Efficacy and safety of an alternative onabotulinumtoxinA injection paradigm for refractory overactive bladder.

AIMS: In studies utilizing a 20-injection-site paradigm of onabotulinumtoxinA treatment for overactive bladder (OAB), some patients performed clean intermittent catheterization (CIC). An alternative injection paradigm of fewer injections targeting the lower bladder may reduce the need for CIC by maintaining upper bladder function. This study evaluated the efficacy and safety of an unapproved alternative 10-injection-site paradigm targeting the lower bladder. METHODS: In this phase 4, double-blind, parallel-group study, patients with OAB and urinary incontinence (UI) for ≥6 months with ≥3 episodes of urinary urgency incontinence (no more than 1 UI-free day) and ≥8 micturitions per day over 3 days during screening were randomized 2:1 to onabotulinumtoxinA 100 U or placebo injected at 10 sites in the lower bladder. RESULTS: Of 120 patients, 78 in the onabotulinumtoxinA group and 39 in the placebo group had efficacy assessments. In the double-blind phase, mean change from baseline at week 12 in daily frequency of UI episodes was greater with onabotulinumtoxinA (-2.9) versus placebo (-0.3) (least squares mean difference [LSMD]: -2.99, p < 0.0001). Achievement of 100% (odds ratio [OR]: 6.15 [95% confidence interval, CI: 0.75-50.37]), ≥75% (OR: 7.25 [2.00-26.29]), and ≥50% improvement (OR: 4.79 [1.87-12.28]) from baseline in UI episodes was greater with onabotulinumtoxinA versus placebo. Reductions from baseline in the daily average number of micturitions (LSMD: -2.24, p < 0.0001), nocturia (LSMD: -0.71, p = 0.0004), and urgency (LSMD: -2.56, p < 0.0001) were greater with onabotulinumtoxinA than with placebo. Treatment benefit was improved or greatly improved in the onabotulinumtoxinA group (74.0% of patients) versus placebo (17.6%) (OR: 13.03 [95% CI: 3.23-52.57]). Mean change from baseline in Incontinence Quality of Life score was greater with onabotulinumtoxinA versus placebo (LSMD: 24.2, p = 0.0012). Two of 78 (2.6%) patients in the onabotulinumtoxinA group used CIC during the double-blind period; no females used CIC during the double-blind period. Commonly reported adverse events (≥5%) were urinary tract infection (UTI), dysuria, and productive cough for both groups; rate of UTI was higher with onabotulinumtoxinA versus placebo. CONCLUSION: In patients treated with onabotulinumtoxinA for OAB with UI, an unapproved alternative injection paradigm targeting the lower bladder demonstrated efficacy over placebo, with a low incidence of CIC.

Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder.

BACKGROUND: Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective ß3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence. METHODS: This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence. DISCUSSION: OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting. Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021.

The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction: Treatment and Follow-up.

PURPOSE: The clinician treating patients with neurogenic lower urinary tract dysfunction (NLUTD) needs to balance a variety of factors when making treatment decisions. In addition to the patient's urologic symptoms and urodynamic findings, other issues that may influence management options of the lower urinary tract include cognition, hand function, type of neurologic disease, mobility, bowel function/management, and social and caregiver support. This Guideline allows the clinician to understand the options available to treat patients, understand the findings that can be seen in NLUTD, and appreciate which options are best for each individual patient. This allows for decisions to be made with the patient, in a shared decision-making manner, such that the patient's quality of life can be optimized with respect to their bladder management. MATERIALS AND METHODS: A comprehensive search for studies assessing patients undergoing evaluation, surveillance, management, or follow-up for NLUTD was conducted from January 2001 through October 2017 and was rerun in February 2021 to capture newer literature. The primary search returned 20,496 unique citations. Following a title and abstract screen, full texts were obtained for 3,036 studies. During full-text review, studies were primarily excluded for not meeting the PICO criteria. One hundred eight-four primary literature studies met the inclusion criteria and were included in the evidence base. RESULTS: This guideline was developed to inform clinicians on the proper evaluation, diagnosis, and risk stratification of adult patients with NLUTD and the non-surgical and surgical treatment options available. Additional statements on urinary tract infection and autonomic dysreflexia were developed to guide the clinician. CONCLUSIONS: NLUTD patients may undergo non-surgical and surgical treatment options depending on their level of risk, symptoms, and urodynamic findings. Appropriate follow-up, primarily based on their risk stratification, must be maintained after treatment.

The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction: Diagnosis and Evaluation.

PURPOSE: The clinician treating patients with neurogenic lower urinary tract dysfunction (NLUTD) needs to balance a variety of factors when making treatment decisions. In addition to the patient's urologic symptoms and urodynamic findings, other issues that may influence management options of the lower urinary tract include cognition, hand function, type of neurologic disease, mobility, bowel function/management, and social and caregiver support. This Guideline allows the clinician to understand the options available to treat patients, understand the findings that can be seen in NLUTD, and appreciate which options are best for each individual patient. This allows for decisions to be made with the patient, in a shared decision-making manner, such that the patient's quality of life can be optimized with respect to their bladder management. MATERIALS AND METHODS: A comprehensive search for studies assessing patients undergoing evaluation, surveillance, management, or follow-up for NLUTD was conducted from January 2001 through October 2017 and was rerun in February 2021 to capture newer literature. The primary search returned 20,496 unique citations. Following a title and abstract screen, full texts were obtained for 3,036 studies. During full-text review, studies were primarily excluded for not meeting the PICO criteria. One hundred eight-four primary literature studies met the inclusion criteria and were included in the evidence base. RESULTS: This guideline was developed to inform clinicians on the proper evaluation, diagnosis, and risk stratification of patients with NLUTD and the non-surgical and surgical treatment options available. Additional statements on urinary tract infection and autonomic dysreflexia were developed to guide the clinician. This Guideline is for adult patients with NLUTD and pediatric NLUTD will not be discussed. CONCLUSIONS: NLUTD patients should be risk-stratified as either low-, moderate-, high-, or unknown-risk. After diagnosis and stratification, patients should be monitored according to their level of risk at regular intervals. Patients who experience new or worsening signs and symptoms should be reevaluated and risk stratification should be repeated.

Contemporary multicenter outcomes of continent cutaneous ileocecocystoplasty in the adult population over a 10-year period: A Neurogenic Bladder Research Group study.

AIMS: Evidence is sparse on the long-term outcomes of continent cutaneous ileocecocystoplasty (CCIC). We hypothesized that obesity, laparoscopic/robotic approach, and concomitant surgeries would affect morbidity after CCIC and aimed to evaluate the outcomes of CCIC in adults in a multicenter contemporary study. METHODS: We retrospectively reviewed the charts of adult patients from sites in the Neurogenic Bladder Research Group undergoing CCIC (2007-2017) who had at least 6 months of follow-up. We evaluated patient demographics, surgical details, 90-day complications, and follow-up surgeries. the Mann-Whitney U test was used to compare continuous variables and χ² and Fisher's Exact tests were used to compare categorical variables. RESULTS: We included 114 patients with a median age of 41 years. The median postoperative length of stay was 8 days. At 3 months postoperatively, major complications occurred in 18 (15.8%), and 24 patients (21.1%) were readmitted. During a median follow-up of 40 months, 48 patients (42.1%) underwent 80 additional related surgeries. Twenty-three patients (20.2%) underwent at least one channel revision, most often due to obstruction (15, 13.2%) or incontinence (4, 3.5%). Of the channel revisions, 10 (8.8%) were major and 14 (12.3%) were minor. Eleven patients (9.6%) abandoned the catheterizable channel during the follow-up period. Obesity and laparoscopic/robotic surgical approach did not affect outcomes, though concomitant surgery was associated with a higher rate of follow-up surgeries. CONCLUSIONS: In this contemporary multicenter series evaluating CCIC, we found that the short-term major complication rate was low, but many patients require follow-up surgeries, mostly related to the catheterizable channel.

Biologic Grafts for Use in Pelvic Organ Prolapse Surgery: a Contemporary Review.

PURPOSE OF REVIEW: Pelvic organ prolapse (POP) is a common condition and there is a plethora of surgical techniques available to address this problem. We present a review of biologic grafts, including the latest literature to help guide a surgeon's choice on the type of biologic materials to augment repairs. RECENT FINDINGS: Since the 2019 Food and Drug Administration (FDA) ban on mesh, including xenograft, there is a sparsity of biologic graft products available for POP repairs. This has led to a significant decrease in surgical application. Surgeons must be familiar with the biochemical properties, processing, and clinical application of biologic grafts prior to use. They should also be familiar with alternative operative techniques that utilize autografts, although there is limited outcome data on these techniques. With heightened awareness of mesh and its complications, biologic grafts have made a resurgence. Surgeons must be well versed on their available options. Current literature is limited, and studies have not demonstrated superiority of biologic graft over native tissue repairs for prolapse. Nevertheless, there is a role for these types of biologic graft material in specific patient populations. Future studies are warranted.

Best practice policy statement on urodynamic antibiotic prophylaxis in the non-index patient.

AIMS: Antibiotic prophylaxis before urodynamic testing (UDS) is widely utilized to prevent urinary tract infection (UTI) with only limited guidance. The Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) convened a Best Practice Policy Panel to formulate recommendations on the urodynamic antibiotic prophylaxis in the non-index patient. METHODS: Recommendations are based on a literature review and the Panel's expert opinion, with all recommendations graded using the Oxford grading system. RESULTS: All patients should be screened for symptoms of UTI and undergo dipstick urinalysis. If the clinician suspects a UTI, the UDS should be postponed until it has been treated. The first choice for prophylaxis is a single oral dose of trimethoprim-sulfamethoxazole before UDS, with alternative antibiotics chosen in case of allergy or intolerance. Individuals who do NOT require routine antibiotic prophylaxis include those without known relevant genitourinary anomalies, diabetics, those with prior genitourinary surgery, a history of recurrent UTI, post-menopausal women, recently hospitalized patients, patients with cardiac valvular disease, nutritional deficiencies or obesity. Identified risk factors that increase the potential for UTI following UDS and for which the panel recommends peri-procedure antibiotics include: known relevant neurogenic lower urinary tract dysfunction, elevated PVR, asymptomatic bacteriuria, immunosuppression, age over 70, and patients with any indwelling catheter, external urinary collection device, or performing intermittent catheterization. Patients with orthopedic implants have a separate risk stratification. CONCLUSIONS: These recommendations can assist urodynamic providers in the appropriate use of antibiotics for UDS testing. Clinical judgment of the provider must always be considered.

Computer simulations of thermal tissue remodeling during transvaginal and transurethral laser treatment of female stress urinary incontinence.

BACKGROUND AND OBJECTIVES: A non-surgical method is being developed for treating female stress urinary incontinence by laser thermal remodeling of subsurface tissues with applied surface tissue cooling. Computer simulations of light transport, heat transfer, and thermal damage in tissue were performed, comparing transvaginal and transurethral approaches. STUDY DESIGN/MATERIALS AND METHODS: Monte Carlo (MC) simulations provided spatial distributions of absorbed photons in the tissue layers (vaginal wall, endopelvic fascia, and urethral wall). Optical properties (n,µa ,µs ,g) were assigned to each tissue at λ = 1064 nm. A 5-mm-diameter laser beam and incident power of 5 W for 15 seconds was used, based on previous experiments. MC output was converted into absorbed energy, serving as input for finite element heat transfer simulations of tissue temperatures over time. Convective heat transfer was simulated with contact probe cooling temperature set at 0°C. Variables used for thermal simulations (κ,c,ρ) were assigned to each tissue layer. MATLAB code was used for Arrhenius integral thermal damage calculations. A temperature matrix was constructed from ANSYS output, and finite sum was incorporated to approximate Arrhenius integral calculations. Tissue damage properties (Ea ,A) were used to compute Arrhenius sums. RESULTS: For the transvaginal approach, 37% of energy was absorbed in the endopelvic fascia target layer with 0.8% deposited beyond it. Peak temperature was 71°C, the treatment zone was 0.8-mm-diameter, and 2.4 mm of the 2.7-mm-thick vaginal wall was preserved. For transurethral approach, 18% energy was absorbed in endopelvic fascia with 0.3% deposited beyond the layer. Peak temperature was 80°C, treatment zone was 2.0-mm-diameter, and 0.6 mm of 2.4-mm-thick urethral wall was preserved. CONCLUSIONS: Computer simulations suggest that transvaginal approach is more feasible than transurethral approach. Lasers Surg. Med. 49:198-205, 2017. © 2016 Wiley Periodicals, Inc.

Use of best-worst scaling to assess patient perceptions of treatments for refractory overactive bladder.

AIMS: Refractory overactive bladder (OAB) treatments, including sacral neuromodulation (SNM), onabotulinumtoxin A (OnabotA), and percutaneous tibial nerve stimulation (PTNS), differ considerably. Best-Worst Scaling (BWS) was used to assess patient preferences for these treatments. METHODS: A cross-sectional Web survey, based on findings from qualitative interviews with 23 OAB patients and 7 clinical experts, was conducted with idiopathic OAB patients in the US and UK. The BWS exercise involved prioritizing subsets of 13 attributes across 13 choice tasks, where patients identified the attribute they considered as best and as worst in each task. Attribute BWS scores, ranging from -1.0 (worst) to 1.0 (best) were calculated based on the rates that each attribute was chosen. Attitudes toward the attributes also were assessed via like/dislike Likert scales, and questions regarding the percentage likelihood (0-100%) of trying each treatment, based on standardized treatment descriptions. RESULTS: The sample included 245 patients (118 US, 127 UK); 79% female, mean age 50 ± 7.8 years. All 13 attribute BWS scores were significantly positive or negative. "Lasting improvement" (0.82), "minimal side effects" (0.67), and "sends signals between bladder and brain" (0.35)' were rated most favorably, and "complications with implant" (-0.65), and "be willing to self-catheterize" (-0.53) were rated worst. All but one of the attribute BWS scores were significantly correlated with the respective like/dislike scores and the percentage likelihood estimates for trying one of the three treatments. CONCLUSION: BWS was successful in assessing the magnitude of patient preferences for key attributes associated with substantially different refractory OAB therapies. Neurourol. Urodynam. 35:1028-1033, 2016. © 2015 Wiley Periodicals, Inc.

The evaluation and management of refractory neurogenic overactive bladder.

Patients with neurologic disease commonly develop overactive bladder (OAB) symptoms of urgency, frequency, and/or urge incontinence that remain bothersome despite oral pharmacologic therapy. Management of refractory OAB in the neurogenic population is a complex issue with no uniform treatment strategy. When treatment fails or patients generally are dissatisfied with the adverse effects of oral therapy, available options include sacral neuromodulation, percutaneous tibial nerve stimulation (PTNS), botulinum toxin injections, and lower urinary tract reconstruction such as augmentation cystoplasty. A thorough knowledge and understanding of available and emerging treatment options for neurogenic detrusor overactivity is paramount to assisting clinicians in choosing an appropriate treatment. This article reviews the non-pharmacologic treatment options for neurogenic OAB, mainly botulinum toxin, neuromodulation, and lower urinary tract reconstruction, and discusses important relevant studies.

Two-year evaluation of the MiniArc in obese versus non-obese patients for treatment of stress urinary incontinence.

OBJECTIVES: Obesity is a well-established risk factor of stress urinary incontinence, which affects up to 35% of adult women worldwide. We evaluated whether there is a difference in outcomes with MiniArc sling for treatment of stress incontinence in obese women versus non-obese women at 24 months. METHODS: A 2-year subanalysis of obese (body mass index >30 kg/m(2) ) versus non-obese patients enrolled into a multicenter, prospective study evaluating the effectiveness of MiniArc sling was carried out. Qualitative (Urogenital Distress Inventory 6 and Incontinence Impact Questionnaire 7) and quantitative measurements, including the cough stress test, were carried out. Secondary outcome measures included procedure time, estimated blood loss, length of stay, perioperative complications, Wong-Baker Faces Pain Scale and adverse events. RESULTS: Of 188 patients, 62 were obese. The mean procedure time, blood loss and length of stay were no different between groups. Obese patients reported significantly more pain immediately postoperatively (2 vs 1, Wong-Baker, P = 0.042), but there was no difference at postoperative day 7. There was no difference in objective cure using the cough stress test (81% obese vs 86% non-obese; P = 0.449). Urogenital Distress Inventory 6 and Incontinence Impact Questionnaire 7 median scores showed no difference between groups in improvement (P = 0.126 and P = 0.087, respectively). No serious device-related complications were reported in either group. CONCLUSIONS: The MiniArc sling represents a safe and effective treatment option for both obese and non-obese patients with stress incontinence. Comparable outcomes at 2 years can be obtained in terms of cure rates using the cough stress test or questionnaires, as well as complication rates.

Neuro-Urology: Call for Universal, Resource-Independent Guidance.

Neurogenic lower urinary tract dysfunction (NLUTD), the abnormal function of the lower urinary tract in the context of neurological pathology, has been the subject of multiple efforts worldwide for the development of clinical practice guidelines. These guidelines are based on the same body of evidence, and are therefore subject to the same gaps. For example, sexual and bowel dysfunction in the context of NLUTD, optimal renal function assessment in those who are non-ambulatory or with low muscle mass, optimal upper tract surveillance timing, and modification of diagnostic and treatment modalities for low-resource nations and communities are inadequately addressed. In addition, many aspects of the conclusions and final recommendations of the guidelines are similar. This duplicative work represents a large expenditure of time and effort, which we believe could be focused instead on evidence gaps. Here, we call for a global unified approach to create a single, resource-independent, comprehensive guidance on NLUTD, neurogenic sexual, and neurogenic bowel dysfunction. Targeted research addressing the evidence gaps should be called for and pursued. This will allow for focus to shift to filling the gaps in the evidence for future guidelines.

Miniarc single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes.

INTRODUCTION AND HYPOTHESIS: We report 2-year data on the effectiveness and safety of the MiniArc single-incision sling in women with stress urinary incontinence. METHODS: This multi-center, prospective, single-arm, industry-sponsored study measured the effectiveness of the MiniArc sling via quantitative (cough stress test and 1-h pad weight test) and qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) measurements. The objective efficacy rate was defined as the number of patients with a negative cough stress test or 1-h pad weight test ≤ 1 g at 2 years. The subjective efficacy rate was determined by patient responses to the UDI-6 question # 3, "Do you experience, and if so, how much are you bothered by urine leakage related to physical activity, coughing, or sneezing?" Secondary objectives were to evaluate procedural variables of implantation and long-term safety. RESULTS: One hundred and eighty women with a mean age of 51.1 years were implanted in the study. Mean procedure time, blood loss, and length of stay were 11.0 min, 41.7 mL and 9.5 h respectively. At 2 years, 142 patients were available for analysis. The objective efficacy rates for the cough stress test (CST) and pad weight test (PWT) were 84.5 % and 80.1 % respectively and the subjective efficacy rate was 92.9 %. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed statistically significant improvement (p < .001). The most common adverse events included UTI (4.8 %), constipation (3.7 %), and temporary urinary retention (3.2 %). CONCLUSION: MiniArc is a safe and effective surgical procedure for the treatment of SUI in women with follow-up through 2 years.

Selective laser vaporization of polypropylene mesh used in treatment of female stress urinary incontinence and pelvic organ prolapse: preliminary studies using a red diode laser.

BACKGROUND AND OBJECTIVES: The most common mesh-related complication experienced by patients undergoing transvaginal polypropylene synthetic slings for stress urinary incontinence (SUI) and transvaginal pelvic organ prolapse (POP) repair with mesh is vaginal mesh erosion. More than half of the patients who experience erosion from synthetic mesh require surgical excision which is technically challenging and risks damage to healthy adjacent tissue. This study explores selective laser vaporization of polypropylene suture/mesh materials commonly used in SUI and POP. MATERIALS AND METHODS: A compact, 7 Watt, 647-nm, red diode laser was operated with a radiant exposure of 81 J/cm(2) , pulse duration of 100 milliseconds, and 1.0-mm-diameter laser spot. The 647-nm wavelength was selected because its absorption by water, hemoglobin, and other tissue chromophores is low, while polypropylene absorption is high. Laser vaporization of ∼200-µm-diameter polypropylene suture/mesh strands, in contact with fresh urinary tissue samples was performed, ex vivo. Temperature mapping of suture/mesh samples with a thermal camera was also conducted. RESULTS: Selective vaporization of polypropylene suture and mesh using a single laser pulse was achieved with peak temperatures of 180 and 232°C, respectively, while direct laser irradiation of tissue alone resulted in only a 1°C temperature increase. CONCLUSIONS: Selective laser vaporization of polypropylene suture/mesh materials is feasible without significant thermal elevation in the adjacent tissue. This technique may be useful for treatment of eroded mesh after SUI or POP procedures that require surgical revision.

An Evaluation of the Efficacy and Safety of Vibegron in the Treatment of Overactive Bladder.

Pharmacologic treatment for overactive bladder (OAB), which is characterized by bothersome symptoms such as urgency and urge urinary incontinence (UUI), includes anticholinergics and ß3-adrenergic receptor agonists. Anticholinergics are associated with adverse effects including dry mouth, constipation, cognitive impairment, and increased risk of dementia. Therefore, the drug class of ß3-adrenergic receptor agonists may represent an effective, safe treatment option. Vibegron, a ß3-adrenergic receptor agonist, was approved for use in Japan (2018) and the United States (2020). Over the past 3 years, 2 phase 3 trials (EMPOWUR, EMPOWUR extension) have been conducted with once-daily vibegron 75 mg for the treatment of OAB, and additional secondary and subgroup analyses have detailed the efficacy and safety of vibegron. In the international phase 3 EMPOWUR trial, treatment with vibegron was associated with significant improvements compared with placebo in efficacy outcomes of micturition frequency, UUI episodes, urgency episodes, and volume voided as early as week 2 that were sustained throughout the 12-week trial. The 40-week EMPOWUR extension study, following the 12-week treatment period, demonstrated sustained efficacy in patients receiving vibegron for 52 weeks. Treatment with vibegron was also associated with improvements in patient-reported measures of quality of life. Across studies, vibegron was generally safe and well tolerated. A separate, dedicated ambulatory blood pressure monitoring study showed that treatment with vibegron was not associated with clinically meaningful effects on blood pressure or heart rate. Across all studies, vibegron was efficacious, safe, and well tolerated and thus represents a valuable treatment option for patients with OAB. Here, nearly 1 year after US approval, we review the published data on efficacy and safety of vibegron 75 mg for the treatment of OAB.

Retropubic and transobturator slings: still useful or should all patients be treated with mini-slings?

Traditional retropubic and transobturator midurethral slings are reliable, safe, and effective treatments for stress urinary incontinence. Unfortunately, they also are associated with rare but severe complications, such as bladder or bowel perforation, vascular injury, nerve damage, and/or groin muscle pain that can occur with the blind passage of trocars. To maintain efficacy and patient satisfaction while avoiding such complications, minimally invasive mini-slings have been developed. These smaller mini-slings can be placed through a single vaginal incision at the level of the midurethra without trocars. Mini-slings often are performed as an outpatient surgery, with minimal morbidity, pain, and quick patient recovery. With continued refinement and surgeon experience, mini-slings potentially may be performed safely in the office setting under local anesthesia while maintaining the efficacy of traditional slings.

Electrical stimulation of the urethra evokes bladder contractions and emptying in spinal cord injury men: case studies.

OBJECTIVE: Electrical stimulation of the urethra can evoke bladder contractions in persons with spinal cord injury (SCI). The objective of this study was to determine whether electrical stimulation of the urethra could evoke bladder contractions that empty the bladder. METHODS: The first patient was a 45-year-old man with a T6 ASIA A SCI secondary to a gunshot wound 15 years prior. The second patient was a 51-year-old man with a T2 ASIA A SCI secondary to a fall from scaffolding 2 years prior. Both patients demonstrated neurogenic detrusor overactivity on urodynamics and managed their bladder with clean intermittent catheterization and oxybutynin medication. Following informed consent, each patient discontinued oxybutynin 2 days prior to urodynamic testing. Urodynamics were performed with a custom 12 French balloon catheter mounted with ring-shaped electrodes (3 mm) positioned in the prostatic urethra. After filling the bladder to approximately three-fourth of capacity at a rate of 25 ml/minute, the urethra was stimulated with a range of parameters to determine whether electrical stimulation could evoke a bladder contraction and empty the bladder. RESULTS: Electrical stimulation of the prostatic urethra evoked bladder contractions (peak detrusor pressures of 60-80 cm H(2)O) that emptied the bladder in both subjects. In the first subject, stimulation (9-12 mA, 20 Hz) emptied 64-75%, leaving post-void residual volumes (PVRs) of 41-20 ml. In the second subject, stimulation (20 mA, 20 Hz) emptied 68-77%, leaving PVRs of 56-45 ml. CONCLUSION: Urethral stimulation evoked bladder emptying in persons with SCI.

Pulse article: survey of neurogenic bladder management in spinal cord injury patients around the world.

STUDY DESIGN: Online survey distributed to healthcare professionals (HCPs) involved in care of spinal cord injury (SCI) patients with neurogenic lower urinary tract dysfunction (NLUTD). OBJECTIVES: Identify and bring awareness to the variation of neurogenic bladder management in around the world. SETTING: International online questionnaire. METHODS: A 32-question survey was drafted and circulated among a global network of SCI experts for review. The survey was disseminated to healthcare professionals involved in the care of NLUTD in SCI patients via social media, grassroots methods, and international societies. The survey was available for 6 weeks and respondents answered questions regarding SCI population demographics, access to care, common neurogenic bladder management, diagnostic and imaging methods, complications, and follow up. RESULTS: A total of 296 healthcare professionals, 132 from North America, 87 from Europe, 27 from Asia, 24 from Australia, 14 from South America, and 6 from Africa, responded to the survey. Global concurrence was noted among management method for patients without adequate hand function, first-line treatment for neurogenic detrusor overactivity, and common complications. Continents highly differed in responses regarding management method for patients with adequate hand function, frequency of patients reusing catheters, timing of urodynamics, and duration of antibiotic therapy for urinary tract infections. CONCLUSIONS: The results of this international survey demonstrate the variability and uniqueness in neurogenic bladder management in SCI patients around the world. Increased international discourse and education will improve global communication and transparency with the efforts of reducing discrepancies in care.

Efficacy of Vibegron and Mirabegron for Overactive Bladder: A Systematic Literature Review and Indirect Treatment Comparison.

BACKGROUND: In the absence of head-to-head trials, we performed an indirect treatment comparison of the ß3-adrenergic agonists vibegron and mirabegron in the treatment of overactive bladder (OAB). METHODS: PubMed, Embase, and Cochrane Library were searched for articles related to phase 3, double-blind, controlled trials of vibegron 75 mg and mirabegron 25/50 mg in patients with OAB. Efficacy outcomes included change from baseline at weeks 4, 12, and 52 in mean daily number of total urinary incontinence episodes and micturitions and mean volume voided/micturition. Effect size was computed as placebo-subtracted change from baseline (weeks 4, 12) or active control (tolterodine)-subtracted change from baseline (week 52) for each treatment group. Adverse events (AEs) are presented descriptively. RESULTS: After removal of duplicates, 49 records were identified, and after screening 9 met inclusion criteria for analysis. Vibegron showed significantly greater reduction in mean daily number of total incontinence episodes than mirabegron 25 mg at week 4, mirabegron 50 mg (weeks 4, 52), and tolterodine (weeks 4, 12) (P < 0.05, each) and significantly greater improvement in volume voided versus mirabegron 25 mg (week 12), mirabegron 50 mg (weeks 12, 52), and tolterodine (week 4) (P < 0.05, each). Confidence intervals of point estimates overlapped zero for all other comparisons of vibegron and mirabegron (25 or 50 mg) or tolterodine, indicating no significant differences between treatments for these time/endpoints. Urinary tract infection, hypertension, and dry mouth were the most commonly occurring AEs for vibegron, mirabegron, and tolterodine, respectively, in the short-term trials; hypertension was the most commonly occurring AE with all three treatments in the long-term trials. CONCLUSIONS: Vibegron was associated with significant improvement in total incontinence episodes versus mirabegron at 4 and 52 weeks and volume voided at 12 and 52 weeks. Improvement in micturitions was similar between vibegron and mirabegron or tolterodine. Incidence of AEs was generally comparable between vibegron and mirabegron.