Development and validation of models predicting treatment patterns in women with urinary urgency and/or urgency incontinence: A Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study.

PURPOSE: To develop a tool to predict a woman's treatment pattern for bothersome urinary urgency (UU) and/or UU incontinence over 1 year after presenting for care at urology or urogynecology clinics. METHODS: The Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study enrolled adult women with bothersome UU and/or UU incontinence using the lower urinary tract symptoms (LUTS) Tool who were seeking care for LUTS. Treatments for UU and/or urgency incontinence were ordered from least to most invasive. Ordinal logistic and Cox proportional hazard regression models were fit to predict the most invasive level of treatment during follow-up and overactive bladder (OAB) medication discontinuation, respectively. Binary logistic regression was performed to predict sling treatment during the study follow-up. Clinical tools were then created using the models listed above to predict treatment pattern over 12 months. RESULTS: Among 349 women, 281 reported UU incontinence, and 68 reported UU at baseline. The highest level of treatment during the study was as follows: 20% no treatment, 24% behavioral treatments, 23% physical therapy, 26% OAB medication, 1% percutaneous tibial nerve stimulation, 3% onabotulinumtoxin A, and 3% sacral neuromodulation. Slings were placed in 10% (n = 36) of participants before baseline and in 11% (n = 40) during study follow-up. Baseline factors associated with predicting the most invasive level of treatment included baseline level of treatment, hypertension, UU incontinence severity, stress urinary incontinence (SUI) severity, and anticholinergic burden score. Less severe baseline depression and less severe UU incontinence were associated with OAB medication discontinuation. UU and SUI severity were associated with sling placement during the study period. Three tools are available to predict: (1) highest level of treatment; (2) OAB medication discontinuation; and (3) sling placement. CONCLUSIONS: OAB treatment prediction tools developed in this study can help providers individualize treatment plans and identify not only patients at risk for treatment discontinuation but also patients who may not be escalated to potentially beneficial OAB treatments, with the goal to improve clinical outcomes for patients suffering from this chronic and often debilitating condition.

Treatment patterns in women with urinary urgency and/or urgency urinary incontinence in the symptoms of Lower Urinary Tract Dysfunction Research Network Observational Cohort Study.

BACKGROUND: Limited epidemiological data exist describing how patients engage with various treatments for overactive bladder (OAB). To improve care for patients with OAB, it is essential to gain a better understanding of how patients interface with OAB treatments longitudinally, that is, how often patients change treatments and the pattern of this treatment change in terms of escalation and de-escalation. OBJECTIVES: To describe treatment patterns for women with bothersome urinary urgency (UU) and/or urgency urinary incontinence (UUI) presenting to specialty care over 1 year. STUDY DESIGN: The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) study enrolled adult women with bothersome UU and/or UUI seeking care for lower urinary tract symptoms (LUTS) between January 2015 and September 2016. An ordinal logistic regression model was fitted to describe the probabilities of escalating or de-escalating level of treatment during 1-year follow-up. RESULTS: Among 349 women, 281 reported UUI and 68 reported UU at baseline. At the end of 1 year of treatment by a urologist or urogynecologist, the highest level of treatment received by participants was 5% expectant management, 36% behavioral treatments (BT), 26% physical therapy (PT), 26% OAB medications, 1% percutaneous tibial nerve stimulation, 3% intradetrusor onabotulinum toxin A injection, and 3% sacral neuromodulation. Participants using BT or PT at baseline were more likely to be de-escalated to no treatment than participants on OAB medications at baseline, who tended to stay on medications. Predictors of the highest level of treatment included starting level of treatment, hypertension, UUI severity, stress urinary incontinence, and anticholinergic burden score. CONCLUSIONS: Treatment patterns for UU and UUI are diverse. Even for patients with significant bother from OAB presenting to specialty clinics, further treatment often only involves conservative or medical therapies. This study highlights the need for improved treatment algorithms to escalate patients with persistent symptoms, or to adjust care in those who have been unsuccessfully treated.

Risk of obstetric anal sphincter injuries at the time of admission for delivery: A clinical prediction model.

OBJECTIVE: To develop and validate a model to predict obstetric anal sphincter injuries (OASIS) using only information available at the time of admission for labour. DESIGN: A clinical predictive model using a retrospective cohort. SETTING: A US health system containing one community and one tertiary hospital. SAMPLE: A total of 22 873 pregnancy episodes with in-hospital delivery at or beyond 21 weeks of gestation. METHODS: Thirty antepartum risk factors were identified as candidate variables, and a prediction model was built using logistic regression predicting OASIS versus no OASIS. Models were fit using the overall study population and separately using hospital-specific cohorts. Bootstrapping was used for internal validation and external cross-validation was performed between the two hospital cohorts. MAIN OUTCOME MEASURES: Model performance was estimated using the bias-corrected concordance index (c-index), calibration plots and decision curves. RESULTS: Fifteen risk factors were retained in the final model. Decreasing parity, previous caesarean birth and cardiovascular disease increased risk of OASIS, whereas tobacco use and black race decreased risk. The final model from the total study population had good discrimination (c-index 0.77, 95% confidence interval [CI] 0.75-0.78) and was able to accurately predict risks between 0 and 35%, where average risk for OASIS was 3%. The site-specific model fit using patients only from the tertiary hospital had c-stat 0.74 (95% CI 0.72-0.77) on community hospital patients, and the community hospital model was 0.77 (95%CI 0.76-0.80) on the tertiary hospital patients. CONCLUSIONS: OASIS can be accurately predicted based on variables known at the time of admission for labour. These predictions could be useful for selectively implementing OASIS prevention strategies.

Clinical prediction is at the heart of preventing birth trauma and pelvic floor disorders for individual women.

INTRODUCTION AND HYPOTHESIS: The purpose of this article is to understand that the majority of studies investigating the role of risk factors for maternal birth trauma and pelvic floor disorders are designed using causal inferential statistical methods and have not been designed to investigate the more useful goal of clinical prediction. METHODS: A review of the literature was conducted to describe notable causal and predictive associations between risk factors and maternal birth trauma outcomes. Examples were obtained to illustrate and contrast differences in clinical usefulness between causal and predictive models. RESULTS: Effects of pregnancy and childbirth on the risk of maternal birth trauma outcomes and subsequent pelvic floor disorders are an area of profound investigation. Numerous observational studies provide evidence that pregnancy and childbirth play a causal role in the increasing prevalence of these outcomes, and clinicians must rely on this observational evidence to guide decisions about preventing maternal birth trauma and pelvic floor disorders. However, there are important differences between the design and evaluation of models for a predictive context including: study design goals, inclusion or exclusion of candidate risk factors, model evaluation and the additional need to assess model error. CONCLUSION: This article contrasts how causal and predictive modeling approaches are different and argues that indiscriminately modeling risk factors for birth trauma and pelvic floor disorder outcomes is costly to women.

Risk Factors for Surgical Failure and Worsening Pelvic Floor Symptoms Within 5 Years After Vaginal Prolapse Repair.

OBJECTIVE: To assess independent risk factors for surgical failure and worsening pelvic floor symptoms within 5 years after vaginal prolapse surgery. METHODS: This secondary analysis includes OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) (n=374) and E-OPTIMAL (Extended) (n=285) trial participants. Surgical failure was defined as apical descent greater than one third of the total vaginal length, anterior or posterior vaginal wall past the hymen, subsequent surgery or bothersome vaginal bulge. Worsening pelvic floor symptoms were defined as increases from baseline as large as the minimally important difference for subscale scores of the Pelvic Floor Distress Inventory: 11 for the Urinary Distress Inventory and Colorectal-Anal Distress Inventory and 34.3 for the Pelvic Organ Prolapse Distress Inventory. Outcomes were measured at 6 months then 1, 2, 3, 4, and 5 years. Chi-square and t test results from bivariate models and clinical relevance were used to inform final models. RESULTS: Baseline risk factors for surgical failure were Hispanic ethnicity (adjusted odds ratio [aOR] 1.92, 95% CI 1.17-3.15), perineal body (aOR 1.34, 95% CI 1.09-1.63), and pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 1.16, 95% CI 1.05-1.28). Risk factors for worsening of pelvic floor symptoms were pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 0.75, 95% CI 0.60-0.94) for worsening Pelvic Organ Prolapse Distress Inventory score, vaginal deliveries (aOR 1.26, 95% CI 1.10-1.44) and pretreatment Urinary Distress Inventory score (aOR 0.86, 95% CI 0.80-0.93) for worsening Urinary Distress Inventory score, and age (aOR 1.03, 95% CI 1.01-1.05) and pretreatment Colorectal-Anal Distress Inventory score (aOR 0.95, 95% CI 0.92-0.98) for worsening Colorectal-Anal Distress Inventory score. CONCLUSIONS: Hispanic ethnicity, larger preoperative perineal body, and higher pretreatment Pelvic Organ Prolapse Distress Inventory scores were risk factors for surgical failure up to 5 years after vaginal prolapse repair. Participants with higher baseline Pelvic Floor Distress Inventory scores were less likely to worsen. Risk factors for worsening Urinary Distress Inventory and Colorectal-Anal Distress Inventory scores included more vaginal deliveries and increased age, respectively. CLINICAL TRIAL REGISTRATION: NCT00597935, NCT01166373.

Automated problem list generation and physicians perspective from a pilot study.

OBJECTIVE: An accurate, comprehensive and up-to-date problem list can help clinicians provide patient-centered care. Unfortunately, problem lists created and maintained in electronic health records by providers tend to be inaccurate, duplicative and out of date. With advances in machine learning and natural language processing, it is possible to automatically generate a problem list from the data in the EHR and keep it current. In this paper, we describe an automated problem list generation method and report on insights from a pilot study of physicians' assessment of the generated problem lists compared to existing providers-curated problem lists in an institution's EHR system. MATERIALS AND METHODS: The natural language processing and machine learning-based Watson1 method models clinical thinking in identifying a patient's problem list using clinical notes and structured data. This pilot study assessed the Watson method and included 15 randomly selected, de-identified patient records from a large healthcare system that were each planned to be reviewed by at least two internal medicine physicians. The physicians created their own problem lists, and then evaluated the overall usefulness of their own problem lists (P), Watson generated problem lists (W), and the existing EHR problem lists (E) on a 10-point scale. The primary outcome was pairwise comparisons of P, W, and E. RESULTS: Six out of the 10 invited physicians completed 27 assessments of P, W, and E, and in process evaluated 732 Watson generated problems and 444 problems in the EHR system. As expected, physicians rated their own lists, P, highest. However, W was rated higher than E. Among 89% of assessments, Watson identified at least one important problem that physicians missed. CONCLUSION: Cognitive computing systems like this Watson system hold the potential for accurate, problem-list-centered summarization of patient records, potentially leading to increased efficiency, better clinical decision support, and improved quality of patient care.

Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women.

OBJECTIVE: This study aimed to describe the incidence of fecal incontinence (FI) at 6, 12, and 24 weeks postpartum; anal incontinence (AI) and fecal urgency at 24 weeks; and identify predictors of AI in women with obstetric anal sphincter injury (OASI). METHODS: Primiparous women sustaining OASIs were identified at 8 clinical sites. Third-degree OASIs were characterized using World Health Organization criteria, 3a (<50%) or 3b (>50%) tear through the sphincter. Fecal incontinence was defined as leakage of liquid/solid stool and/or mucus in the past month; AI was defined as leakage of liquid/solid stool and/or mucus and/or gas in the past month and was assessed at 6, 12, and 24 weeks postpartum using the Fecal Incontinence Severity Index. Logistic regression identified variables associated with AI. RESULTS: Three hundred forty-three women participated: 297 subjects sustained a third-degree OASI, 168 type 3a, 98 type 3b and 31 indeterminant; 45 had a fourth-degree OASI. Overall FI incidence at 6, 12, and 24 weeks was 7% [23/326; 95% confidence interval (CI), 4%-10%], 4% (6/145; 95% CI, 2%-9%), and 9% (13/138; 95% CI, 5%-16%), respectively. At 24 weeks, AI incidence was 24% (95% CI, 17%-32%) and fecal urgency 21% (95% CI, 15%-29%). No significant differences in FI and AI rates were noted by third-degree type or between groups with third and fourth OASI. Flatal incontinence was greater in women sustaining a fourth-degree tear (35% vs 16%, P = 0.04). White race (adjusted odds ratio, 4.64; 95% CI, 1.35-16.02) and shorter duration of second stage (adjusted odds ratio, 1.47 per 30 minute decrease; 95% CI, 1.12-1.92) were associated with AI at 24 weeks. CONCLUSIONS: Overall 24-week incidence of FI is 9% (95% CI, 5%-16%) and AI is 24% (95% CI, 17%-32%). In women with OASI, white race and shorter second-stage labor were associated with postpartum AI. CLINICAL TRIAL REGISTRATION: NCT01166399 (http://clinicaltrials.gov).

Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence.

OBJECTIVES: The objective of this study was to estimate the minimum important difference (MID) for the Fecal Incontinence Severity Index (FISI), the Colorectal-Anal Distress Inventory (CRADI) scale of the Pelvic Floor Distress Inventory, the Colorectal-Anal Impact Questionnaire (CRAIQ) scale of the Pelvic Floor Impact Questionnaire, and the Modified Manchester Health Questionnaire (MMHQ). METHODS: We calculated the MIDs using anchor-based and distribution-based approaches from a multicenter prospective cohort study investigating adaptive behaviors among women receiving nonsurgical and surgical management for fecal incontinence (FI). Patient responses were primarily anchored using a Global Impression of Change scale. The MID was defined as the difference in mean change from baseline between those who indicated they were "a little better" and those who reported "no change" on the Global Impression of Change scale 3 months after treatment. The effect size and SE of measurement were the distribution methods used. RESULTS: The mean changes (SD) in FISI, CRADI, CRAIQ, and MMHQ scores from baseline to 3 months after treatment were -8.8 (12.0), -52.7 (70.0), -60.6 (90.0), and -12.6 (19.2), respectively. The anchor-based MID estimates suggested by an improvement from no change to a little better were -3.6, -11.4 and -4.7, -18.1 and -8.0, and -3.2 for the FISI, CRADI (long and short version), CRAIQ (long and short version), and MMHQ, respectively. These data were supported by 2 distribution-based estimates. CONCLUSIONS: The MID values for the FISI are -4, CRADI (full version, -11; short version, -5), CRAIQ (full version, -18; short version, -8), and MMHQ -3. Statistically significant improvements that meet these thresholds are likely to be clinically important.

Attitudes toward hysterectomy in women undergoing evaluation for uterovaginal prolapse.

OBJECTIVES: To investigate attitudes toward hysterectomy in women seeking care for pelvic organ prolapse. METHODS: Two hundred twenty women referred for evaluation of prolapse without evidence of previous hysterectomy were surveyed with the Pelvic Organ Prolapse Distress Inventory; the Control Preferences Scale; and questions regarding patients' perception of the impact of hysterectomy on health, social life, and emotional well-being. Additional items presented hypothetical scenarios. Surveys were distributed in small batches until 100 responses were obtained from patients who met inclusion criteria. RESULTS: One hundred women with an intact uterus responded. Sixty percent indicated they would decline hysterectomy if presented with an equally efficacious alternative to a hysterectomy-based prolapse repair. The doctor's opinion, risk of surgical complications, and risk of malignancy were the most important factors in surgical decision making. CONCLUSIONS: Many women with prolapse prefer to retain their uterus at the time of surgery in the absence of a substantial benefit to hysterectomy. These findings should provide further impetus to investigate the efficacy of uterine-sparing procedures to help women make informed decisions regarding prolapse surgery.

Adherence to behavioral interventions for stress incontinence: rates, barriers, and predictors.

BACKGROUND: First-line conservative treatment for stress urinary incontinence (SUI) in women is behavioral intervention, including pelvic-floor muscle (PFM) exercise and bladder control strategies. OBJECTIVE: The purposes of this study were: (1) to describe adherence and barriers to exercise and bladder control strategy adherence and (2) to identify predictors of exercise adherence. DESIGN: This study was a planned secondary analysis of data from a multisite, randomized trial comparing intravaginal continence pessary, multicomponent behavioral therapy, and combined therapy in women with stress-predominant urinary incontinence (UI). METHODS: Data were analyzed from the groups who received behavioral intervention alone (n=146) or combined with continence pessary therapy (n=150). Adherence was measured during supervised treatment and at 3, 6, and 12 months post-randomization. Barriers to adherence were surveyed during treatment and at the 3-month time point. Regression analyses were performed to identify predictors of exercise adherence during supervised treatment and at the 3- and 12-month time points. RESULTS: During supervised treatment, ≥86% of the women exercised ≥5 days a week, and ≥80% performed at least 30 contractions on days they exercised. At 3, 6, and 12 months post-randomization, 95%, 88%, and 80% of women, respectively, indicated they were still performing PFM exercises. During supervised treatment and at 3 months post-randomization, ≥87% of the women reported using learned bladder control strategies to prevent SUI. In addition, the majority endorsed at least one barrier to PFM exercise, most commonly "trouble remembering to do exercises." Predictors of exercise adherence changed over time. During supervised intervention, less frequent baseline UI and higher baseline 36-Item Short-Form Health Survey (SF-36) mental scores predicted exercise adherence. At 3 months post-randomization, women who dropped out of the study had weaker PFMs at baseline. At 12 months post-randomization, only "trouble remembering" was associated with exercise adherence. LIMITATIONS: Adherence and barrier questionnaires were not validated. CONCLUSIONS: Adherence to PFM exercises and bladder control strategies for SUI can be high and sustained over time. However, behavioral interventions to help women link exercise to environmental and behavioral cues may only be beneficial over the short term.

Functional bowel disorders and pelvic organ prolapse: a case-control study.

OBJECTIVES: : To compare the relative frequencies of constipation and other functional bowel disorders between patients with and without pelvic organ prolapse (POP). METHODS: : This was a case-control study design. Cases were patients with stage 3-4 POP presenting to a urogynecology clinic and controls were patients presenting to a general gynecology or women's health clinic for annual examinations with stage 0-1 vaginal support. Constipation disorders were defined using responses to the Rome II Modular Questionnaire for functional bowel disorders as well as predefined defecatory disorders. RESULTS: : 128 cases and 127 controls were enrolled. After controlling for race, education, and comorbidities, women with POP were more likely to report symptoms consistent with outlet constipation, including straining during a bowel movement (odds ratio [OR] 3.9, confidence interval [CI] 2.1-7.3), feeling of incomplete rectal emptying (OR 4.0, CI 2.1-7.7), a sensation that stool cannot be passed (OR 3.4, CI 1.7-6.7), and splinting (OR 2.7, CI 1.3-5.7). In spite of this, cases were just as likely to meet the criteria for functional constipation or irritable bowel syndrome (IBS) with constipation as controls but more likely to meet the criteria for IBS-any type (OR 3.8, CI 1.6-9.1) as women with POP reported more discomfort or pain in the abdomen (OR 3.4 CI 1.6-7.1) and >3 bowel movements per day (OR 2.9, CI 1.3-6.3). CONCLUSIONS: : Patients with POP are more likely to have symptoms of outlet constipation and other functional bowel disorders compared with patients without POP. The Rome II criteria may not be an appropriate classification system for functional bowel disorders in patients with advanced POP.

Anatomic relationships of the tension-free vaginal mesh trocars.

OBJECTIVE: The objective of the study was to describe the distances between the major anatomic structures to the path of the tension-free vaginal mesh (TVM) trocars. STUDY DESIGN: Four anterior transobturator and 2 posterior ischiorectal TVM trocars were inserted bilaterally into 8 fresh frozen cadavers. Dissections were performed and mean distances (95% confidence interval) were measured between the closest points along the trocar's path and significant anatomic structures. RESULTS: The mean distances between both anterior transobturator trocars and the medial branch of the obturator vessels were 0.8 cm (range, 0.6 to 1.0) and 0.7 cm (range, 0.4 to 1.1), and bladder were 0.7 cm (range, 0.5 to 0.9) and 1.3 cm (range, 0.8 to 1.9), respectively. The mean distances between the posterior trocar and the rectum and inferior rectal vessels were 0.8 cm (range, 0.6 to 1.0) and 0.9 cm (range, 0.7 to 1.1), respectively. CONCLUSION: The bladder and medial branch of the obturator vessel may be at risk of injury during the passage of the anterior trocars, whereas the rectum and inferior rectal vessels may be at risk during the passage of the posterior trocar.

Bowel symptoms 1 year after surgery for prolapse: further analysis of a randomized trial of rectocele repair.

OBJECTIVE: The purpose of this study was to analyze change in bowel function and its relationship to vaginal anatomy 1 year after rectocele repair and pelvic reconstruction in a randomized trial of 3 techniques of rectocele repair. STUDY DESIGN: The study is an ancillary analysis of data from a randomized trial of 3 techniques of rectocele repair: posterior colporrhaphy, site-specific repair, and site-specific repair with Fortagen graft augmentation. Pelvic examination and validated questionnaires were obtained at baseline, 6 months, and 1 year after surgery. Bowel symptoms included straining, splinting, incomplete emptying, painful defecation, fecal urgency, and fecal incontinence. Logistic regression was used to identify predictors of bothersome postoperative symptoms. RESULTS: One hundred six women with Stage > or = 2 POP, which included a rectocele, were enrolled in the study. Ninety-nine underwent prolapse surgery that included a rectocele repair and completed at least 1 follow-up visit. Ninety-six percent of subjects underwent concomitant prolapse surgery. No differences in change in bowel symptoms were noted between treatment groups. On average, all bowel symptoms evaluated were significantly improved 1 year after surgery. The development of new "bothersome" bowel symptoms after surgery was uncommon (11%). After controlling for age, treatment group, comorbidities, and preoperative bowel symptoms, corrected postoperative vaginal support (Stage 0/1) was associated with a reduced risk of postoperative straining (adj. OR 0.17 95% CI 0.03 to 0.9) and feeling of incomplete emptying (adj. OR 0.1 95% CI 0.01 to 0.52). Normal support of the posterior vaginal wall (Bp < or = -2) was associated with a reduced risk of bothersome incomplete emptying (OR 0.08 95% CI 0.004 to 0.58) but not with other symptoms. CONCLUSION: Resolution or improvement in bowel symptoms can be expected in the majority of women after rectocele repair and pelvic reconstruction. While all symptoms improved after surgery, a reduction in bothersome postoperative straining and incomplete emptying were specifically associated with cure of posterior vaginal wall prolapse.