Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment.

INTRODUCTION AND HYPOTHESIS: Factors that contribute to reoperation and surgical approaches for the management of recurrent uterovaginal prolapse after vaginal mesh hysteropexy (mesh hysteropexy) are unknown. We aimed to describe surgical management of pelvic organ prolapse recurrence after vaginal mesh hysteropexy, and patient characteristics in those who chose reoperation. METHODS: This is a descriptive analysis of women who experienced treatment failure within 5 years of mesh hysteropexy in a multi-site randomized trial. The composite definition of treatment failure included retreatment (pessary or reoperation), prolapse beyond the hymen, or bothersome prolapse symptoms. Characteristics of those pursuing and not pursuing repeat prolapse surgery, measures of prolapse, and symptom severity are described. RESULTS: Over 5-year follow up, 31/91 (34%) of the hysteropexy group met treatment failure criteria. All seven women who pursued reoperation reported bothersome prolapse symptoms; six were anatomic failures. Most seeking reoperation were early treatment failures; six (86%) by the 12-month visit and all by the 18-month visit. Compared to those electing expectant management, those pursuing reoperation had more apical prolapse, POP-Q point C median (IQR) -5.5 (-6.0, -4.0) cm versus +1.0 (-1.0, 3.0) cm respectively. Hysterectomy was performed in 6/7 reoperations (three vaginal, three endoscopic), with apical suspension in 5/6 hysterectomies. One participant with posterior compartment prolapse underwent transvaginal enterocele plication, uterosacral ligament suspension with posterior colpoperineorrhaphy. At a mean surgical follow-up of 34.3 (15.8) months, all women remained without anatomic or symptomatic failure. CONCLUSIONS: When recurrent prolapse after mesh hysteropexy occurred, most women did not choose reoperation. Those who pursued surgery experienced more significant apical prolapse and were universally symptomatic. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01802281.

Risk Factors Associated With Postoperative Mortality Among COVID-19 Positive Patients: Results of 3027 Operations and Procedures.

OBJECTIVE: To investigate the predictors of postoperative mortality in coronavirus disease 2019 (COVID-19)-positive patients. BACKGROUND: COVID-19-positive patients have more postoperative complications. Studies investigating the risk factors for postoperative mortality in COVID-19-positive patients are limited. METHODS: COVID-19-positive patients who underwent surgeries/procedures in Cleveland Clinic between January 2020 and March 2021 were identified retrospectively. The primary outcome was postoperative/procedural 30-day mortality. Secondary outcomes were length of stay, intensive care unit admission, and 30-day readmission. RESULTS: A total of 2543 patients who underwent 3027 surgeries/procedures were included. Total 48.5% of the patients were male. The mean age was 57.8 (18.3) years. A total of 71.2% had at least 1 comorbidity. Total 78.7% of the cases were elective. The median operative time was 94 (47.0-162) minutes and mean length of stay was 6.43 (13.4) days. Postoperative/procedural mortality rate was 4.01%. Increased age [odds ratio (OR): 1.66, 95% CI, 1.4-1.98; P <0.001], being a current smoker [2.76, (1.3-5.82); P =0.008], presence of comorbidity [3.22, (1.03-10.03); P =0.043], emergency [6.35, (3.39-11.89); P <0.001] and urgent versus [1.78, (1.12-2.84); P =0.015] elective surgery, admission through the emergency department [15.97, (2.00-127.31); P =0.009], or inpatient service [32.28, (7.75-134.46); P <0.001] versus outpatients were associated with mortality in the multivariable analysis. Among all specialties, thoracic surgery [3.76, (1.66-8.53); P =0.002] had the highest association with mortality. Total 17.5% of the patients required intensive care unit admission with increased body mass index being a predictor [1.03, (1.01-1.05); P =0.005]. CONCLUSIONS: COVID-19-positive patients have higher risk of postintervention mortality. Risk factors should be carefully evaluated before intervention. Further studies are needed to understand the impact of pandemic on long-term surgical/procedural outcomes.

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

OBJECTIVE: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence. METHODS: Four-hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) compared with midurethral sling alone for mixed incontinence with 1-year follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective or objective failure or both. Subjective failure was defined as not meeting the minimal clinical important difference for improvement on the UDI (Urogenital Distress Inventory) total score (26.1 points). Objective failure was defined as not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for persistent urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated. RESULTS: One hundred twelve of 379 (29.6%) women had overall treatment failure, with 56 of 379 (14.7%) undergoing additional treatment but only two needing intervention for stress incontinence. Previous overactive bladder (OAB) medication (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.96, 95% CI 1.17-3.31); detrusor overactivity on cystometrogram (OR 2.25, aOR 2.82, 95% CI 1.60-4.97); and higher volume at first urge (OR 1.03, aOR 1.04, 95% CI 1.01-1.07) were associated with overall failure. Worse UDI-urgency scores were associated with failure, with an added interaction effect in the midurethral sling-alone group. CONCLUSIONS: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling in women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. Overall, the need for additional urinary treatment was low and primarily for OAB. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959347.

Complications following vaginal colpopexy for the repair of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The primary aim of this study was to compare differences in complication rates across different types of vaginal colpopexy using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. METHODS: Patients who underwent intra- or extraperitoneal vaginal colpopexy with or without concurrent hysterectomy were identified in the 2014-2016 NSQIP database using Current Procedural Terminology codes. Patient demographics, preoperative comorbidities, American Society of Anesthesiologists (ASA) classification system scores, and total operating time were obtained. NSQIP-tracked 30-day codes were used to determine the complication, reoperation, and readmission rates. RESULTS: A total of 9546 colpopexies were performed during the study period. The mean age was 62 ± 12 years, and the mean body mass index (BMI) was 28 ± 6 kg/m2. The majority of patients were white (73%) with an ASA class of 2 (65%). The overall rate of postoperative complications was 10.5%. The most common complications were urinary tract infections (UTI) (5.1%), transfusion (1.0%), and superficial surgical site infection (0.7%). Excluding UTI, the rate of postoperative complications was 5.4%. After performing multivariable logistic regression, higher ASA class (class 3: aOR 1.69, 95% CI 1.16-2.51; class 4: aOR 3.98, 95% CI 1.51, 9.30) and extraperitoneal colpopexy with hysterectomy were independently associated with a higher odds of experiencing a non-UTI postoperative complication (aOR1.43, 95% CI 1.10, 1.84). Minority race was also independently associated with higher odds of experiencing a non-UTI postoperative complication (aOR 1.33, 95% CI 1.15, 1.52). CONCLUSION: One in ten women undergoing vaginal colpopexy experienced a postoperative complication. Minority race and extraperitoneal colpopexy with concurrent hysterectomy were independently associated with an increased risk of a non-UTI postoperative complication.

Hysterectomy Versus Hysteropexy at the Time of Native Tissue Pelvic Organ Prolapse Repair: A Cost-Effectiveness Analysis.

OBJECTIVE: The aim of the study was to determine whether a hysterectomy at the time of native tissue pelvic organ prolapse repair is cost-effective for the prevention of endometrial cancer. METHODS: We created a decision analysis model using TreeAge Pro. We modeled prolapse recurrence after total vaginal hysterectomy with uterosacral ligament suspension (TVH-USLS) versus sacrospinous ligament fixation hysteropexy (SSLF-HPXY). We modeled incidence and diagnostic evaluation of postmenopausal bleeding, including risk of endometrial pathology and diagnosis or death from endometrial cancer. Modeled costs included those associated with the index procedure, subsequent prolapse repair, endometrial biopsy, pelvic ultrasound, hysteroscopy, dilation and curettage, and treatment of endometrial cancer. RESULTS: TVH-USLS costs US $587.61 more than SSLF-HPXY per case of prolapse. TVH-USLS prevents 1.1% of women from experiencing postmenopausal bleeding and its diagnostic workup. It prevents 0.95% of women from undergoing subsequent major surgery for the treatment of either prolapse recurrence or suspected endometrial cancer. Using our model, it costs US $2,698,677 to prevent one cancer death by performing TVH-USLS. As this is lower than the value of a statistical life, it is cost-effective to perform TVH-USLS for cancer prevention. Multiple 1-way sensitivity analyses showed that changes to input variables would not significantly change outcomes. CONCLUSIONS: TVH-USLS increased costs but reduced postmenopausal bleeding and subsequent major surgery compared with SSLF-HPXY. Accounting for these differences, TVH-USLS was a cost-effective approach for the prevention of endometrial cancer. Uterine preservation/removal at the time of prolapse repair should be based on the woman's history and treatment priorities, but cancer prevention should be one aspect of this decision.

Evaluation of Strategies to Prevent Urinary Tract Injury in Minimally Invasive Gynecologic Surgery: A Systematic Review.

OBJECTIVE: To systematically review tools for the prevention of urinary tract injury in adult women undergoing minimally invasive gynecologic surgery. DATA SOURCES: A medical librarian (M.P.H.) searched Ovid Medline 1946 to, Ovid Embase 1929 to, CINAHL 1965 to, Cochrane Library 1974 to, Web of Science 1926 to, and SCOPUS 1974 to present on April 2 and April 3, 2020. METHODS OF STUDY SELECTION: Articles evaluating strategies for the prevention of urinary tract injury at the time of minimally invasive gynecologic surgery were included. Articles that were nongynecologic, nonhuman, and nonadult were excluded. If a study did not describe the surgical approach or type of surgical procedures performed, it was excluded. If the study population was <50% gynecologic or <50% minimally invasive, it was excluded. Articles evaluating techniques for the diagnosis or management of injury, rather than prevention, were excluded. TABULATION, INTEGRATION, AND RESULTS: The search yielded 2344 citations; duplicates were removed, inclusion criteria were applied, and 9 studies remained for analysis. Three studies evaluated bladder catheters, and 6 evaluated ureteral catheters. In the 3 studies evaluating bladder catheters, there were no urinary tract injuries. Urinary tract infection was greater in women who received a bladder catheter. In the studies evaluating the use of ureteral catheters, we found inconsistent reporting and heterogeneity that precluded meta-analysis. The results of the available studies do not indicate that ureteral catheters decrease the risk of injury, and indicate that they increase morbidity. CONCLUSION: The evidence is insufficient to support the routine use of bladder catheters or ureteral catheters for the prevention of urinary tract injury at the time of minimally invasive gynecologic surgery.

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

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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 30-42 months 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. RESULTS: Recruitment and MRI trials of 94 participants were completed by May 2018. CONCLUSIONS: 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.

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

OBJECTIVE: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence. METHODS: Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated. RESULTS: Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure. CONCLUSION: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959347.

A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair.

BACKGROUND: Given the accelerating opioid crisis in the United States and evidence that patients use fewer opioid tablets than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown. OBJECTIVE: The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side-effects, the number of opioid tablets used, and the number of excess tablets prescribed between these groups. STUDY DESIGN: This was a single-center, unmasked, 2-arm, randomized controlled noninferiority trial of women who underwent a prolapse repair with a planned overnight hospitalization. Patients were assigned randomly to 1 of 2 study arms: routine (28 tablets of oxycodone 5 mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of ≥30 on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete 6 weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients' routine postoperative visit 6 weeks after surgery. The sample size for noninferiority was calculated at 59 patients per group for a total of 118 patients. RESULTS: One hundred eighteen patients were assigned randomly; the primary outcome was available for 116. The majority of patients were white, postmenopausal, and nonsmokers; the mean age was 62±10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71; 60%). One hundred ten patients (93%) were satisfied with postoperative pain control. Statistical analysis constructed for noninferiority showed that the difference between the groups was <15% (93% vs 93%; P=.005). Subjects in the reduced arm reported requiring an additional opioid prescription more frequently than in the routine arm (15% vs 2%; P=.01). Patients in the routine arm used more opioid tablets than the reduced arm (median, 3 [interquartile range, 0-14] vs 1 [interquartile range, 0-3]), but overall opioid utilization was low. As such, patients in the routine arm had significantly more unused opioid tablets (median, 26 [interquartile range, 15-28] vs 4 [interquartile range, 2-5]). CONCLUSION: Patient satisfaction with pain control was noninferior in patients who received a reduced quantity of opioid tablets after prolapse repair compared with those who received a routine prescription. A large quantity of excess opioid tablets was seen in both groups. Surgeons should consider prescribing 5-10 opioid tablets after prolapse repair surgery and consider applying these findings to postoperative prescribing after other gynecologic procedures.

Defining the relationship between vaginal and urinary microbiomes.

BACKGROUND: Although the vaginal and urinary microbiomes have been increasingly well-characterized in health and disease, few have described the relationship between these neighboring environments. Elucidating this relationship has implications for understanding how manipulation of the vaginal microbiome may affect the urinary microbiome and treatment of common urinary conditions. OBJECTIVE: To describe the relationship between urinary and vaginal microbiomes using 16S rRNA gene sequencing. We hypothesized that the composition of the urinary and vaginal microbiomes would be significantly associated, with similarities in predominant taxa. STUDY DESIGN: This multicenter study collected vaginal swabs and catheterized urine samples from 186 women with mixed urinary incontinence enrolled in a parent study and 84 similarly aged controls. Investigators decided a priori that if vaginal and/or urinary microbiomes differed between continent and incontinent women, the groups would be analyzed separately; if similar, samples from continent and incontinent women would be pooled and analyzed together. A central laboratory sequenced variable regions 1-3 (v1-3) and characterized bacteria to the genus level. Operational taxonomic unit abundance was described for paired vaginal and urine samples. Pearson's correlation characterized the relationship between individual operational taxonomic units of paired samples. Canonical correlation analysis evaluated the association between clinical variables (including mixed urinary incontinence and control status) and vaginal and urinary operational taxonomic units, using the Canonical correlation analysis function in the Vegan package (R version 3.5). Linear discriminant analysis effect size was used to find taxa that discriminated between vaginal and urinary samples. RESULTS: Urinary and vaginal samples were collected from 212 women (mean age 53±11 years) and results from 197 paired samples were available for analysis. As operational taxonomic units in mixed urinary incontinence and control samples were related in canonical correlation analysis and since taxa did not discriminate between mixed urinary incontinence or controls in either vagina or urine, mixed urinary incontinence and control samples were pooled for further analysis. Canonical correlation analysis of vaginal and urinary samples indicated that that 60 of the 100 most abundant operational taxonomic units in the samples largely overlapped. Lactobacillus was the most abundant genus in both urine and vagina (contributing on average 53% to an individual's urine sample and 64% to an individual's vaginal sample) (Pearson correlation r=0.53). Although less abundant than Lactobacillus, other bacteria with high Pearson correlation coefficients also commonly found in vagina and urine included: Gardnerella (r=0.70), Prevotella (r=0.64), and Ureaplasma (r=0.50). Linear discriminant analysis effect size analysis identified Tepidimonas and Flavobacterium as bacteria that distinguished the urinary environment for both mixed urinary incontinence and controls as these bacteria were absent in the vagina (Tepidimonas effect size 2.38, P<.001, Flavobacterium effect size 2.15, P<.001). Although Lactobacillus was the most abundant bacteria in both urine and vagina, it was more abundant in the vagina (linear discriminant analysis effect size effect size 2.72, P<.001). CONCLUSION: Significant associations between vaginal and urinary microbiomes were demonstrated, with Lactobacillus being predominant in both urine and vagina. Abundance of other bacteria also correlated highly between the vagina and urine. This inter-relatedness has implications for studying manipulation of the urogenital microbiome in treating conditions such as urgency urinary incontinence and urinary tract infections.

Pelvic Organ Prolapse Recurrence and Patient-Centered Outcomes Following Minimally Invasive Abdominal Uterosacral Ligament and Mesh-Augmented Sacrohysteropexy.

OBJECTIVES: The objective of this study was to compare outcomes after minimally invasive uterosacral ligament hysteropexy (USLH) and mesh-augmented sacrohysteropexy (MSH) for women with uterovaginal prolapse including prolapse recurrence and long-term patient satisfaction. METHODS: This was a retrospective cohort study with a cross-sectional survey component. The medical record was queried for perioperative data for patients undergoing USLH and MSH between 2004 and 2016. Pelvic organ prolapse (POP) recurrence was defined as bulge symptoms and/or retreatment with a pessary or surgery. A cross-sectional survey assessed for adverse events and used validated questionnaires to assess symptoms and improvement. RESULTS: Ninety-seven patients met the inclusion criteria: 42 MSH and 55 USLH. Mean age was 48 ± 14 years. Patients undergoing MSH were older, had more advanced POP, and were less likely to undergo concurrent procedures. There were no differences in perioperative complications between groups; 22.7% (n = 22) of patients experienced POP recurrence with 8.3% (n = 8) undergoing repeat surgery. After controlling for preoperative differences, there was no difference in POP recurrence between groups. The incidence of sacrohysteropexy mesh exposure was 7% (n = 3). Sixty-one percent (n = 59) of patients completed the survey; median follow-up time was 104 (46-164) months. Forty-one percent of respondents reported bothersome pelvic floor symptoms. Bulge symptoms were more common after MSH (41% vs 10%, P = 0.006). Ninety-three percent of all patients reported improvement after surgery, which was not different between groups. CONCLUSIONS: One in 5 patients experienced POP recurrence with fewer than 10% undergoing repeat surgery for recurrence. There does not seem to be a significant difference in the incidence of recurrence between MSH and USLH.

Feasibility and Outcomes of Opportunistic Bilateral Salpingectomy in Patients with Traditional Relative Contraindications to Vaginal Hysterectomy.

STUDY OBJECTIVE: To compare the feasibility of opportunistic bilateral salpingectomy (OBS) at the time of vaginal hysterectomy (VH) for benign disease in patients with and without relative contraindications (RCs) to the vaginal approach and to evaluate the factors that contribute to the inability to perform OBS. DESIGN: Retrospective chart review. SETTING: Tertiary medical center. PATIENTS: Women undergoing hysterectomy for benign indications between November 2014 and October 2017 who were consented for either VH with or without removal of tube(s) and/or bilateral salpingectomy. INTERVENTIONS: RCs to the vaginal approach are defined as lack of prolapse (cervix high, cervix not visualized, cervix tucked underneath pubis, or minimal descent), enlarged uterus (≥250 g or a size of a ≥12-week uterus), nulliparity, obesity (body mass index ≥30 kg/m2), previous cesarean section (CS), known adhesions, and known adnexal pathologic condition. MEASUREMENTS AND MAIN RESULTS: A total of 258 patients underwent VH and attempted to undergo OBS within the study period; of these, 112 patients (43.4%) had no RC, and 146 patients (56.6%) had ≥1 RCs. Overall, successful salpingectomy was performed in 86.8% of patients. There was no significant difference in the rate of success in patients without or with ≥1 RCs (84.9% vs 89%, p = .15). Salpingectomy was unsuccessful in 13.2% of patients (n = 34). In a multivariable logistic regression analysis, the odds of unsuccessful OBS were 3.83 times higher in patients without prolapse (confidence interval [CI], 0.99-14.76; p = .051), 2.71 times higher in patients with obesity (CI, 1.23-5.94; p = .013), and 3.07 times higher in patients with previous CS (CI, 1.17-8.08; p = .023) as compared to patients without any relative contraindications. An enlarged uterus was associated with successful salpingectomy (odds ratio, 0.28; 95% CI, 0.08-0.94; p = .039) compared with a normal-sized uterus. When excluding enlarged uterus, patients with 2 to 3 RCs had 11.24 and 6.8 higher odds of an unsuccessful OBS than patients with no (CI, 3.73-33.87; p <.001) and 1 RC (CI, 2.36-19.63; p <.001), respectively. There were no differences in postoperative stay or rates of readmission among patients with or without successful salpingectomy at the time of VH. CONCLUSION: OBS is associated with a high overall rate of success in patients with and without traditional RCs to VH. Lack of prolapse, obesity, and previous CS were associated with failed attempt at salpingectomy. Patients with ≥2 RCs to VH should be counseled about the high likelihood of failed salpingectomy.

Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial.

Importance: Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking. Objective: To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms. Design, Setting, and Participants: Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017. Interventions: Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207). Main Outcomes and Measures: The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms. Results: Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only). Conclusions and Relevance: Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT01959347.

Cystoscopy at the time of benign hysterectomy: a decision analysis.

BACKGROUND: Gynecologists debate the optimal use for intraoperative cystoscopy at the time of benign hysterectomy. Although adding cystoscopy leads to additional up-front cost, it may also enable intraoperative detection of a urinary tract injury that may otherwise go unnoticed. Prompt injury detection and intraoperative repair decreases morbidity and is less costly than postoperative diagnosis and treatment. Because urinary tract injury is rare and not easily studied in a prospective fashion, decision analysis provides a method for evaluating the cost associated with varying strategies for use of cystoscopy. OBJECTIVE: The objective of the study was to quantify costs of routine cystoscopy, selective cystoscopy, or no cystoscopy with benign hysterectomy. STUDY DESIGN: We created a decision analysis model using TreeAge Pro. Separate models evaluated cystoscopy following abdominal, laparoscopic/robotic, and vaginal hysterectomy from the perspective of a third-party payer. We modeled bladder and ureteral injuries detected intraoperatively and postoperatively. Ureteral injury detection included false-positive and false-negative results. Potential costs included diagnostics (imaging, repeat cystoscopy) and treatment (office/emergency room visits, readmission, ureteral stenting, cystotomy closure, ureteral reimplantation). Our model included costs of peritonitis, urinoma, and vesicovaginal/ureterovaginal fistula. Complication rates were determined from published literature. Costs were gathered from Medicare reimbursement as well as published literature when procedure codes could not accurately capture additional length of stay or work-up related to complications. RESULTS: From prior studies, bladder injury incidence was 1.75%, 0.93%, and 2.91% for abdominal, laparoscopic/robotic, and vaginal hysterectomy, respectively. Ureteral injury incidence was 1.61%, 0.46%, and 0.46%, respectively. Hysterectomy costs without cystoscopy varied from $884.89 to $1121.91. Selective cystoscopy added $13.20-26.13 compared with no cystoscopy. Routine cystoscopy added $51.39-57.86 compared with selective cystoscopy. With the increasing risk of injury, selective cystoscopy becomes cost saving. When bladder injury exceeds 4.48-11.44% (based on surgical route) or ureteral injury exceeds 3.96-8.95%, selective cystoscopy costs less than no cystoscopy. Therefore, if surgeons estimate the risk of injury has exceeded these thresholds, cystoscopy may be cost saving. However, for routine cystoscopy to be cost saving, the risk of bladder injury would need to exceed 20.59-47.24% and ureteral injury 27.22-37.72%. Model robustness was checked with multiple 1-way sensitivity analyses, and no relevant thresholds for model variables other than injury rates were identified. CONCLUSION: While routine cystoscopy increased the cost $64.59-83.99, selective cystoscopy had lower increases ($13.20-26.13). These costs are reduced/eliminated with increasing risk of injury. Even a modest increase in suspicion for injury should prompt selective cystoscopy with benign hysterectomy.

Achieving high value in the surgical approach to hysterectomy.

Value-based care, best clinical outcome relative to cost, is a priority in correcting the high costs for average clinical outcomes of health care delivery in the United States. Hysterectomy represents the most common and identifiable nonobstetric major surgical procedure among women. Surgical approaches to hysterectomy in the United States have changed in recent decades. For benign indications, clinical evidence identifies the superiority of vaginal hysterectomy over all other routes. These conclusions rest on clinical outcomes; however, cost differentials also exist across hysterectomy approaches, with the vaginal approach consistently incurring the lowest overall costs. Taken together, vaginal hysterectomy has the highest value, whereas the robotic (given high costs) and abdominal approaches (given less favorable clinical outcomes) have less value. Traditional laparoscopic hysterectomy holds an intermediate value. Increasing the use of high-value hysterectomy approaches can be achieved by adopting multimodal strategies, with changes in the payment models being the most important.

Incidence and risk factors of early postoperative small bowel obstruction in patients undergoing hysterectomy for benign indications.

BACKGROUND: Small bowel obstruction (SBO) is a major cause of postoperative mortality and morbidity following abdominal and pelvic surgery, with 225,000-345,000 annual admissions. SBO may be classified based on onset from day of surgery. Early SBO occurs within the first 30 days following surgery, whereas late SBO occurs after the initial 30-day postoperative window. The majority of either type of bowel obstruction is believed to be secondary to intra-abdominal adhesions. Early SBO warrants special attention because of the difficulty in distinguishing between mechanical and nonmechanical obstruction during this period. Whereas conservative management often leads to resolution of nonmechanical obstruction and some partial SBO, surgical management is associated with a higher rate of complications compared to surgery for late SBO because of the presence of hypervascular adhesions in the early postoperative period. The current literature regarding SBO, and early SBO in particular, following hysterectomy is limited. Given that approximately 400,000 hysterectomies are performed annually, understanding the risk factors associated with SBO following these types of surgeries is imperative for improving patient outcomes. OBJECTIVE: The objective of this study was to evaluate the incidence of and risk factors for early small bowel obstruction (SBO) after hysterectomy for benign indications. MATERIALS AND METHODS: This was a retrospective cohort study using data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database from 2014 to 2016. Current Procedural Terminology codes were used to identify patients undergoing hysterectomy for benign indications with or without concomitant colpopexy, lysis of adhesions (LOA), adnexectomy, or appendectomy. Data on patient demographics and clinical and surgical factors were obtained. Patients were then stratified into those with and those without SBO. Pairwise comparison was performed using the Wilcoxon rank-sum test and Fisher exact tests. Multivariable logistic regression was used to identify significant independent predictors of SBO. RESULTS: Of 47,937 hysterectomies, SBO occurred in 286 patients, at a rate of 5.9 per 1000 hysterectomies. Comparing patients with and without SBO, those with an obstruction were older (49 vs 46 years, P <.001) and were more likely to smoke (21.0% vs 15.8%, P = .02), to have a history of prior abdominal surgery (73.4% vs 65.4%, P = .005), and to have medical comorbidities such as hypertension and dyspnea. Patients experiencing SBO were also more likely to undergo abdominal hysterectomy (72.0% vs 21.2%, P < .001), adhesiolysis (5.2% vs 2.1%, P < .001), appendectomy (1.7% vs 0.5%, P = .02), and cystotomy repair (1.0% vs 0.3%, P = .002). After logistic regression, route of hysterectomy was not a significant risk factor for SBO, whereas wound class ≥3 (adjusted odds ratio [aOR], 5.96; 95% confidence interval [CI], 2.71-12.99) and perioperative transfusion (aOR, 5.01; 95% CI, 3.54-7.13) were the most significant risk factors. Additional risk factors for early SBO included nonwhite race (aOR, 1.84; 95% CI, 1.33-2.48), increasing age (aOR, 1.04; 95% CI, 1.02-1.05), prior abdominal or pelvic surgery (aOR, 1.49; 95% CI, 1.17-2.03), operating times >170 minutes (aOR, 1.90; 95% CI, 1.37-2.58), uterine weight >250 g (aOR, 1.54; 95% CI, 1.11-2.14), lysis of adhesions (aOR, 2.10; 95% CI, 1.23-3.66), and concurrent appendectomy (aOR, 2.64; 95% CI, 1.06-6.65). CONCLUSION: Early SBO is a rare complication of benign hysterectomy. Although route of hysterectomy was not found to be a significant risk factor for early SBO, variables typically associated with abdominal hysterectomy compared to minimally invasive hysterectomy, including higher wound class, larger uteri, and perioperative transfusion (a marker of intraoperative blood loss), were strongly correlated with subsequent development of early obstruction.