Performance of Perioperative Tasks for Women Undergoing Anti-incontinence Surgery: Developed by the AUGS Quality Improvement and Outcomes Research Network.

OBJECTIVES: Surgery for the correction of stress urinary incontinence is an elective procedure that can have a dramatic and positive impact on quality of life. Anti-incontinence procedures, like inguinal hernia repairs or cholecystectomies, can be classified as high-volume/low-morbidity procedures. The performance of a standard set of perioperative tasks has been suggested as one way to optimize quality of care in elective high-volume/low-morbidity procedures. Our primary objective was to evaluate the performance of 5 perioperative tasks-(1) offering nonsurgical treatment, (2) performance of a standard preoperative prolapse examination, (3) cough stress test, (4) postvoid residual test, and (5) intraoperative cystoscopy for women undergoing surgery for stress urinary incontinence-compared among surgeons with and without board certification in female pelvic medicine and reconstructive surgery (FPMRS). STUDY DESIGN: This study was a retrospective chart review of anti-incontinence surgical procedures performed between 2011 and 2013 at 9 health systems. Cases were reviewed for surgical volume, adverse outcomes, and the performance of 5 perioperative tasks and compared between surgeons with and without FPMRS certification. RESULTS: Non-FPMRS surgeons performed fewer anti-incontinence procedures than FPMRS-certified surgeons. Female pelvic medicine and reconstructive surgery surgeons were more likely to perform all 5 perioperative tasks compared with non-FPMRS surgeons. After propensity matching, FPMRS surgeons had fewer patients readmitted within 30 days of surgery compared with non-FPMRS surgeons. CONCLUSIONS: Female pelvic medicine and reconstructive surgery surgeons performed higher volumes of anti-incontinence procedures, were more likely to document the performance of the 5 perioperative tasks, and were less likely to have their patients readmitted within 30 days.

The effect of oral medications on fMRI brain activation: A randomized, double blind, controlled pilot trial of older women with overactive bladder.

INTRODUCTION AND AIM: Observational studies have associated oral anticholinergic medications for overactive bladder (OAB) with cognitive impairment. This is the first pilot trial to compare the effects of two classes of OAB medications on brain activity in women. We evaluated the effect of anticholinergic versus non-anticholinergic (Non-Ach) interventions on regional brain activation during a cognitive task. METHODS: Twelve cognitively normal women seeking OAB therapy were recruited to a randomized, double-blind, parallel, controlled pilot trial. Whole-brain regional activity at baseline and 29 ± 1 days postintervention was assessed with functional magnetic resonance imaging during a working memory task. Average activation strength by region was compared after anticholinergic, beta-3 agonist, or placebo. Two-way ANOVA compared effects of group and time on average activation strength in anticholinergic versus Non-Ach (beta-3 agonists or placebo) groups. RESULTS: The mean (SD) age and body mass index of 12 women were 61 (7) years and 36 (7) kg/m2. Baseline depression and learning scores differed in the anticholinergic group (n = 3) versus the Non-Ach group (n = 9). Right mamillary body activation postintervention was higher after Non-Ach exposure (F 4.9, p < 0.04). In the full sample of participants at follow-up, there was less activation of the right middle frontal gyrus (p = 0.02), superior frontal gyrus (p < 0.01), and supramarginal (p < 0.01) gyrus. CONCLUSION: Activation strength in brain regions underlying working memory was lower over time, and recognition scores improved. A powered trial is needed to adequately evaluate for differential effects of OAB oral medications on regional brain activation.

Postoperative prophylactic antibiotics for retropubic mid-urethral slings.

OBJECTIVES AND HYPOTHESIS: The primary objective is to measure the difference in urinary tract infection (UTI) rates within 6  weeks of placement of a retropubic mid-urethral sling (RMUS) in the setting of various postoperative prophylactic antibiotic regimens. UTI rates were measured by antibiotic prescriptions to treat UTI and/or culture. Secondary aims included determining risk factors for postoperative UTI. METHODS: A retrospective chart review from 2014 to 2016 was performed at Baylor Scott and White Medical Center-Temple for CPT code 57288. Univariate comparisons were performed using chi-square and Student's t-test. Logistic regression analysis was performed for UTI risk factors with univariate p values ≤ 0.1. RESULTS: One hundred twelve subjects were included. Seventeen (15%) were treated for postoperative UTI. Postoperative prophylactic antibiotics included trimethoprim (39.3%), nitrofurantoin (31.3%), trimethoprim-sulfamethoxazole (5.4%), ciprofloxacin (2.7%), and cephalexin (1.8%). Ninety subjects were prescribed postoperative prophylactic antibiotics (80.4%). The postoperative UTI rate was not significantly different between those who were prescribed postoperative prophylactic antibiotics (16%) and those who were not (14%). None of the treatments showed a significant difference on postoperative UTI rate compared to no treatment. Significant risk factors for UTI included catheterization past postoperative day 1 (OR 6.4, 95% CI 1.7 - 23.8; p  = 0.006). CONCLUSIONS: There was no significant difference in postoperative UTI rate in the group without postoperative prophylactic antibiotics compared to those who did receive it. Catheterization past postoperative day 1 was significantly associated with postoperative UTI. However, definitive conclusions are limited by a lack of power.

Retropubic mid-urethral slings and de novo urinary urgency and frequency: The role of retropubic hematomas.

AIMS: This is a prospective cohort study comparing de novo lower urinary tract symptoms (LUTS) in subjects undergoing a retropubic mid-urethral sling who either did or did not develop a postoperative retropubic hematoma within 6 weeks of surgery. The secondary objective was to measure the incidence and prevalence of retropubic hematomas, and subject characteristics associated with retropubic hematomas. METHODS: Eligible subjects were recruited before undergoing a retropubic mid-urethral sling with or without concurrent pelvic reconstructive surgery. Validated urinary symptom questionnaires were completed before surgery and at 6 weeks postoperatively. An abdominal ultrasound was used to establish baseline lower urinary tract imaging. Ultrasound was repeated immediately after surgery and 6 weeks later to assess for the presence of retropubic hematomas. RESULTS: Ninety-four subjects were enrolled. Baseline urgency and frequency were measured in 35% (33/93) of subjects. At 6 weeks postoperatively, 2% (1/52) had de novo LUTS which were not associated with a retropubic hematoma at any time. Immediately after surgery, the incidence of retropubic hematomas was 17% (16/94) while the prevalence of retropubic hematomas 6 weeks after surgery was 4% (3/75). There was no significant difference in the change in hemoglobin before and after surgery between those with and without postoperative retropubic hematomas. CONCLUSIONS: There is no significant association with de novo LUTS and retropubic hematomas. Though there is a 17% incidence of retropubic hematomas detected immediately after surgery, those with hematomas who were not lost to follow-up resolved by the 6-week postoperative visit and is of unclear clinical significance.

Sacral neuromodulation for symptomatic chronic urinary retention in females: do age and comorbidities make a difference?

OBJECTIVES: To evaluate if age and medical comorbidities are associated with progression to implantation of sacral neuromodulation devices in women with symptomatic chronic urinary retention. METHODS: This multisite retrospective cohort included women with symptomatic chronic urinary retention who had a trial phase of sacral neuromodulation. The primary outcome was progression to implantation. Post-implantation outcomes were assessed as stable response versus decreased efficacy. A sub-analysis of catheter-reliant (intermittent-self catheterization or indwelling) patients was performed. Age was analyzed by 10-year units (decades of age). Multivariate logistic regression determined odds ratios for outcomes of implantation and for post-implantation stable response. RESULTS: Implantation occurred in 86% (243/284) women across six academic institutions. Most patients (160/243, 66%) were catheter reliant at the time of trial phase. Increased decade of age was associated with reduced implantation in all women [OR 0.54 (95% CI 0.42, 0.70)] and in the subgroup of catheter-reliant women [OR 0.52 (95% CI 0.37, 0.73)]. Post-implantation stable response occurred in 68% (193/243) of women at median follow-up of 2 years (range 0.3-15 years). Medical comorbidities present at the time of trials did not impact progression to implantation or post-implantation success. CONCLUSIONS: Increasing decade of age is associated with reduced implantation in women with symptomatic chronic urinary retention. There is no age cutoff at which outcomes change. Post-implantation stable response was not associated with age or medical comorbidities.

Sacral neuromodulation for overactive bladder in women: do age and comorbidities make a difference?

OBJECTIVE: To evaluate if age and comorbidities are associated with progression from trial phase to implantation of an implantable pulse generator in women with overactive bladder. METHODS: This multisite retrospective cohort included women with overactive bladder with or without urinary incontinence who had a trial phase for sacral neuromodulation. The primary outcome was progression to implantation. A sub-analysis of implanted patients was performed for the outcome of additional therapies or "implant only" for the duration of follow-up. Multivariate logistic regression models including potential predictors of implantation and post-implantation addition of therapies were performed. RESULTS: At six academic institutions, 91% (785/864) of patients progressed to implantation. Post-implantation success was achieved by 69% (536/782) of patients at median follow-up of 2 (range 0.3 to 15) years. Odds of implantation [OR 0.73 (CI 0.61, 0.88)] and post-implantation success [OR 0.78 (CI 0.98, 0.97)] were lower with increasing decades of age. Medical comorbidities evaluated did not affect implantation rates or post-implant success. CONCLUSIONS: Most women have successful sacral neuromodulation trials despite older age and comorbidities. Higher decade of age has a negative effect on odds of implantation and is associated with addition of therapies post-implantation. Comorbidities assessed in this study did not affect implantation or addition of therapies post-implantation. Most women add therapies to improve efficacy post-implantation, and explantation rates are low.

Pilot Trial of Midstream Urine Collection Device Versus Transurethral Catheter in Women With Lower Urinary Tract Symptoms: Practicality of Use in a Clinical Setting, Patient Preferences, and Comparison of Laboratory Findings.

OBJECTIVES: This study aimed to evaluate successful use of a midstream urine collection device in women with lower urinary tract symptoms and to assess specimen contamination. METHODS: Nonpregnant women 18 years or older without use of antibiotics in the last 4 weeks were recruited. After using the midstream urine collection device to obtain a specimen in a private restroom, a paired specimen was obtained by transurethral catheterization. Patients completed preference questionnaires. Culture organisms and microscopic urinalysis of paired specimens (device vs catheterized) were compared using the McNemar χ2 test. Bivariate analysis was performed. RESULTS: Successful use was demonstrated in 54 (77%) of 70. Reasons for failure included inadequate specimen volume and improper device use. Older median age (50 vs 72 years, P = 0.0003) and history of diabetes (7% vs 27%, P = 0.037) were associated with failed use. Organisms were discordant in 21 (41%) of 51 paired urine culture specimens. The device detected 7 (88%) of 8 uropathogens. There were no detectable differences in microscopic urinalysis. CONCLUSIONS: The midstream urine collection device could increase comfort, and many patients prefer it to transurethral catheterization. With proper patient selection and instructions for use, this device could increase satisfaction. Further studies are needed to assess contamination rates with this device.

Protocol for a multicenter randomized, double blind, controlled pilot trial of higher neural function in overactive bladder patients after anticholinergic, beta-3 adrenergic agonist, or placebo.

INTRODUCTION: Overactive bladder (OAB) syndrome has a negative impact on quality of life and prevalence increases with advanced age. Anticholinergics (AC) and beta-3 adrenergic agonists (ß3a) are commonly prescribed medications for treatment of OAB. AC medication has been associated with dementia in population studies and with cortical atrophy in imaging studies. Higher neural effects of both classes of OAB medications have not been evaluated with functional neuroimaging. Longitudinal clinical assessments of cognition after OAB therapy with AC has produced conflicting results. ß3a medication is has not been associated with dementia in clinical studies; however, higher neural effects are unknown.Our multicenter, double blind, randomized, placebo-controlled trial uses functional magnetic resonance imaging (fMRI) and cognitive testing to evaluate the effects of AC and ß3a on brain functional connectivity in females with non-neurogenic OAB. METHODS AND ANALYSIS: and analysis: Female patients with OAB symptoms ages 50-90 years old without baseline cognitive impairment, moderate to severe depression or anxiety, neurologic disorders, or significant incomplete bladder emptying are invited to participate. Subjects are randomized to one of three interventions for 29 ± 1 day: AC (Solifenacin succinate, Teva), ß3a (Mirabegron, Myrbetriq, Astellas), or placebo. Functional neuroimaging data at baseline and post-intervention will be analyzed accordingly. Clinical cognitive assessments will be compared from baseline to post-intervention. ETHICS: All qualifying patients are properly consented before enrolling in this study that has been approved by the Institutional Review Board of participating institutions.

Prevalence of Pelvic Floor Disorders in Female CrossFit Athletes.

OBJECTIVES: This study aimed to estimate the prevalence of pelvic floor disorders by symptoms in female CrossFit athletes in the United States and characterize subjects reporting pelvic organ prolapse symptoms, urinary incontinence, and fecal incontinence. METHODS: A 27-question anonymous questionnaire was distributed to owners of CrossFit-affiliated gyms. Select questions from validated questionnaires were used to define symptoms. Positive responses with "moderate, or quite a bit" bother defined the presence of urinary incontinence (with stress or urgency). A response of "yes" to "having a bulge or something falling out" defined the presence of pelvic organ prolapse. A response of "yes" to "lose stool beyond your control" questions defined the presence of fecal incontinence. RESULTS: Three hundred fourteen respondents had mean age of 36 ± 10 years and a mean body mass index of 25.2 ± 4 kg/m. Forty-four percent reported ≥1 vaginal delivery. For each workout, respondents reported lifting mean weights of 91 to 217 lb, and 90% reported participation in ≥3 CrossFit workouts per week. Pelvic floor disorder symptoms reported included the following: pelvic organ prolapse, 3.2% (10/314); urinary incontinence, 26.1% (82/314); and fecal incontinence, 6% (19/314). Higher age, parity, and number of vaginal deliveries were associated with urinary incontinence. Higher parity and number of vaginal deliveries were associated with prolapse. Fecal incontinence was not associated with age, body mass index, or obstetric history. CONCLUSION: The prevalence of pelvic floor symptoms in female CrossFit athletes from the general population is likely similar to the general population; however, the prevalence of bothersome urinary incontinence is higher than the general population in women younger than 40 years.

Intraabdominal pressure in women during CrossFit exercises and the effect of age and parity.

To determine intraabdominal pressure (IAP) in women during CrossFit and to determine whether parity, age, or CrossFit experience affects IAP during CrossFit exercises, we evaluated 10 women: 5 experienced and active CrossFitters and 5 who were not regularly engaged in CrossFit. A Laborie urodynamics abdominal pressure probe with the Goby wireless system measured IAP during 10 repetitions of 13 different CrossFit exercises. Women had a mean age of 36 years. A significant difference was found between mean peak IAP of the 5 parous vs the 5 nulliparous women (P = 0.009). Experience with CrossFit did not affect mean peak IAP achieved with exercise. In some exercises, there was a significant change in IAP as participants progressed through repetitions (P = 0.003 for back squats and 0.04 for sit-ups). Participants achieved IAP values that were markedly higher than those previously published.

Temporal summation to thermal stimuli is elevated in women with overactive bladder syndrome.

INTRODUCTION: This study sought to provide a preliminary assessment of whether spinally mediated afferent hyperactivity (i.e., central sensitization) might contribute to manifestations of overactive bladder syndrome (OAB) in women as indexed by elevated temporal summation of evoked heat pain stimuli. METHODS: We recruited 20 adult women with OAB who were planning to undergo interventional therapy for OAB with either onabotulinumtoxinA injection or sacral neuromodulation and 23 healthy controls without OAB symptoms to undergo quantitative sensory testing with cutaneous thermal pain temporal summation. The primary study outcome was the degree of temporal summation, as reflected in the magnitude of positive slope of the line fitted to the series of 10 stimuli at the 49°C target temperatures. Linear regression and analysis of covariance were utilized to compare the degree of temporal summation between study groups. RESULTS: The standardized slope of temporal summation trials for women with OAB was significantly higher than for controls (ß = 3.43, 95% confidence interval = 0.6-6.2, P = 0.017). The adjusted means ±SE of the standardized temporal summation slopes for the full OAB and control groups were 3.0 ± 0.5 (95% confidence interval = 2.0, 4.1) and 1.7 ± 0.5 (95% confidence interval = 0.7, 2.7), respectively. CONCLUSION: In this preliminary study, we demonstrated that women with OAB refractory to primary and secondary therapies exhibited greater thermal cutaneous temporal summation than women without OAB symptoms. This suggests that central sensitization, indexed by temporal summation, may be an underlying factor contributing to OAB in some women. Neurourol. Urodynam. 36:1108-1112, 2017. © 2016 Wiley Periodicals, Inc.

Postoperative pain outcomes after transvaginal mesh revision.

INTRODUCTION AND HYPOTHESIS: Although the current literature discusses mesh complications including pain, as well as suggesting different techniques for removing mesh, there is little literature regarding pain outcomes after surgical removal or revision. The purpose of this study is to determine if surgical removal or revision of vaginal mesh improves patient's subjective complaints of pelvic pain associated with original placement of mesh. METHODS: After obtaining approval from the Vanderbilt University Medical Center Institutional Review Board, a retrospective review of female patients with pain secondary to previous mesh placement who underwent excision or revision of vaginal mesh from January 2000 to August 2012 was performed. Patient age, relevant medical history including menopause status, previous hysterectomy, smoking status, and presence of diabetes, fibromyalgia, interstitial cystitis, and chronic pelvic pain, was obtained. Patients' postoperative pain complaints were assessed. RESULTS: Of the 481 patients who underwent surgery for mesh revision, removal or urethrolysis, 233 patients met our inclusion criteria. One hundred and sixty-nine patients (73 %) reported that their pain improved, 19 (8 %) reported that their pain worsened, and 45 (19 %) reported that their pain remained unchanged after surgery. Prior history of chronic pelvic pain was associated with increased risk of failure of the procedure to relieve pain (OR 0.28, 95 % CI 0.12-0.64, p = 0.003). CONCLUSIONS: Excision or revision of vaginal mesh appears to be effective in improving patients' pain symptoms most of the time. Patients with a history of chronic pelvic pain are at an increased risk of no improvement or of worsening pain.

Analysis of patient and technical factors associated with midurethral sling mesh exposure and perforation.

OBJECTIVES: To evaluate the technical and patient characteristics associated with the development of mesh perforation and exposure in patients after midurethral sling surgeries. METHODS: After a retrospective review of referred patients, the risk of mesh perforation of the urinary tract over exposure in the vagina was analyzed with multivariate logistic regression, adjusting for the possible predictors of age, body mass index, smoking status at the time of mesh placement, presence of diabetes, type of sling placed, type of surgeon and trocar injury at the time of mesh placement. RESULTS: A total of 77 women were identified, 27 with mesh perforation and 50 with mesh exposure. The patients' average body mass index was 29.2, and 13% were diabetic. Nine (33%) patients in the perforation group and two (4%) patients in the exposure group had evidence of trocar injury to the bladder or urethra at the time of mesh placement (P < 0.001). After multivariate logistic regression analysis, trocar injury (odds ratio 25.90, 95% confidence interval 2.84-236.58, P = 0.004) and diabetes (odds ratio 9.90, 95% confidence interval 1.1.25-78.64, P = 0.03) were associated with an increased risk of mesh perforation. Increased body mass index (odds ratio 0.88, 95% confidence interval 0.77-0.99, P = 0.05) was associated with a decreased risk of mesh perforation. Finally, postoperative hematomas and blood transfusions occurred more commonly in the mesh perforation group (15% vs 0%, P = 0.01). CONCLUSIONS: Trocar injury, diabetes and bleeding complications at the time of surgery are associated with higher risk of mesh perforation in patients undergoing midurethral sling placement.

The fellowship effect: how the establishment of a fellowship in female pelvic medicine and reconstructive surgery affected resident vaginal hysterectomy training.

OBJECTIVE: We report on trends in resident-performed vaginal hysterectomies before and after the establishment of a female pelvic medicine and reconstructive surgery fellowship at Vanderbilt University Medical Center. STUDY DESIGN: We examined medical records and resident self-reports concerning all hysterectomies at our institution in an 8-year period: 4 years before fellowship and 4 years after. Route of hysterectomy, resident and fellow involvement, and division of attending surgeon were recorded from the electronic medical record. Resident Accreditation Council for Graduate Medical Education (ACGME) case log data were used to estimate the number of hysterectomies where residents reported themselves as the primary surgeon. RESULTS: During the 8-year period of this study, 3317 hysterectomies were performed at our institution, 41% (1371) before and 59% (1946) after fellowship. Prior to fellowship, 29% (393) were vaginal, 56% (766) were abdominal, and 15% (212) were laparoscopic/robotic. After addition of fellowship, 23% (449) were vaginal, 31% (597) were abdominal, and 46% (900) were laparoscopic/robotic. Of the total vaginal hysterectomies (TVH), there was resident involvement in 98.0% (385) cases before fellowship and 98.2% (441) cases after fellowship. From the ACGME case log data, the resident identified himself/herself as the primary surgeon in 388 cases before and 393 cases after fellowship. During this time period, medical records indicate a fellow was involved in 42% (189) of TVH, with resident involvement in all but 5 of these procedures. CONCLUSION: Frequency of resident involvement in TVH cases, either as primary surgeon or team member, remained constant after the addition of the female pelvic medicine and reconstructive surgery fellowship.

Clinical findings associated with bladder trabeculations in women.

INTRODUCTION AND HYPOTHESIS: This study evaluated whether bladder trabeculations are associated with advanced prolapse, urinary urgency, or detrusor overactivity among women undergoing office cystoscopy. It is well established that bladder trabeculations are associated with bladder outlet obstruction (BOO) in men; however, the clinical significance of trabeculations in women is unclear. Whereas an analogous relationship has been proposed between prostatic obstruction in men and advanced pelvic organ prolapse (POP) in women, little data in the medical literature supports this theory. METHODS: A retrospective cohort study was conducted using Current Procedural Terminology (CPT) codes (52000, 52204) to identify all women who underwent office cystoscopy at our urogynecology center between January 2008 and May 2011. The 551 women identified were grouped by the presence or absence of bladder trabeculations. Multivariable logistic regression was used to estimate the association between trabeculations and the primary aim, increasing stage of prolapse, and the secondary aims: bladder outlet obstruction, detrusor overactivity, or urge urinary incontinence (UUI). RESULTS: Of the 551 women meeting inclusion criteria, 86 had trabeculations. Controlling for age, the odds of bladder trabeculations were eightfold greater for women with stage IV POP when compared with women with stage 0 prolapse [odds ratio (OR) 8.2, 95% confidence interval (CI) 1.6-43.1]. The odds of bladder trabeculations were twofold greater for women with detrusor overactivity (OR 2.3, 95% CI 1.3-4.0) found on urodynamic study and also as reflected subjectively by answers to Pelvic Floor Distress Inventory (PFDI) item number 16 (OR 4.2, 95% CI 1.3-14.5). CONCLUSION: In this study, bladder trabeculations were associated with stage IV prolapse in the anterior compartment as well as with detrusor overactivity and UUI.

Assessment of four tissue models on knot tensile strength.

OBJECTIVE: To determine whether the tissue model onto which a knot is tied influences the knot's tensile strength. STUDY DESIGN: Zero-gauge, nonexpired, silk, polyglactin 910, polydioxanone, and polypropylene sutures were tied on 4 different mock tissue models. The tissue models were standard metal hex head screw, uncooked chicken breast, a tube of packaged "string" cheese, and a cylinder of bubble wrap. The knots were tied without a surgeon's knot and with 4 additional square knots (1 = 1 = 1 = 1 = 1). The knots were tied by a single obstetrician/gynecologist investigator (J.M.D.) over the period of 1 week to minimize fatigue. We compared the knots when subjected to a tensiometer until the suture broke or untied. A minimum of 20 knots per group were needed to detect a moderate effect size with a power of 85% and a type I error rate of 5%. RESULTS: A total of 407 knots were tied with 4 types of material (silk, polyglactin 910, polydioxanone, and polypropylene), using 4 different models (chicken, bubble wrap, cheese, and metal). Among the knot failures, 113 of 407 untied rather than broke (28%). No differences in the likelihood of knots coming untied between the different models (p = 0.34) or tension at failure (p = 0.81) were noted. A 4 × 4 factorial analysis of variance (ANOVA) was conducted to determine the effects of the suture material and model type on tension at failure and whether there was any interaction between the 2 factors. No significant difference was observed in the interaction between suture material and model type (p = 0.35), and no effect for model type was found (p = 0.22). CONCLUSIONS: Tissue models that use materials more similar to human tissue do not seem to influence knot strength when compared with standard metal models. We propose that it is possible to have an accurate understanding of how knots withstand force and to simulate an in vivo environment by using low-cost, easily accessible natural and synthetic materials for the mechanism onto which the knot is tied.