Apical Suspension Procedures Research Articles

Unequal Access and Overall Scarcity of Apical Suspension in Native Tissue Prolapse Repair.

Evaluation of racial and ethnic differences in apical suspension during prolapse repair is crucial for equitable gynecological care. The objective was to assess racial and ethnic disparities in apical suspension during native tissue prolapse repair. We analyzed data from the 2019 Healthcare Cost and Utilization Project National Inpatient Sample and Nationwide Ambulatory Surgery Sample, using Current Procedural Terminology and International Classification of Diseases, Tenth Revision, codes. Bivariate analysis identified demographic and hospital-based differences between native tissue apical suspension procedures versus non-apical suspension during vaginal hysterectomy for prolapse, further analyzed with multivariable logistic regression. A separate analysis examined posthysterectomy prolapse surgical procedures. Of the 62,553 vaginal hysterectomies, 26,094 (41%) were for prolapse. Among these, 14,027 (54%) included apical suspension. The cohort's racial and ethnic identity was 73% non-Hispanic White, 5% Black, 15% Hispanic, 3% Asian, 0% Native American, and 3% other. Multivariable analysis confirmed Black patients were more likely to receive apical suspension compared to non-Hispanic White patients (adjusted odds ratio [aOR] 1.26, 95% CI: 1.04-1.53, P = 0.02), and Hispanic patients were less likely to receive apical suspension (aOR 0.74, 95% CI: 0.63-0.87, P < 0.001). Among 60,074 posthysterectomy prolapse surgical procedures, only 18% included apical suspension. Compared to non-Hispanic Whites, Black, Hispanic, and Asian patients were less likely to receive apical suspension (Black: aOR 0.8, 95% CI: 0.68-0.95, P = 0.013; Hispanic: aOR 0.89, 95% CI: 0.77-1.04, P = 0.14; Asian: aOR 0.52, 95% CI: 0.41-0.66, P < 0.001). The study highlights persistent racial and ethnic disparities in apical suspension provision. There is a notable lack of apical suspension in native tissue repairs, especially after hysterectomy.

Obesity and Native Tissue Repairs: A Secondary Analysis of the OPTIMAL Trial.

The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial compared sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) surgical outcomes. Increasing body mass index (BMI) is associated with an increased risk of pelvic organ prolapse, and the prevalence of obesity is increasing worldwide. The purpose of this study was to better understand the effect of obesity on the results of native tissue vaginal apical suspension procedures. This was a secondary analysis of the OPTIMAL Trial data set. Subgroup analysis was performed to compare surgical failure rates between SSLF and ULS across BMI subgroups after 2 years. There were 75, 120, 63, and 39 patients in the normal, overweight, class 1 obesity, and class 2 obesity or greater BMI subgroups, respectively. There were no statistically significant differences in surgical failure rates between SSLF and ULS within BMI subgroups; however, failure rates increased in the ULS group between the nonobese and obese groups (normal, 35.9% SSLF vs 30.6% ULS [ P = 0.81]; overweight, 38.6% vs 30.2% [ P = 0.44]; class 1 obesity, 38.7% vs 40.6% [ P = 0.92]; class 2 obesity or greater, 21.1% vs 45% [ P = 0.21]). The risk of surgical failure between SSLF and ULS was not significant across BMI subgroups. Additional investigation is required to further elucidate whether SSLF or ULS is a more reliable option for obese patients.

Statewide geographic variation in hysterectomy approach for pelvic organ prolapse: a county-level analysis

There are no definitive guidelines for surgical treatment of pelvic organ prolapse. Previous data suggests geographic variation in apical repair rates in health systems throughout the United States. Such variation can reflect lack of standardized treatment pathways. An additional area of variation for pelvic organ prolapse repair may be hysterectomy approach which could not only influence concurrent repair procedures, but also healthcare utilization. This study aimed to examine statewide geographic variation in surgical approach of hysterectomy for prolapse repair and concurrent use of colporrhaphy and colpopexy. We conducted a retrospective analysis of Blue Cross Blue Shield, Medicare, and Medicaid fee-for-service insurance claims for hysterectomies performed for prolapse in Michigan between October 2015 and December 2021. Prolapse was identified with International Classification of Disease Tenth Revision codes. The primary outcome was variation in surgical approach for hysterectomy as determined by Current Procedural Terminology code (vaginal, laparoscopic, laparoscopic assisted vaginal, or abdominal) on a county level. Patient home address zip codes were used to determine county of residence. A hierarchical multivariable logistic regression model with vaginal approach as the dependent variable and county-level random effects was estimated. Patient attributes, including age, comorbidities (diabetes mellitus, chronic obstructive pulmonary disease, congestive heart failure, morbid obesity), concurrent gynecologic diagnoses, health insurance type, and social vulnerability index were used as fixed-effects. To estimate variation between counties in vaginal hysterectomy rates, a median odds ratio was calculated. There were 6974 hysterectomies for prolapse representing 78 total counties that met eligibility criteria. Of these, 2865 (41.1%) underwent vaginal hysterectomy, 1119 (16.0%) underwent laparoscopic assisted vaginal hysterectomy, and 2990 (42.9%) underwent laparoscopic hysterectomy. The proportion of vaginal hysterectomy across 78 counties ranged from 5.8% to 86.8%. The median odds ratio was 1.86 (95% credible interval, 1.33-3.83), consistent with a high level of variation. Thirty-seven counties were considered statistical outliers because the observed proportion of vaginal hysterectomy was outside the predicted range (as defined by confidence intervals of the funnel plot). Vaginal hysterectomy was associated with higher rates of concurrent colporrhaphy than laparoscopic assisted vaginal hysterectomy or laparoscopic hysterectomy (88.5% vs 65.6% vs 41.1%, respectively; P<.001) and lower rates of concurrent colpopexy (45.7% vs 51.7% vs 80.1%, respectively; P<.001). This statewide analysis reveals a significant level of variation in the surgical approach for hysterectomies performed for prolapse. The variation in surgical approach for hysterectomy may help account for high rates of variation in concurrent procedures, especially apical suspension procedures. These data highlight how geographic location may influence the surgical procedures a patient undergoes for uterine prolapse.

PROMIS pain intensity and interference after pelvic organ prolapse surgery.

Patient-Reported Outcome Measurement Information System (PROMIS) questionnaires provide valid comparisons across disciplines. Pain measures can be used to track functional outcomes. Limited PROMIS pain data exist in gynecological surgery. We sought to use pain intensity and pain interference short forms to assess pain and recovery after pelvic organ prolapse surgery. The PROMIS pain intensity and pain interference questionnaires were given to patients undergoing uterosacral ligament suspension (USLS), sacrospinous ligament fixation (SSLF) or minimally invasive sacrocolpopexy (MISC) at baseline, 1 week, and 6 weeks postoperatively. Clinical minimally important change was defined as a difference of 2-6T-score points. Mean pain intensity and pain interference T-scores were compared at baseline, 1 week and 6 weeks with ANOVA. Multiple linear regression assessed 1-week scores adjusted for apical suspension type, advanced prolapse, concurrent hysterectomy, concurrent anterior or posterior repair, and concurrent sling. At 1 week, all apical suspension groups showed minimally important change in pain intensity and pain interference T-scores. Between groups at 1 week, pain interference was higher in USLS (66.3±6.6) and MISC (65.5±5.9) than in SSLF (59.2±9.8), p=0.01. Multiple linear regression showed an association of hysterectomy with increases in pain intensity and pain interference. USLS had a higher proportion of concurrent hysterectomy (100%) than SSLF (0%) and MISC (30.8%), p<0.01. No difference was found based on apical suspension type alone. No differences were found in PROMIS pain intensity and pain at 1week postoperatively after apical suspension procedures.

Developing a 3d quantification strategy to evaluate vaginal apical fixation alternation after apical suspension procedures

Developing a 3d quantification strategy to evaluate vaginal apical fixation alternation after apical suspension procedures

Frailty and Acute Postoperative Urinary Retention in Older Women Undergoing Pelvic Organ Prolapse Surgery.

Acute postoperative urinary retention (POUR) is common after pelvic reconstructive surgery, occurring in 15-45% of women. There is a paucity of data on the relationship between frailty and POUR after prolapse surgery. This study aimed to examine the association between frailty and POUR in older women who underwent pelvic organ prolapse surgery. This secondary analysis of a prospective study of postoperative delirium enrolled women 60 years and older undergoing prolapse surgery. The Fried Frailty Index was used to assess frailty before surgery. Acute POUR was defined as failure to pass a retrograde voiding trial at hospital discharge with postvoid residual volume of greater than 100 mL. Analyses included 165 women, with a mean ± SD age of 72.5 ± 6.1 years and a body mass index of 28.0 ± 4.4 kg/m2. There were 49 laparoscopic/robotic apical suspension procedures (29.7%), 60 vaginal obliterative procedures (36.4%), 47 vaginal apical suspension procedures (28.5%), and 9 isolated anterior and/or posterior colporrhaphies (5.5%), of which 9 had a concomitant incontinence procedure. Seventy-eight women (47.3%) experienced acute POUR. Thirty-one (18.8%) met the criteria for "not frail," 115 (88.5%) were "prefrail," and 19 (11.5%) were "frail." Neither frailty status nor score was associated with POUR. In an analysis of individual Fried Frailty Index components, self-reported unintentional weight loss was significantly associated with POUR (odds ratio, 4.6; 95% confidence interval, 1.23-17.15). This remained significant on multivariable logistic regression (adjusted odds ratio, 4.06; 95% confidence interval, 1.01-16.39). Frailty was not associated with POUR in older women undergoing prolapse surgery. The observed association between POUR and unintended weight loss before surgery warrants further investigation.

Long-term reoperation risk after apical prolapse repair in female pelvic reconstructive surgery

Although several different apical suspension procedures are available to women with pelvic organ prolapse, data on long-term efficacy and safety profiles are limited. The primary aim of this study was to analyze longitudinal reoperation risk for recurrent prolapse among the 4 apical suspension procedures over 2 to 15 years. Secondary aims included evaluation of all-cause reoperation, defined as a repeated surgery for the indications of recurrent prolapse and adverse events, and total retreatment rate, which included a repeated treatment with another surgery or a pessary. This was a multicenter, retrospective cohort study within Kaiser Permanente Southern California that included women who underwent sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament fixation, or colpocleisis from January 2006 through December 2018. Women who underwent concomitant rectal prolapse repair or vaginal prolapse repair with mesh augmentation were excluded. Data were abstracted using procedural and diagnostic codes through July 2021, with manual review of 10% of each variable. Patient demographics and pessary use were compared using analysis of variance or chi square tests for continuous and categorical variables, respectively. Time-to-event analysis was used to contrast reoperation rates. A Cox regression model was used to perform an adjusted multivariate analysis of the following predictors of reoperation for recurrence: index surgery, concomitant procedures, patient demographics, baseline comorbidities, and year of index surgery. Censoring events included exit from the health maintenance organization and death. The cohort included 9681 women with maximum follow-up of 14.8 years. The overall incidence of reoperation for recurrent prolapse was 7.4 reoperations per 1000 patient-years, which differed significantly by type of apical suspension (P<.0001). The incidence of reoperation was lower after colpocleisis (1.4 events per 1000 patient-years) and sacrocolpopexy (4.8 events per 1000 patient-years) when compared with uterosacral ligament suspension (9 events per 1000 patient-years) and sacrospinous ligament fixation (13.9 events per 1000 patient-years). All pairwise comparisons between procedures were significant (P=.0003-.0018) after correction for multiplicity, except for uterosacral ligament suspension or uterosacral ligament hysteropexy vs sacrospinous ligament fixation or sacrospinous ligament hysteropexy (P=.05). The index procedure was the only significant predictor of reoperation for recurrence (P=.0003-.0024) on multivariate regression analysis. Reoperations for complications or sequelae (overall 2.9 events per 1000 patient-years) also differed by index procedure (P<.0001) and were highest after sacrocolpopexy (4.4 events per 1000 patient-years). The incidence of all-cause reoperation for recurrence and adverse events after sacrocolpopexy, however, was comparable to that of the other reconstructive procedures (P=.1-.4) in pairwise comparisons with Bonferroni correction. Similarly, frequency of pessary use differed by index procedure (P<.0001) and was highest after sacrospinous ligament fixation at 9.3% (43/464). Among nearly 10,000 patients undergoing prolapse surgery within a large managed care organization, colpocleisis and sacrocolpopexy offered the most durable obliterative and reconstructive prolapse repairs, respectively. All-cause reoperation rates were lowest after colpocleisis by a large margin, but similar among reconstructive apical suspension procedures.

Trends in Apical Suspension at the Time of Hysterectomy for Pelvic Organ Prolapse: Impact of American College of Obstetricians and Gynecologists Recommendations.

The aim of the study was to compare national surgical practice patterns of performing apical suspension procedures (ASPs) at the time of hysterectomy for pelvic organ prolapse (POP) before and after the publication of the American College of Obstetricians and Gynecologists (ACOG) 2017 Practice Bulletin on POP. The American College of Surgeons National Surgical Quality Improvement Program database was queried for hysterectomy cases performed for POP indications for the years 2015-2016 and 2018-2019. The primary outcome was the use of ASP at the time of hysterectomy for POP. Secondary outcomes included the use of anterior, posterior, and paravaginal prolapse repair procedures. Multivariable regression analysis was performed to identify factors associated with performing a hysterectomy without an ASP. A total of 11,336 cases were included, and apical prolapse was the primary POP diagnosis in 86.3% of these cases. There was no statistically significant change in the utilization of ASPs in 2018-2019 compared with 2015-2016 (51.4% vs 49.8%, P = 0.081). Urogynecologists were significantly more likely than general gynecologists to perform ASPs (65.6% vs 37.5%, P < 0.001), which was confirmed on multivariable logistic regression analysis (adjusted odds ratio, 3.257; P < 0.001). The use of concomitant anterior repairs (44.1% vs 39.5%, P < 0.001) and posterior repairs (47.5% vs 41.3%, P < 0.001) increased in the 2018-2019 cohort. There was no overall increase in the utilization of concomitant ASPs at the time of hysterectomy done for POP indications despite the 2017 American College of Obstetricians and Gynecologists practice bulletin. Urogynecologists were more likely to perform ASPs than general gynecologists.

Complications After Vesicovaginal Fistula Repair Based on Surgeon Specialty in the United States: Analysis of a National Database.

This study aimed to compare the rates of major and minor complications for vesicovaginal fistula (VVF) repair based on surgeon specialty and to identify risk factors for adverse outcomes. This was a retrospective cohort analysis of the American College of Surgeons National Surgical Quality Improvement Program between the years 2014 and 2019. Cases were identified using Current Procedural Terminology codes for VVF repair. Minor and major complication rates for VVF repair were compared between 2 cohorts defined by surgeon specialty: gynecology versus urology. Additional outcomes included readmissions and reoperations. Multivariable logistic regression analysis was performed to investigate risk factors for complications. A total of 319 VVF repairs were included in the analysis, of which 115 (36.1%) were performed by gynecologists and 204 (63.9%) by urologists. There were no significant differences in the demographic or medical characteristics between the gynecology and urology cohorts except for race. Gynecologists performed more concomitant hysterectomies (10.4% vs 1.0%, P < 0.001) and apical suspension procedures (6.1% vs 0%, P < 0.001). There were no differences in minor (7.8% vs 6.4%, P = 0.623) or major (2.6% vs 3.4%, P = 1.000) complications between the cohorts. The overall readmission rate was 4.7%, and the reoperation rate was 2.2% with no differences between specialties. On multivariable logistic regression analysis, body mass index and concurrent hysterectomy were risk factors for major or minor complications with no increased risk associated with surgeon specialty or route of surgery. Complication rates did not differ for VVF repairs performed by gynecologists compared with urologists. Readmission and reoperation rates were low for both groups.

Longitudinal reoperation risk after apical suspension procedures in female pelvic reconstructive surgery

To analyze longitudinal reoperation risk for recurrent pelvic organ prolapse (POP) among the 4 apical suspension procedures over a period of 2 through 15 years. This multicenter, retrospective cohort study included adult women who underwent sacrocolpopexy (SCP), uterosacral ligament suspension (USLS), sacrospinous ligament fixation (SSLF), or colpocleisis (CC) from January 1, 2006 through December 31, 2018, with follow up through July 25, 2021. Women who underwent vaginal prolapse repair with mesh augmentation or concomitant rectopexy were excluded. Data were abstracted using procedural and diagnosis codes with manual review of 10% of each variable. The primary outcome was reoperation for POP in any compartment. Rates were compared using a X2 test with Bonferroni correction. Time to event distributions was contrasted with a log rank test. Multivariate analysis using a Cox proportional hazards model with Firth correction evaluated the following predictors: index surgery, patient characteristics (age, race/ethnicity, body mass index [BMI], smoking status), concomitant procedures (hysterectomy, compartment repairs, incontinence procedures), and year of index surgery. Censoring events included exit from the health maintenance organization and death. This cohort included 9,117 women with mean age of 60.6 (SD ±11.6) years and BMI of 28 kg/m2 (±4.9) at the time of index surgery. Most women were Hispanic (48.3%) or White (40.2%). The overall reoperation rate was 5.1%. Rates by procedure are shown in Table 1. Significant differences were found in the following pairwise comparisons: SCP (3.6%) versus USLS (6.1%; P <0.0006), SCP (3.6%) versus SSLF (9%; P <0.0006), SCP (3.6%) versus CC (0.8%; P <0.0006), USLS (6.1%) versus CC (0.8%; P <0.0006), and SSLF (9%) versus CC (0.8%; P <0.0006). Reoperation rate did not significantly differ between USLS (6.1%) and SSLF (9%; P =0.074) after correction for multiplicity. Similarly, pairwise comparisons of time to event distributions were significant (P =0.0003-0.0018), except for USLS versus SSLF (P =0.05). Index procedure was found to be a significant predictor of reoperation when compared to SCP (Table 1, P =0.0003-0.0024). No other covariates were shown to consistently predict reoperation upon either crude or adjusted analysis. While overall reoperation rate after apical suspension is low, index surgery is a significant predictor of reoperation. CC offers the most durable prolapse repair, followed by SCP. USLS and SSLF appear to be comparable to one another in durability.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

19 The impact of obesity on native tissue repair outcomes: A secondary analysis of the OPTIMAL trial data

The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial was a multi-site, prospective randomized trial which compared sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) surgical outcomes, and also evaluated the impact of perioperative pelvic muscle training (PMT). Increasing body mass index (BMI) is associated with increased risk of pelvic organ prolapse and the prevalence of obesity is increasing worldwide. The purpose of this study is to better understand the impact of obesity on the results of native tissue vaginal apical suspension procedures. This study is a secondary analysis of data collected during the OPTIMAL trial, which is now a deidentified public dataset in the NIH Data and Specimen Hub database. Subgroup analysis of patients who received SSLF or ULS procedures and PMT or usual care was performed to determine if there were differences in surgical failure rates across a range of BMIs after two years. The sample size in this analysis was 297; not all of the original OPTIMAL data was available due to the deidentification process. Data were analyzed using ANOVA test, Tukey’s HSD post-hoc analysis, Fisher’s exact test, and Wald correct proportion risk difference test which is a method of identifying 95% confidence intervals. There were 75, 120, 63, and 39 patients in the normal, overweight, class 1 obesity, and class 2 obesity or greater BMI subgroups, respectively. The groups were not significantly different based on surgical arm or PMT arm, smoking, estrogen use, menopausal status, or number of cesarean sections (Table 1). However, there were differences in age, race, and number of vaginal births. In each BMI subgroup, the surgical failure rates and risk differences were not significantly different for the surgical or PMT arms (Table 2). Interestingly, the surgical failure rate increased in the ULS group with increasing BMI (normal = 30.56%, overweight = 30.16%, class 1 obese = 40.63%, class 2 obese or greater = 45%). Additionally, the risk difference between ULS and SSLF groups increased with BMI (normal = 5.34%, overweight = 8.44%, class 1 obesity = 1.92%, class 2 obesity or greater = 23.95%). The risk of surgical failure between ULS and SSLF, or PMT and usual care, is not significantly associated with increasing BMI. However, the increasing failure rate of ULS and difference in failure rates of ULS compared to SSLF with increasing BMI in our study may indicate an association if analyzed for a longer time period.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Readmissions and perioperative outcomes for same-day versus next-day discharge after prolapse surgery.

We aimed to evaluate the safety of same-day discharge (SDD) compared with next-day discharge (NDD) after prolapse surgery on a national level hypothesizing that readmission and complication rates after SDD would not be higher than NDD. We performed a retrospective cohort study using the National Surgical Quality Improvement Program database including 2014-2018. Current Procedural Terminology (CPT) codes were used to identify minimally invasive apical suspensions or obliterative procedures. Exclusion criteria were length of stay > 1day, unrelated concomitant procedures, serious medical comorbidities, American Society of Anesthesiologists (ASA) Class >2, and complication during index admission. The primary outcome was 30-day readmission, and secondary outcomes included 30-day complications. 12,583 were included in analysis. SDD rate was 16.7%. The majority of women were white (91%) with a mean age of 59years and mean body mass index of 28kg/m². Medical comorbidities were similar between the SDD and NDD groups. Overall incidence of 30-day readmission was 1.7%. SDD had lower odds of 30-day readmission than NDD (aOR 0.63, 95% CI 0.41-0.98). SDD had lower odds of 30-day complications but this failed to reach statistical significance (aOR 0.67, 95% CI 0.44-1.03). In this cohort, 30-day readmission and complication rates were not higher after SDD compared to NDD in women undergoing minimally-invasive apical suspension or obliterative procedures. We interpret these findings carefully given study limitations but believe our findings support the safety of SDD after minimally invasive apical suspension or obliterative procedures in a low-risk population.

Comparison of treatment outcomes for native tissue repair and sacrocolpopexy as apical suspension procedures at the time of hysterectomy for uterine prolapse

Concomitant apical suspension should be performed at the time of hysterectomy for uterine prolapse to reduce the risk of recurrent prolapse. Native tissue repair (NTR) and sacrocolpopexy (SCP) are commonly used apical suspension procedures; however, it remains unclear which one is preferred. This study aimed to compare the treatment outcomes of NTR and SCP in terms of surgical failure, complication and reoperation rates. Surgical failure was defined as the presence of vaginal bulge symptoms, any prolapse beyond the hymen, or retreatment for prolapse. This retrospective cohort study included 523 patients who had undergone NTR (n = 272) or SCP (n = 251) along with hysterectomy for uterine prolapse and who had at least 4-month follow-up visits. During the median 3-year follow-up period, the surgical failure rate was higher in the NTR group (21.3% vs 6.4%, P < 0.01), with a low rate of retreatment in both groups. Overall complication rates were similar, but complications requiring surgical correction under anesthesia were more common in the SCP group (7.2% vs 0.4%, P < 0.01). As a result, the total reoperation rate was significantly higher in the SCP group (8.0% vs 2.6%, P = 0.02). Taken together, NTR may be a preferred option for apical suspension when hysterectomy is performed for uterine prolapse.

Guideline No. 413: Surgical Management of Apical Pelvic Organ Prolapse in Women

To compare success and complication rates of apical suspension procedures for the surgical management of symptomatic uterine or vaginal vault prolapse. Women with symptomatic uterine or vaginal vault prolapse seeking surgical correction. Interventions included abdominal apical reconstructive repairs (sacrocolpopexy, sacrohysteropexy, or uterosacral hysteropexy) via open, laparoscopic, or robotic approaches; vaginal apical reconstructive repairs (vault suspensions or hysteropexy, sacrospinous, uterosacral, iliococcygeus, McCall's, or Manchester types); and vaginal obliterative procedures (with or without uterus in situ). Individual procedures or broad categories of procedures were compared: (1) vaginal versus abdominal routes for reconstruction, (2) abdominal procedures for reconstruction, (3) vaginal procedures for reconstruction, (4) hysterectomy and suspension versus hysteropexy for reconstruction, and (5) reconstructive versus obliterative options. The Urogynaecology Committee selected outcomes of interest: objective failure (obtained via validated pelvic organ prolapse [POP] quantification systems and defined as overall objective failure as well as failure rate by compartment); subjective failure (recurrence of bulge symptoms determined subjectively, with or without use of a validated questionnaire); reoperation for POP recurrence; complications of postoperative lower urinary tract symptoms (de novo or postoperative stress urinary incontinence; reoperation for persistent, recurrent, or de novo stress urinary incontinence; urge urinary incontinence; and voiding dysfunction); perioperatively recognized urinary tract injury (bladder or ureter); other complications (mesh exposure, defined as mesh being visible and exposed in the vagina, and non-sexual pelvic pain); and sexual function (de novo dyspareunia and sexual function score according to a validated questionnaire). This guideline will benefit patients seeking surgical correction of apical POP by improving counselling on surgical treatment options and possible outcomes. It will also benefit surgical providers by improving their knowledge of various surgical approaches. Data presented could be used to develop frameworks and tools for shared decision-making. We searched Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and Embase from 2002 to 2019. The search included multiple terms for apical POP surgical procedures, approaches, and complications. We excluded POP repairs using transvaginal mesh and studies that compared procedures without apical suspension. We included randomized controlled trials and prospective or retrospective comparative studies. We limited language of publication to English and French and accessibility to full text. A systematic review and meta-analysis was performed. The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and weak recommendations). Gynaecologists, urologists, urogynaecologists, and other health care providers who assess, counsel, and care for women with POP. All statements refer to correction of apical vaginal prolapse in the short and medium term (up to 5 years), except when otherwise specified.

Methods for the defining mechanisms of anterior vaginal wall descent (DEMAND) study.

The protocol and analysis methods for the Defining Mechanisms of Anterior Vaginal Wall Descent (DEMAND) study are presented. DEMAND was designed to identify mechanisms and contributors of prolapse recurrence after two transvaginal apical suspension procedures for uterovaginal prolapse. DEMAND is a supplementary cohort study of a clinical trial in which women with uterovaginal prolapse randomized to (1) vaginal hysterectomy with uterosacral ligament suspension or (2) vaginal mesh hysteropexy underwent pelvic magnetic resonance imaging (MRI) at 30-42months post-surgery. Standardized protocols have been developed to systematize MRI examinations across multiple sites and to improve reliability of MRI measurements. Anatomical failure, based on MRI, is defined as prolapse beyond the hymen. Anatomic measures from co-registered rest, maximal strain, and post-strain rest (recovery) sequences are obtained from the "true mid-sagittal" plane defined by a 3D pelvic coordinate system. The primary outcome is the mechanism of failure (apical descent versus anterior vaginal wall elongation). Secondary outcomes include displacement of the vaginal apex and perineal body and elongation of the anterior wall, posterior wall, perimeter, and introitus of the vagina between (1) rest and strain and (2) rest and recovery. Recruitment and MRI trials of 94 participants were completed by May 2018. Methods papers which detail studies designed to evaluate anatomic outcomes of prolapse surgeries are few. We describe a systematic, standardized approach to define and quantitatively assess mechanisms of anatomic failure following prolapse repair. This study will provide a better understanding of how apical prolapse repairs fail anatomically.

Apical suspension is underutilized for repair of stage IV pelvic organ prolapse: an analysis of national practice patterns in the United States.

Support of the vaginal apex is paramount for a durable repair of pelvic organ prolapse (POP). Our aim is to assess national utilization of apical suspension procedures for the surgical treatment of complete POP. We hypothesize that there might be a high rate of apical suspension with advanced prolapse. The 2006-2016 National Surgical Quality Improvement Program database was queried for a primary postoperative diagnosis of complete POP. The primary outcome was type of repair. Secondary outcomes included patient characteristics associated with apical suspension or colpocleisis. Procedures were delineated using CPT codes. Chi-squared and multivariate logistic regression analyses were used to evaluate factors associated with repair type. A total of 2,784 women underwent surgery for complete POP with a mean age of 64.6± 11.0years. Overall, 1,300 (46.7%) patients underwent apical suspension: 487 sacrocolpopexies (17.5%), 428 extraperitoneal suspensions (15.4%), and 391 uterosacral suspensions (14.0%). 5.2% (144) underwent colpocleisis, and 47.5% (1,332) of women had a concurrent hysterectomy (CH). With CH, 38.6% (502) had apical suspension or colpocleisis versus 69.5% (940) of post-hysterectomy cases. On logistic regression, CH was inversely associated with apical suspension (adjusted odds ratio [aOR] 0.37, CI 0.32-0.44, p < 0.001). Colpocleisis was associated with older age (aOR 4.9 per 10years, CI 3.8-6.3, p < 0.001), post-hysterectomy surgery (aOR 0.23, CI 0.1-0.4, p < 0.001 for CH), and higher comorbidity index (OR 1.7, CI 1.1-2.6, p = 0.009). Complication rates are similar with and without apical suspension (8.2% versus 7.0%, p = 0.269). During surgery for complete POP, an apical suspension procedure is performed in 46.7% of patients and is more common post-hysterectomy.

I-STOP Sling Tape: Is It Associated With Reduced Exposure Rates in Apical Prolapse and Urinary Incontinence Procedures?

Background: Type 1 polypropylene synthetic mesh has been the preferred mesh material used for reconstructive surgery in the female pelvis in the past. I-STOP is an inelastic monofilament macroporous polypropylene mesh tape with looped edges. Our primary aim was to assess the incidence of mesh complications, including exposure/erosion in women who underwent I-STOP suburethral sling or apical sling suspension procedures. Methods: This study was a retrospective review of a comprehensive urogynecological database at the Cleveland Clinic Florida of who underwent I-STOP suburethral sling procedures or apical sling suspension between 2009 and 2018. A total of 165 apical slings and 476 suburethral slings were collected at predetermined follow-up visits at 6 weeks, 6 months, and then yearly. Results: Of the apical slings, 86 (52%) had a follow-up for 6 months or longer, with the maximum patient follow-up of 99 months (mean of 19 months). Zero of the 86 patients that were followed up in the review developed mesh erosion/exposure. A total of 307 (64%) patients who underwent I-STOP suburethral slings had follow-up for 6 months or longer with the maximum patient follow-up of 158 months (mean of 36 months). Two patients developed mesh erosion/exposure with a calculated complication rate at 0.42%. No patients in either group developed clinically evident mesh contraction. Conclusions: Our study demonstrated lower mesh erosion/exposure and complication rates with the use of the I-STOP tape both in apical sling and suburethral sling procedures compared to complication rates reported with the use of other mesh products. J Clin Gynecol Obstet. 2020;9(1-2):12-16 doi: https://doi.org/10.14740/jcgo643

Perineorrhaphy Outcomes Related to Body Imagery: A Randomized Trial of Body Image Perception.

The aim of this study was to determine if a perineorrhaphy at the time of apical pelvic organ prolapse surgery positively affects women's body image. This is a randomized controlled trial of women undergoing apical suspension procedures in which women (GH ≥2 cm to ≤6 cm) received either perineorrhaphy or no perineorrhaphy. The primary aim compared body image between the groups postoperatively using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire. Secondary outcomes included prolapse stage, pain, pelvic floor muscle strength, pelvic floor symptoms, and sexual function. Between- and within-group differences were compared using Fisher exact test for categorical variables and t tests for continuous variables. When continuous variables were not normally distributed, the Welch-Satterthwaite test was used. Within-group analyses were performed via paired t tests for select continuous variables. Forty-six women were enrolled; 45 (97.8%) completed the 6-week assessment and 38 (82.6%) completed the 3-month assessment. There were no differences in baseline characteristics. Although women within groups had an expected improvement in mean Body Image in Pelvic Organ Prolapse and subscale scores between baseline and 3 months (P < 0.05), there were no differences in the mean scores between groups. In addition, there were no differences between groups in any of the secondary outcomes. Performance of apical prolapse surgery improved women's body image, irrespective of performance of a perineorrhaphy. Other important outcomes, including pain, did not differ between women in the 2 groups. These findings demonstrate the need for further trials to investigate the utility of this procedure.

55: Cost-effectiveness analysis of surgical repair for apical prolapse

To evaluate the cost effectiveness of three routes of surgical repair for apical prolapse. We constructed a decision tree model to assess the cost effectiveness of apical suspension procedures, including vaginal sacrospinous and uterosacral ligament suspension, laparoscopic sacrocolpopexy, and robotic sacrocolpopexy, compared to expectant management. We modeled time horizons of 1 and 10 years, accounting for differing morbidities and recurrence rates. Outcomes included up to two separate surgical repairs for apical prolapse, effectiveness of prolapse repair, risk of re-operation, and complications. We calculated costs from the healthcare system’s perspective for the vaginal ($17,265), laparoscopic ($18,485) and robotic ($22,053) procedures, as well as an office visit ($379), lab tests ($184), imaging ($947) and antibiotics ($9). We estimated health utilities for no prolapse/cure at 1.0, symptomatic prolapse at 0.71, vaginal surgery at 0.96, laparoscopic and robotic surgeries at 0.90, and re-operation at 0.60. We discounted future costs and utilities at a rate of 3% annually. The base case analysis showed that, over a 1-year period, initial vaginal surgery followed by repeat vaginal surgery for recurrence, is the most cost-effective option. The incremental cost-effectiveness ratio (ICER) for this option is $150,756/QALY, whereas the ICER for initial laparoscopic surgery followed by repeat laparoscopic surgery if needed is $170,350/QALY, and the ICER for initial robotic surgery followed by repeat robotic surgery if needed is $201,282/QALY. However, over a 10-year period, initial laparoscopic surgery followed by repeat laparoscopic surgery for recurrence is the most cost-effective option (ICER $9,990/QALY). Whereas the ICER for initial vaginal surgery followed by repeat vaginal surgery for recurrence is $11,207/QALY, and the ICER for initial robotic surgery followed by repeat robotic surgery if needed for recurrence is $11,804/QALY. Sensitivity analyses showed that for patients with increased morbidity associated with laparoscopic surgery, initial vaginal surgery was the more cost-effective option when the QALY for laparoscopic surgery decreased below 0.68. Initial robotic surgery was more cost-effective than initial vaginal surgery when the cost of robotic surgery decreased by at least $1,175 per surgery. These results suggest that vaginal apical suspension is more cost-effective if the relevant time horizon is short-term or if there is increased morbidity with a laparoscopic approach. However, laparoscopic sacrocolpopexy is most cost-effective if the relevant time horizon is long-term. Further sensitivity analyses and Monte Carlo simulation is planned in our future analyses.

Teaching learners to raise the roof: a vaginal surgery simulator for apical suspension.

The objective was to discuss the importance of apical suspension following vaginal hysterectomy and demonstrate a surgical model to aide in educating learners on a variety of apical suspension procedures. Rates of pelvic organ prolapse are not insignificant following hysterectomy. Re-support of the vaginal apex should be performed at the time of hysterectomy in those with or without a diagnosis of prolapse. Exposure to vaginal apical support procedures may be limited owing to declining rates of vaginal hysterectomy and limited trainee work hours. Surgical models are increasingly being used to supplement operating room experience. The model we present was originally developed for hysterectomy, although its design allows for teaching a variety of apical support procedures that incorporate the uterosacral ligament (USL) for support. We demonstrate performing a USL suspension, internal McCall suture, and modified McCall suture using the model. The model is constructed from readily available supplies, is multi-use, and inexpensive. It allows learners to identify relevant anatomy, understand/visualize surgical steps, and practice suturing technique. Pelvic organ prolapse is common in women, although opportunities to teach apical suspension procedures may be limited. The proposed vaginal surgery simulator can be used to supplement the experience of gynecological surgery trainees with apical suspension procedures.