Predicting a beneficial response to motor control training in patients with low back pain: a longitudinal cohort study.

PURPOSE: Exercise therapy such as motor control training (MCT) has been shown to reduce pain and disability in people with low back pain (LBP). It is unknown which patients are most likely to benefit. This longitudinal cohort study aimed to: (1) retrospectively examine records from a large cohort of patients who received MCT treatment, (2) identify potentially important predictors of response to MCT and (3) test the predictors on an independent (split) sample derived from the original cohort of patients, using one group to identify the predictors and the other to test them. METHODS: The response of 775 patients with LBP to MCT was classified as 'improved' or 'not improved' based on self-reported change in pain levels and symptoms. Measures were examined for associations with improvement and entered into a logistic regression model to classify patients as low, medium or high benefits of improvement with MCT. The model was tested on an independent sample. RESULTS: A positive response was seen in patients with: no evidence of scoliosis [OR = 4.0, 95% CI (1.7, 9.6)], LBP without associated groin pain [OR = 2.2, 95% CI (1.0, 5.0)], LBP which was chronic recurrent in nature [OR = 3.1, 95% CI (1.8, 5.3)] and poor results on muscle testing of the multifidus muscle [OR = 2.0, 95% CI (1.1, 3.7)]. Testing on an independent sample confirmed that patients could be classified into benefit groups. CONCLUSIONS: This study provides a first step towards assisting clinicians to select patients most likely to respond to MCT. These slides can be retrieved under Electronic Supplementary Material.

Randomized trial of fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to evaluate the 5-year surgical outcomes of abdominal sacrocolpopexy among subjects randomized to receive polypropylene mesh or cadaveric fascia lata. METHODS: All 100 subjects from the original randomized clinical trial were eligible. Primary outcome was objective anatomic failure: any pelvic organ prolapse quantification (POP-Q) point ≥ - 1. Secondary outcome was clinical failure-presence of bulge or prolapse symptoms and either a POP-Q point C ≥ ½ TVL or any POP-Q point >0-and interim surgical re-treatment. Wilcoxon tests and Fisher's exact test were performed. RESULTS: Fifty-eight subjects returned for 5-year follow-up-29 mesh and 29 fascia. Objective anatomic success rates were: mesh, 93% (27/29) and fascia, 62% (18/29) (p = 0.02). Clinical success rates were: mesh, 97% (28/29) and fascia, 90% (26/29) (p = 0.61). CONCLUSIONS: Polypropylene mesh was superior to cadaveric fascia lata using objective anatomic outcomes. Success rates of mesh and fascia were comparable using a clinical definition that combined symptoms with anatomic measures.

Can urethral retroresistance pressures predict midurethral sling outcomes?

OBJECTIVE: To determine whether preoperative urethral resistance pressure (URP) measurements could predict success or failure of a tension-free vaginal tape (TVT) sling. METHODS: Subjects came from a previously published study comparing URP measurements to a validated urinary incontinence symptom survey (UISS). We contacted patients from that study to determine whether they had subsequently undergone TVT surgery. Within that cohort, we determined the "current" (i.e., postoperative) UISS and Sandvik urinary incontinence severity score. Success of a TVT sling in this group was defined in 4 ways: (1) postoperative UISS score <3, (2) postoperative UISS score < 75% of the preoperative score, (3) postoperative Sandvik score <6, and (4) postoperative Sandvik score <2. These definitions of "success" were compared across demographic and treatment variables using the Student's t test, ANOVA, chi2 and ROC curves. RESULTS: We contacted 69 women who had in fact received a TVT sling after their participation in the previously published study mentioned above. Among these 69 women, mean preoperative urethral retroresistance pressure values were not predictive of surgical success. CONCLUSION: Preoperative urethral retroresistance pressure measurements did not reliably predict surgical success or failure; therefore, this urodynamic test is of little value to the clinician.

Operant behavior in dwarf hamsters (Phodopus campbelli): Effects of rate of reinforcement and reinforcer flavor variety.

We investigated operant behavior in a novel species, the dwarf hamster (Phodopus campbelli). In two experiments, hamsters were trained to lever-press for food reinforcement. In Experiment 1, rate of reinforcement was manipulated across conditions using four variable-interval schedules of reinforcement (delivering one to eight reinforcers per min). As predicted, within-session decreases in responding were steepest on the richest schedule. In Experiment 2, lever-pressing was reinforced by either a constant or a variety of flavored food pellets. Within-session decreases in responding were steeper when the reinforcer flavor remained constant than when it was varied within the session. In both experiments, subjects hoarded most reinforcers in their cheek pouches rather than consuming them in the operant chambers. These results are incompatible with post-ingestive satiety variables as explanations for within-session decreases in operant responding and suggest that habituation to repeatedly presented reinforcers best accounts for subjects' response patterns. Additionally, a mathematical model that describes behavior undergoing habituation also described the present results, thus strengthening the conclusion that habituation mediates the reinforcing efficacy of food.

Proteomic techniques identify urine proteins that differentiate patients with interstitial cystitis from asymptomatic control subjects.

OBJECTIVE: The purpose of this study was to identify differences in urine proteins between patients with interstitial cystitis (IC) and asymptomatic control (AC) subjects with the use of proteomic techniques. STUDY DESIGN: Nine patients with IC and their age-, race-, and sex-matched AC subjects volunteered a urine specimen. Urine proteins were separated with the use of 2-dimensional polyacrylamide gels. Differing proteins underwent digestion and matrix-assisted laser desorption ionization-time of flight mass spectrometry. Computer-assisted data analysis was used to identify the corresponding protein. Differences in urine protein responses between patients with IC and AC subjects were evaluated by the Mann-Whitney U test to account for the nonnormal frequency distribution of the parameter estimate or chi-square when data were bimodal. RESULTS: Four proteins differed significantly between patients with IC and AC subjects. The AC subjects had a greater concentration of a uromodulin (P = .019) and two kininogens (P = .023, .046). The patients with IC had a greater concentration of inter-alpha-trypsin inhibitor heavy chain H4 (P = .019). CONCLUSION: These urine protein isoforms may be biomarkers for IC.

Measuring the utility of incontinence care seeking.

The purpose of this study was to establish the structure and factor validity of an expectation questionnaire and estimate its reliability in an ethnically heterogeneous incontinent female population. CATIs were conducted on a nonprobability sample of 275 incontinent women to assess the likelihood of a specific outcome of incontinence care seeking. Principal component and confirmatory factor analysis were performed to estimate factor loadings and establish the fit of the expectation questionnaire. Cronbach's alpha coefficients were estimated to establish the reliability of the final expectation questionnaire. Six items loaded on a control factor (factor loadings 0.502-0.806). The control item with the highest loading was "I would be able to resume my normal activities" (r = 0.806). Four items loaded on an internalized fear/anxiety factor (factor loadings 0.449-0.497). The internalized fear/anxiety item with the highest loading was "I would be told it was caused by something I had done in my past" (r = 0.485). Two items loaded on an externalized fear/anxiety factor (factor loadings 0.553-0.726). The externalized fear/anxiety item with the highest loading was "I would be referred to a specialist" (r = 0.553). A chi2/df value of 1.70, goodness-of-fit index of 0.95, comparative fit index of 0.95, and a root mean square error of approximation of 0.050 (probability of close fit of 0.463) established the fit of our final expectation questionnaire. Cronbach's alpha coefficient for the final 12-item expectation questionnaire was 0.56. The 12-item expectation questionnaire is a valid and reliable tool for measuring utility of incontinence care seeking in an ethnically heterogeneous incontinent female population.

Measuring barriers to incontinence care seeking.

AIMS: The objective of this study was to establish the factor validity of a modified Melnyck's Barrier Scale and estimate its reliability in an ethnically heterogeneous incontinent female population. METHODS: Computer assisted telephone interviews (CATI) were conducted on a nonprobability sample of 275 incontinent females (95 Caucasian, 95 African American, 80 Hispanic, 5 Other). Study participants were asked to rate the degree to which barrier items affected their seeking medical care for incontinence on a 4-point Likert scale ranging from 0 (none) to 3 (greatly). A confirmatory factor analysis was conducted to confirm the structure of the modified Melnyk's Barrier Scale and assess its fit in our racially heterogeneous incontinent female population. Cronbach's alpha coefficients were estimated to establish the reliability of the final barrier measurement model and its subscales. RESULTS: The 14-item modified Melnyk's Barrier Scale contained 3 items that loaded on the inconvenience factor (factor loadings 0.659-0.812). Three items loaded on the relationship factor (factor loadings 0.452-0.796). Two items loaded on the site-related factor (factor loadings 0.554-0.960). Three items loaded on the cost factor (factor loadings 0.481-0.891). Three items loaded on the fear factor (factor loadings 0.457-0.624). Cronbach's alpha coefficient for the final 14-item modified Melnyk's Barrier Scale was 0.828 (Inconvenience subscale 0.79, Relationship subscale 0.68, Site related subscale 0.69, cost subscale 0.71, fear subscale 0.57). CONCLUSION: We offer the Barriers to Incontinence Care Seeking questionnaire (BICS-Q) to epidemiologic researchers, given its factor validity and reliability, to operationalize barriers when studying relationships between ethnicity and health care disparities.

Construct validity of the incontinence severity index.

AIMS: To assess the construct validity of the incontinence severity index (ISI) by testing its correlation with two health-related quality of life measures, the short forms of the Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7), in women with urodynamic stress incontinence. MATERIALS AND METHODS: A cohort of 170 women with the urodynamic stress incontinence who underwent corrective surgery completed the ISI, IIQ-7, and the UDI-6 both pre- and post-treatment. We correlated the pre- and post-treatment responses between the ISI, the IIQ-7, the UDI-6 and their subscales. We also assessed the sensitivity of the ISI to change by correlating the percent change in score between the three instruments. The results were analyzed using a non-parametric test of correlation, the Spearman's rho. RESULTS: The ISI scores were generally not well correlated with the pre-treatment IIQ-7 and UDI-6 scores (r < 0.40). The post-treatment scores and percent change from pre- to post-treatment of the ISI, however, were highly correlated with that of the IIQ-7 and UDI-6 (r's > 0.70, P < 0.001). The ISI was most highly correlated with the UDI-6 stress symptoms subscale and most poorly correlated with the UDI-6 obstructive/discomfort subscale. CONCLUSIONS: This study provides valuable insight into the construct validity of the ISI. Evidence of its convergent validity is found in the high correlation with the stress symptoms subscales of the UDI-6, while the poorer correlation with the obstructive subscale provides evidence of its divergent validity. These data also suggest that the ISI is highly sensitive to change seen with treatment.

A randomized controlled trial comparing fascia lata and synthetic mesh for sacral colpopexy.

OBJECTIVE: To compare the objective anatomic outcomes after sacral colpopexy performed with cadaveric fascia lata and polypropylene mesh. METHODS: Patients undergoing a sacral colpopexy were randomized to receive either fascia lata or polypropylene mesh in a double-blinded fashion. Data were collected at 6 weeks, 3 months, 6 months, and 1 year postoperatively. The main outcome measures were pelvic organ prolapse quantification (POP-Q) system stage and individual POP-Q points over time. Objective anatomic failure was defined as POP-Q stage 2 or more at any point during the follow-up period. Proportions of patients with objective anatomic failure at 1 year in each group were compared using the chi(2) test. Mean POP-Q points and stage at 1 year were compared by using the independent samples t test. RESULTS: One hundred patients were randomized to receive either fascia (n = 46) or mesh (n = 54). Of the 89 patients returning for 1-year follow-up, 91% (41/45) of the mesh group and 68% (30/44) of the fascia group were classified as objectively cured (P = .007). We found significant differences between the mesh and fascia groups with respect to the 1-year postoperative comparisons of points Aa, C, and POP-Q stage. There were no differences between the 2 groups with respect to points TVL (total vaginal length), GH (genital hiatus), PB (perineal body), Ap or Bp (2 points along the posterior vaginal wall). CONCLUSIONS: Polypropylene mesh was superior to fascia lata in terms of POP-Q points, POP-Q stage, and objective anatomic failure rates. LEVEL OF EVIDENCE: I.

A randomized, double-blinded, sham-controlled trial of postpartum extracorporeal magnetic innervation to restore pelvic muscle strength in primiparous patients.

OBJECTIVE: The purpose of this study was to determine the effects of extracorporeal magnetic innervation (ExMI) on pelvic muscle strength of primiparous patients. STUDY DESIGN: Primigravid patients were randomized to receive either active or sham ExMI postpartum treatments for 8 weeks. The main outcome measure was pelvic muscle strength measured by perineometry at baseline (midtrimester), 6 weeks (before treatments), 14 weeks, 6 months, and 12 months postpartum. Mixed randomized-repeated measures ANOVA was used to analyze the mean perineometry values between the 2 groups and across all 5 time periods. RESULTS: Fifty-one patients enrolled, and 18 were lost to attrition. There were no differences in demographics or delivery characteristics between the active and sham groups. There was an overall time effect, F(3,85) = 3.1, P = .049, but no group, F(1,31) = 0.007, P = .94, or (group)(time) interaction, F(3,85) = 1.8, P = .15. CONCLUSION: We found no differences in pelvic muscle strength between patients receiving active or sham ExMI treatments in the early postpartum period.

Is the cough-stress test necessary when placing the tension-free vaginal tape?

OBJECTIVE: To estimate whether the mode of anesthesia (and the resultant ability or inability to perform the cough-stress test) used during the tension-free vaginal tape (TVT) procedure affects postoperative continence. METHODS: A cohort of 170 women who underwent the TVT procedure without any other concomitant surgery completed the short form of the Urogenital Distress Inventory (UDI-6) to assess their continence status preoperatively and postoperatively. Chi-squared, t, and Mann-Whitney U tests were used to determine the association between these data and anesthesia type during univariate analysis. RESULTS: Both anesthesia groups showed significant improvement from their preoperative UDI-6 scores to their postoperative scores. However, when comparing the change from pre- to postoperative UDI-Stress Symptoms subscale scores between the 2 groups, we found a significant difference. Mean improvement in the local group was 58.3 (+/- 33.8) compared with 41.7 (+/- 39.4) in the general group (P = .02). CONCLUSION: Women who undergo TVT show significant improvements in incontinence severity regardless of anesthesia type. However, greater improvements in stress incontinence, as measured by the UDI-Stress Symptoms subscale, are seen when the TVT is placed while using the cough-stress test under local analgesia. LEVEL OF EVIDENCE: II-2.

A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy.

OBJECTIVE: The purpose of this study was to compare the efficacy of chlorhexidine and povidone iodine for cleansing the operative field for vaginal surgery. STUDY DESIGN: This was a randomized controlled trial that compared 10% povidone iodine and 4% chlorhexidine gluconate as surgical scrubs. Our primary end point was the proportion of contaminated specimens (defined as total bacterial colony counts of >/=5000 colony-forming units) per group found throughout the surgical procedures. All patients received standard infection prophylaxis that included preoperative intravenous antibiotics. Immediately before antibiotic administration and baseline aerobic and anaerobic cultures of the vaginal flora were obtained, which were followed by cultures at 30 minutes after the surgical scrub and hourly thereafter throughout each patient's surgery. RESULTS: A total of 50 patients were enrolled between October 2002 and September 2003. There were no differences between the povidone iodine (n = 27) and chlorhexidine (n = 23) groups with respect to age, race, exogenous hormone use, body mass index, gravity, parity, preoperative mean colony counts, or operative time. Among the first set of intraoperative specimens (which were obtained 30 minutes after the surgical scrub), 63% of the cultures (17/27) from the povidone iodine group and 22% of the cultures (5/23) from the chlorhexidine group were classified as contaminated ( P = .003; relative risk, 6.12; 95% CI, 1.7, 21.6). Subsequent cultures failed to demonstrate significant differences. CONCLUSION: Chlorhexidine gluconate was more effective than povidone iodine in decreasing the bacterial colony counts that were found in the operative field for vaginal hysterectomy.

Elective cesarean section to prevent anal incontinence and brachial plexus injuries associated with macrosomia--a decision analysis.

Our aim was to determine the cost-effectiveness of a policy of elective C-section for macrosomic infants to prevent maternal anal incontinence, urinary incontinence, and newborn brachial plexus injuries. We used a decision analytic model to compare the standard of care with a policy whereby all primigravid patients in the United States would undergo an ultrasound at 39 weeks gestation, followed by an elective C-section for any fetus estimated at > or =4500 g. The following clinical consequences were considered crucial to the analysis: brachial plexus injury to the newborn; maternal anal and urinary incontinence; emergency hysterectomy; hemorrhage requiring blood transfusion; and maternal mortality. Our outcome measures included (1) number of brachial plexus injuries or cases of incontinence averted, (2) incremental monetary cost per 100,000 deliveries, (3) expected quality of life of the mother and her child, and (4) "quality-adjusted life years" (QALY) associated with the two policies. For every 100,000 deliveries, the policy of elective C-section resulted in 16.6 fewer permanent brachial plexus injuries, 185.7 fewer cases of anal incontinence, and cost savings of $3,211,000. Therefore, this policy would prevent one case of anal incontinence for every 539 elective C-sections performed. The expected quality of life associated with the elective C-section policy was also greater (quality of life score 0.923 vs 0.917 on a scale from 0.0 to 1.0 and 53.6 QALY vs 53.2). A policy whereby primigravid patients in the United States have a 39 week ultrasound-estimated fetal weight followed by C-section for any fetuses > or =4500 g appears cost effective. However, the monetary costs in our analysis were sensitive to the probability estimates of urinary incontinence following C-section and vaginal delivery and the cost estimates for urinary incontinence, vaginal delivery, and C-section.

Comorbidities affect the impact of urinary incontinence as measured by disease-specific quality of life instruments.

The aim of this study was to determine if the impact of urinary incontinence on activities of daily living, as measured by a disease-specific quality of life instrument, is dependent on comorbid conditions. Incontinent kidney transplant recipients participated in a survey to determine the impact of urinary incontinence on activities of daily living using the Incontinence Impact Questionnaire (IIQ-7). Similar information was collected from the charts of nontransplant incontinent women. Participants were matched for age, incontinence severity, pads per day, and leaks per day noted in a 3-day 24-h bladder diary. IIQ-7 scores from participants were compared using Mann-Whitney U tests. Nontransplant incontinent women reported a 200% greater affect of incontinence on activities of daily living than incontinent renal transplant recipients (35.5+/-26.5 vs 12.9+/-15.4, p<0.0001) despite similarities in incontinence severity measures. Urinary incontinence has less of an impact on activities of daily living for renal transplant recipients than nontransplant incontinent women with similar incontinence severity measures because the disease-specific quality of life instrument used in this study was sensitive to their comorbid condition (transplant status).

Does socioeconomic status explain racial differences in urinary incontinence knowledge?

OBJECTIVE: This study was undertaken to discover whether urinary incontinence knowledge differs between racial/ethnic groups. If incontinence knowledge differs between racial/ethnic groups, is the difference explained by socioeconomic status (SES). STUDY DESIGN: In this cross-sectional study, 212 women from 3 counties in California were interviewed by telephone. Urinary incontinence knowledge was measured by an Incontinence Quiz. SES was calculated. Race was categorized as white or minority (non-Hispanic black, Hispanic, and other). RESULTS: White women scored better than minority women on the Incontinence Quiz (6.16 +/- 2.86 vs 5.46 +/- 2.66, P=.071). Higher SES was significantly associated with higher Incontinence Quiz total score (r=0.177, P=.010). Racial differences in Incontinence Quiz total score no longer trended toward significance after adjusting for SES in multivariable analysis. Race/ethnicity and SES were analyzed for association with each question of the Incontinence Quiz CONCLUSION: Socioeconomic status explains racial differences in total urinary incontinence knowledge. Consideration of socioeconomic status may improve the effectiveness of urinary incontinence educational programs.

Prevalence and severity of urinary incontinence in kidney transplant recipients.

OBJECTIVE: To estimate the prevalence and severity of urinary incontinence and its impact on activities of daily living in kidney transplant recipients. METHODS: The continence status, severity, and impact of urinary incontinence on activities of daily living in female kidney transplant recipients was studied by using Sandvik's Incontinence Severity Index and the Incontinence Impact Questionnaire. Clinical and sociodemographic data from post-transplant incontinent and continent participants were compared by using chi(2), Student t, and Mann-Whitney U tests. RESULTS: One hundred of 123 female kidney transplant recipients completed the survey for a response rate of 81.3%. The prevalence of urinary incontinence in female kidney transplant recipients was 28%. The mean Sandvik's Incontinence Severity Index score was 5.1 (median 3.5; 95% confidence interval 3.6, 6.6). The mean Incontinence Impact Questionnaire score was 12.9 (median 4.8; 95% confidence interval 6.7, 18.9). Incontinent kidney transplant recipients recorded a greater daily fluid intake on their 3-day diaries than continent kidney transplant recipients (2,951.9 +/- 1,228.6 mL compared with 1,854.6 +/- 614.8 mL, P =.04). CONCLUSIONS: The prevalence rate of urinary incontinence from interviewed kidney transplant recipients was 28%, which had minimal impact on activities of daily living and may not be predicted by a history of incontinence before kidney failure. LEVEL OF EVIDENCE: II-3

Bacterial colony counts during vaginal surgery.

OBJECTIVE: To describe the bacterial types and colony counts present before and during vaginal surgery. METHODS: A descriptive study was undertaken of patients undergoing vaginal hysterectomy with or without reconstructive pelvic surgery. Aerobic and anaerobic bacterial cultures were obtained immediately before and throughout the surgical cases at preselected time intervals. Standard antimicrobial prophylaxis was administered in all cases. Mean total colony counts and mean anaerobic colony counts were determined by adding all colonies regardless of bacteria type. 'Contamination' was defined as > or = 5000 colony-forming units/ml. RESULTS: A total of 31 patients aged 26 to 82 years (mean age +/- SD, 51 +/- 15) were included. The highest total and anaerobic colony counts were found at the first intraoperative time interval. On the first set of cultures (30 minutes after the surgical scrub), 52% (16/31) of the surgical fields were contaminated, and at 90 minutes, 41% (12/29) were contaminated. A negligible number of subsequent cultures were contaminated. CONCLUSIONS: Any future interventions designed to minimize bacterial colony counts should focus on the first 30 to 90 minutes of surgery.

Long-term success of abdominal sacral colpopexy using synthetic mesh.

OBJECTIVE: The aim was to determine the minimum meaningful study period required for prospective trials involving sacral colpopexy. STUDY DESIGN: This is a retrospective analysis of 245 patients who underwent sacral colpopexy. Postoperative pelvic organ prolapse quantitation was our objective end point. In an effort to control for selection bias, patients who returned for postoperative examinations were compared with those who did not for clinical and demographic information. A validated prolapse-specific quality of life instrument was used to determine the subjective end points. RESULTS: Objective failure (any postoperative POP-Q point > or = stage II) was found in 37 (15.1%) patients. Of these, 26 (70.3%) occurred within 6 months, and 30 (81.1%) occurred within 1 year. Another 5 objective failures were discovered between 1 and 2 years after surgery for a total of 94.6% of failures occurring within 2 years. There were no clinically significant differences between the groups of women with and without objective postoperative follow-up, indicating minimal selection bias. CONCLUSION: It is reasonable to construct randomized controlled trials involving sacral colpopexy that only include 1- or 2-year follow-up.