A porcine bladder model of pre-clinical urodynamics demonstrates increased afferent nerve activity during filling.

INTRODUCTION AND OBJECTIVES: Urodynamics are the accepted gold standard for the evaluation of multiple forms of voiding dysfunction. However, the tests are expensive, invasive, poorly reproducible, and often prone to artifacts. Therefore, there is a pressing need to develop next-generation urodynamics. The purpose of this study was to develop a novel ex vivo porcine bladder urodynamics model with afferent pelvic nerve signaling that can be used as a preclinical surrogate for bladder sensation. METHODS: Porcine bladders including the ureters and vascular supply were harvested from local abattoirs using an established protocol in both male and female animals. Ex vivo bladder perfusion was performed using physiologic MOPS (3-(N-morpholino) propanesulfonic acid) buffer solution. The pelvic nerve adjacent to the bladder was grasped with micro-hook electrodes and electroneurogram (ENG) signals recorded at 20 kHz. Bladders were filled with saline at a nonphysiologic rate (100 mL/min) to a volume of 1 L using standard urodynamics equipment to simultaneously record intravesical pressure. ENG amplitude was calculated as the area under the curve for each minute, and ENG firing rate was calculated as number of spikes (above baseline threshold) per minute. At the conclusion of the experiment, representative nerve samples were removed and processed for nerve histology by a pathologist (hematoxylin and eosin and S100 stains). RESULTS: A total of 10 pig bladders were used, and nerve histology confirmed the presence of nerve in all adequately processed samples. Vesical pressure, ENG firing rate, and ENG amplitude all increased as a function of filling. During filling tertiles (low fill: min 1-3, med fill: min 4-6, and high fill: min 7-10), normalized pressures were 0.22 ± 0.04, 0.38 ± 0.05, and 0.72 ± 0.07 (cmH2O). Similarly, normalized ENG firing rates were 0.08 ± 0.03, 0.31 ± 0.06, and 0.43 ± 0.04 spikes/minute, respectively, and normalized nerve amplitudes were 0.11 ± 0.06, 0.39 ± 0.06, and 0.56 ± 0.14) µV, respectively. Strong relationships between average normalized pressure values and averaged normalized ENG firing rate (r2 = 0.66) and average normalized ENG amplitude (r2 = 0.8) were identified. CONCLUSIONS: The ex vivo perfused porcine bladder can be used as a preclinical model for the development of next-generation urodynamics technologies. Importantly, the model includes a reproducible method to measure afferent nerve activity that directly correlates with intravesical pressure during filling and could potentially be used as a surrogate measure of bladder sensation.

Reducing pelvic floor injury by induction of labor.

INTRODUCTION AND HYPOTHESIS: We hypothesized that elective induction of labor (eIOL) at 39 weeks is protective of levator ani muscle injury (LAMI) and is associated with decreased pelvic symptoms at 6 weeks postpartum compared to expectant management of labor. METHODS: Prospective cohort pilot study of uncomplicated, primiparous women with a singleton, vertex gestation enrolled immediately post-vaginal delivery (VD). Subjects were dichotomized into two groups based on labor management: eIOL without complication defined by the ARRIVE trial versus spontaneous VD between 39 weeks0/7 and 42 weeks5/7 or no indication for IOL prior to 40 weeks5/7. The primary outcome was LAMI at 6 weeks postpartum as evidenced by any of the following ultrasound measures: (1) increased levator hiatal area (LHA) > 2500 mm2, (2) increased elasticity index (EI, > 75th quartile) or (3) levator enthesis avulsion. RESULTS: Analysis represents 45/102 consented women from July 2019-October 2020 (eIOL n = 22 and spontaneous VD, n = 23). Neither maternal, clinical, sociodemographic characteristics nor pelvic symptoms differed between groups. Fewer women had LAMI as defined by the primary outcome with eIOL (n = 5, 23.8%) compared to spontaneous VD (n = 15, 65.2%), p = 0.008. Levator enthesis was more deformable (increased EI) with spontaneous VD as compared to the eIOL [10.66 (8.99) vs. 5.68 (2.93), p = 0.046]. On univariate logistic regression women undergoing spontaneous VD had unadjusted OR of 6.0 (1.6-22.5, p = 0.008) of sustaining LAMI compared to those undergoing eIOL. CONCLUSIONS: Composite measures of LAMI though not pelvic floor symptoms were markedly increased in women undergoing spontaneous VD compared to those undergoing eIOL at 39 weeks.

Validation of Transvaginal Hysterectomy Surgical Model - Modification of the Flowerpot Model to Improve Vesicovaginal Plane Simulation.

STUDY OBJECTIVE: To establish face and construct validity for a novel variation of American College of Obstetrics and Gynecology "Flowerpot Model" for transvaginal hysterectomy (TVH) surgical simulation with improved vesicovaginal dissection during surgical education simulation. DESIGN: Cross-sectional face and construct validation study using the "Flowerpot Model." The vesicovaginal dissection plane was modified to include additional felt and balloon materials to simulate the bladder. SETTING: Single academic center. PARTICIPANTS: Fourteen residents and fellows, postgraduate year (PGY) 2 to 6, subdivided into junior (n = 8) with ≤10 prior TVH surgeries and senior groups (n = 6) with >10 prior TVH surgeries performed. INTERVENTIONS: All subjects watched a brief introductory video and then were filmed simulating a TVH. MEASUREMENTS AND MAIN RESULTS: For face validity, subjects completed an anatomic checklist and pre/post simulation satisfaction survey. For construct validation, 2 independent, blinded expert surgeons (M.A. and J.M.) graded films using the Global Rating Scale of Operative Performance (GRS). Primary outcome was mean GRS between groups. The junior group consisted of PGY 2 to 3 with ≤ 10 prior TVH, median 7.5 (interquartile range [IQR] 6.75) and senior group PGY 3 to 6 with >10 TVH, median 19 (IQR 10) (p <.01). Subjects were "satisfied" or "very satisfied" with bladder and anterior peritoneal fold simulation (92%) and found vesicovaginal dissection "realistic" (100%). GRS score was significantly different between groups (juniors, 19.5 [IQR 5] vs seniors, 28.5 [IQR 8.5]; p = .048). Intergrader correlation was high (ρ = 0.87, p <.01). Surgeon volume of prior TVH was not significantly correlated to average GRS score, ρ = 0.49 (p = .10). The model improved comfort and confidence scores in the junior group more than senior group (p = .04), but senior group still had higher post simulation confidence scores than the junior group (p = .02). CONCLUSION: Face and construct validity with the modified Flowerpot Model was demonstrated. This low fidelity model is capable of simulation of a TVH with a novel vesicovaginal dissection. Prior surgical experience was not correlated to GRS score or time to procedure completion.

A stepwise approach for functional near infrared spectroscopy measurement during natural bladder filling.

Background: Functional near infrared spectroscopy (fNIRS) is a versatile, noninvasive, and inexpensive tool that can be used to measure oxyhemoglobin (O2Hb) changes in the cortical brain caused by increasing bladder sensation during filling in upright posture. This study's purpose is to provide a rigorous methodologic template that can be implemented for comparative studies of fNIRS in the diagnosis and management of lower urinary tract symptoms including overactive bladder (OAB) and other forms of lower urinary tract dysfunction. Methods: Participants without any urologic conditions completed a validated oral hydration protocol facilitating and equilibrating natural bladder filling. First desire to void and real time bladder sensation (0-100%) were recorded using a Sensation Meter. A 24-channel fNIRS template simultaneously recorded prefrontal cortical O2Hb. Each channel was analyzed between "first desire" to void and 100% sensation, defined in this study as the period of "high sensation". Channels were sub-divided by cortical regions: right (nine channels), left (nine channels), middle (six channels). Results: A total of eight participants (male: n=4, female: n=4) were enrolled with mean age 39±19.9 years and body mass index (BMI) of 25±3.93 kg/m2. There were no differences in age, BMI, race, or OAB survey scores based on biological sex. Signal acquisition improved with power bank use, postural head support for motion reduction, and head cap optimization. Acceleration-based concurrent motion measurement was effectively utilized to remove motion artifacts. O2Hb concentration patterns appeared irregular during low sensation and increased during high sensation after first desire across the frontal cortex. Conclusions: Employing a stepwise approach, this study defined a methodological guide for improved prefrontal fNIRS signal acquisition and analysis during bladder filling. The technique demonstrated that prefrontal fNIRS cortical O2Hb increases with elevated bladder sensation in normal subjects and sets the stage for comparative studies in individuals with OAB and other forms of lower urinary tract dysfunction.

Impact of Menopausal Status on Uropathogen Prevalence and Antimicrobial Resistance Profiles.

OBJECTIVES: The unique factors associated with urinary tract infections (UTIs) in postmenopausal (PMP) women have been significantly less investigated as compared with premenopausal (PreMP) women. Our objective was to compare the prevalence of uropathogens and antibiotic resistance patterns between PreMP and PMP women with UTIs. METHODS: This was a cross-sectional analysis of PreMP and PMP women treated for a UTI in a urogynecologic practice between November 2016 and November 2017. Diagnostic criteria for UTI included lower urinary tract symptoms and a positive urine culture. Our primary outcome was proportion of non-Escherichia coli UTIs between groups. RESULTS: We had 370 women with mean (SD) age of 66.7 (12.8) years and body mass index of 29.1 (7.1) kg/m2. Most women were PMP (88.6%). Postmenopausal status did not increase the proportion of non-E. coli UTI (42.7% PMP vs 33.3% PreMP, P = 0.25) or decrease the proportion of pansensitive UTI (36.0% PMP vs 42.9% PreMP, P = 0.38).In multivariable analysis, women with a history of rUTI were at higher odds of having a non-E. coli UTI (adjusted odds ratio, 1.93; 95% confidence interval, 1.21-3.08; P = 0.01) and at lower odds of pansensitive urine culture (adjusted odds ratio, 0.37; 95% confidence interval, 0.22-0.63; P < 0.01) as compared with those without rUTI, when controlling for confounders. Postmenopausal women with a history of rUTI had the highest proportion of non-E. coli UTIs (51.1%, P < 0.01) and lowest proportion of pansensitive uropathogens (29.1%, P < 0.01) as compared with other PMP women and PreMP without a history of rUTI. CONCLUSIONS: In a urogynecologic population, a history of rUTI, more than menopausal status, significantly impacted the prevalence of specific uropathogens and resistant organisms.

Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial.

OBJECTIVE: To compare 6-month safety and efficacy outcomes of fractionated CO2 laser (laser) with topical clobetasol propionate (steroid) for treatment of symptomatic vulvar lichen sclerosus. METHODS: We conducted a single-center randomized controlled trial that compared fractionated CO2 laser with steroid treatment for patients with biopsy-proven lichen sclerosus. Randomization was stratified by prior clobetasol propionate use. The primary outcome was mean change in Skindex-29 score at 6 months. A total sample size of 52 participants were recruited to detect a mean difference of 16 points on the Skindex-29 (SD±22) with 80% power, based on a one-sided two-sample t test with α=0.05, accounting for 10% attrition. Secondary outcomes included validated subjective and objective measures. Intention-to-treat, per protocol, and regression analysis based on prior steroid exposure were performed. RESULTS: From October 2015 to July 2018, 202 women were screened, 52 were randomized, and 51 completed a 6-month follow-up. No significant difference was found in baseline demographics, symptoms, and physician assessment scores. There was greater improvement in the Skindex-29 score in the laser arm at 6-months (10.9 point effect size, 95% CI 3.42-18.41; P=.007). Overall, 89% (23/27) of patients in the laser group rated symptoms as being "better or much better" compared with 62% (13/24) of patients in the steroid group, P=.07. More patients (81%, 21/27) were "satisfied or very satisfied" with laser treatment compared with steroid treatment (41%, 9/24); P=.01. After stratification for previous steroid use, the significant change of Skindex-29 score was only seen in the previously exposed group. There was one adverse event in each group: minor burning and blistering at the laser site and reactivation of genital herpes 1 week after starting steroid. CONCLUSION: Fractionated CO2 laser treatment showed significant improvement in subjective symptoms and objective measures compared with clobetasol propionate, without serious safety or adverse events at 6 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02573883.

A Cost Analysis of Icon Reusable Underwear Versus Disposable Pads for Mild to Moderate Urinary Incontinence.

OBJECTIVE: The objective of this study was to perform a cost analysis assessing the economic feasibility of reusable underwear as alternative for disposable pads for women with mild to moderate urinary incontinence. METHODS: A consumer-perspective cost analysis was performed with the following assumptions: (1) consumers have mild to moderate urinary incontinence and use 2 pads per day (PPD); (2) consumers have a 2-week supply of underwear; (3) there is no difference in laundering cost between 2 incontinence options; (4) there is no difference in use of labor/other accessories of care; (5) there is no difference in skin complaints/associated cost; (6) cost of products are nonfluctuant with time; and (7) all incontinence products were purchased online. Sensitivity analyses were performed varying the longevity of underwear, price of regular underwear, price of pads, pads used per day, and shipping and handling. RESULTS: The total cost of disposable pads with regular underwear was US $392.40, whereas the cost of Icon underwear was US $380.80 over the course of 2 years. Icon costs less than using regular underwear with disposable pads as long as the cost of the regular underwear is at least US $2.17. Icon is economically inferior if the cost per pad is US $0.15 when using 3 PPD or if the cost per pad is US $0.24 when using less than 2 PPD. CONCLUSIONS: Reusable incontinence underwear can be an economically feasible alternative to disposable pads for light to moderate urinary incontinence after 2 years of use assuming underwear has a 2-year longevity and the consumer is using 2 PPD with regular underwear.

Randomized Cross-over Comparison of Icon™ Reusable Underwear to Disposable Pads for the Management of Mild to Moderate Urinary Incontinence.

OBJECTIVE: The objective of this study was to compare disposable pads to Icon™ reusable underwear for the management of urinary incontinence on dimensions of quality of life and product performance. METHODS: This randomized cross-over trial included women with mild to moderate urinary incontinence as defined by baseline responses to the International Consultation on Incontinence Questionnaire-Short Form. Excluded were patients who had fecal incontinence or an active urinary tract infection. Participants were randomized to 2 days of Icon™ underwear or disposable pads use and then completed another 2 days using the alternate product. Outcome measures were responses to Incontinence Quality of Life Instrument (I-QOL) and Product Performance Questionnaire for each product. RESULTS: Of the 70 women who were randomized, 52 completed the study. There was no significant difference between Icon™ underwear and disposable pads with regards to I-QOL total scores (66.2 ± 23.4 vs 65.5 ± 24.5, P = 0.71) or I-QOL subscores: avoidance and limiting behaviors (62.1 ± 24.4 vs 62.4 ± 25.0, P = 0.88), psychosocial impacts (74.4 ± 25.0 vs 73.4 ± 25.6, P = 0.51), and social embarrassment (57.8 ± 27.8 vs 56.1 ± 29.5, P = 0.43). Icon™ underwear scored significantly better than disposable pads on the Product Performance Questionnaire, with regards to overall impression (P = 0.0002), fit (P < 0.0001), discreteness (P < 0.0001), comfort when dry (P < 0.0001), comfort when wet (P = 0.0008), ability to keep skin dry (P = 0.0034), and kindness to skin (P < 0.0001). There was no difference between products in ability to hold urine without leaking (P = 0.40) or prevent odor when worn (P = 0.41). CONCLUSIONS: There was no difference in quality of life measures between Icon™ underwear and disposable pad users; however, Icon™ underwear was preferred on product performance.