Antibiotic use, best practice statement adherence, and UTI rate for intradetrusor onabotulinumtoxin-A injection for overactive bladder: A multi-institutional collaboration from the SUFU Research Network (SURN).

INTRODUCTION: Onabotulinumtoxin A (BTX-A) is a well-established treatment for overactive bladder (OAB). The American Urological Association (AUA) 2008 Antibiotic Best Practice Statement (BPS) recommended trimethoprim-sulfamethoxazole or fluoroquinolone for cystoscopy with manipulation. The aim of the study was to evaluate concordance with antibiotic best practices at the time of BTX-A injection and urinary tract infection (UTI) rates based on antibiotic regimen. METHODS: Men and women undergoing first-time BTX-A injection for idiopathic OAB with 100 units in 2016, within the SUFU Research Network (SURN) multi-institutional retrospective database were included. Patients on suppressive antibiotics were excluded. The primary outcome was concordance of periprocedural antibiotic use with the AUA 2008 BPS antimicrobials of choice for "cystoscopy with manipulation." As a secondary outcome we compared the incidence of UTI among women within 30 days after BTX-A administration. Each outcome was further stratified by procedure setting (office vs. operating room; OR). RESULTS: Of the cohort of 216 subjects (175 women, 41 men) undergoing BTX-A, 24 different periprocedural antibiotic regimens were utilized, and 98 (45%) underwent BTX-A injections in the OR setting while 118 (55%) underwent BTX-A injection in the office. Antibiotics were given to 86% of patients in the OR versus 77% in office, and 8.3% of subjects received BPS concordant antibiotics in the OR versus 82% in office. UTI rates did not vary significantly among the 141 subjects who received antibiotics and had 30-day follow-up (8% BPS-concordant vs. 16% BPS-discordant, CI -2.4% to 19%, p = 0.13). A sensitivity analysis of UTI rates based on procedure setting (office vs. OR) did not demonstrate any difference in UTI rates (p = 0.14). CONCLUSIONS: This retrospective multi-institutional study demonstrates that antibiotic regimens and adherence to the 2008 AUA BPS were highly variable among providers with lower rates of BPS concordant antibiotic use in the OR setting. UTI rates at 30 days following BTX-A did not vary significantly based on concordance with the BPS or procedure setting.

The PSR13, a tool for evaluating patient-perceived recovery after vaginal prolapse repair surgery.

INTRODUCTION AND HYPOTHESIS: Surgical recovery is the return to preoperative functional, psychologic, and social activity, or a return to normalcy. To date, little is known about the global post-surgical recovery experience from the patients' perspective. The aim of this study was to validate the Post-Discharge Surgical Recovery scale 13 (PSR13) in women undergoing vaginal prolapse repair procedures and evaluate the patient-perceived postoperative recovery experience over a 12-week period. METHODS: Fifty women undergoing vaginal prolapse repairs completed the PSR13 and global surgical recovery scale (GSR) at 1, 2, 4, 6, and 12 weeks post-surgery. Validity, the minimal clinically important difference (MCID), and responsiveness to change over time of the PSR13 was evaluated using descriptive statistics and linear regression models. The proportion of patients deemed fully recovered at each time point (defined as PSR13 score ≥ 80) was also assessed. RESULTS: The PSR13 correlated significantly (p < 0.001) with the single-item recovery scale and showed excellent internal consistency reliability (Cronbach α = 0.91, range 0.77 to 0.93). The MCID was estimated at 7.0 points. The PSR13 scores improved at varying rates over time, with the greatest amount of patient-perceived recovery occurring between 4 and 6 weeks after surgery. The proportion of patients deemed fully recovered at 6- and 12- weeks postoperatively was 37% and 56%, respectively. CONCLUSIONS: The PSR13 is a useful instrument to assess overall return to normalcy from the patient's perspective and can be applied to evaluate the recovery experience among women undergoing vaginal prolapse repairs, in both the research and clinical setting.

Treatment of overactive bladder in men: Is it really different?

INTRODUCTION: Overactive bladder (OAB) in men is a topic that is gaining increasing attention as there is a wider understanding that OAB is not a female condition. There are several treatments; however, data in male populations are lacking compared to female cohorts. The high likelihood of concomitant benign prostatic hyperplasia (BPH) and benign prostatic obstruction (BPO) adds to the complexity of the treatment algorithm. The overlap in urinary storage symptoms also makes the interpretation of the literature challenging. METHODS: Articles that evaluated men with OAB and men with OAB and BPH/BPO were evaluated and assessed. RESULTS: Behavioral interventions can offer a significant benefit to male patients with OAB. Medical therapies that have been studied in men with OAB include anticholinergics, beta-3 agonists, and phosphodiesterase-5 inhibits. These agents can be offered in addition to alpha-blockers for men with coexisting BPH/BPO. The literature on Onabotulinumtoxin-A and neuromodulation modulation in the male population is growing and shows promising results. CONCLUSION: Male OAB is complex; however, there is a growing body of literature to help guide treatments. Many treatments are available and they have shown considerable success.

Selectivity and Maximum Response of Vibegron and Mirabegron for ß3-Adrenergic Receptors.

Background: The ß3-adrenergic agonists vibegron and mirabegron have shown favorable safety profiles and efficacy for the treatment of overactive bladder. However, ß-adrenergic receptors are also found outside the bladder, which could lead to off-target activity. Objective: This study assessed the selectivity of vibegron and mirabegron for ß-adrenergic receptors and the maximal effect and potency for ß3-adrenergic receptors. Methods: Functional cellular assays were performed using Chinese hamster ovary-K1 cells expressing ß1-, Chinese hamster ovary cells expressing ß2-, and human embryonic kidney 293 cells expressing ß3-adrenergic receptors. Cells were incubated with vibegron, mirabegron, or control (ß1 and ß3, isoproterenol; ß2, procaterol). Responses were quantified using homogeneous time-resolved fluorescence of cyclic adenosine monophosphate and were normalized to the respective control. Half-maximal effective concentration and maximum response values were determined by nonlinear least-squares regression analysis. Results: Activation of ß3-adrenergic receptors with vibegron or mirabegron resulted in concentration-dependent ß3-adrenergic receptor responses. Mean (SEM) half-maximal effective concentration values at ß3-adrenergic receptors were 2.13 (0.25) nM for vibegron and 10.0 (0.56) nM for mirabegron. At a concentration of 10 µM, ß3-adrenergic activity relative to isoproterenol was 104% for vibegron and 88% for mirabegron. Maximum response at ß3-adrenergic receptors was 99.2% for vibegron and 80.4% for mirabegron. ß1-adrenergic activity was 0% and 3% for vibegron and mirabegron, respectively; ß2-adrenergic activity was 2% and 15%, respectively. Conclusions: Vibegron showed no measurable ß1 and low ß2 activity compared with mirabegron, which showed low ß1 and some ß2 activity. Both showed considerable selectivity at ß3-adrenergic receptors; however, vibegron demonstrated near-exclusive ß3 activity and a higher maximum ß3 response.

Thirty-six-month Prospective Study of Transvaginal Bovine Graft vs Native Tissue Repair for the Treatment of Pelvic Organ Prolapse.

OBJECTIVE(S): To compare the safety and effectiveness of dermal bovine transvaginal graft, Xenform, to native tissue in the surgical treatment of anterior and/or apical pelvic organ prolapse. This study was designed in conjunction with Food and Drug Administration requirements. METHODS: This was a prospective, non-randomized, parallel cohort, multi-center trial. The primary objective was to demonstrate noninferiority between transvaginal graft and native tissue repair at 36 months compared to baseline. Treatment success was based on a composite of objective and subjective measures. The co-primary outcome was the rate of serious device- or procedure-related adverse events. A total of 228 patients at 25 sites were included in the study arm and 485 patients underwent native tissue repair. Propensity score stratification was applied to achieve balance between treatment groups. Study outcomes were compared in per protocol and intent-to-treat analysis. RESULTS: The primary outcome, treatment success at 36 months, was 83.6% (191/228) for transvaginal graft and 80.5% (390/485) native tissue repair (0.2%, 90% confidence interval [-5.6% to 5.9%]), demonstrating noninferiority at a preset margin of -12%. The overall rate of severe adverse events was 5.3% (12/228) in transvaginal graft vs 2.7% (13/485) in native tissue repair groups. The study group demonstrated noninferiority in serious adverse events at the preset margin of 11.6% (2.0%, 90% confidence interval [-0.8% to 4.7%]). There were no reports of graft erosion, and graft exposure rates were low (0.9% [2/228]). CONCLUSIONS: Transvaginal repair of anterior and/or apical prolapse with a biological graft is noninferior to traditional native tissue repair in effectiveness and safety at 36 months.

Incomplete bladder emptying and urinary tract infections after botulinum toxin injection for overactive bladder: Multi-institutional collaboration from the SUFU research network.

INTRODUCTION: Onabotulinumtoxin A (BTX-A) is an effective therapy for overactive bladder (OAB), however, adverse events may prevent patients from initiating therapy. The study objective was to report real-world rates of incomplete emptying and urinary tract infection (UTI) in men and women undergoing BTX-A for OAB. METHODS: Eleven clinical sites performed a retrospective study of adults undergoing first-time BTX-A injection (100 units) for idiopathic OAB in 2016. Exclusions included: postvoid residual (PVR) > 150 ml, prior BTX-A, pelvic radiation, or need for preprocedure catheterization. Primary outcomes at 6 months were incomplete emptying (clean intermittent catheterization [CIC] or PVR ≥ 300 ml without the need for CIC); and UTI (symptoms with either positive culture or urinalysis or empiric treatment). We compared rates of incomplete emptying and UTI within and between sexes, using univariate and multivariable models. RESULTS: 278 patients (48 men and 230 women) met inclusion criteria. Mean age was 65.5 years (range: 24-95). 35% of men and 17% of women had incomplete emptying. Men had 2.4 (95% CI: 1.04-5.49) higher odds of incomplete emptying than women. 17% of men and 23.5% of women had ≥1 UTI, the majority of which occurred within the first month following injection. The strongest predictor of UTI was a history of prior UTI (OR: 4.2 [95% CI: 1.7-10.3]). CONCLUSIONS: In this multicenter retrospective study, rates of incomplete emptying and UTI were higher than many previously published studies. Men were at particular risk for incomplete emptying. Prior UTI was the primary risk factor for postprocedure UTI.

Evidence for the Appropriate Use of Telemedicine in Female Pelvic Medicine and Reconstructive Surgery.

Purpose of Review: To summarize the available literature regarding telehealth interventions in the management of pelvic floor disorders. Recent Findings: Most Female Pelvic Medicine and Reconstructive Surgery (FPMRS) patients own and feel comfortable operating the technology required to participate in telehealth interventions and would be willing to interact remotely with their providers. Telehealth may be an appropriate and effective tool for patient education about bladder and pelvic physiology and pathophysiology, remote pelvic floor muscle strengthening when in-person physical therapy is not accessible, overactive bladder follow-up and medication management, and for postoperative care following uncomplicated incontinence and prolapse surgery. Summary: There is a growing body of literature specific to FPMRS supporting various telehealth interventions that could reasonably be expected to improve access to sub-specialty care while maintaining or improving healthcare quality and reducing costs to the patient and the healthcare system.

The Effect of Symptomatic Stress Urinary Incontinence on Catheterization Rates After Intradetrusor OnabotulinumtoxinA Injections.

OBJECTIVES: To determine whether catheterization rates after intradetrusor onabotulinumtoxinA injection for nonneurogenic overactive bladder and urgency incontinence differ between women with urgency urinary incontinence only and women with urgency-predominant mixed urinary incontinence. METHODS: This was a retrospective cohort study of patients that underwent intradetrusor onabotulinumtoxinA injection of 100 U for nonneurogenic urgency urinary incontinence. The primary outcome was the difference in catheterization rates between women with urgency urinary incontinence alone compared with women with urgency-predominant mixed urinary incontinence. Descriptive statistics and multivariate logistic regression analysis were performed. RESULTS: Of the 177 women included in the final analysis, 105 had urgency urinary incontinence and 72 had urgency-predominant mixed urinary incontinence. The overall catheterization rate after onabotulinumtoxinA injection was 11.3%, with significantly fewer women with mixed urinary incontinence requiring catheterization when compared with women with urgency urinary incontinence alone (4.2% vs 16.2%; P = 0.03), despite an older population (P = 0.02). Patient-reported improvement (P = 0.37) and decision to continue onabotulinumtoxinA treatments (P = 0.89) were similar between groups. Multivariate logistic regression analysis revealed that women with mixed urinary incontinence had significantly lower odds of requiring catheterization after onabotulinumtoxinA injections than women with urgency urinary incontinence alone (odds ratio, 0.16; 95% confidence interval, 0.04-0.67; P = 0.01). CONCLUSIONS: Findings suggest that the presence of symptomatic stress urinary incontinence is associated with lower rates of catheterization after intradetrusor onabotulinumtoxinA, but does not compromise efficacy of treatment for urgency-predominant mixed urinary incontinence.

Trends in Reported Case Logs of OnabotulinumtoxinA and Sacral Neuromodulation.

INTRODUCTION: We investigated current trends in reported case logs of third line treatments for primarily overactive bladder including sacral neuromodulation, percutaneous tibial nerve stimulation and chemodenervation. METHODS: Data on third line overactive bladder procedure volume was obtained from the American Board of Urology annualized case logs between 2010 and 2016. Entries from certifying, recertifying, and female pelvic medicine and reconstructive surgery applying urologists were considered. Statistical analysis was then performed to identify trends and surgeon characteristics that predicted the number of procedures performed. RESULTS: Case log reported procedures of third line therapies increased from 1,822 in 2010 to a peak of 6,143 in 2013. From 2010 to 2016, 25% (1,375/5,499) of all urologists logged at least 1 chemodenervation or neuromodulation procedure, while only 2 urologists logged percutaneous tibial nerve stimulation cases. In total, 26,874 neuromodulation or chemodenervation procedures were logged. Neuromodulation usage peaked in 2013, the year of U.S. Food and Drug Administration approval for chemodenervation, and has since been declining. Chemodenervation procedures increased each year after 2013 until declining in 2016. Female pelvic medicine and reconstructive surgery surgeons performed significantly more procedures than all other specialty categories (p ≤0.01). Gender, practice region, practice size and practice setting were also significant predictors of the number of procedures performed. CONCLUSIONS: Chemodenervation and neuromodulation have increased considerably in the past 6 years. There are differences in the types of procedures being performed based on gender, subspecialty, certification status, practice region, practice size and practice setting.

Venous thromboembolism prophylaxis in vaginal surgery for pelvic organ prolapse: Predictors of high risk in a low-risk population.

AIM: Venous thromboembolism (VTE) rates in vaginal pelvic organ prolapse (POP) repair are low. Our aim is to evaluate specific risk factors for VTE in patients undergoing vaginal POP repair. METHODS: This is a cross-sectional study using the American College of Surgeons NSQIP database. Using CPT codes, cases of vaginal POP repair between 2014 and 2017 were identified. Patient and operative characteristics were collected. VTE was defined as pulmonary embolism (PE) or deep vein thrombosis (DVT) within 30 days from surgery. Univariate analyses were performed using the Student t test for continuous and χ2  tests for categorical variables. Multivariate logistic regression was performed to identify factors independently associated with VTE. RESULTS: Of 44 207 women who underwent vaginal POP repair, there were 69 cases of VTE (0.16%). VTE rates for obliterative (0.15%) and functional (0.16%) vaginal POP repair, as well as for repairs with hysterectomy (0.17%) and without hysterectomy (0.12%) were not significantly different (p = .616 and .216, respectively). Multivariate analysis demonstrated predictors for postoperative VTE to be ASA physical status classification ≥ 3 (aOR, 1.99; p = .014), length of stay >75th percentile (aOR, 2.01; p = .007), operative time >3 h (aOR, 2.24; p = .007), and dyspnea (aOR, 3.26, p = .004). CONCLUSION: Despite the low incidence of VTE after vaginal POP repair, patients with ASA physical status classification ≥ 3, length of stay >75th percentile, operative time >3 h, and dyspnea were at higher risk for VTE. Vaginal POP repair may have independent VTE risk factors not captured in standard risk assessment tools.

Gel-Infused Translabial Ultrasound in the Evaluation of Female Urethral Stricture.

OBJECTIVES: The aims of this study were to describe our technique of gel-infused translabial ultrasound (GITLUS) to assess the female urethra for stricture and to highlight its utility when compared with other diagnostic techniques. METHODS: Consecutive patients presenting with prior diagnosis and/or suspicion for female urethral stricture underwent evaluation with uroflowmetry, postvoid residual, video urodynamics, and cystoscopy at the surgeon's discretion. All patients underwent GITLUS; 8-MHz curvilinear and 6-MHz linear high-frequency transducers were used to image the urethra from meatus to bladder neck while instilling 20 mL of lidocaine jelly to distend the urethra. Stricture location, length, caliber, and presence of periurethral fibrosis were assessed. Two healthy volunteers underwent GITLUS to serve as a comparison. RESULTS: Eight patients with suspected stricture underwent GITLUS. In all cases, GITLUS identified and characterized stricture and demonstrated periurethral fibrosis. Two healthy volunteers underwent GITLUS, which demonstrated a patent urethra and no evidence of fibrosis. Cystoscopy and video urodynamics on patients with stricture did not perform as well at identifying and fully assessing strictures. Six patients underwent definitive surgical repair, and GITLUS findings were confirmed. One patient had a postoperative GITLUS demonstrating resolution of the stricture and periurethral fibrosis. CONCLUSIONS: Gel-infused translabial ultrasound is a novel and accurate technique that in this small series appeared to identify and further characterize female urethral stricture in cases where it was utilized. Further research is needed to determine its role in preoperative planning and in providing a definitive diagnosis of stricture when other studies are equivocal.

Impact of preoperative urodynamics on women undergoing pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Preoperative urodynamic studies (UDS) are frequently performed before pelvic organ prolapse (POP) surgery to assess urethral and bladder function. The primary goal of this study is to examine how preoperative UDS are utilized and what value these studies have in patient treatment and/or counseling. METHODS: We retrospectively reviewed patients who underwent prolapse surgery and had preoperative UDS between June 2010 and February 2015. Indications for UDS were classified into four categories: (1) occult stress urinary incontinence only, (2) overactive bladder symptoms, (3) mixed or insensible urinary incontinence, and (4) voiding symptoms and/or elevated post-void residual. We identified changes in management or counseling that were directly attributable to UDS results prior to surgery. RESULTS: Three hundred ninety-two patients underwent urodynamic testing for indications 2-4 above, and 316 met the inclusion criteria. Fifty-seven percent (180/316) had OAB symptoms (34.4% wet, 65.6% dry), 40.2% (127/316) had mixed incontinence, and 17.1% (54/316) had voiding symptoms and/or elevated PVR. A total of 3.5% (11/316) patients had alteration in their management or counseling based on the results of the UDS; 29.4% (50/170) of the women evaluated for occult SUI alone or with other symptoms demonstrated it and 41 underwent sling placement. CONCLUSIONS: UDS did not have a significant impact on preoperative management or counseling in POP surgery if demonstration of occult SUI was not the indication for preoperative study in women committed to POP surgery. Major alterations in treatment were rare and occurred mostly in women with stress incontinence that also had concomitant voiding symptoms and/or elevated PVR.

Rectus Fascia Versus Fascia Lata for Autologous Fascial Pubovaginal Sling: A Single-Center Comparison of Perioperative and Functional Outcomes.

OBJECTIVE: To compare perioperative and functional outcomes of autologous fascia lata versus rectus fascia pubovaginal sling in female patients with stress urinary incontinence (SUI). METHODS: The charts of all patients undergoing pubovaginal sling for SUI from 2012 to 2017 at a single center were retrospectively reviewed. Patients were divided into 2 groups: those with the sling harvested from the fascia lata (FL group) and those with the sling harvested from the rectus fascia (RF group). RESULTS: Between 2012 and 2017, 105 women underwent pubovaginal slings: 21 using FL and 84 using RF. Operative time did not differ significantly between the FL and RF groups (84 vs 81.9 minutes; P=0.68). Estimated blood loss was lower in the FL group (91.7 vs 141.6 mL; P=0.04). There were more wound complications in the RF group, although this was not statistically significant (0% vs 14.3%; P=0.12). Overall complications were comparable between FL and RF groups (52.4% vs 48.9%; P=0.81), but the proportion of Clavien grade 2 or greater were higher in the RF group (4.8% vs 20.2%; P=0.11). Overall, wound complications accounted for 29.3% of postoperative complications in the RF group (12/41). Functional outcomes were comparable between FL and RF groups, with similar rates of patients without SUI symptoms after 1 month (82.4% vs 76.4%; P=0.74), 1 year (55.6% vs 63.8%; P=0.76), and at the latest follow-up (66.7% vs 65.8%; P=0.87). CONCLUSIONS: When compared with rectus fascia for pubovaginal sling, fascia lata may decrease perioperative morbidity, especially wound complications, without compromising functional outcomes.

Radiation exposure during videourodynamic testing: Is dose reduction possible using a standardized protocol?

AIMS: To evaluate the impact of a protocol for standardized image capture during video urodynamics (VUD) on radiation exposure. Secondly, to categorize radiation exposure by condition warranting VUD and to identify clinical variables that correlate with increased radiation exposure. METHODS: One hundred fifty patients underwent VUD using our standardized protocol. All images were taken using low dose and pulsed settings. Four images are captured: one scout image, one filling image, one voiding image, and one post-void image. If the patient is unable to void with the catheter in place, the catheter is removed and a second image is taken during an attempt at unintubated flow. If vesicoureteral reflux (VUR) is identified, an alternate protocol is entered to document parameters. The mean radiation exposure measured in dose area product (DAP), fluoroscopy time, and number of images were noted and compared with previously published fluoroscopy data collected at our institution before protocol implementation. RESULTS: The mean fluoroscopy exposure after the implementation of our protocol was 273.5 mGy/cm2 taking 5.2 images in 4.5 seconds. Protocol implementation leads to a 51.2% reduction in radiation exposure calculated by mean DAP (P < .0001) and a 96.5% reduction in fluoroscopy time (P < .0001). The presence of VUR, fluoroscopy time, and body mass index (BMI) > 25 were associated with higher radiation exposure (P < .0001). CONCLUSION: Implementation and adherence to a standardized protocol for fluoroscopy led to a reduction in radiation exposure fluoroscopy time. The presence of VUR, fluoroscopy time, and BMI > 25 were associated with higher radiation exposure.

The current state and the future of robotic surgery in female pelvic medicine and reconstructive surgery.

In this article, we review the current uses and future directions of robotic surgery in the field of female pelvic medicine and reconstructive surgery. Pelvic surgery is ideal for the use of surgical robots, which provide improved visualization and ease of suturing deep within the pelvis. Robots have been successfully used for the treatment of pelvic organ prolapse, in procedures such as sacrocolpopexy, sacrohysteropexy, and uterosacral ligament plication. Surgeons have used the robotic successfully to treat various etiologies of female pelvic pain including fibroids, endometriosis, and nerve entrapment. Robotic repair of iatrogenic injury has been described with excellent outcomes and avoidance of conversion to open surgery in the event of an injury caused using the robotic platform. While more data is needed on this topic, there has been increasing interest in using the robot for urologic reconstruction including repair of vesico-vaginal fistula, cystectomy, augmentation cystoplasty, and continent and non-continent diversions. Recently the use of the robot has been described in the treatment of stress urinary incontinence in females, with robotic placement of an artificial urinary sphincter. While robotic surgery is associated with increased cost, the outcomes of robotic surgery in female urology are promising. More studies that properly evaluate the benefits of robotic surgery as compared to open and laparoscopic approaches are needed.

Diagnosis and treatment of urinary and sexual dysfunction in hereditary TTR amyloidosis.

PURPOSE: We aimed to review the current knowledge on the epidemiology, diagnosis, and management of urinary and sexual dysfunction in patients with TTR amyloidosis (ATTR). METHODS: We performed a review of the literature, screening for randomized controlled trials, prospective and retrospective series, position papers, and guidelines on urinary and sexual dysfunction in ATTR patients published in PubMed and Embase. RESULTS: Lower urinary tract dysfunction is present in up to 83% of patients with ATTR. Voiding symptoms are the most common, reported in 34.8-87.5% of patients, while urinary tract infections are reported in up to 50%. Urinary incontinence is observed in 16.7-37.5% of the ATTR population, mostly due to decreased urethral resistance. Sexual dysfunction affects over 40% of ATTR patients, with erectile dysfunction and sexual arousal disorder being the most common symptoms in male and female patients, respectively. In addition to a thorough clinical examination, invasive pressure-flow urodynamic testing is a cornerstone in the assessment of ATTR lower urinary tract dysfunction. The most common finding is detrusor underactivity and intrinsic sphincter deficiency. Poor bladder compliance can also be observed in patients, due to amyloid deposits on the bladder wall. Urinary tract imaging may be of interest to rule out upper urinary tract deterioration. Given the paucity of data in the ATTR population, treatment should be tailored to the individual patient. CONCLUSION: Urinary and sexual dysfunction are highly prevalent in ATTR patients. Comprehensive assessment and multidisciplinary management are keys to avoiding upper urinary tract damage and improving patients' quality of life.

Pharmacokinetic and Pharmacodynamic Properties of a Micro-Dose Nasal Spray Formulation of Desmopressin (AV002) in Healthy Water-Loaded Subjects.

PURPOSE: Antidiuretic therapy with desmopressin for nocturia has been hampered by formulations with high doses, low bioavailability and variable pharmacokinetics. AV002 (SER120), a novel, emulsified, microdose desmopressin nasal spray, with a permeation enhancer (cylcopentadecanolide), was developed to have pharmacokinetic characteristics suitable for nocturia treatment. METHODS: Twelve healthy subjects participated in an open-label, dose-escalating study. Water-loaded subjects were sequentially dosed every 48 h with AV002 0.5, 1.0, 2.0 µg and 0.12 µg desmopressin subcutaneous (SC) bolus injection. RESULTS: AV002 intranasal administration produced a time-to-maximum concentration (Tmax) between 15 and 30 min and a maximum concentration (Cmax) <10 pg/mL. Cmax and area under the curve showed dose proportionality. Coefficient of variation for AV002 was similar to that observed for the SC dose. Bioavailability of AV002 was approximately 8% compared to SC injection. AV002 demonstrated pharmacodynamic effects within 20 min of dosing and showed increasing magnitude and duration with escalating doses. AV002 2.0 µg had maximum median urine osmolality of 629 mOsm/kg and median urine output ≤2 mL/min for 5-6 h. CONCLUSIONS: AV002 demonstrated rapid absorption, high bioavailability, limited duration of action, and low coefficient of variation, suggesting it may be a suitable formulation for nocturia treatment. Trial registration not required (single-center, phase 1).

Exploring stress urinary incontinence outcomes after sling excision for perforation or exposure.

OBJECTIVE: This study assessed stress urinary incontinence (SUI) outcomes after sling excision for urinary tract perforation or vaginal exposure, and compared the outcomes of concomitant versus staged autologous fascia pubovaginal sling (AFPVS). METHODS: A retrospective chart review of all patients who underwent midurethral sling (MUS) excision for urinary tract perforation or vaginal exposure at a tertiary referral center between 2010 and 2015 was performed. Therapeutic strategies were categorized as concomitant AFPVS, staged AFPVS, and no anti-incontinence procedure. RESULTS: In all, 32 patients were included for analysis: 13 with vaginal tape exposure (40.6%) and 19 with urinary tract tape exposure (59.4%). In patients who had SUI prior to sling excision (43.8%), the rate of resolved or improved SUI postoperatively was higher in the concomitant AFPVS group than in those who underwent sling excision alone (83.3% vs 12.5%, respectively; P = 0.03). Of 18 patients with no SUI prior to sling excision, 12 experienced recurrent SUI after sling removal (66.7%). The rate of recurrent SUI was lower in patients with vaginal MUS exposure than urinary tract MUS perforation, but this did not reach statistical significance (57.1% vs 72.7%, respectively; P = 0.63). The rates of resolved SUI after AFPVS were comparable in patients with concomitant and staged AFPVS (66.7% vs 71.4%, respectively; P = 0.99). CONCLUSIONS: Many patients with MUS perforations or exposures will have SUI at initial presentation or develop SUI after removal of the synthetic sling. The decision to perform a concomitant AFPVS or to stage the surgical management of SUI can be individualized.

Current Role of Urethrolysis and Partial Excision in Patients Seeking Revision of Anti-Incontinence Sling.

OBJECTIVES: Stress urinary incontinence is highly prevalent and sling surgery has increased since 2000. Urethrolysis traditionally had been standard management of complications after anti-incontinence surgery; however, partial excision is a less aggressive option. This study describes the different populations in a contemporary cohort that undergo sling excision and urethrolysis and their surgical outcomes. METHODS: Chart analysis was performed on patients assigned Current Procedural Terminology codes for removal or revision of sling for stress incontinence, urethrolysis, or revision of graft at our institution from 2010 to 2015. Demographics, indications, outcomes, and subsequent treatment were evaluated. RESULTS: A total of 110 patients underwent surgery and were included. Partial excision was performed on 82 patients and urethrolysis on 28 patients. About 32.7% had prior revision, and median length to revision was 3.1 years. Overall success was 75.0% for urethrolysis and 86.6% for partial excision. Without concomitant sling placement, stress incontinence developed in 25.0% of urethrolysis and 21.6% of partial excision patients. New onset overactive bladder symptoms developed in 21.4% of urethrolysis patients and 7.3% of partial excision, which was significantly different (P = 0.039). CONCLUSIONS: Both approaches had good success, 75.0% for formal urethrolysis and 86.6% for partial excision. New onset urgency was lower for partial excision, but rates of all other complications were similar. These procedures are often used for different patient populations, and thus, outcomes are not meant to be directly compared. Future work on sling revision should report these procedures separately.