2013. The date of initial participant enrollment was on April 22, 2013.

This study was presented orally at the Pelvic Floor Disorders Week, Phoenix, AZ, October 12–16, 2021.

This study received an award for best clinical paper.

Nonpersonally identifying individual participant data along with a data dictionary and explanation of deidentification methodology is available for use.

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.

The study protocol, annotated case report forms and annotated quality of life forms, data dictionary, and deidentification methodology are available.

Data became available on March 28, 2022 and are available indefinitely.

Data can be requested for use via the NICHD Data and Specimen Hub (DASH; https://dash.nichd.nih.gov/study/417076. There is no data use limitation.

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.

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