Measuring Pelvic Organ Prolapse: An Evolution.

INTRODUCTION AND HYPOTHESIS: Advances in our understanding of pelvic organ prolapse (POP) have been made with the introduction of valid, reliable measures of anatomy and patient-reported outcome measures. METHODS: This review provides an overview of the evolution of POP measurement and its implications for clinical practice and research. RESULTS: Since the introduction of the Pelvic Organ Prolapse Quantification (POPQ), studies have demonstrated that some degree of loss of anatomic support is normal, with as many as 40% of normal women having stage 2 prolapse. Vaginal support is dynamic and can wax and wane but is largely stable over time. Vaginal bulge symptoms are the most reliable and specific symptom for POP and the hymen is an important threshold for symptom development. Most pelvic floor symptoms have only weak to moderate correlation with the anatomic severity of POP. Treatment success rates are highly variable depending upon criteria used and definitions of anatomic success commonly used are too strict and often not clinically relevant. There is substantial discordance between subjective and anatomic measures of success, and both are dynamic, fluctuating between success and failure for many patients without intervening treatment. CONCLUSIONS: Pelvic organ prolapse is multidimensional, dynamic, and has a complex impact on patients. Patients' symptoms are more clinically relevant than anatomic support. Symptomatic cure, particularly the absence of vaginal bulge symptoms, is more clinically relevant than anatomic cure and composite outcomes can be misleading and overestimate failure rates. Future studies should compare treatments using continuous variables along multiple dimensions rather than using composite outcomes or dichotomizing patients into success or failure.

International urogynecological consultation chapter 4.1: definition of outcomes for pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: This manuscript of Chapter 4 of the International Urogynecological Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature and makes recommendations on the definition of success in the surgical treatment of pelvic organ prolapse. METHODS: An international group containing seven urogynecologists performed an exhaustive search of the literature using two PubMed searches and using PICO methodology. The first search was from 01/01/2012-06/12/2022. A second search from inception to 7/24/2022 was done to access older references. Publications were eliminated if not relevant to the clinical definition of surgical success for the treatment of POP. All abstracts were reviewed for inclusion and any disagreements were adjudicated by majority consensus of the writing group. The resulting list of articles were used to inform a comprehensive review and creation of the definition of success in the surgical treatment of POP. OUTCOMES: The original search yielded 12,161 references of which 45 were used by the writing group. Ultimately, 68 references are included in the manuscript. For research purposes, surgical success should be primarily defined by the absence of bothersome patient bulge symptoms or retreatment for POP and a time frame of at least 12 months follow-up should be used. Secondary outcomes, including anatomic measures of POP and related pelvic floor symptoms, should not contribute to a definition of success or failure. For clinical practice, surgical success should primarily be defined as the absence of bothersome patient bulge symptoms. Surgeons may consider using PASS (patient acceptable symptom state) or patient goal attainment assessments, and patients should be followed for a minimum of at least one encounter at 6-12 weeks post-operatively. For surgeries involving mesh longer-term follow-up is recommended.

Standard Restrictions vs Expedited Activity After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial.

Importance: Restrictions on postoperative activity following pelvic organ prolapse (POP) surgery are not evidence based. Nonetheless, many pelvic surgeons place lifting and activity restrictions on patients following surgery. Objective: To evaluate whether expedited activity results in noninferior anatomic and symptomatic outcomes compared with standard activity restrictions after POP surgery. Design, Setting, and Participants: This randomized noninferiority clinical trial included patients undergoing vaginal or laparoscopic apical reconstructive surgery for POP between July 1, 2020, and October 31, 2021, at a single academic tertiary referral center in Durham, North Carolina. Anatomic outcomes were assessed by masked examiners, and subjective outcomes were assessed via validated surveys, both completed at 3 months postoperatively. Patients meeting minimum physical activity criteria with at least stage II bothersome POP were eligible. A total of 218 patients were approached, of whom 123 were randomly assigned and 107 had complete outcome data and were included in the analysis. Interventions: Patients were randomly assigned to receive standard restrictions vs expedited postoperative activity instructions. Main Outcomes and Measures: The anatomic coprimary outcome was maximum anatomic POP support loss (SLmax), which is the most distal point of pelvic organ support loss according to the Pelvic Organ Prolapse Quantification System (noninferiority margin, 1.0 cm). The symptomatic coprimary outcome was the Pelvic Organ Prolapse Distress Inventory (POPDI) symptom score (noninferiority margin, 34.3 points). Differences between outcomes were assessed using linear regression models controlling for baseline SLmax and POPDI, respectively. Results: Of 123 participants randomized, 107 had complete 3-month outcome data and were included in the analysis. Mean (SD) age was 62.8 (10.1) years. At 3 months, mean (SD) SLmax was -1.7 (1.4) cm in the expedited group and -1.5 (1.4) cm in the standard group (P = .44). After adjusting for baseline SLmax, the mean maximum support loss was 0.18 cm higher within the vaginal canal in the expedited group (95% CI, -0.68 to 0.33 cm). The coprimary outcome of POPDI score was a mean (SD) 23.7 (41.8) points in the expedited group vs 25.7 (39.3) points in the standard group (P = .80). After adjusting for baseline scores, mean POPDI scores were 5.79 points lower in the expedited group (95% CI, -20.41 to 8.84). Conclusions and Relevance: The findings demonstrate that expedited activity after prolapse surgery results in noninferior anatomic and symptomatic prolapse outcomes. It is reasonable to instruct patients undergoing minimally invasive prolapse surgery to resume physical activities ad lib postoperatively. Trial Registration: ClinicalTrials.gov Identifier: NCT04329715.

The Patient Acceptable Symptom State in Female Urinary Incontinence.

OBJECTIVE: The objective of this study is to characterize an acceptable health state, using the patient acceptable symptom state (PASS) question, in adult women with urinary incontinence. METHODS: This is a prospective multicenter cohort study determining PASS thresholds from condition-specific measures using an electronic research platform in English-speaking women seeking nonsurgical treatment of urinary incontinence between March 2019 and May 2020. Exclusions included pregnancy, isolated overactive bladder, and pelvic organ prolapse greater than stage II. The cohort was described and then grouped based on achievement of PASS. The PASS thresholds were determined using the 75th percentile and univariate regression methods. Multivariable regression modeling was used to understand the influence of covariates on PASS achievement. RESULTS: The study was completed by 100 (80%) of the 125 enrolled subjects. Of these, 45% (n = 45) achieved PASS after a median of 7 weeks of treatment (range, 6-13 weeks). The corresponding questionnaire score for PASS was estimated to be 6 for the Incontinence Severity Index, 3 for the Patient Global Impression of Severity and Improvement, 37.5 using the Urinary Distress Inventory 6, and 33.3 using the Incontinence Impact Questionnaire 7. Increasing age was independently associated with achieving PASS after adjusting for treatment adherence and outcomes scores (adjusted odds ratio, 1.05 [95% confidence interval, 1.01-1.10]; P = 0.02). CONCLUSIONS: PASS was achieved in 45% of women after conservative treatment of urinary incontinence. PASS offers a new perspective for analysis and interpretation of outcome measures used in pelvic floor disorders and can serve as a reference for future research and clinical care pathways.

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.

Reliability of Symptoms and Dipstick for Postoperative Catheter-Associated Urinary Tract Infections.

OBJECTIVE: The aim of the study was to determine the diagnostic reliability of patient symptoms and urine dipstick results, including blood, leukocyte esterase, and nitrite, in diagnosing postoperative catheter-associated urinary tract infections (CAUTIs) after gynecologic surgery. METHODS: A prospective cohort study of patients undergoing gynecologic surgeries who required short-term (>24 hours) postoperative catheterization was conducted. Patients completed a questionnaire regarding symptoms. Urine dipstick analysis was completed on catheterized urine samples and urine was sent for culture for all patients. Positive likelihood ratios (LRs) were used to examine diagnostic reliability of patient symptoms and urine dipstick results in diagnosing postoperative CAUTIs. RESULTS: Fifty-seven patients with postoperative short-term indwelling catheterization were recruited, 25 (44%) of whom had CAUTIs diagnosed by urine culture at recruitment and 32 (56%) of whom did not have CAUTIs. Urine dipstick parameters were found to successfully diagnose CAUTIs, with positive LRs of 1.44 (95% confidence interval [CI], 1.04-1.99), 6.77 (95% CI, 2.23-20.52), and 9.47 (95% CI, 1.23-72.69) for blood, leukocyte esterase, and nitrite, respectively. The combination of leukocyte esterase and nitrite yielded a positive LR of 9.48 (95% CI, 2.62-34.25). Individual symptoms, alone or in combination, did not successfully diagnose positive urine culture (positive LRs <1.8). CONCLUSIONS: Urine dipstick parameters are reliable diagnostic tests for diagnosing postoperative CAUTIs after gynecologic surgery, particularly when in combination. Patient symptoms have little diagnostic value for positive urine cultures in catheterized patients after gynecologic surgery.

No evidence of benefit for laminar flow in theatre for sling-assisted, implant-based breast reconstruction.

INTRODUCTION: Recent years have seen a large increase in the proportion and number of sling-assisted, implant-based breast reconstructions. These are associated with significant rates of loss of the reconstruction. Various methods have been suggested to reduce this loss rate. One such method is the use of operating theatres with laminar flow. The majority of cases of sling-assisted, implant-based breast reconstruction in south-east Scotland are performed in two adjacent theatres, one with laminar flow and one without. This provided the opportunity to assess whether there was any difference in outcome potentially attributable to laminar flow. METHODS: Patients undergoing sling-assisted, implant-based breast reconstruction between August 2013 and December 2018 were studied with follow up for at least 6 months. RESULTS: 307 patients underwent a total of 470 procedures. 247 procedures were performed with laminar flow and 223 without. There was no difference in the indications for mastectomy, incision used or rates of smoking or radiotherapy between the two groups. Implant loss occurred in 15.8% of procedures with laminar flow and 14.3% of those without (p = 0.66). Wound problems occurred in 27.5% of procedures with laminar flow and 27.8% of those without (p = 0.97). There was no significant difference in loss rates between surgeons, mastectomy indication, sling materials or with chemotherapy use. Increased loss rates were observed in smokers, with radiotherapy, with incisions other than transverse, with larger breasts and with increasing patient weight. CONCLUSION: This study finds no evidence of benefit for laminar flow in theatre for sling-assisted, implant-based breast reconstruction.

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.

Immediate Postoperative Pelvic Organ Prolapse Quantification Measures and 2-Year Risk of Prolapse Recurrence.

OBJECTIVE: To assess whether resting genital hiatus, perineal body, and total vaginal length measured intraoperatively at the conclusion of surgery are associated with prolapse recurrence 2 years after native tissue pelvic organ prolapse reconstruction. METHODS: This ancillary analysis of the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial included women who had an immediate postoperative pelvic organ prolapse quantification (POP-Q) examination and 2-year follow-up. Primary outcome was bothersome bulge symptoms. Secondary outcomes were anatomic failure, surgical failure (either anatomic failure or bothersome bulge symptoms), and sexual function. Descriptive statistics assessed relationships between postprocedure POP-Q measures and these four outcomes. Multivariable models were fit to the data to control for baseline differences in bivariate comparisons. Receiver operating characteristic curves were generated to identify an optimal genital hiatus cut point associated with bothersome bulge, and this threshold was explored. RESULTS: This analysis included 368 participants. Bivariate analyses identified age, body mass index, vaginal deliveries, baseline genital hiatus, perineal body, and advanced POP-Q stage (3 or higher vs 2) as clinically relevant variables to include in multivariable models. After adjusting for these variables, the association between immediate postoperative genital hiatus and bothersome bulge (adjusted odds ratio [aOR] 1.4; 95% CI 0.9-2.1) was not significant at the P<.05 level; however, immediate postoperative genital hiatus was associated with anatomic (aOR 1.6; 95% CI 1.1-2.3) and surgical failure (aOR 1.5; 95% CI 1.0-2.1). Immediate postoperative genital hiatus of 3.5 cm was the selected cutoff (area under the curve 0.58, 95% CI 0.50-0.66 from the bothersome bulge model). Women with genital hiatus 3.5 cm or greater were more likely to have anatomic and surgical failures at 2 years. No POP-Q measures were correlated with 2-year sexual function. CONCLUSION: A larger immediate postoperative genital hiatus measurement of 3.5 cm or greater is not associated with bothersome bulge symptoms or sexual dysfunction but is associated with anatomic and surgical failures 2 years after native tissue vaginal reconstructive surgery.

The responsiveness and minimally important difference for the Accidental Bowel Leakage Evaluation questionnaire.

INTRODUCTION AND HYPOTHESIS: We describe the responsiveness and minimally important difference (MID) of the Accidental Bowel Leakage Evaluation (ABLE) questionnaire. METHODS: Women with bowel leakage completed ABLE, Patient Global Impression of Improvement, Colo-Rectal Anal Distress Inventory, and Vaizey questionnaires pretreatment and again at 24 weeks post-treatment. Change scores were correlated between questionnaires. Student's t tests compared ABLE change scores for improved versus not improved based on other measures. The MID was determined by anchor- and distribution-based approaches. RESULTS: In 266 women, the mean age was 63.75 (SD = 11.14) and 79% were white. Mean baseline ABLE scores were 2.32 ± 0.56 (possible range 1-5) with a reduction of 0.62 (SD = 0.79) by 24 weeks. ABLE change scores correlated with related measures change scores (r = 0.24 to 0.53) and differed between women who improved and did not improve (all p < 0.001). Standardized response means for participants who improved were large ranging from -0.89 to -1.12. Distribution-based methods suggest a MID of -0.19 based on the criterion of one SEM and -0.28 based on half a standard deviation. Anchor-based MIDs ranged from -0.10 to -0.45. We recommend a MID of -0.20. CONCLUSIONS: The ABLE questionnaire is responsive to change, with a suggested MID of -0.20.

Accidental Bowel Leakage Evaluation: A New Patient-Centered Validated Measure of Accidental Bowel Leakage Symptoms in Women.

BACKGROUND: Questionnaires assessing accidental bowel leakage lack important patient-centered symptoms. OBJECTIVE: We aimed to create a valid measure of accidental bowel leakage symptoms. DESIGN: We previously created a conceptual framework capturing patient-centered accidental bowel leakage symptoms. The framework included bowel leakage type, severity and bother, and ancillary bowel symptoms, including predictability, awareness, leakage control, emptying disorders, and discomfort. SETTINGS: The study was conducted in outpatient clinics. PATIENTS: Women with at least monthly accidental bowel leakage were included. INTERVENTIONS: Participants completed the Accidental Bowel Leakage Evaluation at baseline and 12 and 24 weeks, as well as bowel diaries and other validated pelvic floor questionnaires. A subset completed items twice before treatment. Final item selection was based on psychometric properties and clinical importance. MAIN OUTCOME MEASURES: Psychometric analyses included Cronbach α, confirmatory factor, and item response theory analyses. Construct validity was based on correlations with measures of similar constructs. RESULTS: A total of 296 women completed baseline items, and 70 provided test-retest data. The cohort was predominately white (79%) and middle aged (64 ± 11 y). Confirmatory factor analyses supported the conceptual framework. The final 18-item scale demonstrated good internal consistency (Cronbach α = 0.77-0.90) and test-retest reliability (intraclass correlation = 0.80). Construct validity was demonstrated with baseline and 12- and 24-week scale scores, which correlated with the Vaizey (r = 0.52, 0.68, and 0.69), Colorectal Anal Distress Inventory (r = 0.54, 0.65, 0.71), Colorectal Anal Impact Questionnaire (r = 0.48, 0.53, 0.53), and hygiene (r = 0.39, 0.43, 0.49) and avoidance subscales scores of the adaptive index (r = 0.45, 0.44, 0.43) and average number of pad changes per day on bowel diaries (r = 0.35, 0.38, 0.31; all p < 0.001). LIMITATIONS: The study was limited by nature of involving validation in a care-seeking population. CONCLUSIONS: The Accidental Bowel Leakage Evaluation instrument is a reliable, patient-centered measure with good validity properties. This instrument improves on currently available measures by adding patient-important domains of predictability, awareness, control, emptying, and discomfort. See Video Abstract at http://links.lww.com/DCR/B172. EVALUACIóN DE FUGA INTESTINAL ACCIDENTAL: UNA NUEVA MEDIDA VALIDADA Y CENTRADA EN PACIENTES FEMENINOS CON SíNTOMAS DE FUGA INTESTINAL ACCIDENTAL: Los cuestionarios que evalúan la fuga intestinal accidental, carecen de síntomas centrados en el paciente.Nuestro objetivo fue crear una medida válida de síntomas de fuga intestinal accidental.Previamente creamos un marco conceptual centrado en el paciente, para capturar síntomas de fuga intestinal accidental. El marco incluía tipo de fuga intestinal, gravedad, molestia, y síntomas intestinales auxiliares, incluyendo previsibilidad, conciencia, control de fugas, trastornos de vaciado e incomodidad.Clínicas de pacientes externos.Mujeres con al menos una fuga intestinal accidental mensual.Las participantes completaron la Evaluación de Fuga Intestinal Accidental al inicio del estudio y a las 12 y 24 semanas, así como diarios intestinales y otros cuestionarios validados del piso pélvico. Un subconjunto completó los elementos dos veces antes del tratamiento. La selección final del elemento se basó en las propiedades psicométricas y la importancia clínica.Los análisis psicométricos incluyeron el Alfa de Cronbach, factor confirmatorio y análisis de la teoría de respuesta al elemento. La validez de constructo se basó en correlaciones con medidas de constructos similares.Un total de 296 mujeres completaron los elementos de referencia y 70 proporcionaron datos de test-retest. La cohorte fue predominantemente blanca (79%) y de mediana edad (64 +/- 11 años). Análisis factorial confirmatorio respaldó el marco conceptual. La escala final de 18 elementos, demostró una buena consistencia interna (Alfa de Cronbach = 0,77-0,90) y fiabilidad test-retest (correlación intraclase = 0,80). La validez de constructo se demostró con puntajes de escala de referencia de 12 y 24 semanas que se correlacionaron con Vaizey (r = 0,52, 0,68 y 0,69), Inventario de Ansiedad colorecto anal (r = 0,54, 0,65, 0,71), Cuestionarios de Impacto colorecto anal (r = 0,48, 0,53, 0,53) e higiene (r = 0,39, 0,43, 0,49), puntuaciones de subescalas de evitación del índice adaptativo (r = 0,45, 0,44, 0,43), número promedio de cambios de almohadilla por día, de los diarios intestinales (r = 0.35, 0.38, 0.31), todos p <.001.Validación de una población en busca de atención.El instrumento de Evaluación de Fuga Intestinal Accidental es una medida confiable, centrada en el paciente y con buenas propiedades de validez. Este instrumento mejora las medidas actualmente disponibles, al agregar dominios importantes para el paciente de previsibilidad, conciencia, control, vaciado e incomodidad. Consulte Video Resumen en http://links.lww.com/DCR/B172. (Traducción-Dr. Fidel Ruiz Healy).

Summary: 2017 International Consultation on Incontinence Evidence-Based Surgical Pathway for Pelvic Organ Prolapse.

OBJECTIVE: The aim of this article is to summarize the relevant findings that inform the 2017 International Consultation on Incontinence pathway for surgical treatment of pelvic organ prolapse (POP). METHODS: We conducted an evidence-based review of the English-language peer-reviewed literature relating to POP surgery published prior to December 2016. Level 1 evidence (randomized controlled trials [RCTs] or systematic reviews of RCTs) was preferred; however, level 2 (poor-quality RCT, prospective cohort studies) or 3 evidence (case series or retrospective studies) has been included if level 1 data were lacking. The committee evaluated the literature and made recommendations based on the Oxford grading system summarized as follows: grade A recommendation usually depends on consistent level 1 evidence; grade B recommendation usually depends on consistent level 2 and/or 3 studies, or "majority evidence" from RCTs; grade C recommendation usually depends on level 3 studies or "majority evidence" from level 2/3 studies or Delphi-processed expert opinion; grade D, "no recommendation possible," would be used where the evidence is inadequate or conflicting. RESULTS: The recommendations from each chapter of the review are presented and serve to inform an evidence-based pathway for the surgical treatment of prolapse. A Web-based interactive application of the pathway is presented. CONCLUSIONS: The 2017 International Consultation on Incontinence pathway on surgery for POP is designed as an adjunct to transparent consultation and consent relating to POP surgery. The final decision regarding surgical intervention can be made only after a shared decision-making process between the patient and the clinician that will evaluate a variety of individual factors that cannot be assessed in the pathway.

The Effect of Catheterization on Susceptibility of Uropathogens After Pelvic Reconstructive Surgery.

OBJECTIVE: The aim of this study was to determine whether bacterial uropathogens from positive urine cultures and uropathogen antibiotic susceptibility differ between catheterized (C) and noncatheterized (NC) patients after pelvic reconstructive surgery. METHODS: This is a retrospective cohort study of patients with a positive urine culture within 1 year of pelvic reconstructive surgery. Patients were categorized as having an indwelling catheter placed for urinary retention or voiding dysfunction within 48 hours of specimen collection versus no catheter. Microbiology reports provided uropathogens and antibiotic susceptibility for each culture. Student t test, χ, and logistic regression were used to compare rates of non-Escherichia coli uropathogens and susceptibility to first-line antibiotics between C and NC groups. RESULTS: A total of 427 positive urine cultures from 317 unique patients were identified. Positive urine cultures from C patients were less likely to contain E. coli (47.1% NC vs 29.2% C; P = 0.0009), with enterococcus being the most common non-E. coli uropathogen. The odds of non-E. coli uropathogens increased with age (adjusted odds ratio, 4.25; 95% confidence interval, 1.95-9.28; P = 0.0003 for the oldest patients). Cultures from C patients were more likely to have a uropathogen not susceptible to sulfamethoxazole/trimethoprim (20.5% NC vs 32.1% C; P = 0.03), nitrofurantoin (19.2% NC vs 34.6% C; P = 0.002), and cefazolin (18.1% NC vs 49.4% C; P < 0.0001). CONCLUSIONS: After pelvic reconstructive surgery, patients with a positive urine culture who have undergone catheterization within 48 hours of specimen collection are more likely to have non-E. coli uropathogens, with 1 in 3 cultures being not susceptible to common first-line antibiotics. This highlights the importance of performing susceptibility testing rather than treating empirically after pelvic reconstructive surgery.

Intraoperative Evaluation of Urinary Tract Injuries at the Time of Pelvic Surgery: A Systematic Review.

OBJECTIVE: The aim of this study was to determine the safety and efficacy of methods for intraoperative evaluation of urinary tract injury during pelvic surgery. METHODS: PubMed, EMBASE, CINAHL, Web of Science, Scopus, ProQuest, the Cochrane Library, and Clinicaltrials.gov were searched from 1947 to February 2018. Articles or abstracts describing the routine evaluation of urinary tract injuries during pelvic surgery in adults were included, surgical indications of urinary tract anomaly, stones, or malignancy were excluded. There were no restrictions on study design or language. Outcomes included injuries diagnosed intraoperatively, delayed diagnoses, adverse effects, subjective assessments, time to use, and cost. Data were extracted in duplicate at an individual-participant level. Prevalence of injuries, sensitivity, specificity, and predictive values of each diagnostic method were calculated. A combination of generalized linear models and a Bayesian approach were used to separately pool diagnostic accuracy measures. RESULTS: There were 5303 titles, 527 abstracts, and 164 full-text articles assessed for eligibility; 69 articles were analyzed. Diagnostic methods retrieved were cystoscopy using saline, dextrose or unspecified distention media, oral phenazopyridine and vitamin B, intravenous (IV) methylene blue, IV sodium fluorescein, IV indigo carmine, prophylactic retrograde ureteral stents, and transabdominal Doppler ultrasound. Prevalence of urinary tract injury ranged from 0.3% to 2.8%. Sensitivity ranged 63% to 91%, and specificity, 99.7% to 100%, with no significant differences suggested between methods. CONCLUSIONS: All evaluable methods of intraoperative urinary tract assessment during pelvic surgery are safe and effective with specificity of greater than 99% and low rates of complications. Larger, more rigorous studies are required to evaluate the diagnostic accuracy of some newer methods.

Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial.

BACKGROUND: Well designed, large comparative effectiveness trials assessing the efficacy of primary interventions for faecal incontinence are few in number. The objectives of this study were to compare different combinations of anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo. METHODS: In this randomised factorial trial, participants were recruited from eight clinical sites in the USA. Women with at least one episode of faecal incontinence per month in the past 3 months were randomly assigned 0·5:1:1:1 to one of four groups: oral placebo plus education only, placebo plus anorectal manometry-assisted biofeedback, loperamide plus education only, and loperamide plus anorectal manometry-assisted biofeedback. Participants received 2 mg per day of loperamide or oral placebo with the option of dose escalation or reduction. Women assigned to biofeedback received six visits, including strength and sensory biofeedback training. All participants received a standardised faecal incontinence patient education pamphlet and were followed for 24 weeks after starting treatment. The primary endpoint was change in St Mark's (Vaizey) faecal incontinence severity score between baseline and 24 weeks, analysed by intention-to-treat using general linear mixed modelling. Investigators, interviewers, and outcome evaluators were masked to biofeedback assignment. Participants and all study staff other than the research pharmacist were masked to medication assignment. Randomisation took place within the electronic data capture system, was stratified by site using randomly permuted blocks (block size 7), and the sizes of the blocks and the allocation sequence were known only to the data coordinating centre. This trial is registered with ClinicalTrials.gov, number NCT02008565. FINDINGS: Between April 1, 2014, and Sept 30, 2015, 377 women were enrolled, of whom 300 were randomly assigned to placebo plus education (n=42), placebo plus biofeedback (n=84), loperamide plus education (n=88), and the combined intervention of loperamide plus biofeedback (n=86). At 24 weeks, there were no differences between loperamide versus placebo (model estimated score change -1·5 points, 95% CI -3·4 to 0·4, p=0·12), biofeedback versus education (-0·7 points, -2·6 to 1·2, p=0·47), and loperamide and biofeedback versus placebo and biofeedback (-1·9 points, -4·1 to 0·3, p=0·092) or versus loperamide plus education (-1·1 points, -3·4 to 1·1, p=0·33). Constipation was the most common grade 3 or higher adverse event and was reported by two (2%) of 86 participants in the loperamide and biofeedback group and two (2%) of 88 in the loperamide plus education group. The percentage of participants with any serious adverse events did not differ between the treatment groups. Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group). INTERPRETATION: In women with normal stool consistency and faecal incontinence bothersome enough to seek treatment, we were unable to find evidence against the null hypotheses that loperamide is equivalent to placebo, that anal exercises with biofeedback is equivalent to an educational pamphlet, and that loperamide and biofeedback are equivalent to oral placebo and biofeedback or loperamide plus an educational pamphlet. Because these are common first-line treatments for faecal incontinence, clinicians could consider combining loperamide, anal manometry-assisted biofeedback, and a standard educational pamphlet, but this is likely to result in only negligible improvement over individual therapies and patients should be counselled regarding possible constipation. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health.

Pain and activity after vaginal reconstructive surgery for pelvic organ prolapse and stress urinary incontinence.

BACKGROUND: Little is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse. OBJECTIVE: The objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension. STUDY DESIGN: This planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected. RESULTS: Before surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain. CONCLUSION: Pain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks.