Characteristics Associated With Clinically Important Treatment Responses in Women Undergoing Nonsurgical Therapy for Fecal Incontinence.

OBJECTIVE: To identify baseline clinical and demographic characteristics associated with clinically important treatment responses in a randomized trial of nonsurgical therapies for fecal incontinence (FI). METHODS: Women (N = 296) with FI were randomized to loperamide or placebo- and manometry-assisted biofeedback exercises or educational pamphlet in a 2 × 2 factorial design. Treatment response was defined in 3 ways from baseline to 24 weeks: minimal clinically important difference (MID) of -5 points in St. Mark's score, ≥50% reduction in FI episodes, and combined St. Mark's MID and ≥50% reduction FI episodes. Multivariable logistic regression models included baseline characteristics and treatment groups with and without controlling for drug and exercise adherence. RESULTS: Treatment response defined by St. Mark's MID was associated with higher symptom severity (adjusted odds ratio [aOR] 1.20, 95% confidence interval [CI] 1.11-1.28) and being overweight vs normal/underweight (aOR 2.15, 95% CI 1.07-4.34); these predictors remained controlling for adherence. Fifty percent reduction in FI episodes was associated with the combined loperamide/biofeedback group compared with placebo/pamphlet (aOR 4.04, 95% CI 1.36-11.98), St. Mark's score in the placebo/pamphlet group (aOR 1.29, 95% CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95% CI 1.09-5.25), and passive vs urge plus passive FI (aOR 3.26, 95% CI 1.48-7.17). Controlling for adherence, associations remained, except St. Mark's score. DISCUSSION: Higher severity of FI symptoms, being overweight, drug adherence, FI subtype, and combined biofeedback and medication treatment were associated with clinically important treatment responses. This information may assist in counseling patients, regarding efficacy and expectations of nonsurgical treatments of FI.

Contribution of the second stage of labour to pelvic floor dysfunction: a prospective cohort comparison of nulliparous women.

OBJECTIVE: Maternal expulsive efforts are thought to damage the pelvic floor. We aimed to compare pelvic floor function and anatomy between women who delivered vaginally (VB) versus those with caesarean delivery (CD) prior to the second stage of labour. DESIGN: Prospective cohort. SETTING: University Hospital Midwifery practice. POPULATION: Nulliparas. METHODS: Pregnant nulliparas were recruited during pregnancy and women who underwent CD prior to the 2nd stage of labour at birth were recruited immediately postpartum. Both groups were followed prospectively to 6 months postpartum. MAIN OUTCOME MEASURES: POPQ, perineal ultrasound (U/S) and Paper Towel Test (PTT), an objective measure of stress incontinence; Incontinence Severity Index (ISI), Pelvic Floor Impact Questionnaire (PFIQ-7), Wexner Fecal Incontinence Scale (W) and Female Sexual Function Index (FSFI). RESULTS: 336/448 (75%) VB and 138/224 (62%) CD followed up. The VB group was younger (23.9 ± 4.9 versus 26.6 ± 6.1 years, P < 0.001) and less overweight/obese (38 versus 56%, P < 0.001); baseline functional measures were similar (all P > 0.05). At follow-up, urinary incontinence (UI) (55 versus 46% ISI > 0, P = 0.10), fecal incontinence (FI) (8 versus 13% FI on W, P = 0.12), sexual activity rates (88 versus 92%, P = 0.18) and PFIQ-seven scores were similar. Positive PTT tests (17 versus 6%, P = 0.002) and ≥ Stage 2 prolapse (22 versus 15%, P = 0.03) were higher with VB; differences were limited to points Aa and Ba. U/S findings were not different between groups. Stepwise multivariate analyses controlling for age, body mass index, and non-Hispanic White race for prolapse of points Aa and Ba did not alter conclusions (all P < 0.004). CONCLUSIONS: VB resulted in prolapse changes and objective UI but not in increased self-report pelvic floor dysfunction at 6 months postpartum compared with women who delivered by CD prior to the second stage of labour. The second stage of labour had a modest effect on postpartum pelvic floor function.

The minimum important difference for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire.

INTRODUCTION AND HYPOTHESIS: Although the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ) is widely used to assess sexual function in women, the minimum important difference (MID) (defined as the smallest difference in scores of a patient-reported outcome measure that is perceived by patients as beneficial or harmful and which would lead the clinician to consider a change in treatment) is not known. The objective was to estimate the MID for the PISQ. METHODS: Two study populations, one of women with overactive bladder (OAB) and urgency UI (UUI) treated with tolterodine in a placebo-controlled trial (cohort I), and one of women treated surgically for prolapse and/or UI (cohort II) were used. Cohort I anchors were the Overactive Bladder Questionnaire (OAB-q), the Patient Perception of Bladder Condition (PPBC), the Patient Perception of Treatment Benefit Questionnaire (PPTBQ), and the change in number of UUI episodes in bladder diaries. Distribution MIDs were also calculated. RESULTS: In the anchor-based analysis, the MID values for changes in PISQ total scores at 3 months in cohort I were 5 points using the UUI anchor (diary-dry women), 5 points using the PPBC anchor, 5 points with the PPTBQ, and 9 points with the OAB-q. In cohort II, the MID at week 12 in PISQ total scores was 7 points in women with improved IIQ-7 scores. The distribution-based MID in PISQ total scores was 5.3 points in cohort I and 5.8 points in cohort II. CONCLUSION: A reasonable estimate of MID for the PISQ total score is 6 points. Improvements that meet these thresholds may be considered clinically important.

A new measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR).

INTRODUCTION AND HYPOTHESIS: The objective of this study was to create a valid, reliable, and responsive sexual function measure in women with pelvic floor disorders (PFDs) for both sexually active (SA) and inactive (NSA) women. METHODS: Expert review identified concept gaps and generated items evaluated with cognitive interviews. Women underwent Pelvic Organ Prolapse Quantification (POPQ) exams and completed the Incontinence Severity Index (ISI), a prolapse question from the Epidemiology of Prolapse and Incontinence Questionnaire (ISI scores), the Pelvic Floor Distress Inventory-20 (PFDI-20), and the Female Sexual Function Index (FSFI). Principle components and orthogonal varimax rotation and principle factor analysis with oblique rotation identified item grouping. Cronbach's alpha measured internal consistency. Factor correlations evaluated criterion validation. Change scores compared to change scores in other measures evaluated responsiveness among women who underwent surgery. RESULTS: A total of 589 women gave baseline data, 200 returned surveys after treatment, and 147 provided test-retest data. For SA women, 3 subscales each in 2 domains (21 items) and for NSA women 2 subscales in each of 2 domains (12 items) emerged with robust psychometric properties. Cronbach's alpha ranged from .63 to .91. For SA women, correlations were in the anticipated direction with PFDI-20, ISI, and FSFI scores, POPQ, and EPIQ question #35 (all p < .05). PFDI-20, ISI, and FSFI subscale change scores correlated with Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire International Urogynecological Association-revised (PISQ-IR) factor change scores and with mean change scores in women who underwent surgery (all p < .05). For NSA women, PISQ-IR scores correlated with PFDI-20, ISI scores, and with EPIQ question #35 (all p < .05). No items demonstrated differences between test and retest (all p ≥ .05), indicating stability over time. CONCLUSIONS: The PISQ-IR is a valid, reliable, and responsive measure of sexual function.

Obesity and retropubic surgery for stress incontinence: is there really an increased risk of intraoperative complications?

OBJECTIVE: The objective of the study was to evaluate the impact of obesity on length of surgery, blood loss, and intra- and postoperative complications in women who underwent retropubic surgery for stress urinary incontinence. STUDY DESIGN: Of 449 women participating in a multicenter, randomized trial evaluating antibiotic prophylaxis in women with suprapubic catheters, 250 women underwent retropubic anti-incontinence procedures. This is a prospective nested cohort study of these women, 79 (32%) of whom were obese (body mass index 30 or greater) and 171 (68%) overweight or normal weight (body mass index less than 30). Data collected included demographic variables, past medical history, physical examination, and intraoperative and postoperative complications. Data were analyzed with Fisher's exact for dichotomous variables, Student t tests for continuous variables, and analysis of variance for multivariate analysis. Significance was set at P < .05. RESULTS: Obese women undergoing stress urinary incontinence surgery were younger than nonobese women (48.7 versus 51.9 years, respectively, P < .019). The number and type of additional surgeries performed were similar between groups with the exception that obese women were less likely to undergo abdominal apical suspensions (P = .006) or abdominal paravaginal repairs (P = .001); therefore, estimated blood loss, change in hematocrit, length of stay, surgery, and suprapubic catheterization comparisons are adjusted for the performance of these procedures. Estimated surgical blood loss was greater for obese women (344 versus 284 P = .03); however, change in hematocrit was lower for obese than nonobese women (6.6 versus 7.3, P = .048). Mean length of surgery was 15 minutes longer in obese women (P = .02). Length of hospital stay did not vary between groups (P = NS). Major intraoperative complications were uncommon (14 [5.6%]), with no difference between weight groups. Incidence of postoperative urinary tract infection, wound infections, or postoperative major complications were likewise similar between groups (all P > .05). CONCLUSION: Surgery takes longer for obese patients, but blood loss as recorded by change in hematocrit is lower. Major complications were rare and similar between weight groups, as were infectious complications.

Performance of threading scoring functions designed using new optimization method.

We present a new procedure for optimization of a threading scoring function. A scoring function is usually formulated in terms of the structural environment states that describe the protein fold model. We propose a method for the optimal selection of those structural environment states that naturally follows from the probabilistic description of the threading problem and is done prior to threading experiments. We demonstrate the selection of the optimal structural environment states for the solvent exposure of the amino acid position, and present the results of threading experiments performed using scoring functions designed with and without the optimization of the structural environment states. These results confirm that the optimal scoring function predicts the sequence-to-structure alignments most accurately. Threading experiments performed with 15 optimally designed scoring functions show that the correlation coefficient between the information content of the amino acid distribution that determines the scoring function and the accuracy of the optimal sequence-to-structure alignment is 0.94.

Current limitations to protein threading approaches.

A short review of the threading approach to protein structure prediction, including presentation of some open statistical problems. Also discussed is one of the likely sources of the current limited success, that being the form of the pairwise potentials used in most threading approaches.

Effects of carbon dioxide-saturated normal saline and Ringer's lactate on postsurgical adhesion formation in the rabbit.

OBJECTIVE: To evaluate the effect of combining carbon dioxide gas (CO2) with normal saline versus CO2 with lactated Ringer's solution on adhesion formation in the rabbit model. METHODS: Sixty New Zealand white rabbits underwent surgery based on a proven experimental adhesion model. Following abdominal closure, the animals were randomly assigned to three groups: Group 1 underwent abdominal CO2 insufflation only; group 2 underwent abdominal irrigation with CO2-saturated normal saline; group 3 underwent abdominal irrigation with CO2-saturated lactated Ringer's solution. Three weeks later, the rabbits were sacrificed and the adhesions were scored in a blinded fashion based on the extent, type, and tenacity, with a maximum possible score of 11. RESULTS: The mean (+/- standard deviation) adhesion scores were 7.75 +/- 2.82 in group 1, 7.85 +/- 2.58 in group 2, and 4.75 +/- 2.95 in group 3. There was no difference in severity of adhesions between groups 1 and 2. However, the mean adhesion score was significantly lower in group 3 (lactated Ringer's with CO2) than in either group 1 (CO2) or group 2 (normal saline with CO2) (P = .004 and P = .002, respectively). CONCLUSION: It appears that when CO2 is the insufflating gas, lactated Ringer's solution has a protective effect against adhesion formation in the rabbit model.

A randomized trial of burch retropubic urethropexy and anterior colporrhaphy for stress urinary incontinence.

OBJECTIVE: In a randomized trial, we compared the success of Burch retropubic urethropexy to the modified anterior colporrhaphy for the treatment of genuine stress urinary incontinence. METHODS: Thirty-five patients with stress incontinence were randomly assigned to undergo Burch retropubic urethropexy or modified anterior colporrhaphy. Subjects had preoperative and 1-year postoperative physical examinations, multichannel urodynamic testing, 20-minute pad test, and subjective grading of incontinence severity with questionnaires. Data were evaluated using Fisher exact test, Wilcoxon two-sample test, logistic regression analysis, and analysis of variance. RESULTS: Objective cure 1 year postoperatively was significantly greater for the women treated by Burch retropubic urethropexy than by modified anterior colporrhaphy (16 of 18 [89%] versus five of 16 [31%], relative risk .15, 95% confidence interval .04, .59). Patients' subjective ratings of incontinence severity 1 year after surgical treatment were significantly lower in women who had Burch retropubic urethropexy. CONCLUSION: Burch retropubic urethropexy yields a significantly superior objective cure for genuine stress urinary incontinence than the modified anterior colporrhaphy in a randomized trial.

Early feeding and the incidence of gastrointestinal symptoms after major gynecologic surgery.

OBJECTIVE: To compare early feeding with traditional postoperative dietary management for development of postoperative gastrointestinal symptoms, including ileus after major gynecologic surgery for benign conditions. METHODS: Women who had major gynecologic surgery for benign conditions were randomly allocated to early feeding of low residue diets 6 hours postoperatively or traditional dietary management of clear liquids with normal bowel sounds, and regular diet with passage of flatus. Demographic and perioperative data were collected, and patients answered questionnaires on their perception of bowel function and pain using the McGill Pain Scale. Power analysis found that 130 women were needed to find a twofold greater incidence of ileus in the early feeding group with 80% power and alpha =.05. RESULTS: Complete data were available for 139 women, 67 allocated to the early feeding group and 72 to the late feeding group. The incidence of postoperative ileus for the study population was 4.4% and did not differ between groups (early 3% versus late 5. 8%, P =.68). There were no differences in patient demographics, surgical procedures, anesthesia used, and intraoperative complications between groups. With the exception of more complaints of nausea in the late feeding group (23% versus 13%, P =.04), there were no differences in other postoperative variables, including other perioperative complications, pain medicine requirements, fluid and caloric intake, median pain scores, and gastrointestinal function. The low incidence of perioperative complications made the power to detect differences between groups low. CONCLUSION: Low residue diet 6 hours after major gynecologic surgery for benign indications was not associated with increased postoperative gastrointestinal complaints, including ileus.

Neighbourhoods and homicide mortality: an analysis of race/ethnic differences.

OBJECTIVE: To examine whether measures of neighbourhood economic deprivation, social disorganisation, and acculturation explain homicide mortality differentials between Mexican Americans, non-Hispanic black Americans, and non-Hispanic white Americans, net of individual factors. DESIGN: Prospective study, National Health Interview Survey (1986-1994) linked to subsequent mortality in the National Death Index (1986-1997). SETTING: United States of America. PARTICIPANTS: A nationally representative sample of non-institutionalised Mexican Americans, non-Hispanic black Americans, and non-Hispanic white Americans, aged 18-50 at the point of interview. ANALYSIS: Cox proportional hazard models estimate the risk of death associated with various neighbourhood and individual factors. MAIN RESULTS: Both individual and neighbourhood risk factors partially account for race/ethnic disparities in homicide. Homicide mortality risks are between 20% and 50% higher for residents of areas that have economic inequality of 0.50 or greater based on the coefficient of variation, or where 4% or more of the residents are Mexican American, 10% or more of the residents are non-Hispanic black, or 20% or more of the households are headed by single parents (p< or = 0.05). But residents of areas where 10% or more of their neighbours are foreign born have 35% lower mortality risks than people living in areas with fewer foreign born people (p< or =0.05). These differences persist even after controlling for individual level risk factors. CONCLUSIONS: The findings support economic deprivation, social disorganisation, and acculturation theories, and suggest that both neighbourhood and individual risk factors affect race/ethnic differences in homicide mortality. Public health policies must focus on both individual and neighbourhood factors to reduce homicide risks in vulnerable populations.

Life expectancies of cigarette smokers and nonsmokers in the United States.

This research employs the National Health Interview and the National Mortality Followback Surveys to calculate life expectancies by age and sex for white nonsmokers, former smokers, and current smokers in the United States in 1986. In general, life expectancies are higher for never smokers than for former smokers, and higher for former smokers than for current smokers. Heavy smokers have lower life expectancies than persons with all other smoking statuses; indeed, compared to never smokers, heavy smokers at age 25 can expect at least a 25% shorter life. Gender differences in life expectancies were found to persist even with the elimination of smoking. Differences in life expectancy by sex thus appear to be due, in part, to cigarette smoking, but also to occupational, environmental, and sociodemographic factors.

Pregnancy-induced hypertension: genesis of and response to endothelial injury and the role of endothelin 1.

This paper discusses the spectrum of pregnancy-induced hypertension and presents a theory for its etiology. Endothelial injury is the purported precursor to pregnancy-induced hypertensive disorders, and this discussion expands on a possible mechanism by which injury could occur as a result of incomplete trophoblastic invasion. We review endothelin physiology and compare and contrast the evidence surrounding endothelin 1 as a putative mediator of PIH. An approach to treatment utilizing antagonists to the endothelin 1 receptor is introduced.

Overactive bladder significantly affects quality of life.

Overactive bladder (OAB), with symptoms of frequency, urgency, and urge incontinence, substantially affects the lives of millions of people. The symptoms associated with OAB can significantly affect the social, psychological, occupational, domestic, physical, and sexual aspects of those who suffer from it. Unfortunately, many sufferers are reluctant to discuss their condition with their healthcare provider or family members. As a result, OAB remains underreported, despite increased awareness and improved diagnosis and treatment. Health-related quality of life can be measured objectively, and several instruments have been developed, validated, and used in research. Currently, there are 2 major types of quality-of-life questionnaires: generic and disease specific. Although these questionnaires have been helpful and are widely used, the goal is to establish a single questionnaire that is acceptable throughout the world for use by urologists, gynecologists, urogynecologists, geriatricians, and epidemiologists.

Longer life but worse health? Measurement and dynamics.

A number of recent cross-sectional studies of longevity and health among the elderly have concluded that recent positive trends in the prolongation of life have not been matched by similar trends in the extension of healthy life. This paper challenges that pessimistic conclusion by examining conceptual issues related to the measurement and dynamics of the mortality-disability process. It uses data from the 1986 Longitudinal Study of Aging (U.S. Department of Health and Human Services, 1988) to illustrate its principal points.

Ethnic differences in smoking patterns: findings from NHIS.

This research endeavors to broaden our knowledge of smokers' characteristics within ethnic groups. Special attention is given to Mexican Americans, a group that until recently has received scant attention in comparative research on smoking. In general, we find that ethnic differences in smoking vary across several dimensions. Many Mexican American females never smoke. If they do, they begin smoking late, smoke few cigarettes per day, and are likely to quit. Although many anglo (non-Hispanic white) males and females have tried smoking, a much higher proportion of males have quit. Blacks generally display rates intermediate to Mexican Americans and anglos, with relatively low rates of cigarette consumption. Discussed in this report are potential mortality effects, possible intervention strategies, and possible directions for future research.

A multistate analysis of active life expectancy.

With today's lower mortality rates, longer expectations of life, and new medical technologies, the nation's health policy focus has shifted from emphasis on individual survival to emphasis on personal health and independent living. Using longitudinal data sets and new methodological techniques, researchers have begun to assess active life expectancies, estimating not only how long a subpopulation can expect to live beyond each age, but what fractions of the expected remaining lifetime will be lived as independent, dependent, or institutionalized. New ideas are addressed, applying recently developed multistate life table methods to Waves One and Two of the Massachusetts Health Care Panel Study. Expectations of active life are presented for those 65 and older who initially are in one of two functional states of well-being. Included are expectations of life, for those, for example, who were independent and remained so, or those who were dependent and became independent. Although public health officials are concerned about the number of elderly who cease being independent, preliminary analysis shows that a significant number of the dependent elderly regain their independence, a situation which needs to be addressed in health care planning.