Correlation Between Mobile-Application Electronic Bowel Diary and Validated Questionnaires in Women with Fecal Incontinence.

INTRODUCTION AND HYPOTHESIS: Despite growing interest in a mobile-app bowel diary to assess fecal incontinence (FI) symptoms, data are limited regarding the correlation between mobile-app diary and questionnaire-based outcomes. The primary aim is to determine whether percentage reduction in FI episodes (FIEs)/week recorded on a mobile-app diary correlates with changes in scores of validated FI-symptom measures from baseline to 12 weeks in women with FI undergoing percutaneous tibial nerve stimulation (PTNS) versus sham. METHODS: This is a planned secondary analysis of a multicenter randomized trial in which women with FI underwent PTNS or sham. FIEs were collected using a mobile-app diary at baseline and after 12 weekly sessions. FI-symptom-validated measures included St. Mark's, Accidental Bowel Leakage Evaluation, FI Severity Index (FISI), Colorectal Anal Distress Inventory, Colorectal Anal Impact Questionnaire, FI Quality of Life, Patient Global Impression of Improvement (PGI-I), and Patient Global Symptom Control (PGSC) rating. Spearman's correlation coefficient (ρ) was computed between %-reduction in FIEs/week and change in questionnaire scores from baseline to 12 weeks. Significance was set at 0.005 to account for multiple comparisons. RESULTS: Baseline characteristics of 163 women (109 PTNS, 54 sham) include mean age 63.4±11.6, 81% white, body mass index 29.4±6.6 kg/m2, 4% previous FI surgeries, 6.6±5.5 FIEs/week, and St. Mark's score 17.4±2.6. A significant correlation was demonstrated between %-reduction in FIEs/week and all questionnaires (p<0.005). A moderate-strength correlation (|ρ|>0.4) was observed for St. Mark's (ρ=0.48), FISI (ρ=0.46), PGI-I (ρ=0.51), and PGSC (ρ=-0.43). CONCLUSIONS: In women with FI randomized to PTNS versus sham, a moderate correlation was noted between FIEs measured via mobile-app diary and FI-symptom-validated questionnaire scores.

Dietary Intake and Symptom Severity in Women with Fecal Incontinence.

INTRODUCTION AND HYPOTHESIS: The goal of this study was to determine whether dietary fat/fiber intake was associated with fecal incontinence (FI) severity. METHODS: Planned supplemental analysis of a randomized clinical trial evaluating the impact of 12-week treatment with percutaneous tibial nerve stimulation versus sham in reducing FI severity in women. All subjects completed a food screener questionnaire at baseline. FI severity was measured using the seven-item validated St. Mark's (Vaizey) FI severity scale. Participants also completed a 7-day bowel diary capturing the number of FI-free days, FI events, and bowel movements per week. Spearman's correlations were calculated between dietary, St. Mark's score, and bowel diary measures. RESULTS: One hundred and eighty-six women were included in this analysis. Mean calories from fats were 32% (interquartile range [IQR] 30-35%). Mean dietary fiber intake was 13.9 ± 4.3 g. The percentage of calories from fats was at the higher end of recommended values, whereas fiber intake was lower than recommended for adult women (recommended values: calories from fat 20-35% and 22-28 g of fiber/day). There was no correlation between St. Mark's score and fat intake (r = 0.11, p = 0.14) or dietary fiber intake (r = -0.01, p = 0.90). There was a weak negative correlation between the number of FI-free days and total fat intake (r = -0.20, p = 0.008). Other correlations between dietary fat/fiber intake and bowel diary measures were negligible or nonsignificant. CONCLUSION: Overall, in women with moderate to severe FI, there was no association between FI severity and dietary fat/fiber intake. Weak associations between FI frequency and fat intake may suggest a role for dietary assessment in the evaluation of women with FI.

Impact of sex and aging on radiographic and functional parameters of the anal sphincter complex in patients with accidental bowel leakage.

AIMS: Treatment outcomes for accidental bowel leakage (ABL) may be influenced by age-related sarcopenia. We sought to determine if thickness of the anal sphincter complex on endoanal ultrasound correlated with function in women and men with ABL and if women demonstrated age-related anal sphincter thinning. METHODS: Consecutive patients with ABL presenting to our pelvic floor clinic from 2012 to 2017 were included. Clinical data were obtained from medical records. External anal sphincter (EAS), imaged by endoanal ultrasound at proximal, mid and distal locations, and IAS thickness were measured at 12, 3, 6, and 9 o'clock; puborectalis muscle (PRM) was measured at 4, 6, and 8 o'clock; and averaged. Anorectal manometry was conducted when clinically indicated. Data were compared using Mann-Whitney tests and linear regression. Results are reported as mean ± SD or median (IQR). RESULTS: Women (n = 136) were younger than men (n = 26) (61 ± 13 vs. 67 ± 13 years, p = 0.02). More women than men had pelvic surgery and less had colorectal surgery, spinal disorders, or a history of smoking (p < 0.05). Eighty-two percentage of women had an anal sphincter defect versus 31% of men (p < 0.01). All anal sphincter complex components were thinner in women than men with lower squeeze and resting pressures (p < 0.03), even in nulliparous women. Mean resting pressure was lower in older 6.1 (4.6-7.8) versus younger women 8.3 (5.0-12.9) mmHg, p = 0.04. CONCLUSIONS: Women, even nulliparous, with ABL demonstrate thinner and weaker anal sphincters than men, Aging correlated with an increase in anal sphincter thickness, suggesting that age-related changes in the intrinsic components of the anal sphincter complex associated with ABL are complex and are not always well demonstrated on endoanal ultrasound.

Impact of treatment for fecal incontinence on constipation symptoms.

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

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.

Sacral neuromodulation versus onabotulinumtoxinA for refractory urgency urinary incontinence: impact on fecal incontinence symptoms and sexual function.

BACKGROUND: Women with refractory urgency urinary incontinence can be treated with onabotulinumtoxinA or sacral neuromodulation. Little data exists on the comparative effects of treatment of refractory urgency urinary incontinence on other pelvic floor complaints, such as bowel and sexual function. OBJECTIVE: The objective of this study was to compare the impact of these treatments on fecal incontinence and sexual symptoms. METHODS: This was a planned supplemental analysis of a randomized trial in women with refractory urgency urinary incontinence treated with onabotulinumtoxinA (n = 190) or sacral neuromodulation (n = 174). Fecal incontinence and sexual symptoms were assessed at baseline and at 6, 12, and 24 months. Fecal incontinence symptoms were measured using the St Mark's (Vaizey) Fecal Incontinence severity scale. Sexual symptoms were measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The PISQ-IR allows measurement of sexual symptoms in both sexually active and non-sexually active adults. Primary outcomes were change in Vaizey and PISQ-12 scores between baseline and 6 months. Secondary outcomes were change in PISQ-IR total and subscores between baseline and 6 months and change in Vaizey, PISQ-12, and PISQ-IR scores between baseline and 12 and 24 months. Intent-to-treat analysis was performed using repeated measures mixed model to estimate change in all parameters from baseline while adjusting for the baseline score. A subgroup analysis of women with clinically significant bowel symptoms was conducted based on baseline Vaizey score of ≥12. RESULTS: At baseline, mean Vaizey scores were indicative of mild fecal incontinence symptoms and were not different between onabotulinumtoxinA and sacral neuromodulation groups (7.6 ± 5.3 vs 6.6 ± 4.9, P = .07). The proportion of sexually active women (56% vs 63%, P = .25), mean PISQ-12 score (33.4 ± 7.5 vs 32.7 ± 6.7, P = .55), or PISQ-IR subscores were also not different between the onabotulinumtoxinA and sacral neuromodulation groups at baseline. There was no difference between women treated with onabotulinumtoxinA and those treated with sacral neuromodulation at 6 months in terms of improvement in fecal incontinence symptom score (Vaizey: -1.9, 95% confidence interval -2.6 to -1.2 vs -0.9, 95% confidence interval -1.7 to -0.2, P = .07) or sexual symptoms score (PISQ-12: 2.2, 95% confidence interval 0.7 to 3.7 vs 2.2, 95% confidence interval 0.7 to 3.7, P = .99). There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months. Similar findings were noted at 12 and 24 months. In a subgroup (onabotulinumtoxinA = 33 and sacral neuromodulation = 22) with clinically significant fecal incontinence at baseline (Vaizey score ≥12), there was a clinically meaningful improvement in symptoms in both groups from baseline to 6 months, with no difference in improvement between the onabotulinumtoxinA and sacral neuromodulation groups (-5.1, 95% confidence interval -7.3 to -2.8 vs -5.6, 95% confidence interval -8.5 to -2.6, P = .8). CONCLUSION: There were no differences in improvement of fecal incontinence and sexual symptoms in women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral neuromodulation. Women with significant fecal incontinence symptoms at baseline had clinically important improvement in symptoms, with no difference between the treatments. Our findings can help clinicians counseling women considering treatment for refractory urgency urinary incontinence.

Metabolites and microbial composition of stool of women with fecal incontinence: Study design and methods.

AIMS: This paper aims to report the rationale, design, and the specific methodology of an ongoing nested observational study that will determine the association of the metabolite and microbial composition of stool with fecal incontinence (FI). METHODS: Eligible cases are participants with FI enrolled in the Controlling Anal Incontinence in women by Performing Anal Exercises with Biofeedback or Loperamide (CAPABLe) trial, a Pelvic Floor Disorders Network trial across eight clinical centers in the United States. Women of similar age without FI in the last year served as controls. All subject collected stool samples at the baseline and 24-week visit at home using a standardized collection method. Samples were shipped to and stored at centralized laboratories. RESULTS: Specimen collection commenced December 2014 and was completed in May 2016. Fecal water and DNA has been extracted and is currently being analyzed by targeted metabolic profiling for stool metabolites and 16S rRNA gene sequencing for stool microbiota. CONCLUSIONS: This article describes the rationale and design of a study that could provide a paradigm shift for the treatment of FI in women.

Structure-function relationship of the human external anal sphincter.

INTRODUCTION AND HYPOTHESIS: Obstetrical external anal sphincter (EAS) injury and subsequent dysfunction are leading risk factors for female fecal incontinence (FI). Limited knowledge of the EAS structure-function relationship hinders treatment optimization. We directly measured functionally relevant intrinsic parameters of human EAS and tested whether vaginal delivery alters the EAS structure-function relationship. METHODS: Major predictors of in vivo EAS function were compared between specimens procured from vaginally nulliparous (VN, n = 5) and vaginally parous (VP, n = 7) cadaveric donors: operational sarcomere length (Ls), which dictates force-length relationship; physiological cross-sectional area (PCSA), which determines isometric force-generating capacity; fiber length (Lfn), responsible for muscle excursion and contractile velocity; and muscle stiffness. Data were analyzed using unpaired and paired t tests, α < 0.05. Results are presented as mean ± SEM. RESULTS: The VN and VP (median parity 3) groups were similar in age and BMI. No gross anatomical defects were identified. EAS Ls (2.36 ± 0.05 µm) was shorter than the optimal Lso (2.7 µm), at which contractile force is maximal, P = 0.0001. Stiffness was lower at Ls than Lso (5.4 ± 14 kPa/µm vs 35.3 ± 12 kPa/µm, P < 0.0001). This structural design allows active and passive tension to increase with EAS stretching. EAS relatively long Lfn (106 ± 24.8 mm) permits rapid contraction without decreased force, whereas intermediate PCSA (1.3 ± 0.3 cm2) is conducive to maintaining resting tone. All parameters were similar between groups. CONCLUSIONS: This first direct examination of human EAS underscores how EAS intrinsic design matches its intended function. Knowledge of the EAS structure-function relationship is important for understanding the pathogenesis of FI and the optimization of treatments for EAS dysfunction.

Measuring the impact of a posterior compartment procedure on symptoms of obstructed defecation and posterior vaginal compartment anatomy.

INTRODUCTION AND HYPOTHESIS: We hypothesized that there would be a significant difference in changes in obstructed defecation symptoms and posterior compartment prolapse between women who underwent posterior vaginal wall prolapse repair (PR) and those who did not. METHODS: This was a two-site prospective cohort study of women undergoing prolapse or incontinence surgery in which a PR was, or was not, performed at the discretion of the surgeon. Women were assessed using validated obstructed defecation questionnaires and standardized examination measures (including POP-Q, measurement of transverse gh, and assessment for a rectovaginal pocket and laxity) prior to pelvic surgery and 12 weeks after surgery. RESULTS: Of 68 women who underwent surgery, 43 had PR. The PR group had higher obstructed defecation symptoms and greater posterior compartment prolapse at baseline. At 12 weeks, obstructed defecation symptoms had improved significantly more in the PR group than in the no PR group (all p < 0.03). Anatomic outcomes showed greater improvement in point Bp in the PR group (-3.4 vs. -0.7 no PR, p < 0.001) and resolution of the rectovaginal pocket (86 % vs. 42 %, p = 0.002). There were no significant changes in obstructed defecation symptoms or anatomic outcomes from baseline in the no PR group, while the PR group showed significantly improved obstructed defecation symptoms and anatomic outcomes after repair (p < 0.001 for both). CONCLUSIONS: Significant improvements in obstructed defecation symptoms and posterior compartment prolapse were seen after PR, but not in women who did not receive PR. Obstructed defecation symptoms, Bp and rectovaginal pocket were the measures best able to demonstrate improvement after PR. We recommend the use of these measures to assess the impact of surgery in the posterior compartment.

Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

INTRODUCTION AND HYPOTHESIS: Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity. PURPOSE: We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS). METHODS: The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher's exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome. RESULTS: Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial. CONCLUSIONS: Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data.

A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: We investigated the efficiency and efficacy of vaginal mesh attachment using interrupted, non-barbed, delayed absorbable sutures in comparison with a running, barbed, delayed absorbable suture during laparoscopic sacrocolpopexy (LSC) and robotic sacrocolpopexy (RSC). METHODS: Women undergoing LSC or RSC were recruited. Participants were randomized to at least six 0 PDS non-barbed interrupted sutures or at least six passes of a 1 PDS barbed suture (Quill™) on each anterior and posterior polypropylene mesh leaflet. The primary outcome was the time to attach the mesh to the vagina. The LSC and RSC groups were block randomized by suture type. Secondary outcomes included: (1) intraoperative surgeon assessment of satisfaction as measured using a 10-cm visual analog scale (VAS), (2) postoperative POP-Q evaluation for anatomic failure, and (3) overall appearance of vaginal walls measured using a VAS. RESULTS: Of the 64 included subjects who were randomized, 32 had mesh attachment with the barbed suture (16 LSC, 16 RSC) and 32 had attachment with non-barbed sutures (16 LSC, 16 RSC). Among all the subjects (LSC and RSC), the non-barbed suture group had significantly longer mesh attachment times than the barbed suture group (42 vs. 29 min, p < 0.001). The non-barbed suture group had significantly better scores for intraoperative ease of suture placement, surgeon satisfaction with mesh appearance, and global satisfaction. At 12 months, there were no significant differences in anatomic failure between the suture groups or overall appearance of the vaginal walls (p > 0.05). CONCLUSIONS: The barbed suture technique was 11 - 16 min faster for attaching mesh to the vagina than the non-barbed suture technique. Anatomic outcomes at 12 months were comparable between the suture groups. It is reasonable to use a running, barbed suture in minimally invasive sacrocolpopexy.

Sexual activity and function in women more than 2 years after midurethral sling placement.

OBJECTIVE: The purpose of this study was to assess prospectively the effects of midurethral sling surgery on sexual function and activity. STUDY DESIGN: Sexual activity and function was assessed in 597 women with stress urinary incontinence who were enrolled in a randomized equivalence trial of retropubic compared with transobturator midurethral slings. Repeated measures analysis of variance was used to assess changes in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores over a 2-year period. RESULTS: Significant, similar improvements in sexual function were seen in both midurethral sling groups. Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores increased from 32.8 at baseline to 37.6 at 6 months and 37.3 at 24 months (P < .0001). Dyspareunia, incontinence during sex, and fear of incontinence during sex each significantly improved after surgery. Preoperative urge incontinence was associated with abstinence after surgery (P = .02); postoperative urge incontinence negatively impacted sexual function (P = .047). CONCLUSION: Midurethral sling surgery for stress urinary incontinence significantly improves sexual function, although coexistent urge incontinence has a negative impact.

Minimum important difference for validated instruments in women with urge incontinence.

AIMS: Minimum important difference (MID) estimates the minimum degree of change in an instrument's score that correlates with subjective sense of improvement. The aim of this study was to estimate the MID for the Urogenital Distress Inventory (UDI), Incontinence Impact Questionnaire (IIQ) and Overactive Bladder Questionnaire (OAB-q) using anchor and distribution-based approaches in patients with urge-predominant incontinence and whether MID changes over time. METHODS: This was a sub-analysis of a multi-center trial of 307 women with pure urge (11) or urge-predominant (296) incontinence who completed condition-specific instruments 10 weeks and 8 months after randomization to anticholinergic medication with or without behavioral therapy. We applied anchor-based methods only when the Kendall's rank correlations between the anchors (Global Perception of Improvement (GPI), Patient Satisfaction Questionnaire (PSQ), and incontinence episodes) and the incontinence instruments (UDI, UDI irritative subscale, IIQ, and OAB-q subscales) were ≥ 0.3. We applied three distribution-based methods to all instruments: effect sizes of ± 0.2 SD (small) and ± 0.5 SD (medium), and standard error of measurement of ± 1. Analyses were performed at both time points. RESULTS: Anchor-based MIDs for the UDI ranged from -35 to -45 and -15 to -25 for the irritative subscale distribution-based methods MIDs for UDI and IIQ ranged between -10 to -25 and -19 to -49, respectively, reflective of a reduction in bother and symptom severity (SS). OAB-q subscale MIDs ranged from +5 to +12, denoting improved quality of life (HRQL) and -13 to -25, consistent with a reduction in SS. CONCLUSIONS: The MID in women with urge-predominant UI for the UDI and UDI irritative are -35 and -15. Our findings are consistent with previously reported MIDs for the OAB-q subscales. Distribution-based method MIDs are lower values than anchor-based values. The MID did not typically change over the time.

Measurement of intraabdominal pressure in pregnant women at term.

OBJECTIVE: To determine the baseline intraabdominal pressure (IAP) in pregnant women at term. STUDY DESIGN: Pregnant women at term undergoing scheduled cesarean delivery in the absence of labor had IAP measured via an intravesical catheter. Abdominal pressures were obtained in the dorsal supine position with a leftward tilt after the placement of spinal anesthesia. Measurements were taken immediately before and after cesarean delivery. RESULTS: One hundred subjects were included in this Institutional Research Board-approved study. The median preoperative IAP measurement was 22 mm Hg, and the median postoperative IAP measurement was 16 mm Hg. The decrease in the IAP from the preoperative to the postoperative measurement was statistically significant (p < 0.0001). CONCLUSION: The median IAP measurement for pregnant patients at term is 22 mm Hg and is followed by a statistically significant decline after delivery.

A randomized clinical trial comparing pelvic floor muscle training to a Pilates exercise program for improving pelvic muscle strength.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to determine whether a Pilates exercise program and a pelvic floor muscle-training (PFMT) program could provide similar improvements in pelvic muscle strength. METHODS: Sixty-two women with little or no pelvic floor dysfunction were randomized to Pilates or PFMT. Each group had 24 biweekly 1-h sessions with either a physical therapist or Pilates instructor. Strength was measured via perineometry (cmH(2)O). Two questionnaires--pelvic floor distress inventory (PFDI-20) and pelvic floor impact questionnaire (PFIQ-7)--were also collected. RESULTS: At baseline, the Pilates and PFMT groups measured 14.9 +/- 12.5 and 12.5 +/- 10.4 cmH(2)O, respectively (p = 0.41). Both the Pilates and PFMT groups got stronger (6.2 +/- 7.5 cmH(2)O, p = 0.0002 and 6.6 +/- 7.4 cmH(2)O, p = 0.0002, respectively), with no difference between groups p = 0.85. PFIQ and PFDI scores improved from baseline but not between groups. CONCLUSIONS: Further study is required to determine if Pilates can actually treat pelvic floor dysfunction.

The influence of race on the incidence of respiratory distress syndrome after antenatal betamethasone or dexamethasone.

OBJECTIVE: To compare the incidence of respiratory distress syndrome (RDS) in African American and Caucasian neonates after antenatal betamethasone or dexamethasone. STUDY DESIGN: This was a retrospective review of all deliveries occurring at < or = 32 weeks' gestation at Hackensack University Medical Center from 2001 to 2004. Only patients who received a complete course of antenatal steroids were included. The type (betamethasone or dexamethasone) was based on pharmacy supply. Statistical analysis was performed using Pearson's chi2 and Fisher's exact test. RESULTS: The African American (n = 32) and Caucasian (n = 86) groups were similar in terms of maternal age, gestational age and infant birth weight. African Americans receiving dexamethasone had a 1.65-fold increased risk of delivering infants with RDS as compared to those who received betamethasone (91.3% vs. 55.6%, respectively; p = 0.038). No difference was noted among Caucasians. CONCLUSION: Among African American neonates, the incidence of RDS was higher in those who received dexamethasone vs. betamethasone.

Management of Fecal Incontinence.

Nine percent of adult women experience episodes of fecal incontinence at least monthly. Fecal incontinence is more common in older women and those with chronic bowel disturbance, diabetes, obesity, prior anal sphincter injury, or urinary incontinence. Fecal incontinence negatively affects quality of life and mental health and is associated with increased risk of nursing home placement. Fewer than 30% of women with fecal incontinence seek care, and lack of information about effective solutions is an important barrier for both patients and health care professionals. Even among women with both urinary and fecal incontinence presenting for urogynecologic care, the rate of verbal disclosure of fecal incontinence symptoms remains low. This article provides an overview of the evaluation and management of fecal incontinence for the busy obstetrician-gynecologist, incorporating existing guidance from the American College of Obstetricians and Gynecologists, the American College of Gastroenterology, and the American Society of Colon and Rectal Surgeons. The initial clinical evaluation of fecal incontinence requires a focused history and physical examination. Recording patient symptoms using a standard diary or questionnaire can help document symptoms and response to treatment. Invasive diagnostic testing and imaging generally are not needed to initiate treatment but may be considered in complex cases. Most women have mild symptoms that will improve with optimized stool consistency and medications. Additional treatment options include pelvic floor muscle strengthening with or without biofeedback, devices placed anally or vaginally, and surgery, including sacral neurostimulation, anal sphincteroplasty, and, for severely affected individuals for whom other interventions fail, colonic diversion.

A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence.

OBJECTIVE: The aim of this study was to characterize clinical success, impact on quality of life, and durability up to 1 year in women with fecal incontinence (FI) responsive to an initial test period with a trial vaginal bowel control system. METHODS: This was a prospective open-label study in subjects with FI and successfully fit who underwent an initial 2-week trial period. Those achieving 50% or greater reduction in FI episodes were provided the long-term system. Primary outcome was success at 3 months defined as 50% or greater reduction in baseline FI episodes, also assessed at 6 and 12 months. Secondary outcomes included symptom impact measured with Fecal Incontinence Quality of Life scale, symptom severity by the St Mark's (Vaizey) questionnaire, Patient Global Impression of Improvement, and satisfaction. Adverse events were collected. Primary analysis was intention to treat (ITT). RESULTS: Seventy-three subjects with baseline mean of 14.1 ± 12.15 FI episodes over 2 weeks entered the treatment period. Success rate at 3 months was 72.6% (53/73, P < 0.0001); per-protocol, 84.1% (53/63, P < 0.0001). Significant improvement in all Fecal Incontinence Quality of Life subscales and St Mark's questionnaire meeting minimally important differences was noted. Satisfaction was 91.7%, 89.7%, and 94.4% at 3, 6, and 12 months, respectively; 77.4%, 77.6%, and 79.6% were very much/much better on the Patient Global Impression of Improvement at 3, 6, and 12 months, respectively. Most common adverse event was vaginal wall injury, with most adverse events (90/134, 67%) occurring during fitting period. CONCLUSIONS: In women with successful fitting and initial treatment response, durable efficacy was seen at 3, 6, and 12 months by objective and subjective measures, with favorable safety.

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.

Perioperative Behavioral Therapy and Pelvic Muscle Strengthening Do Not Enhance Quality of Life After Pelvic Surgery: Secondary Report of a Randomized Controlled Trial.

BACKGROUND: There is significant need for trials evaluating the long-term effectiveness of a rigorous program of perioperative behavioral therapy with pelvic floor muscle training (BPMT) in women undergoing transvaginal reconstructive surgery for prolapse. OBJECTIVE: The purpose of this study was to evaluate the effect of perioperative BPMT on health-related quality of life (HRQOL) and sexual function following vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). DESIGN: This study is a secondary report of a 2 × 2 factorial randomized controlled trial. SETTING: This study was a multicenter trial. PARTICIPANTS: Participants were adult women with stage 2-4 POP and SUI. INTERVENTION: Perioperative BPMT versus usual care and sacrospinous ligament fixation (SSLF) versus uterosacral ligament suspension (ULS) were provided. MEASUREMENTS: Participants undergoing transvaginal surgery (SSLF or ULS for POP and a midurethral sling for SUI) received usual care or five perioperative BPMT visits. The primary outcome was change in body image and in Pelvic Floor Impact Questionnaire (PFIQ) short-form subscale, 36-item Short-Form Health Survey (SF-36), Pelvic Organ Prolapse-Urinary Incontinence Sexual Questionnaire short form (PISQ-12), Patient Global Impression of Improvement (PGII), and Brink scores. RESULTS: The 374 participants were randomized to BPMT (n = 186) and usual care (n = 188). Outcomes were available for 137 (74%) of BPMT participants and 146 (78%) of the usual care participants at 24 months. There were no statistically significant differences between groups in PFIQ, SF-36, PGII, PISQ-12, or body image scale measures. LIMITATIONS: The clinicians providing BPMT had variable expertise. Findings might not apply to vaginal prolapse procedures without slings or abdominal apical prolapse procedures. CONCLUSIONS: Perioperative BPMT performed as an adjunct to vaginal surgery for POP and SUI provided no additional improvement in QOL or sexual function compared with usual care.