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OBJECTIVE: The aim of this study was to compare the efficacy of a non-hormone alternative, vaginal hyaluronic acid (HLA), to a standard-of-care therapy, vaginal estrogen, for the treatment of genitourinary syndrome of menopause (GSM). METHODS: This was a randomized, parallel arm pilot trial. Women with GSM were randomized to an HLA vaginal suppository or vaginal estrogen cream for 12 wk to compare the primary outcome, the vulvovaginal symptom questionnaire (VSQ) score. Secondary outcomes included the following: the female sexual function index (FSFI), the vaginal symptom index (VSI), visual analog scale (VAS) for dyspareunia, vaginal itching, and vaginal dryness, patient global impression of improvement (PGI-I) at follow-up, vaginal maturation index, and vaginal pH. Differences between treatment groups were estimated using the two-sided, two-sample t-test and 95% confidence intervals. RESULTS: Forty-nine women were randomized and 45 participants (vaginal estrogen = 23, vaginal HLA = 22) provided data at week 12. Baseline characteristics were similar in both groups. On the VSQ, there was no observed difference in overall scores between the HLA and vaginal estrogen groups at 12 wk (P = 0.81). Improvement was seen within both treatment groups on the VSQ after 12 wk. The VAS score, total VSI score, total FSFI score, and vaginal pH improved over time; however, improvement did not differ between study arms. Over 90% participants noted improvement on the PGI-I in both groups (P = 0.61). No treatment-related serious adverse events occurred. CONCLUSIONS: There were no clinically meaningful differences between vaginal HLA and vaginal estrogen for the treatment of GSM after 12 wk. Vaginal HLA may be a promising non-hormone therapy for GSM.
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IMPORTANCE: Urinary incontinence (UI) is a common and treatable medical condition among women, but only approximately one third of women seek care. OBJECTIVE: The objective of this study was to determine factors associated with care-seeking behavior in women with UI. STUDY DESIGN: This was a cross-sectional study using patient-reported survey data collected by the National Association for Continence from November 2018 to January 2019. This survey included 60 questions and was conducted using SurveyMonkey. Descriptive statistics were used for baseline characteristics, the χ2 test was used for categorical variables, and multivariate logistic regression was used to determine predictors of care-seeking behavior. RESULTS: Four hundred eighty-five women completed the survey, 30.7% were not care seeking, and 69.3% were care seeking for UI. Most women were 55 years or older and had UI for more than 4 years. Care-seeking women had more overactive bladder symptoms. Women who sought care were more likely to report feelings of anger, depression, hopelessness, isolation, and report greater social effects from UI than non-care-seeking women. Less than 10% of women who sought care were asked about their UI by a medical professional. In the multivariate logistic regression expenditure of $5 or more on monthly incontinence maintenance, daily UI and older age were associated with seeking care. CONCLUSIONS: Most women in our study population sought care for UI. Factors associated with seeking care were expenditure greater than $5 per month on incontinence, daily UI, and age. This information demonstrates the need for effective implementation of screening interventions to increase treatment access.
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Vejiga Urinaria Hiperactiva , Incontinencia Urinaria , Humanos , Femenino , Estudios Transversales , Incontinencia Urinaria/epidemiología , Aceptación de la Atención de Salud , Vejiga Urinaria Hiperactiva/epidemiología , Encuestas y CuestionariosRESUMEN
INTRODUCTION: Bladder outlet obstruction (BOO) in women includes functional and anatomic etiologies. Primary bladder neck obstruction (PBNO), Fowler's syndrome (FS), and dysfunctional voiding (DV) are some examples of functional obstructions, whereas pelvic organ prolapse (POP), periurethral masses, and intragenic causes are some of the anatomic causes. METHODS: This literature review describes the etiologies of female BOO, unique aspects of the workup and diagnosis, and the data for the standard surgical treatments and newer surgical techniques to treat women. Urethral stenosis and sling-related obstruction are treated in the other articles of this series. Where possible the focus is the efficacy and outcomes. RESULTS: Treatment of PBNO using a transurethral incision of the bladder neck and injection of botulinum toxin in the bladder neck decreases the BOO. After the failure of conservative approaches, sacral neuromodulation (SNM) is effective for FS, while DV may benefit from SNM or botulinum toxin injections. Concerning POP, most surgeries have been reported to significantly improve a pre-existent BOO but the level of evidence is low. Benign urethral and periurethral masses may provoke BOO, and surgical excision usually resolves this condition. CONCLUSION: Although most surgical treatments of BOO for functional and benign anatomical etiologies in women seem to be effective, data are scarce even for more common conditions like POP. Further studies are required to give better advice on the choice of surgical technique for these patients.
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INTRODUCTION: Overactive bladder (OAB) patients who do not achieve satisfactory results with second-line OAB medications should be offered third-line therapies (percutaneous tibial nerve stimulation, sacral neuromodulation, onabotulinumtoxinA bladder injection [BTX-A]). We aimed to determine which clinical factors affect progression from second- to third-line OAB therapy. METHODS: Between 2014 and 2020, the AUA Quality Registry was queried for adult patients with idiopathic OAB. For the primary outcome, patient and provider factors associated with increased odds of progression from second- to third-line therapy were assessed. Secondary outcomes included median time for progression to third-line therapy and third-line therapy utilization across subgroups. RESULTS: A total of 641,122 patients met inclusion criteria and were included in analysis. Of these, only 7487 (1.2%) received third-line therapy after receiving second-line therapy. On multivariate analysis, patients aged 65 to 79, women, White race, history of dual anticholinergic and ß3 agonist therapy, metropolitan area, government insurance, and single specialty practice had the greatest odds of progressing to third-line therapy. Black and Asian race, male gender, and rural setting had lower odds of progressing to third-line therapy. BTX-A was the most common therapy overall (40% BTX-A, 32% sacral neuromodulation, 28% percutaneous tibial nerve stimulation). The median time of progression from second- to third-line therapy was 15.4 months (IQR 5.9, 32.4). Patients < 50 years old and women progressed fastest to third-line therapy. CONCLUSIONS: Very few patients received third-line therapies, and the time to progression from second- to third-line therapies is > 1 year. The study findings highlight a potential need to improve third-line therapy implementation.
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Toxinas Botulínicas Tipo A , Terapia por Estimulación Eléctrica , Vejiga Urinaria Hiperactiva , Adulto , Humanos , Masculino , Femenino , Persona de Mediana Edad , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Terapia por Estimulación Eléctrica/métodos , Toxinas Botulínicas Tipo A/uso terapéutico , Antagonistas Colinérgicos/uso terapéutico , Nervio TibialRESUMEN
OBJECTIVE: To report out-of-pocket costs associated with overactive bladder (OAB) medications among Medicare beneficiaries and the uninsured. METHODS: We performed a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data (Q1-2022). FDA-approved medications for OAB were identified. We calculated out-of-pocket costs for Medicare beneficiaries in each Part D prescription benefit phase, average retail price, total yearly costs and discounted prices through cash-pay discount coupons (GoodRx) or online pharmacies like Mark Cuban Cost Plus Drug Company (MCCPDC). We also report plan utilization management requirements. RESULTS: We analyzed 5721 plan formularies for 18 medications. Mirabegron was the only beta-3 agonist (B3). Only Vesicare oral solution (14.3% of plans) and Mirabegron (0.1%) required prior authorization. Many plans required step therapy for selective generic anticholinergics (ACH) (12.4%-43.3%), while the B3 rarely required step therapy (0.6%). Monthly costs varied by coverage phase and averaged $59 for ACHs in the initial coverage phase ($14 in catastrophic; $72 in coverage gap). The monthly cost for the B3 averaged $47 in the initial coverage phase ($26 in catastrophic; $129 in coverage gap). The total yearly cost for generic ACHs ranged from $494 (oxybutynin IR) to $1452 (darifenacin) and the yearly cost for brand-name ACHs ranged from $1175 (Toviaz ER) to $2198 (Oxytrol). The total yearly cost for the B3 was $1283. CONCLUSION: We evaluated coverage, out-of-pocket costs, total yearly costs, and utilization management for OAB medications to make pricing more transparent. While selective medications may be "covered," coverage does not translate into affordable drug prices.
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Medicare Part D , Vejiga Urinaria Hiperactiva , Anciano , Humanos , Estados Unidos , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Estudios Transversales , Acetanilidas/uso terapéuticoRESUMEN
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.
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Toxinas Botulínicas Tipo A , Vejiga Urinaria Hiperactiva , Infecciones Urinarias , Masculino , Humanos , Femenino , Antibacterianos/uso terapéutico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/complicaciones , Estudios Retrospectivos , Infecciones Urinarias/tratamiento farmacológico , Infecciones Urinarias/epidemiología , Infecciones Urinarias/etiología , Proteínas RepresorasRESUMEN
OBJECTIVE: To determine how a patient's demographics, including insurance type, race/ethnicity, gender, and age, may impact the choice of medication prescribed for overactive bladder (OAB). METHODS: We queried the AUA Quality Registry for adults between 2014 and 2020 with a diagnosis of OAB for >1year, excluding neurogenic causes. Variables included age, race/ethnicity, gender, insurance type, medication first prescribed, year of prescription, provider metropolitan status, and provider practice type. Primary outcome was which factors were associated with increased odds of beta-3 prescription as first medication choice. RESULTS: We found 1,453,566 patients with OAB, 641,122 (44.1%) with complete data. Of these, 112,021 (17.5%) were prescribed medication. On multivariate analysis, patients with Medicaid, Medicare, and other/self-pay insurance were less likely to receive a beta-3 vs an anticholinergic compared to private or military insurance. Compared to white patients, Asian, Black, and other races were less likely to receive a beta-3, as were patients outside of metropolitan areas. Age >50, prescriptions after 2014, and nonacademic settings were associated with increased odds of beta-3 prescription. There was no difference between genders. CONCLUSION: Many nonclinical factors, including insurance type and race, may affect which medication is first prescribed for OAB. This is useful for practicing urologists and may help lower barriers to beta-3 prescription through policy change and advocacy.
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Agonistas de Receptores Adrenérgicos beta 3 , Vejiga Urinaria Hiperactiva , Adulto , Anciano , Femenino , Humanos , Masculino , Asiático , Medicare , Sistema de Registros , Estados Unidos , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Negro o Afroamericano , Agonistas de Receptores Adrenérgicos beta 3/uso terapéuticoRESUMEN
OBJECTIVE: Functional and anatomic bladder outlet obstruction (BOO) in women are more prevalent than previously suspected and remain a diagnostic challenge. Several urodynamic diagnostic criteria for female BOO have been proposed, but studies validating the criteria by assessing treatment outcomes are lacking. We sought to correlate video urodynamic (VUD) diagnostic criteria with symptom improvement in women with functional bladder outlet obstruction. METHODS: A retrospective cohort study of women diagnosed with primary bladder neck obstruction (PBNO) by VUD criteria who underwent bladder neck incision (BNI) between 2010 and 2022 was performed. Patient demographic, clinical, and urodynamic characteristics were collected before and after treatment and analyzed. RESULTS: Twenty-six women with mean age 64.7 years underwent BNI. Nineteen patients (73.1%) were cured, four (15.4%) improved, and three (11.5%) failed. After BNI the mean postoperative Qmax was significantly higher (9.4 vs. 3 mL/s, p = 0.006) and mean postvoid residual (PVR) was significantly lower (102 vs. 514 mL, p ≤ 0.001). Patients who did not require a catheter preoperatively were more likely to be cured than those who did (90% vs. 62.5%, p = 0.03). The PdetQmax of patients that were cured or improved did not differ significantly from those who were not (50.7 cm H2 O vs. 32 cm H2 O, p = 0.21). CONCLUSIONS: The diagnosis of PBNO by VUD criteria for obstruction correlated with treatment outcomes with success in 88.5% and 56% becoming catheter independent. Successful treatment was independent of preoperative PdetQmax.
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Background: Physicians often report low levels of confidence in diagnosing and treating female sexual dysfunction (FSD), which may stem from inadequate education and exposure to the topic. Aim: The study sought to determine the extent to which FSD is covered in undergraduate medical education and evaluate student comfort with the topic and familiarity with treatments. Methods: We created a novel, 50-question survey to be administered online to any current U.S. medical student. Obstetrician-gynecologist clerkship directors at 146 U.S. medical schools were contacted and asked to invite any current student at their school to participate. A link to the electronic REDCap (Research Electronic Data Capture) survey was distributed to eligible students via the clerkship directors. The survey collected data regarding (1) coverage of FSD and male sexual dysfunction (MSD) in preclinical and clinical curricula, (2) student self-ratings of comfort in hypothetical scenarios in which a patient exhibits symptoms of FSD or MSD, and (3) student familiarity with treatments for FSD and MSD. Outcomes: Outcomes included the proportion of students reporting that their school covered FSD/MSD in its preclinical/clinical curriculum, the mean comfort ratings for each of the FSD and MSD scenarios, and the proportion of students indicating knowledge of various FSD and MSD treatments. Results: A smaller proportion of students (N = 236) reported receiving instruction in FSD (58.5%) compared with MSD (78.4%) in their preclinical curriculum (P < .001). Students' average self-ratings of comfort in the sexual dysfunction scenarios were significantly lower for patients with symptoms of FSD compared with MSD (P < .001). Students had higher average self-ratings of confidence in FSD scenarios if their intended specialty was obstetrician-gynecologist (P = .003), if their school included FSD in its clinical curriculum (P = .01), and if they had ever participated in the care of a patient with FSD (P = .006). Clinical Implications: There are important gaps in the coverage of FSD in undergraduate medical education that may be mitigated through improvements to curriculum and increased exposure to patients with FSD. Strengths and Limitations: This is the first study, to our knowledge, to directly survey medical students regarding their educational experience and comfort with FSD. Our study was limited by a small sample size, the use of a novel and nonvalidated questionnaire, and the potential for bias given our sampling method. Conclusion: Medical schools must work toward improving instruction in FSD for their students to address these disparities and improve students' comfort with the topic.
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Purpose of Review: This review discusses the role and benefits of telemedicine as an integral component of the post-pandemic care paradigm in urological practice and, in particular, as part of the care of patients with overactive bladder (OAB). Recent Findings: The COVID-19 pandemic accelerated the implementation of telemedicine across almost every medical specialty and (at least temporarily) swept away barriers including those regarding reimbursement and licensure. Telemedicine benefits patients and providers alike including savings on transportation costs, access to specialists or tertiary care from geographically remote locations, and minimized exposure to a contagious illness. Integration of telemedicine into clinical practice can reduce costs for office/exam space and staffing overhead, as well as facilitate greater scheduling efficiency. Many, if not most, aspects of care for the uncomplicated OAB patient can be as effectively managed remotely as with in-person encounters, across the treatment algorithm. Summary: Telemedicine will almost certainly remain a key component in the care of OAB, general urology, and throughout all medical specialties.
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Ehlers-Danlos syndrome (EDS) is a hereditary tissue and collagen synthesis disorder that can predispose patients to gynecologic and obstetric complications. Female patients often suffer from bothersome pelvic floor disorders, but due to the medical complexity of EDS, special considerations are needed for the treatment of pelvic organ prolapse and associated incontinence. In this paper, we present three unique cases of pelvic organ prolapse (POP) in EDS patients and delve deeper into the multidisciplinary approach involving urogynecology, rheumatology, physiatry, gastroenterology, and anesthesiology required to appropriately manage this condition.
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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.
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Prolapso de Órgano Pélvico , Prolapso Uterino , Cuidados Posteriores , Femenino , Procedimientos Quirúrgicos Ginecológicos/métodos , Humanos , Alta del Paciente , Prolapso de Órgano Pélvico/cirugía , Reproducibilidad de los Resultados , Prolapso Uterino/cirugíaRESUMEN
PURPOSE: Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of overactive bladder with urgency urinary incontinence in adults refractory to or intolerant of anticholinergics. Delivery of onabotulinumtoxinA via instillation would reduce the need for intradetrusor injections. The objective of this trial was to assess the efficacy and safety of intravesical instillation of an onabotulinumtoxinA + hydrogel admixture. MATERIALS AND METHODS: After review of a stage 1 safety phase by an independent committee, participants were recruited into stage 2 and randomized to either onabotulinumtoxinA 100, 300, 400, or 500 U, or placebo, all with hydrogel admixture. End points included change from baseline to week 12 in the number of urinary incontinence episodes (primary); micturition, urgency urinary, and nocturia episodes/day; volume voided per micturition; proportion of participants with a ≥50% decrease from baseline in urinary incontinence episodes/day; and Overactive Bladder Questionnaire total score. Adverse events were reported. RESULTS: Change from baseline to week 12 in number of urinary incontinence episodes was -2.72 with placebo and ranged from -0.89 to -1.85 in the onabotulinumtoxinA + hydrogel treatment groups. No difference from placebo was observed for any efficacy end point. The proportions of participants with treatment-emergent adverse events were similar among all groups, with asymptomatic bacteriuria the highest reported (6.7%-15.5%). There were no reports of urinary retention or elevated post-void residual volume. CONCLUSIONS: Intravesical instillation of an onabotulinumtoxinA + hydrogel admixture for the treatment of refractory overactive bladder was well tolerated, but it showed no improvement over placebo.
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Toxinas Botulínicas Tipo A , Vejiga Urinaria Hiperactiva , Incontinencia Urinaria , Administración Intravesical , Adulto , Humanos , Hidrogeles , Calidad de Vida , Resultado del Tratamiento , Vejiga Urinaria Hiperactiva/complicaciones , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Incontinencia Urinaria/tratamiento farmacológicoRESUMEN
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.
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Hiperplasia Prostática , Obstrucción Uretral , Vejiga Urinaria Hiperactiva , Humanos , Masculino , Femenino , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/complicaciones , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/tratamiento farmacológico , Antagonistas Adrenérgicos alfa/uso terapéutico , Obstrucción Uretral/complicaciones , Antagonistas ColinérgicosRESUMEN
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.
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Prolapso de Órgano Pélvico , Prolapso Uterino , Animales , Bovinos , Femenino , Procedimientos Quirúrgicos Ginecológicos/métodos , Humanos , Prolapso de Órgano Pélvico/cirugía , Estudios Prospectivos , Mallas Quirúrgicas , Resultado del Tratamiento , Prolapso Uterino/cirugíaRESUMEN
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.
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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.
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Toxinas Botulínicas Tipo A , Vejiga Urinaria Hiperactiva , Retención Urinaria , Infecciones Urinarias , Adulto , Anciano , Toxinas Botulínicas Tipo A/uso terapéutico , Femenino , Humanos , Masculino , Proteínas Represoras/uso terapéutico , Estudios Retrospectivos , Vejiga Urinaria , Vejiga Urinaria Hiperactiva/complicaciones , Retención Urinaria/complicaciones , Infecciones Urinarias/tratamiento farmacológico , Infecciones Urinarias/epidemiologíaRESUMEN
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.
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OBJECTIVE: To describe and assess the outcomes of dorsal onlay oral mucosa graft urethroplasty for female urethral stricture. METHODS: We retrospectively reviewed the charts of all female patients who underwent dorsal onlay oral (buccal or lingual) mucosa urethroplasty for urethral stricture between 2011 and 2020 at two academic institutions. The primary endpoint was clinical success defined as any subjective improvement in LUTS self-assessed by the patients 1-3 months after catheter removal. Four surgeons performed the urethroplasties using a standardized technique: suprameatal incision, dissection and longitudinal opening of the dorsal aspect of the urethra, harvest of the oral mucosa graft, graft onlay sutured into the urethral opening. RESULTS: Nineteen patients were included. The clinical success rate was 94.7% at 1-3 months and 90.9% at 1 year. After a median follow-up of 12 months (range 1-49) there was one recurrence (5.3%), clinical success was achieved in 17 patients (89.5%) and both the maximum urinary flow rate and post void residual were significantly improved (15.2 vs 7.4 ml/s preoperatively; P = .008 and 71.5 vs 161.1 ml preoperatively; P = .001 respectively). The de novo stress urinary incontinence rate was 15.7% at 1-3 months and 9.1% at 1 year. CONCLUSION: Dorsal onlay oral mucosa graft urethroplasty for female urethral stricture appears feasible across multiple surgeons and is associated with a low perioperative morbidity, satisfactory functional outcomes and a low recurrence rate. Other series with larger sample size and longer follow-up are needed to confirm these findings.