Longitudinal Fluctuations in Treatment Response After OnabotulinumToxinA and Sacral Neuromodulation for Refractory Urgency Incontinence.

PURPOSE: We compared fluctuations in treatment response after onabotulinumtoxinA and sacral neuromodulation for urgency incontinence using Markov models. MATERIALS AND METHODS: We fit data from a randomized trial to Markov models to compare transitions of success/failure over 6 months between 200 U onabotulinumtoxinA and sacral neuromodulation. Objective failure was <50% reduction in urgency incontinence episodes from baseline; subjective failure "strongly disagree" to "neutral" to the Patient Global Symptom Control questionnaire. RESULTS: Of the 357 participants (median baseline daily urgency incontinence episodes 4.7 [IQR 3.7-6.0]) 61% vs 51% and 3.2% vs 6.1% reported persistent states of objective success and failure over 6 months after onabotulinumtoxinA vs sacral neuromodulation. Participants receiving onabotulinumtoxinA vs sacral neuromodulation had lower 30-day transition probabilities from objective and subjective success to failure (10% vs 14%, ratio 0.75 [95% CI 0.55-0.95]; 14% vs 21%, ratio 0.70 [95% CI 0.51-0.89]). The 30-day transition probability from objective and subjective failure to success did not differ between onabotulinumtoxinA and sacral neuromodulation (40% vs 36%, ratio 1.11 [95% CI 0.73-1.50]; 18% vs 17%, ratio 1.14 [95% CI 0.65-1.64]). CONCLUSIONS: Over 6 months after treatment, 2 in 5 women's symptoms fluctuate. Within these initial 6 months, women receiving onabotulinumtoxinA transitioned from success to failure over 30 days less often than sacral neuromodulation. For both treatments, there was an almost 20%-40% probability over 30 days that women returned to subjective and objective success after failure. Markov models add important information to longitudinal models on how symptoms fluctuate after urgency incontinence treatment.

Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: Results From the ROSETTA Trial.

PURPOSE: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence. MATERIALS AND METHODS: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression. RESULTS: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response. CONCLUSIONS: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.

Postpartum readmission for hypertension and pre-eclampsia: development and validation of a predictive model.

OBJECTIVE: To develop a model for predicting postpartum readmission for hypertension and pre-eclampsia at delivery discharge and assess external validation or model transportability across clinical sites. DESIGN: Prediction model using data available in the electronic health record from two clinical sites. SETTING: Two tertiary care health systems from the Southern (2014-2015) and Northeastern USA (2017-2019). POPULATION: A total of 28 201 postpartum individuals: 10 100 in the South and 18 101 in the Northeast. METHODS: An internal-external cross validation (IECV) approach was used to assess external validation or model transportability across the two sites. In IECV, data from each health system were first used to develop and internally validate a prediction model; each model was then externally validated using the other health system. Models were fit using penalised logistic regression, and accuracy was estimated using discrimination (concordance index), calibration curves and decision curves. Internal validation was performed using bootstrapping with bias-corrected performance measures. Decision curve analysis was used to display potential cut points where the model provided net benefit for clinical decision-making. MAIN OUTCOME MEASURES: The outcome was postpartum readmission for either hypertension or pre-eclampsia <6 weeks after delivery. RESULTS: The postpartum readmission rate for hypertension and pre-eclampsia overall was 0.9% (0.3% and 1.2% by site, respectively). The final model included six variables: age, parity, maximum postpartum diastolic blood pressure, birthweight, pre-eclampsia before discharge and delivery mode (and interaction between pre-eclampsia × delivery mode). Discrimination was adequate at both health systems on internal validation (c-statistic South: 0.88; 95% confidence interval [CI] 0.87-0.89; Northeast: 0.74; 95% CI 0.74-0.74). In IECV, discrimination was inconsistent across sites, with improved discrimination for the Northeastern model on the Southern cohort (c-statistic 0.61 and 0.86, respectively), but calibration was not adequate. Next, model updating was performed using the combined dataset to develop a new model. This final model had adequate discrimination (c-statistic: 0.80, 95% CI 0.80-0.80), moderate calibration (intercept -0.153, slope 0.960, Emax 0.042) and provided superior net benefit at clinical decision-making thresholds between 1% and 7% for interventions preventing readmission. An online calculator is provided here. CONCLUSIONS: Postpartum readmission for hypertension and pre-eclampsia may be accurately predicted but further model validation is needed. Model updating using data from multiple sites will be needed before use across clinical settings.

Natural history of lower urinary tract symptoms in treatment-seeking women with pelvic organ prolapse; the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

BACKGROUND: The association of pelvic organ prolapse with overactive bladder and other lower urinary tract symptoms, and the natural history of those symptoms are not well characterized. Previous cross-sectional studies demonstrated conflicting relationships between prolapse and lower urinary tract symptoms. OBJECTIVE: This study primarily aimed to determine the baseline association between lower urinary tract symptoms and prolapse and to assess longitudinal differences in symptoms over 12 months in women with and without prolapse. Secondary aims were to explore associations between lower urinary tract symptoms and prolapse treatment. We hypothesized that: (1) prolapse is associated with the presence of lower urinary tract symptoms, (2) lower urinary tract symptoms are stable over time in patients with and without prolapse, and (3) prolapse treatment is associated with lower urinary tract symptom improvement. STUDY DESIGN: Women enrolled in the Symptoms of Lower Urinary Tract Dysfunction Research Network Observational Cohort Study with adequate 12-month follow-up data were included. Prolapse and lower urinary tract symptom treatment during follow-up was guided by standard of care. Outcome measures included the Lower Urinary Tract Symptoms Tool total severity score (in addition to overactive bladder, obstructive, and stress urinary incontinence subscales) and Urogenital Distress Inventory-6 Short Form. Prolapse (yes or no) was defined primarily when Pelvic Organ Prolapse Quantification System points Ba, C or Bp were >0 (beyond the hymen). Mixed-effects models with random effects for patient slopes and intercepts were fitted for each lower urinary tract symptom outcome and prolapse predictor, adjusted for other covariates. The study had >90% power to detect differences as small as 0.4 standard deviation for less prevalent group comparisons (eg, prolapse vs not). RESULTS: A total of 371 women were analyzed, including 313 (84%) with no prolapse and 58 (16%) with prolapse. Women with prolapse were older (64.6±8.8 vs 55.3±14.1 years; P<.001) and more likely to have prolapse surgery (28% vs 1%; P<.001) and pessary treatment (26% vs 4%; P<.001) during the study. Average baseline Lower Urinary Tract Symptoms Tool total severity scores were lower (fewer symptoms) for participants with prolapse compared with those without (38.9±14.0 vs 43.2±14.0; P=.036), but there were no differences in average scores between prolapse groups for other scales. For all urinary outcomes, average scores were significantly lower (improved) at 3 and 12 months compared with baseline (all P<.05). In mixed-effects models, there were no statistically significant interactions between pelvic organ prolapse measurement and visit and time-dependent prolapse treatment groups (P>.05 for all regression interaction coefficients). The Lower Urinary Tract Symptoms Tool obstructive severity score had a statistically significant positive association with Pelvic Organ Prolapse Quantification System Ba, Bp, and point of maximum vaginal descent. The Lower Urinary Tract Symptoms Tool total severity scale had a statistically significant negative association with Pelvic Organ Prolapse Quantification System Ba and point of maximum vaginal descent. No other associations between prolapse and lower urinary tract symptoms were significant (P>.05 for all regression coefficients). Symptom differences between prolapse groups were small: all regression coefficients (interpretable as additive percentage change in each score) were between -5 and 5 (standard deviation of outcomes ranged from 14.0-32.4). CONCLUSION: Among treatment-seeking women with urinary symptoms, obstructive symptoms were positively associated with prolapse, and overall lower urinary tract symptom severity was negatively associated with prolapse. Lower Urinary Tract Symptoms Tool scores improved over 12 months regardless of prolapse status, including in those with treated prolapse, untreated prolapse, and without prolapse.

Predicting outcomes after intradetrusor onabotulinumtoxina for non-neurogenic urgency incontinence in women.

AIMS: Develop models to predict outcomes after intradetrusor injection of 100 or 200 units of onabotulinumtoxinA in women with non-neurogenic urgency urinary incontinence (UUI). METHODS: Models were developed using 307 women from two randomized trials assessing efficacy of onabotulinumtoxinA for non-neurogenic UUI. Cox, linear and logistic regression models were fit using: (1) time to recurrence over 12 months, (2) change from baseline daily UUI episodes (UUIE) at 6 months, and (3) need for self-catheterization over 6 months. Model discrimination of Cox and logistic regression models was calculated using c-index. Mean absolute error determined accuracy of the linear model. Calibration was demonstrated using calibration curves. All models were internally validated using bootstrapping. RESULTS: Median time to recurrence was 6 (interquartile range [IQR]: 2-12) months. Increasing age, 200 units of onabotulinumtoxinA, higher body mass index (BMI) and baseline UUIE were associated with decreased time to recurrence. The c-index was 0.63 (95% confidence interval [CI]: 0.59, 0.67). Median change in daily UUIE from baseline at 6 months was -3.5 (IQR: -5.0, -2.3). Increasing age, lower baseline UUIE, 200 units of onabotulinumtoxinA, higher BMI and IIQ-SF were associated with less improvement in UUIE. The mean absolute error predicting change in UUIE was accurate to 1.6 (95% CI: 1.5, 1.7) UUI episodes. The overall rate of self-catheterization was 17.6% (95% CI: 13.6%-22.4%). Lower BMI, 200 units of onabotulinumtoxinA, increased baseline postvoid residual and maximum capacity were associated with higher risk of self-catheterization. The c-index was 0.66 (95% CI: 0.61, 0.76). The three calculators are available at http://riskcalc.duke.edu. CONCLUSIONS: After external validation, these models will assist clinicians in providing more accurate estimates of expected treatment outcomes after onabotulinumtoxinA for non-neurogenic UUI in women.

External Validation of Postpartum Hemorrhage Prediction Models Using Electronic Health Record Data.

OBJECTIVE: A recent study leveraging machine learning methods found that postpartum hemorrhage (PPH) can be predicted accurately at the time of labor admission in the U.S. Consortium for Safe Labor (CSL) dataset, with a C-statistic as high as 0.93. These CSL models were developed in older data (2002-2008) and used an estimated blood loss (EBL) of ≥1,000 mL to define PPH. We sought to externally validate these models using a more recent cohort of births where blood loss was measured using quantitative blood loss (QBL) methods. STUDY DESIGN: Using data from 5,261 deliveries between February 1, 2019 and May 11, 2020 at a single tertiary hospital, we mapped our electronic health record (EHR) data to the 55 predictors described in previously published CSL models. PPH was defined as QBL ≥1,000 mL within 24 hours after delivery. Model discrimination and calibration of the four CSL models were measured using our cohort. In a secondary analysis, we fit new models in our study cohort using the same predictors and algorithms as the original CSL models. RESULTS: The original study cohort had a substantially lower rate of PPH, 4.8% (7,279/228,438) versus 25% (1,321/5,261), possibly due to differences in measurement. The CSL models had lower discrimination in our study cohort, with a C-statistic as high as 0.57 (logistic regression). Models refit in our study cohort achieved better discrimination, with a C-statistic as high as 0.64 (random forest). Calibration improved in the refit models as compared with the original models. CONCLUSION: The CSL models' accuracy was lower in a contemporary EHR where PPH is assessed using QBL. As institutions continue to adopt QBL methods, further data are needed to understand the differences between EBL and QBL to enable accurate prediction of PPH. KEY POINTS: · Machine learning methods may help predict PPH.. · EBL models do not generalize when QBL is used.. · Blood loss estimation alters model accuracy..

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.

Prevalence of childhood trauma and its association with lower urinary tract symptoms in women and men in the LURN study.

AIMS: To describe the association between childhood traumas (death of a family member, severe illness, sexual trauma, parental separation) reported by women and men and lower urinary tract symptoms (LUTS). METHODS: In this secondary analysis of the Lower Urinary Tract Research Network Observational Cohort Study, participants completed the LUTS tool, childhood trauma events scale (CTES), PROMIS depression and anxiety and perceived stress scale. LUTS tool responses were combined to quantify urinary urgency, frequency, incontinence, and overall LUTS severity. Multivariable linear regression tested associations between trauma and LUTS; mental health scores were tested for potential mediation. RESULTS: In this cohort (n = 1011; 520 women, 491 men), more women reported experiencing at least one trauma (75% vs. 64%, p < .001), greater than three traumas (26% vs. 15%, p < .001), and childhood sexual trauma (23% vs. 7%, p < .001), and reported higher impact from traumatic events compared with men (median [interquartile rnage] CTES score = 10 [5-15] vs. 6 [4-12], p < .001). The number of childhood traumatic events was not associated with severity of overall LUTS (p = .79), urinary frequency (p = .75), urgency (p = .61), or incontinence (p = .21). Childhood sexual trauma was significantly associated with higher incontinence severity (adjusted mean difference 4.5 points, 95% confidence interval= 1.11-7.88, p = .009). Mental health was a mediator between trauma and LUTS among those with at least one childhood trauma. CONCLUSION: Although total childhood trauma is not associated with LUTS, childhood sexual trauma is associated with urinary incontinence severity. For patients with childhood trauma, half of the effect of CTE Impact score on overall LUTS severity is mediated through the association between trauma and the patient's mental health.

A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10.

PURPOSE: Lower urinary tract symptoms are common in men and women. Members of the LURN (Lower Urinary Tract Dysfunction Research Network) sought to create a brief, clinically relevant tool to improve existing measurements of lower urinary tract symptoms in men and women. MATERIALS AND METHODS: Using a modified Delphi methodology during an expert consensus meeting we reduced the LURN CASUS (Comprehensive Assessment of Self-Reported Urinary Symptoms) questionnaire to a brief set of clinically relevant items measuring lower urinary tract symptoms. The sum score of these items was evaluated by comparing it to the AUA SI (American Urological Association Symptom Index), the UDI-6 (Urinary Distress Inventory Short Form) in women only and the CASUS lower urinary tract symptoms screening questions using the Pearson correlation, regression analysis and ROC curves. RESULTS: The LURN SI-10 (10-Item LURN Symptom Index) assesses urinary frequency, nocturia, urgency, incontinence, bladder pain, voiding and post-micturition symptoms (score range 0 to 38). The correlation between LURN SI-10 and AUA SI scores was 0.77 in men and 0.70 in women. The UDI-6 and the LURN SI-10 correlated highly in women (r=0.76). The LURN SI-10 showed good accuracy to predict moderate and severe lower urinary tract symptoms as defined by the AUA SI (ROC AUC range 0.82-0.90). Similar accuracy was shown in predicting different levels of symptom status using the UDI-6 (AUC range 0.84-0.86). CONCLUSIONS: The LURN SI-10 correlates well with the AUA SI and the UDI-6. It includes items related to a broader spectrum of lower urinary tract symptoms, particularly incontinence, bladder pain and post-micturition symptoms, and it applies to men and women.

Association between adjuvant posterior repair and success of native tissue apical suspension.

BACKGROUND: Posterior repairs and perineorrhaphies are often performed in prolapse surgery to reduce the size of the genital hiatus. The benefit of an adjuvant posterior repair at the time of sacrospinous ligament fixation or uterosacral ligament suspension is unknown. OBJECTIVE: We aimed to determine whether an adjuvant posterior repair at transvaginal apical suspension is associated with improved surgical success. MATERIALS AND METHODS: This secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial compared 24-month outcomes in 190 participants who had a posterior repair (posterior repair group) and 184 who did not (no posterior repair group) at the time of sacrospinous ligament fixation or uterosacral ligament suspension. Concomitant posterior repair was performed at the surgeon's discretion. Primary composite outcome of "surgical success" was defined as no prolapse beyond the hymen, point C ≤ -2/3 total vaginal length, no bothersome bulge symptoms, and no retreatment at 24 months. The individual components were secondary outcomes. Propensity score methods were used to build models that balanced posterior repair group and the no posterior repair group for ethnographic factors and preoperative Pelvic Organ Prolapse Quantification values. Adjusted odds ratios were calculated to predict surgical success based on the performance of a posterior repair. Groups were also compared with unadjusted χ2 analyses. An unadjusted probability curve was created for surgical success as predicted by preoperative genital hiatus. RESULTS: Women in the posterior repair group were less likely to be Hispanic or Latina, and were more likely to have had a prior hysterectomy and to be on estrogen therapy. The groups did not differ with respect to preoperative Pelvic Organ Prolapse Quantification stage; however, subjects in the posterior repair group had significantly greater preoperative posterior wall prolapse. There were no group differences in surgical success using propensity score methods (66.7% posterior repair vs 62.0% no posterior repair; adjusted odds ratio, 1.07; 95% confidence interval, 0.56-2.07; P = 0.83) or unadjusted test (66.2% posterior repair vs 61.7% no posterior repair; P = 0.47). Individual outcome measures of prolapse recurrence (bothersome bulge symptoms, prolapse beyond the hymen, or retreatment for prolapse) also did not differ by group. Similarly, there were no differences between groups in anatomic outcomes of any individual compartment (anterior, apical, or posterior) at 24 months. There was high variation in performance of posterior repair by surgeon (interquartile range, 15-79%). The unadjusted probability of overall success at 24 months, regardless of posterior repair, decreased with increasing genital hiatus, such that a genital hiatus of 4.5 cm was associated with 65.8% success (95% confidence interval, 60.1-71.1%). CONCLUSION: Concomitant posterior repair at sacrospinous ligament fixation or uterosacral ligament suspension was not associated with surgical success after adjusting for baseline covariates using propensity scores or unadjusted comparison. Posterior repair may not compensate for the pathophysiology that leads to enlarged preoperative genital hiatus, which remains prognostic of prolapse recurrence.

Impact of treatment for fecal incontinence on constipation symptoms.

OBJECTIVE: Defecatory symptoms, such as a sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence. Treatments for fecal incontinence, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for fecal incontinence with education only, loperamide, anal muscle exercises with biofeedback or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and nonresponders to fecal incontinence treatment. STUDY DESIGN: This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for fecal incontinence in a 2 × 2 factorial design. Women with at least monthly fecal incontinence and normal stool consistency were randomized to 4 groups: (1) oral placebo plus education only, (2) oral loperamide plus education only, (3) placebo plus anorectal manometry-assisted biofeedback, and (4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms questionnaire at baseline, 12 weeks, and 24 weeks. The Patient Assessment of Constipation Symptoms consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to fecal incontinence treatment were defined as women with a minimally important clinical improvement of ≥5 points on the St Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in Patient Assessment of Constipation Symptoms scores from baseline through 24 weeks. RESULTS: At 24 weeks, there were small changes in Patient Assessment of Constipation Symptoms global scores in all 4 groups: oral placebo plus education (-0.3; 95% confidence interval, -0.5 to -0.1), loperamide plus education (-0.1, 95% confidence interval, -0.3 to0.0), oral placebo plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2), and loperamide plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2). No differences were observed in change in Patient Assessment of Constipation Symptoms scores between women randomized to placebo plus education and those randomized to loperamide plus education (P = .17) or placebo plus biofeedback (P = .82). Change in Patient Assessment of Constipation Symptoms scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in Patient Assessment of Constipation Symptoms scores than nonresponders (-0.4; 95% confidence interval, -0.5 to -0.3 vs -0.2; 95% confidence interval, -0.3 to -0.0, P < .01, mean difference, 0.2, 95% confidence interval, 0.1-0.4). CONCLUSION: Change in constipation symptoms following treatment of fecal incontinence in women are small and are not significantly different between groups. Loperamide treatment for fecal incontinence does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in fecal incontinence symptoms report greater improvement in constipation symptoms.

Patient Characteristics Associated with More Bother from Lower Urinary Tract Symptoms.

PURPOSE: Some patients continue to have bothersome lower urinary tract symptoms despite treatment. We examined characteristics associated with bother from lower urinary tract symptoms in a prospective cohort. MATERIALS AND METHODS: In this 1-year prospective, observational cohort study we obtained data on patients with lower urinary tract symptoms who were seeking care at a total of 6 tertiary care centers in the United States. Participants answered the AUA-SI (American Urological Association Symptom Index) global urinary bother question at study entry and 12 months later. Multilevel logistic and linear regression was used to identify factors associated with worsening bother and bother at 12 months, respectively. RESULTS: Of the 756 participants 121 (16%) had worsened lower urinary tract symptom bother during the study period. When adjusted for other variables, worsened lower urinary tract symptom bother was more likely among men who were nonwhite (OR 1.79, 95% CI 0.94-3.40) or who had diabetes (OR 1.68, 95% CI 0.86-3.27) and among women with diabetes (OR 1.77, 95% CI 0.85-3.67), prior treatment of lower urinary tract symptoms (OR 2.58, 95% CI 1.22-5.46) or a higher depression level (OR 1.29, 95% CI 1.10-1.52). Baseline factors associated with more severe bother at 12 months in men included more severe bother at baseline, nonwhite race, worse urinary frequency and incontinence, and higher levels of stress (p <0.05). Among women more severe bother at baseline, urinary urgency and frequency, and worse physical function were associated with more severe bother at 12 months. CONCLUSIONS: Urinary symptom severity at baseline, race, depression and psychological stress were associated with the bother of lower urinary tract symptoms in a prospective cohort of men and women treated at tertiary care facilities. These findings may inform the clinical care of patients with bothersome lower urinary tract symptoms and direct providers to better prognosticate for patients with challenging lower urinary tract symptoms cases.

Are prediction models for vaginal birth after cesarean accurate?

BACKGROUND: The use of trial of labor after cesarean delivery calculators in the prediction of successful vaginal birth after cesarean delivery gives physicians an evidence-based tool to assist with patient counseling and risk stratification. Before deployment of prediction models for routine care at an institutional level, it is recommended to test their performance initially in the institution's target population. This allows the institution to understand not only the overall accuracy of the model for the intended population but also to comprehend where the accuracy of the model is most limited when predicting across the range of predictions (calibration). OBJECTIVE: The purpose of this study was to compare 3 models that predict successful vaginal birth after cesarean delivery with the use of a single tertiary referral cohort before continuous model deployment in the electronic medical record. STUDY DESIGN: All cesarean births for failed trial of labor after cesarean delivery and successful vaginal birth after cesarean delivery at an academic health system between May 2013 and March 2016 were reviewed. Women with a history of 1 previous cesarean birth who underwent a trial of labor with a term (≥37 weeks gestation), cephalic, and singleton gestation were included. Women with antepartum intrauterine fetal death or fetal anomalies were excluded. The probability of successful vaginal birth after cesarean delivery was calculated with the use of 3 prediction models: Grobman 2007, Grobman 2009, and Metz 2013 and compared with actual vaginal birth after cesarean delivery success. Each model's performance was measured with the use of concordance indices, Brier scores, and calibration plots. Decision curve analysis identified the range of threshold probabilities for which the best prediction model would be of clinical value. RESULTS: Four hundred four women met the eligibility criteria. The observed rate of successful vaginal birth after cesarean delivery was 75% (305/404). Concordance indices were 0.717 (95% confidence interval, 0.659-0.778), 0.703 (95% confidence interval, 0.647-0.758), and 0.727 (95% confidence interval, 0.669-0.779), respectively. Brier scores were 0.172, 0.205, and 0.179, respectively. Calibration demonstrated that Grobman 2007 and Metz vaginal birth after cesarean delivery models were most accurate when predicted probabilities were >60% and were beneficial for counseling women who did not desire to have vaginal birth after cesarean delivery but had a predicted success rates of 60-90%. The models underpredicted actual probabilities when predicting success at <60%. The Grobman 2007 and Metz vaginal birth after cesarean delivery models provided greatest net benefit between threshold probabilities of 60-90% but did not provide a net benefit with lower predicted probabilities of success compared with a strategy of recommending vaginal birth after cesarean delivery for all women . CONCLUSION: When 3 commonly used vaginal birth after cesarean delivery prediction models are compared in the same population, there are differences in performance that may affect an institution's choice of which model to use.

Gaining the patient perspective on pelvic floor disorders' surgical adverse events.

BACKGROUND: The Institute for Healthcare Improvement defines an adverse event as an unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization or that results in death. The majority of research has focused on adverse events from the provider's perspective. OBJECTIVE: The objective of this qualitative study was to describe patient perceptions on adverse events following surgery for pelvic floor disorders. STUDY DESIGN: Women representing the following 3 separate surgical populations participated in focus groups: (1) preoperative (women <12 weeks prior to surgery); (2) short-term postoperative (women up to 12 weeks after surgery); and (3) long-term postoperative (women 1-5 years after surgery). Deidentified transcripts of audio recordings were coded and analyzed with NVivo 10 software to identify themes, concepts, and adverse events. Women were asked to rank patient-identified and surgeon-identified adverse events in order of perceived severity. RESULTS: Eighty-one women participated in 12 focus groups. Group demographics were similar between groups, and all groups shared similar perspectives regarding surgical expectations. Women commonly reported an unclear understanding of their surgery and categorized adverse events such as incontinence, constipation, nocturia, and lack of improvement in sexual function as very severe, ranking these comparably with intensive care unit admissions or other major surgical complications. Women also expressed a sense of personal failure and shame if symptoms recurred. CONCLUSION: Women consider functional outcomes such as incontinence, sexual dysfunction, and recurrence of symptoms as severe adverse events and rate them as similar in severity to intensive care unit admissions and death.

A new outcome measure for LUTS: Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) questionnaire.

AIMS: To develop a representative, self-report assessment of lower urinary tract symptoms (LUTS) for men and women, the symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29). METHODS: Women and men seeking treatment for LUTS at one of six academic medical centers in the US were assessed at baseline, 3-month and 12-month intervals. Twelve-month data on 78 LURN SI-29 items were analyzed among 353 women and 420 men using exploratory factor analysis (EFA), with factor structure confirmed using confirmatory factor analysis (CFA). Internal consistency, reliability, and validity of the five developed scales were evaluated by assessing correlations with the American Urological Association Symptom Index (AUA-SI), the genitourinary pain index (GUPI), and the Pelvic Floor Distress Inventory-20 (PFDI-20), and by examining expected sex differences in scores. RESULTS: EFA results (n = 150 women; 150 men) produced an interpretable eight-factor solution, with three of the factors comprised of dichotomous items addressing LUTS-associated sensations. The remaining five factors, confirmed with CFA in an independent sample of 473 participants, produced five scales: incontinence, urgency, voiding difficulty, bladder pain, and nocturia. Subscales and total LURN SI-29 scores were correlated as expected with AUA-SI, GUPI, and PFDI-20. LURN SI-29 scores also performed as expected in differentiating men from women based upon clinically expected differences, with men reporting more voiding difficulties and nocturia, and women reporting more urgency and incontinence. CONCLUSIONS: The LURN SI-29 questionnaire has the potential to improve research and clinical outcome measurement for both men and women with LUTS.

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

BACKGROUND/AIMS: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. RESULTS: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. CONCLUSION: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Predicting non-home discharge in epithelial ovarian cancer patients: External validation of a predictive model.

OBJECTIVE: To externally validate a model predicting non-home discharge in women undergoing primary cytoreductive surgery (CRS) for epithelial ovarian cancer (EOC). METHODS: Women undergoing primary CRS via laparotomy for EOC at three tertiary medical centers in an academic health system from January 2010 to December 2015 were included. Patients were excluded if they received neoadjuvant chemotherapy, had a non-epithelial malignancy, were not undergoing primary cytoreduction, or lacked documented model components. Non-home discharge included skilled nursing facility, acute rehabilitation facility, hospice, or inpatient death. The predicted probability of non-home discharge was calculated using age, pre-operative CA-125, American Society of Anesthesiologists (ASA) score and Eastern Cooperative Oncology Group (ECOG) performance status as described in the previously published predictive model. Model discrimination was calculated using a concordance index and calibration curves were plotted to characterize model performance across the cohort. RESULTS: A total of 204 admissions met inclusion criteria. The overall rate of non-home discharge was 12% (95% CI 8-18%). Mean age was 60.8 years (SD 11.0). Median length of stay (LOS) was significantly longer for patients with non-home discharge (8 vs. 5 days, P < 0.001). The predictive model had a concordance index of 0.86 (95% CI 0.76-0.93), which was similar to model performance in the original study (CI 0.88). The model provided accurate predictions across all probabilities (0 to 100%). CONCLUSIONS: Non-home discharge can be accurately predicted using preoperative clinical variables. Use of this validated non-home discharge predictive model may facilitate preoperative patient counseling, early discharge planning, and potentially decrease cost of care.