Surgical Outcomes in Benign Gynecologic Surgery Patients during the COVID-19 Pandemic (SOCOVID study).

STUDY OBJECTIVE: To determine the incidence of perioperative coronavirus disease (COVID-19) in women undergoing benign gynecologic surgery and to evaluate perioperative complication rates in patients with active, previous, or no previous severe acute respiratory syndrome coronavirus 2 infection. DESIGN: A multicenter prospective cohort study. SETTING: Ten institutions in the United States. PATIENTS: Patients aged >18 years who underwent benign gynecologic surgery from July 1, 2020, to December 31, 2020, were included. All patients were followed up from the time of surgery to 10 weeks postoperatively. Those with intrauterine pregnancy or known gynecologic malignancy were excluded. INTERVENTIONS: Benign gynecologic surgery. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the incidence of perioperative COVID-19 infections, which was stratified as (1) previous COVID-19 infection, (2) preoperative COVID-19 infection, and (3) postoperative COVID-19 infection. Secondary outcomes included adverse events and mortality after surgery and predictors for postoperative COVID-19 infection. If surgery was delayed because of the COVID-19 pandemic, the reason for postponement and any subsequent adverse event was recorded. Of 3423 patients included for final analysis, 189 (5.5%) postponed their gynecologic surgery during the pandemic. Forty-three patients (1.3% of total cases) had a history of COVID-19. The majority (182, 96.3%) had no sequelae attributed to surgical postponement. After hospital discharge to 10 weeks postoperatively, 39 patients (1.1%) became infected with severe acute respiratory syndrome coronavirus 2. The mean duration of time between hospital discharge and the follow-up positive COVID-19 test was 22.1 ± 12.3 days (range, 4-50 days). Eleven (31.4% of postoperative COVID-19 infections, 0.3% of total cases) of the newly diagnosed COVID-19 infections occurred within 14 days of hospital discharge. On multivariable logistic regression, living in the Southwest (adjusted odds ratio, 6.8) and single-unit increase in age-adjusted Charlson comorbidity index (adjusted odds ratio, 1.2) increased the odds of postoperative COVID-19 infection. Perioperative complications were not significantly higher in patients with a history of positive COVID-19 than those without a history of COVID-19, although the mean duration of time between previous COVID-19 diagnosis and surgery was 97 days (14 weeks). CONCLUSION: In this large multicenter prospective cohort study of benign gynecologic surgeries, only 1.1% of patients developed a postoperative COVID-19 infection, with 0.3% of infection in the immediate 14 days after surgery. The incidence of postoperative complications was not different in those with and without previous COVID-19 infections.

Clinically Depressed Patients Having Anterior Cruciate Ligament Reconstruction Show Improved but Inferior Rate of Achieving Minimum Clinically Important Difference for Patient-Reported Outcomes Measurement Information System Compared With Situationally Depressed or Nondepressed Patients.

PURPOSE: To determine whether the preoperative diagnosis of depression predicted worse postoperative outcomes, including physical therapy (PT) compliance, return-to-sport, and patient-reported outcomes using the Patient-Reported Outcomes Measurement Information System (PROMIS) after anterior cruciate ligament (ACL) reconstruction. METHODS: A multisurgeon series of consecutive patients who had undergone ACL reconstruction with minimum 2-year follow-up were included. Chart review was conducted to determine depression diagnosis status, demographic data, rehabilitation PT compliance, return to sports, and patient-reported outcome data using PROMIS. Patients who met the PROMIS threshold for mild depression but did not carry a clinical diagnosis of depression were classified as "situationally depressed." RESULTS: Ninety-five of 115 consecutive patients (81%) met inclusion criteria with an average follow-up of 34 ± 1.9 months. Fourteen patients (15%) had a preoperative diagnosis of depression, whereas 21 (22%) were considered situationally depressed. Clinically depressed patients had a greater rate of PT noncompliance (33.2% ± 17.6% vs 21.9% ± 12.6%; P = .02) and a lower postoperative PROMIS Physical Function (50.8 ± 7.7 vs 57.8 ± 11.0; P = .03 compared with patients without depression. Situationally depressed patients had lower preoperative physical function (35.4 vs 42.5; P = .04) with no differences in postoperative outcomes scores compared to the non-depressed cohort.19/21 (90.5%) of situationally depressed patients had postoperative resolution of their depressive symptoms. CONCLUSIONS: Situationally depressed patients without a clinical diagnosis of depression can expect significant improvements in both pain and function, as well as a resolution of their depressed mood based on PROMIS scores as they progress through recovery after ACL reconstruction. Clinically depressed patients also experience significant improvements; however, their rate of achieving the minimum clinically important difference for PROMIS outcomes may be less than their nondepressed or situationally depressed counterparts. LEVEL OF EVIDENCE: III, prognostic comparative trial.

Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse.

BACKGROUND: The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of pelvic organ prolapse surgeries. OBJECTIVE: This study aimed to describe the relationships and overlap among the participants who met the anatomic, subjective, and retreatment definitions of success or failure after pelvic organ prolapse surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years among these definitions. STUDY DESIGN: Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥stage II pelvic organ prolapse in a cohort of women (N=1250) from 4 randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by a composite measure requiring 1 or more of (1) anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of >0), (2) subjective failure (presence of bothersome vaginal bulge symptoms), or (3) pessary or surgical retreatment for pelvic organ prolapse. Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years were compared among participants who met a variety of definitions of success and failure including novel "intermittent" success and failure over time. RESULTS: Among the 433 of 1250 women (34.6%) who had surgical failure outcomes at ≥1 time point, 85.5% (370 of 433) met only 1 component of the composite outcome at the assessment of initial failure (anatomic failure, 46.7% [202 of 433]; subjective failure, 36.7% [159 of 433]; retreatment, 2.1% [9 of 433]). Only 12.9% (56 of 433) met the criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% of these (105 of 433) transitioned between success and failure during follow-up, of whom 83.8% (88 of 105) met the criteria for success at their last follow-up. There were associations between success or failure classification and the 1- and 2-year quality-adjusted life years and a time-varying group effect on Pelvic Organ Prolapse Distress Inventory and Short-Form Six-Dimension health index scores. CONCLUSION: True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with most intermittent failures being in a state of "surgical success" at their last follow-up. Current composite definitions of success or failure may result in the overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after pelvic organ prolapse surgery.

Subgroups of failure after surgery for pelvic organ prolapse and associations with quality of life outcomes: a longitudinal cluster analysis.

BACKGROUND: Treatment outcomes after pelvic organ prolapse surgery are often presented as dichotomous "success or failure" based on anatomic and symptom criteria. However, clinical experience suggests that some women with outcome "failures" are asymptomatic and perceive their surgery to be successful and that other women have anatomic resolution but continue to report symptoms. Characterizing failure types could be a useful step to clarify definitions of success, understand mechanisms of failure, and identify individuals who may benefit from specific therapies. OBJECTIVE: This study aimed to identify clusters of women with similar failure patterns over time and assess associations among clusters and the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, Patient Global Impression of Improvement, patient satisfaction item questionnaire, and quality-adjusted life-year. STUDY DESIGN: Outcomes were evaluated for up to 5 years in a cohort of participants (N=709) with stage ≥2 pelvic organ prolapse who underwent surgical pelvic organ prolapse repair and had sufficient follow-up in 1 of 4 multicenter surgical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical success was defined as a composite measure requiring anatomic success (Pelvic Organ Prolapse Quantification system points Ba, Bp, and C of ≤0), subjective success (absence of bothersome vaginal bulge symptoms), and absence of retreatment for pelvic organ prolapse. Participants who experienced surgical failure and attended ≥4 visits from baseline to 60 months after surgery were longitudinally clustered, accounting for similar trajectories in Ba, Bp, and C and degree of vaginal bulge bother; moreover, missing data were imputed. Participants with surgical success were grouped into a separate cluster. RESULTS: Surgical failure was reported in 276 of 709 women (39%) included in the analysis. Failures clustered into the following 4 mutually exclusive subgroups: (1) asymptomatic intermittent anterior wall failures, (2) symptomatic intermittent anterior wall failures, (3) asymptomatic intermittent anterior and posterior wall failures, and (4) symptomatic all-compartment failures. Each cluster had different bulge symptoms, anatomy, and retreatment associations with quality of life outcomes. Asymptomatic intermittent anterior wall failures (n=150) were similar to surgical successes with Ba values that averaged around -1 cm but fluctuated between anatomic success (Ba≤0) and failure (Ba>0) over time. Symptomatic intermittent anterior wall failures (n=82) were anatomically similar to asymptomatic intermittent anterior failures, but women in this cluster persistently reported bothersome bulge symptoms and the lowest quality of life, Short-Form Six-Dimension health index scores, and perceived success. Women with asymptomatic intermittent anterior and posterior wall failures (n=28) had the most severe preoperative pelvic organ prolapse but the lowest symptomatic failure rate and retreatment rate. Participants with symptomatic all-compartment failures (n=16) had symptomatic and anatomic failure early after surgery and the highest retreatment of any cluster. CONCLUSION: In particular, the following 4 clusters of pelvic organ prolapse surgical failure were identified in participants up to 5 years after pelvic organ prolapse surgery: asymptomatic intermittent anterior wall failures, symptomatic intermittent anterior wall failures, asymptomatic intermittent anterior and posterior wall failures, and symptomatic all-compartment failures. These groups provide granularity about the nature of surgical failures after pelvic organ prolapse surgery. Future work is planned for predicting these distinct outcomes using patient characteristics that can be used for counseling women individually.

Prospective study of a single-incision sling versus a transobturator sling in women with stress urinary incontinence: 3-year results.

BACKGROUND: Long-term safety and efficacy data on use of single-incision slings in stress urinary incontinence are limited. OBJECTIVE: To determine whether the single-incision sling Solyx (Boston Scientific, Marlborough, MA) is noninferior to the transobturator sling Obtryx II (Boston Scientific) in efficacy and safety for treatment of stress urinary incontinence. This 522 post-market surveillance study has been designed in response to a Food and Drug Administration request to evaluate improvement in stress urinary incontinence at 36 months following single-incision sling compared with baseline, as well as provide an assessment of mesh-related complications and subject-reported outcomes, relative to the transobturator sling control. STUDY DESIGN: This prospective, nonrandomized, parallel cohort, multicenter postapproval study enrolled subjects to receive single-incision sling or transobturator sling. Study sites were assigned to a cohort group based on documented competency with the cohort device. Patient follow-up was 36 months to compare efficacy and adverse events for noninferiority. Inclusion criteria included stress predominant urinary incontinence, a positive cough stress test, and post-void residual ≤150 cc. Participants were ineligible if they had undergone previous stress urinary incontinence surgery or had a previous mesh complication. Primary endpoint was treatment success defined by composite negative cough stress test and subjective improvement in stress urinary incontinence using Patient Global Impression of Improvement at 36 months. Secondary endpoints included adverse events and indications for retreatment. Noninferiority margins of 15% and 10% were prespecified for the primary efficacy and safety endpoints. Data analysis was performed using intent-to-treat and per-protocol methods. Due to the observational nature of the study, a propensity score methodology was applied to account for differences in patient and surgeon characteristics between treatment groups. The study design and variables to be included in the propensity score model were reviewed and approved by Food and Drug Administration reviewers before outcome analyses were performed. RESULTS: No evidence of imbalance in baseline characteristics was observed between groups after propensity score stratification in the 281 subjects. EBL (72.3±92 vs 73.1±63.9 mL, P=.786), time to spontaneous void (1.1±2 vs 0.8±2.8 days, P=.998), and time to discharge (0.7±0.7 vs 0.6±0.6 days, P=.524) were similar between groups. At 36 months, treatment success was 90.4% in the single-incision sling group and 88.9% in the transobturator sling group (P=.93). At 36 months, mesh-related complications were similar between groups (mesh exposure: 2.8% vs 5.0%, P=.38). Serious adverse events including pain during intercourse (0.7% vs 0%, P=1.00), pelvic pain (0.7% vs 0%, P=1.00), and urinary retention (2.8% vs 4.3%, P=.54) were similar between groups. CONCLUSION: Single-incision sling was not inferior to transobturator sling for long-term treatment success of stress urinary incontinence. The rates of serious adverse events were acceptably low and similar between groups.

Psychometric evaluation of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference Computer Adaptive Test for subacromial impingement syndrome.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (CAT) was previously validated for rotator cuff disease and shoulder instability. This study evaluated the psychometric properties of the PROMIS Physical Function (PF) CAT, PROMIS Pain Interference (PI) CAT, and the American Shoulder and Elbow Surgeons (ASES) Shoulder Function Score for subacromial impingement syndrome. METHODS: PROMIS PF CAT, PI CAT, and ASES (Pain, Function, Total) were collected on all visits for 2 surgeons between January 2016 and August 2016. New patients, aged 18 years and older, were selected by International Classification of Diseases code for impingement syndrome of the shoulder. The mean number of questions answered determined efficiency. Person-item maps were created to determine ceiling and floor effects as well as person reliability. Convergent validity was determined by comparison of PROMIS domains to ASES scores with Pearson correlations. RESULTS: For PROMIS PF CAT, the mean number of items answered was 4.54 (range 4-12). The ceiling effect was 1.56%, and the floor effect was 3.13%. The person reliability was 0.94. Pearson correlation coefficients between the PF CAT and ASES were 0.664 (ASES Function), 0.426 (ASES Pain), and 0.649 (ASES Total). For PROMIS PI CAT, the mean number of items answered was 4.27 (range 3-11). The ceiling effect was 4.69%, and the floor effect was 8.33%. The person reliability was 0.92. Pearson correlation coefficients between the PI CAT and ASES were: 0.667 (ASES Function), 0.594 (ASES Pain), and 0.729 (ASES Total). CONCLUSIONS: The psychometric properties of PROMIS PF and PI CATs were favorable for subacromial impingement syndrome.

Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications.

INTRODUCTION AND HYPOTHESIS: We compared treatment success and adverse events between women undergoing open abdominal sacrocolpopexy (ASC) vs vaginal repair (VAR) using data from women enrolled in one of three multicenter trials. We hypothesized that ASC would result in better outcomes than VAR. METHODS: Participants underwent apical repair of stage 2-4 prolapse. Vaginal repair included uterosacral, sacrospinous, and iliococcygeal suspensions; sacrocolpopexies were via laparotomy. Success was defined as no bothersome bulge symptoms, no prolapse beyond the hymen, and no retreatment up to 24 months. Adverse events were collected at multiple time points. Outcomes were analyzed using longitudinal mixed-effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random. Comparisons were controlled for center, age, body mass index (BMI), initial Pelvic Organ Prolapse Quantification (POP-Q) stage, baseline scores, prior prolapse repair, and concurrent repairs. RESULTS: Of women who met inclusion criteria (1022 of 1159 eligibile), 701 underwent vaginal repair. The ASC group (n = 321) was older, more likely white, had prior prolapse repairs, and stage 4 prolapse (all p < 0.05). While POP-Q measurements and symptoms improved in both groups, treatment success was higher in the ASC group [odds ratio (OR) 6.00, 95% confidence interval (CI) 3.45-10.44). The groups did not differ significantly in most questionnaire responses at 12 months and overall improvement in bowel and bladder function. By 24 months, fewer patients had undergone retreatment (2% ASC vs 5% VAR); serious adverse events did not differ significantly through 6 weeks (13% vs 5%, OR 2.0, 95% CI 0.9-4.7), and 12 months (26% vs 13%, OR 1.6, 95% CI 0.9-2.9), respectively. CONCLUSIONS: Open sacrocolpopexy resulted in more successful prolapse treatment at 2 years.

Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial.

Importance: Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy data. Objective: To compare outcomes in women randomized to (1) ULS or SSLF and (2) usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse. Design, Setting, and Participants: This 2 × 2 factorial randomized clinical trial was conducted at 9 US medical centers. Eligible participants who completed the Operations and Pelvic Muscle Training in the Management of Apical Support Loss Trial enrolled between January 2008 and March 2011 and were followed up 5 years after their index surgery from April 2011 through June 2016. Interventions: Two randomizations: (1) BPMT (n = 186) or usual care (n = 188) and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186). Main Outcomes and Measures: The primary surgical outcome was time to surgical failure. Surgical failure was defined as (1) apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure), or (2) bothersome bulge symptoms. The primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300). Results: The original study randomized 374 patients, of whom 309 were eligible for this extended trial. For this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial. By year 5, the estimated surgical failure rate was 61.5% in the ULS group and 70.3% in the SSLF group (adjusted difference, -8.8% [95% CI, -24.2 to 6.6]). The estimated anatomic failure rate was 45.6% in the BPMT group and 47.2% in the usual care group (adjusted difference, -1.6% [95% CI, -21.2 to 17.9]). Improvements in Pelvic Organ Prolapse Distress Inventory scores were -59.4 in the BPMT group and -61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, -13.7 to 18.4]). Conclusions and Relevance: Among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, there was no significant difference between ULS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores at 5 years. Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved. Trial Registration: clinicaltrials.gov Identifier: NCT01166373.

Safety of Manual Morcellation After Vaginal or Laparoscopic-assisted Vaginal Hysterectomy.

UNLABELLED: STUDY OBJECTIVE: To determine the safety of manual vaginal morcellation by evaluating the rates of incidental uterine malignancy and manual vaginal morcellation after vaginal or laparoscopic-assisted vaginal hysterectomy. DESIGN: Retrospective analysis (Canadian Task Force classification II-2). SETTING: University of Texas Southwestern Medical Center, Dallas, TX. PATIENTS: Women (n = 1,629) undergoing vaginal or laparoscopic-assisted vaginal hysterectomy. INTERVENTIONS: Vaginal hysterectomy (n = 1,091) or laparoscopic-assisted vaginal hysterectomy (n = 538) with and without scalpel morcellation. MEASUREMENTS AND MAIN RESULTS: The number of uterine malignancies, rate of vaginal morcellation, surgical indications, pathology diagnoses, and uterine weights were evaluated. Chi-square analysis was used to compare categoric data, and analysis of variance was used to compare uterine weights. There were no cases of leiomyosarcomas. There were 2 other sarcomas, 4 smooth muscle tumors of uncertain malignant potential, and 8 endometrial adenocarcinomas. The vaginal morcellation rate was 19.4%, but no malignancy was morcellated. Myomas were more common preoperatively and histologically in morcellated specimens. Mean (± standard deviation) uterine weights for morcellated versus nonmorcellated laparoscopic-assisted vaginal hysterectomy specimens were 285.5 ± 159.3 versus 140.1 ± 83.6 g (p < .001), respectively, and 199.9 ± 92.8 versus 111.9 ± 61.4 (p < .001), respectively, for vaginal hysterectomy. CONCLUSION: Vaginal manual morcellation is safe with a low risk of incidental malignancy. Variables that influence the decision for the vaginal approach may also affect malignancy risk and morcellation decisions. Thus, all patients undergoing vaginal or laparoscopic-assisted vaginal hysterectomy should be counseled regarding incidental malignancy, risk of morcellation, and alternatives for intact specimen removal.

A midurethral sling to reduce incontinence after vaginal prolapse repair.

BACKGROUND: Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk. METHODS: We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence. RESULTS: Of the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P=0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons). CONCLUSIONS: A prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; OPUS ClinicalTrials.gov number, NCT00460434.).

Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.

BACKGROUND: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

The female urinary microbiome in urgency urinary incontinence.

OBJECTIVE: The purpose of this study was to characterize the urinary microbiota in women who are planning treatment for urgency urinary incontinence and to describe clinical associations with urinary symptoms, urinary tract infection, and treatment outcomes. STUDY DESIGN: Catheterized urine samples were collected from multisite randomized trial participants who had no clinical evidence of urinary tract infection; 16S ribosomal RNA gene sequencing was used to dichotomize participants as either DNA sequence-positive or sequence-negative. Associations with demographics, urinary symptoms, urinary tract infection risk, and treatment outcomes were determined. In sequence-positive samples, microbiotas were characterized on the basis of their dominant microorganisms. RESULTS: More than one-half (51.1%; 93/182) of the participants' urine samples were sequence-positive. Sequence-positive participants were younger (55.8 vs 61.3 years old; P = .0007), had a higher body mass index (33.7 vs 30.1 kg/m(2); P = .0009), had a higher mean baseline daily urgency urinary incontinence episodes (5.7 vs 4.2 episodes; P < .0001), responded better to treatment (decrease in urgency urinary incontinence episodes, -4.4 vs -3.3; P = .0013), and were less likely to experience urinary tract infection (9% vs 27%; P = .0011). In sequence-positive samples, 8 major bacterial clusters were identified; 7 clusters were dominated not only by a single genus, most commonly Lactobacillus (45%) or Gardnerella (17%), but also by other taxa (25%). The remaining cluster had no dominant genus (13%). CONCLUSION: DNA sequencing confirmed urinary bacterial DNA in many women with urgency urinary incontinence who had no signs of infection. Sequence status was associated with baseline urgency urinary incontinence episodes, treatment response, and posttreatment urinary tract infection risk.

Urinary bacteria in adult women with urgency urinary incontinence.

INTRODUCTION AND HYPOTHESIS: This study's aims were to detect and quantify bacterial DNA in the urine of randomized trial participants about to undergo treatment for urinary urgency incontinence (UUI) without clinical evidence of urinary tract infection (UTI) and to determine if the presence of bacterial DNA in baseline urine relates to either baseline urinary symptoms or UTI risk after urinary tract instrumentation. METHODS: Women without clinical evidence of baseline UTI were randomized to cystoscopic onabotulinum toxin A injection and oral placebo medication versus cystoscopic placebo injection and active oral medication. Bacterial DNA in participants' catheterized urine was measured by quantitative polymerase chain reaction (qPCR). RESULTS: Bacterial DNA was detected in the urine of 38.7 % of participants (60 out of 155). In these 60 qPCR-positive participants, baseline daily UUI episodes were greater than in the 95 qPCR-negative participants (5.71 [±2.60] vs 4.72 [±2.86], p = 0.004). Neither symptom severity by questionnaire nor treatment outcome was associated with qPCR status or with qPCR level in qPCR-positive subjects. In contrast, the presence of urinary bacterial DNA was associated with UTI risk: only 10 % of the qPCR-positive women developed a UTI post-treatment, while 24 % of the qPCR-negative women did so. The median qPCR level for qPCR-positive samples did not differ significantly by UTI status (UTI 2.58 × 10(5) vs no UTI 1.35 × 10(5) copies/mL, p = 0.6). CONCLUSIONS: These results may indicate a urinary bacterial contribution to both baseline UUI and the risk of post-treatment UTI.

Systematic review of robotic surgery in gynecology: robotic techniques compared with laparoscopy and laparotomy.

The Society of Gynecologic Surgeons Systematic Review Group performed a systematic review of both randomized and observational studies to compare robotic vs nonrobotic surgical approaches (laparoscopic, abdominal, and vaginal) for treatment of both benign and malignant gynecologic indications to compare surgical and patient-centered outcomes, costs, and adverse events associated with the various surgical approaches. MEDLINE and the Cochrane Central Register of Controlled Trials were searched from inception to May 15, 2012, for English-language studies with terms related to robotic surgery and gynecology. Studies of any design that included at least 30 women who had undergone robotic-assisted laparoscopic gynecologic surgery were included for review. The literature yielded 1213 citations, of which 97 full-text articles were reviewed. Forty-four studies (30 comparative and 14 noncomparative) met eligibility criteria. Study data were extracted into structured electronic forms and reconciled by a second, independent reviewer. Our analysis revealed that, compared with open surgery, robotic surgery consistently confers shorter hospital stay. The proficiency plateau seems to be lower for robotic surgery than for conventional laparoscopy. Of the various gynecologic applications, there seems to be evidence that renders robotic techniques advantageous over traditional open surgery for management of endometrial cancer. However, insofar as superiority, conflicting data are obtained when comparing robotics vs laparoscopic techniques. Therefore, the specific method of minimally invasive surgery, whether conventional laparoscopy or robotic surgery, should be tailored to patient selection, surgeon ability, and equipment availability.

Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial.

IMPORTANCE: More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE: To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS: The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188). MAIN OUTCOMES AND MEASURES: The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success. RESULTS: At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE: Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00597935.

Effects of Social Determinants of Health and Social Support on Surgical Outcomes Among Patients Undergoing Hysterectomy.

OBJECTIVE: To describe composite 30-day postoperative complication rates among patients undergoing hysterectomy during the coronavirus disease 2019 (COVID-19) pandemic and to determine baseline and postoperative mental health symptoms, levels of social support, and socioeconomic status and their association with hysterectomy outcomes. METHODS: This multicenter prospective cohort study at eight centers across the United States enrolled patients who underwent minimally invasive hysterectomy for benign indications during the COVID-19 pandemic. Patients completed preoperative and postoperative surveys assessing mental health (PHQ-9 [Patient Health Questionnaire]), social support (MOS-SS [Medical Outcomes Study Social Support Survey]), and socioeconomic status (Hollingshead Index [Hollingshead Four Factor Index of Socioeconomic Status]). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection rates and 30-day composite complication rates were measured and categorized by Clavien-Dindo Grade. Bivariate associations of survey data on complications were assessed. Logistic regression analyses were used to identify independent predictors of 30-day complications and complication severity. RESULTS: Postoperative complications within 30 days occurred in 67 of 273 (24.5%) patients. Most (88.1%) complications were mild, but eight (11.9%) experienced severe complications. Only three patients (1.1%) tested positive for SARS-CoV-2 infection. There were no differences in complication rates when comparing race and ethnicity, age, or socioeconomic status. Survey responses that indicated more depression and worse support from preoperative to postoperative were seen in patients with severe complications (P=.008 and P=.09, respectively). Multivariate analysis demonstrated that an increase in support scores was protective against severe complications (P=.02). Worsening depression scores were associated with more severe complications (P=.03). CONCLUSION: This study showed a high rate of complications (24.5%) among patients who underwent hysterectomy during the COVID-19 pandemic. Lower social support and worse mental health status are associated with worse postoperative outcomes after hysterectomy.

Retropubic versus transobturator midurethral slings for stress incontinence.

BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Endoanal ultrasound for detection of sphincter defects following childbirth.

INTRODUCTION AND HYPOTHESIS: The objectives of this study were to estimate the rates of sonographically detected anal sphincter defects within 72 h of childbirth and to evaluate intra- and interobserver agreement using three-dimensional (3-D) endoanal sonography data. METHODS: This is a prospective observational study of primiparous women delivered vaginally. Women without clinically identified anal sphincter lacerations underwent endoanal ultrasonography within 72 h of delivery. Intra- and interobserver agreement for diagnosis of sphincter defects using 3-D endoanal sonography data was calculated using kappa statistics. RESULTS: The rate of sphincter defects in 107 women undergoing 3-D endoanal sonography was 12 %. Characteristics of women with sonographically detected sphincter defects, compared to those without, included a significantly increased rate of clinically diagnosed second-degree lacerations (54 vs 20 %, p 0.008). The intra- and interobserver agreement for diagnosis of sphincter defects using 3-D endoanal sonography data was 0.82 [confidence interval (CI) 0.66-0.99] and 0.72 (CI 0.54-0.92), respectively. CONCLUSIONS: Anal sphincter defects detected using endoanal sonography are common, occurring in 12 % of primiparous women, and are significantly associated with other less severe perineal lacerations. Overall and combining sonographically detected defects with clinically diagnosed lacerations, we estimate that 17.8 % of primiparous women delivered vaginally sustain anal sphincter injuries. The intraobserver agreement for diagnosis of sphincter defects is very good and the interobserver agreement is good.

Preoperative Simulation of Retropubic Midurethral Sling to Decrease Bladder Perforation Rate Among Obstetrics and Gynecology Residents.

IMPORTANCE: Bladder perforation is an often avoidable complication of retropubic midurethral sling procedures. Bladder injury rates decrease with surgeon experience, but literature on techniques to train novice surgeons is limited. OBJECTIVE: Our objective was to decrease the bladder perforation rate among obstetrics and gynecology residents during retropubic midurethral sling procedures through implementation of an instructional video and low-fidelity simulation. STUDY DESIGN: A baseline bladder perforation rate was determined by retrospective chart review. A prospective educational intervention, consisting of a 10-minute instructional video with preoperative simulation using a simple bony pelvis model, was then implemented among residents on the urogynecology service from December 2017 through March 2020. The primary outcome was the change in the bladder perforation rate. Compliance with the intervention protocol was a secondary outcome. Categorical data were evaluated using the χ 2 or Fisher exact test. Continuous variables were assessed using the Student t test or Mann-Whitney U test as appropriate. RESULTS: Two hundred fifteen retropubic midurethral sling cases were included in analysis. There were no significant demographic differences between the patients undergoing surgery preintervention and postintervention. Resident surgeons were in their second (47.4%) and third (52.6%) years of training. The postintervention bladder perforation rate was 6.5%, which is a 35% reduction from the preintervention perforation rate of 10% ( P = 0.19). The instructional video and preoperative simulation were successfully implemented in 193 of 215 (89.8%) eligible cases. CONCLUSION: Despite high compliance, the combination of the instructional video and preoperative low-fidelity bony pelvis simulation was not effective in reducing tension-free vaginal tape-associated bladder perforations among residents.

Ulnohumeral joint static cartilage compression is affected by radial head implant size.

INTRODUCTION: Radiocapitellar joint arthroplasty is a commonly performed procedure, which often leads to early failure or instability. Few studies assess the effect of radiocapitellar joint arthroplasty on the ulnohumeral joint. We hypothesized that static forces of contact (compressing cartilage, or cartilage relaxation contact force) would reveal the effect of varying radial head implant size and elbow position on the ulnohumeral joint. METHODS: A minimally-invasive method of measuring cartilage relaxation contact force was utilized in 10 fresh-frozen human cadaveric specimens that did not require significant dissection or intraarticular sensor placement. Specimens were rigidly fixed in various positions of elbow flexion and forearm pronosupination with increasing radial head implant lengths. Uniaxial distracting forces were applied and displacement was repeatedly measured with resultant best-fit polynomial curves to determine inflections corresponding to the force required to overcome static cartilage relaxation as in previous work. FINDINGS: Baseline mean (intra-cadaver) cartilage relaxation contact force was 11.8 N (standard error of the mean = 0.3) at 90° of elbow flexion and neutral rotation. There was little variation within specimens (Intraclass correlation coefficient > 0.94). Cartilage relaxation contact force increased at the ulnohumeral joint with radial head implant overstuffing (> 4 mm, P < 0.05) and elbow flexion (120°, P < 0.001). Pronosupination altered cartilage relaxation contact force in an implant-length independent manner (P < 0.05). INTERPRETATION: Radiocapitellar joint arthroplasty implant length and elbow joint position independently contribute to increased cartilage relaxation contact force at the ulnohumeral joint. This further supports attempts at anatomic reconstruction of the radiocapitellar joint to prevent pathologic ulnohumeral joint loading.