Characteristics Associated With Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence.

OBJECTIVES: We previously showed that management with a novel vaginal bowel control system was efficacious in women with moderate to severe fecal incontinence. The objective of this secondary analysis was to evaluate the clinical characteristics associated with device-fitting success. METHODS: This is a secondary analysis of an institutional review board-approved, multicenter, prospective, open-label clinical study of women aged 19 to 75 years with 4 or more episodes of fecal incontinence recorded on a 2-week baseline bowel diary. Those successfully fitted with the vaginal bowel control device entered a 1-month treatment period, and efficacy was assessed with a repeat bowel diary. Demographic data, medical and surgical history, and pelvic examination findings were compared across women with successful and unsuccessful completion of the fitting period. Multivariate logistic regression analysis was performed. RESULTS: Six clinical sites in the United States recruited from August 2012 through October 2013. Overall, 110 women underwent attempted fitting, of which 61 (55.5%) of 110 were successful and entered the treatment portion of the study. Multivariate logistic regression analysis revealed that previous prolapse surgery (P = 0.007) and shorter vaginal length (P = 0.041) were independently associated with unsuccessful fitting. Women who have not undergone previous prolapse surgery had 4.7 times the odds (95% confidence interval [CI], 1.53-14.53) of a successful fit. In addition, for every additional centimeter of vaginal length, women had 1.49 times the odds (95% CI, 1.02-2.17) of a successful fit. CONCLUSIONS: Shorter vaginal length and previous prolapse surgery were associated with an increased risk of fitting failure. These findings may be used to inform patients regarding their expectation of successful fitting.

Internet Use Among Urogynecology Patients in North Carolina.

OBJECTIVES: Given limited information regarding digital technology use among patients, we sought to evaluate Internet use among younger (<65 years) as compared to older (≥65 years) women and to assess factors associated with Internet use. METHODS: We administered an anonymous questionnaire on digital technology use to English-speaking women who presented to our Urogynecology practice during a 1-month period. The questionnaire assessed the following sociodemographics: age, race, education, income, and insurance status. For our primary outcome, we assessed Internet use among younger versus older women. We also conducted a logistic regression analysis to evaluate the association of age with Internet use, while adjusting for potential confounders. RESULTS: A total of 556 women presented during the study period. Among these women, 506 completed the survey, for a 91% response rate. There were 282 (55.7%) younger women and 222 (43.9%) older women. Most of the younger and older cohorts were white (77% vs 86.5%, P = 0.02). Younger women were more educated (79.8% vs 59.5% ≥ college education; P < 0.0001) and had a higher income (58.3% vs 39.8% ≥ $50,000; P < 0.0001). For our primary outcome, younger women were significantly more likely to use the Internet (93.8% vs 66.3%, P < 0.001). In a logistic regression model which adjusted for age, race, education, and income, younger women remained significantly more likely to use the Internet (odds ratio, 6.6; 95% CI, 3.4-13.0). CONCLUSIONS: Although women younger than 65 years reported greater Internet use when compared to women 65 years or older, most of older women also used the Internet.

Implementation of a standardized digital rectal exam to improve the accuracy of rectocele diagnosis.

INTRODUCTION AND HYPOTHESIS: The standardized evaluation of posterior compartment prolapse using the Pelvic Organ Prolapse Quantification (POP-Q) system is limited. The primary objective of this study is to develop and validate the interexaminer reliability of a new system for assessing the posterior vaginal wall for the presence of a rectocele. METHODS: This was a cross-sectional study of women presenting to an academic urogynecology clinic. Subjects underwent a routine pelvic examination that included a standard POP-Q followed by two Standardized Digital Rectal Exams (SDRE) by two different providers, each blinded to the other's results. The SDRE measures the distance from the leading edge of a posterior bulge to the hymen with a finger in the distal rectum - first visually and then an actual measured distance using a marked cotton swab (Q-tip measurement). Correlations between examiners for the SDRE and the POP-Q were analyzed using Pearson's correlation coefficient (ρ). RESULTS: Eight attending and fellow urogynecologists examined 50 subjects. Mean age was 57.3 years, mean BMI 30.9 kg/m(2), with an overall median POP-Q stage 2 (range 0-3), and median posterior POP-Q stage 1 (range 0-3). Overall, 54 % of women had a noteworthy rectocele by typical digital rectal exam. Interexaminer correlations with SDRE for both the visual assessment (ρ = 0.697, p < 0.0001) and the Q-tip measurement (ρ = 0.767, p = p < 0.001) were strong. The intraexaminer visual assessment and the Q-tip measurement were highly correlated (ρ = 0.934, p = <0.001). CONCLUSION: This standardized rectal examination provides a consistent method for the reporting of distal rectoceles that can lend additional information to the POP-Q exam.

Randomized trial of a web-based tool for prolapse: impact on patient understanding and provider counseling.

INTRODUCTION AND HYPOTHESIS: Effective patient/provider communication is important to ensure patient understanding, safety, and satisfaction. Our hypothesis was that interactive patient/provider counseling using a web-based tool (iPad application) would have a greater impact on patient satisfaction with understanding prolapse symptoms compared with standard counseling (SC). METHODS: Women with complaints of seeing/sensing a vaginal bulge were enrolled in this randomized controlled trial. Participants completed pre- and postvisit Likert scale questionnaires on satisfaction with prolapse knowledge and related anxiety. After new patient histories and physical examinations, study participants were randomized to SC or SC with iPad. Ninety participants were required to detect a 30% difference in satisfaction with prolapse knowledge between the two groups. RESULTS: Ninety women were randomized to SC (n = 44) or SC with iPad (n = 46). At baseline, 47% of women were satisfied with their understanding of bulge symptoms (50% SC vs. 43.5% SC with iPad, p = 0.5). After counseling, 97% of women reported increased satisfaction with understanding of bulge symptoms (p < 0.0001), with no difference between groups [42/44 (95.5%) SC vs. 45/46 (97.8%) SC with iPad, p = 0.5]. Baseline anxiety was high: 70% (65.9% SC vs. 73.9% SC with iPad, p = 0.4). After counseling, anxiety decreased to 30% (p < 0.0001), with improvement in both groups (31.8% SC vs. 28.3% SC with iPad™, p = 0.7). Counseling times were similar between groups (9.5 min., SC vs. 8.9 min., SC with iPad, p = 0.4). CONCLUSIONS: Interactive counseling was associated with increased patient satisfaction with understanding bulge symptoms and decreased anxiety whether a web-based tool was used or not.

Obstetric sphincter injury interacts with diarrhea and urgency to increase the risk of fecal incontinence in women with irritable bowel syndrome.

OBJECTIVES: This study aimed to confirm that fecal urgency and diarrhea are independent risk factors for fecal incontinence (FI), to identify obstetrical risk factors associated with FI in women with irritable bowel syndrome, and to determine whether obstetric anal sphincter injuries interact with diarrhea or urgency to explain the occurrence of FI. METHODS: The study is a supplement to a diary study of bowel symptoms in 164 female patients with irritable bowel syndrome. Subjects completed daily bowel symptom diaries for 90 consecutive days and rated each bowel movement for stool consistency and presence of urgency, pain, and FI. All female participants from the parent study were invited to complete a telephone-administered 33-item bowel symptom and obstetric history questionnaire, which included the fecal incontinence severity index. RESULTS: Of the 164 women in the parent study, 115 (70.1%) completed the interview. Seventy-four (45.1%) reported FI on their diary including 34 (29.6%) who reported at least 1 episode per month, 112 (97.4%) reported episodes of urgency, and 106 (92.2%) reported episodes of diarrhea. The mean fecal incontinence severity index score was 13.9 (9.7). On multivariable analysis, FI was significantly associated with parity (P = 0.007), operative abdominal delivery (P = 0.049), obstetrical sphincter lacerations (P = 0.007), fecal urgency (P = 0.005), diarrhea (P = 0.008), and hysterectomy (P = 0.004), but was not associated with episiotomy, pelvic organ prolapse, or urinary incontinence. The synergistic interactions of obstetric anal sphincter laceration with urgency (P = 0.002) and diarrhea (P = 0.004) were significant risk factors for FI. CONCLUSIONS: Fecal urgency and diarrhea are independent risk factors for FI, and they interact with obstetric anal sphincter laceration to amplify the risk of FI.

Effect of anticholinergic use for the treatment of overactive bladder on cognitive function in postmenopausal women.

BACKGROUND: Overactive bladder (OAB) is a common condition affecting the elderly. The mainstay of treatment for OAB is medical therapy with anticholinergics. However, adverse events have been reported with this class of drugs, including cognitive changes. OBJECTIVE: The objective of this study was to investigate the effect of an anticholinergic medication, trospium chloride, on cognitive function in postmenopausal women being treated for OAB. METHODS: This was a prospective cohort study conducted at a urogynaecology clinic at one academic medical centre from January to December 2010, with 12-week follow-up after medication initiation. Women aged 55 years or older seeking treatment for OAB and opting for anticholinergic therapy were recruited. Baseline cognitive function was assessed via the Hopkins Verbal Learning Test-Revised Form (HVLT-R) [and its five subscales], the Orientation, Memory & Concentration (OMC) short form, and the Mini-Cog evaluation. After initiation of trospium chloride extended release, cognitive function was reassessed at Day 1, Week 1, Week 4 and Week 12. Bladder function was assessed via three condition-specific quality-of-life questionnaires. Secondary outcomes included change in bladder symptoms, correlation between cognitive and bladder symptoms, and overall medication compliance. The main outcome measure was change in HVLT-R score at Week 4 after medication initiation, compared with baseline (pre-medication) score. RESULTS: Of 50 women enrolled, 35 completed the assessment. The average age was 70.4 years and 77.1% had previously taken anticholinergic medication for OAB. At enrollment 65.7% had severe overactive bladder and 71.4% had severe urge incontinence. Cognitive function showed an initial decline on Day 1 in HVLT-R total score (p = 0.037), HVLT-R Delayed Recognition subscale (p = 0.011) and HVLT-R Recognition Bias subscale (p = 0.01). At Week 1 the HVLT-R Learning subscale declined from baseline (p = 0.029). All HVLT-R scores normalized by Week 4. OMC remained stable throughout. The Mini-Cog nadired at a 90.9% pass rate at Week 4. OAB symptoms did not improve until Week 4, based on questionnaire scores (p < 0.05). CONCLUSION: Cognitive function exhibited early changes after initiation of trospium chloride but normalized within 4 weeks. Cognitive changes occurred weeks prior to OAB symptom improvement. Surveillance for cognitive changes with anticholinergic use should be part of OAB management.

Diagnostic accuracy of visual urethral mobility exam versus Q-Tip test: a randomized crossover trial.

OBJECTIVE: The objective of the study was to compare the diagnostic accuracy of a visual urethral mobility examination (VUME) with a Q-Tip test in the assessment of urethral hypermobility. STUDY DESIGN: Subjects were randomized to a VUME or Q-Tip test first, followed by the alternate assessment. Outcomes included hypermobile, not hypermobile, or indeterminate. Hypermobility was defined as 30° or greater from the horizontal. Pain perception and test preference were assessed. RESULTS: For the 54 subjects, 61.1% demonstrated hypermobility on VUME vs 72.2% on the Q-Tip test (P = .39). Assessment of hypermobility was correlated between the 2 tools (ρ = 0.47, P = .001). Positive and negative predictive value, sensitivity, and specificity for VUME were 88%, 56%, 78%, and 71%, respectively, with a Q-Tip test as the reference standard. Mean pain score on visual analog scale was 0.72 for VUME and 3.15 for Q-tip test (P < .001). VUME was preferred by 83% of subjects. CONCLUSION: VUME is a diagnostic alternative to the Q-Tip test for the assessment of urethral hypermobility and is preferred by subjects.

Overlapping anal sphincteroplasty: impact of suture selection on bowel symptoms.

OBJECTIVE: To look at women who underwent overlapping anal sphincteroplasty (OAS) with the use of either permanent or absorbable sutures and to describe patient-reported fecal continence and quality of life. STUDY DESIGN: A case series of 40 women who underwent OAS completed the Modified Manchester Health Questionnaire a mean of 50 months after surgery. Descriptive statistics were used to describe those who had permanent sutures and those who had absorbable sutures. RESULTS: The primary outcome, loss of solid stool, was similar at 50% for each group. Severity of incontinence symptoms, as measured by the Fecal Incontinence Severity Index, was lower in the permanent suture group (15.9 vs. 24.0). There was no difference in overall impact on quality of life. CONCLUSION: While overall patient-reported fecal incontinence was similar, permanent suture use at time of OAS was associated with decreased fecal incontinence severity.

Bupivacaine injection during midurethral sling and postoperative pain: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to investigate the impact of retropubic injection of 0.125% bupivacaine during midurethral sling placement on postoperative pain. METHODS: A randomized, double-blind trial of 42 women undergoing midurethral sling for stress incontinence was conducted. The intervention group received an injection of 0.125% bupivacaine in the retropubic space prior to midurethral sling placement, while the control group received no injection. Pain scores were recorded via a 10-cm visual analog scale at 2, 6, and 24 h postoperatively. RESULTS: Pain scores were lower in the bupivacaine group compared to the control group at 2 h (1.9 versus 2.6, p = 0.05). Mean pain scores were similar at all other time points (all p > 0.45). Participants in both groups used similar amounts of pain medication in the hospital, except that patients in the bupivacaine group used more PO non-steroidal anti-inflammatory drugs (p = 0.047). CONCLUSIONS: Retropubic injection of 0.125% bupivacaine at the time of midurethral sling placement decreases short-term postoperative pain.

Validation of web-based administration of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12).

INTRODUCTION AND HYPOTHESIS: We studied a web-based version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). METHODS: A randomized crossover study in which subjects completed both a web-based and paper-based version of the PISQ-12, with a 2-week separation between the completion of the two versions. Demographic data and questionnaire preferences were also assessed. Group 1 completed the web version first, and group 2 completed the paper version first. RESULTS: We recruited 52 women and 50 (96.2%) completed the study. Demographic data were similar for the two groups. There was no difference in total PISQ-12 score (P = 0.41) and a high degree of correlation between versions (r = 0.88). Women preferred the web-based PISQ-12 (77.6%) over the paper-based version. CONCLUSION: The web-based version of the PISQ-12 is a reliable alternative to the standard paper-based version and was preferred by women in this study regardless of age, race, and education.

Maternal outcomes associated with planned vaginal versus planned primary cesarean delivery.

We compared maternal morbidity between planned vaginal and planned cesarean delivery. A university hospital's database was queried for delivery outcomes. Between 1995 and 2005, 26,356 deliveries occurred. Subjects were divided into two groups: planned vaginal and planned cesarean delivery. This was based on intent to deliver vaginally or by cesarean, despite actual route of delivery. Planned vaginal delivery included successful vaginal delivery and labored cesarean delivery intended for vaginal delivery. Planned cesarean delivery included unlabored and labored cesarean delivery and vaginal delivery intended for cesarean. Chart abstraction confirmed the delivery plan. Primary outcomes were chorioamnionitis, postpartum hemorrhage, and transfusion. Secondary outcomes were also measured. A subanalysis compared actual vaginal delivery, labored cesarean delivery, and unlabored cesarean delivery. There were 3868 planned vaginal deliveries and 180 planned cesarean deliveries. Planned cesarean delivery had less chorioamnionitis (2.2% versus 17.2%), postpartum hemorrhage (1.1% versus 6.0%), uterine atony (0.6% versus 6.4%), and prolonged rupture of membranes (2.2% versus 17.5%) but a longer hospital stay (3.2 versus 2.6 days). There were no differences in transfusion rates. For healthy primiparous women, planned cesarean delivery decreases certain morbidities. Labored cesarean delivery had increased risks compared with both vaginal delivery and unlabored cesarean delivery.

Urethral condyloma accuminata causing bladder outlet obstruction in pregnancy: a case report.

BACKGROUND: Condyloma accuminata represents the most common sexually transmitted disease in the United States. Pregnancy can lead to enlargement of existing lesions or development of new lesions. CASE: A 31-year-old woman presented at 28 weeks' gestation with a complaint of difficulty voiding due to an obstructing urethral mass. In the weeks preceding presentation voiding had become progressively more difficult, leading to Valsalva voiding, the use of the Credé maneuver and the sensation of incomplete emptying. Excision in the office setting resulted in complete resolution of her symptoms with return to normal voiding. CONCLUSION: Resection of obstructive urethral condyloma can be a safe and effective treatment for bladder outlet obstruction during pregnancy with rapid return to normal voiding.

Body mass index as a risk factor for cystotomy during suprapubic placement of mid-urethral slings.

INTRODUCTION AND HYPOTHESIS: This study aims to investigate whether body mass index (BMI) is a risk factor for cystotomy during sling placement via suprapubic approach for stress urinary incontinence. METHODS: Retrospective chart review was performed for suprapubic mid-urethral sling placement between June 2005 and October 2007. Data collected included demographics, BMI, and history of prior and concomitant procedures. Primary outcome was cystotomy during sling placement. RESULTS: Of 198 women identified, 129 had a BMI < 30 kg/m2 and 69 had a BMI > or = 30 kg/m2. There were 18 (14.0%) cystotomies in the BMI < 30 kg/m2 group and three (4.3%) in the BMI > or = 30 kg/m2 group (p = 0.04). BMI < 30 kg/m2 remained a risk factor for cystotomy after controlling for confounders (OR 4.63, 95% CI 1.20-17.86), as did prior anti-incontinence surgery (OR 3.55, 95% CI 1.01-12.50). CONCLUSIONS: BMI < 30 kg/m2 may be a risk factor for cystotomy during sling placement utilizing the suprapubic approach.

A randomized controlled trial of clean intermittent self-catheterization versus suprapubic catheterization after urogynecologic surgery.

OBJECTIVE: The purpose of this study was to compare the risk of significant bacteruria between clean intermittent self-catheterization (CISC) and suprapubic catheterization (SPC) after urogynecologic surgery. STUDY DESIGN: Patients were randomized to CISC or SPC. A urinalysis and patient satisfaction questionnaire were conducted on postoperative days 2 and 7. Urine culture was performed for positive urinalysis. Significant bacteruria was defined as > 100,000 cfu/mL. To detect a decrease in bacteruria risk from 25% to 10%, 113 subjects per group were needed with 80% power and alpha of 0.05. RESULTS: Of 248 randomized patients, 210 were included in the final analysis. The overall risk of bacteruria was 27% with no difference between SPC and CISC (31% vs 23%, P = .23). Patients reported more frustration (P = .01) and more difficulty (P = .003) using CISC. CONCLUSION: There was no difference in risk of significant bacteruria between CISC and SPC. Patients reported more frustration and difficulty with self-catheterization.

Microscopic hematuria as a predictive factor for detecting bladder cancer at cystoscopy in women with irritative voiding symptoms.

OBJECTIVE: The purpose of this study was to assess microscopic hematuria as a predictive factor for detecting bladder cancer at cystoscopy in women with irritative voiding symptoms. STUDY DESIGN: We conducted a retrospective cohort analysis of women with irritative voiding symptoms who presented for urodynamic testing and cystoscopy. Irritative voiding symptoms were defined as urgency, urge incontinence, frequency, dysuria, and/or nocturia. Patient demographics, risk factors for bladder cancer, presence of microscopic hematuria, urodynamic findings, and cystoscopy and biopsy results were recorded. RESULTS: Of 735 patients with irritative voiding symptoms, 264 (35.9%) had microscopic hematuria and 471 (64.1%) had no hematuria. Bladder cancer was detected in 3 women, for an overall detection rate of 0.4%. Microscopic hematuria, urgency, frequency, dysuria, nocturia, age, and tobacco use were not significantly associated with bladder cancer. CONCLUSION: In this cohort of women with irritative voiding symptoms, microscopic hematuria was not predictive for bladder cancer.