Naturalistic Bladder Filling Reveals Subtypes in Overactive Bladder Syndrome That Differentially Engages Urinary Urgency-Related Brain Circuits: Results From the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

PURPOSE: Overactive bladder (OAB) may be attributed to dysfunction in supraspinal brain circuits. Overactive bladder participants enrolled in the LURN (Symptoms of Lower Urinary Tract Dysfunction Research Network) study reported sensations of urinary urgency during a bladder-filling paradigm while undergoing brain functional MRI to map supraspinal dysfunction. MATERIALS AND METHODS: OAB participants and controls (CONs) completed 2 resting-state functional MRI scans following consumption of 350 mL water. Scans were conducted at fuller and emptier bladder states, interleaved with voiding. Urgency ratings (0-10) were assessed. Patterns of urgency during bladder filling were investigated using latent class trajectory models. Clusters of participants encompassing each pattern (ie, subtype) were derived from aggregated groups of OAB and CON independent of diagnosis. RESULTS: Two distinct patterns of urgency trajectories were revealed: first subtype with OAB and CON who were unresponsive to bladder filling (OAB-1 and CON-1) and second highly responsive subtype predominantly containing OAB (OAB-2). OAB-2 participants scored significantly higher on urinary symptoms but not pain or psychosocial measures. Neuroimaging analyses showed change in urgency due to both bladder filling and voided volume related to multiple loci of brain network connectivity in OAB-2, and in some cases, different than OAB-1 and/or CON-1. Sensorimotor to dorsomedial/dorsolateral prefrontal connectivity mediated the relationship between stimulus (voided volume) and percept (urgency) in OAB-2. CONCLUSIONS: Our results reveal different OAB subtypes with latent class trajectory models of urgency ratings during natural bladder filling. Functional MRI revealed differences in pathophysiology between subtypes, namely sensorimotor-prefrontal connectivity is a key locus in OAB patients with higher urinary symptoms.

Does COVID-19 cause or worsen LUT dysfunction, what are the mechanisms and possible treatments? ICI-RS 2023.

INTRODUCTION: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) and produced a worldwide pandemic in 2020. There have been 770,875,433 confirmed cases and 6,959,316 attributed deaths worldwide until September 19, 2023. The virus can also affect the lower urinary tract (LUT) leading to bladder inflammation and producing lower urinary tract symptoms (LUTS) in both the acute and chronic phases of disease. METHODS: At the 2023 meeting of the International Consultation on Incontinence-Research Society (ICI-RS), the literature relating to COVID-19 and bladder dysfunction was reviewed. The LUTS reported, as well as the pathophysiology of these bladder symptoms, were the subject of considerable discussion. A number of different topics were discussed including lower LUTS reported in COVID-19, how SARS-CoV-2 may infect and affect the urinary tract, and proposed mechanisms for how viral infection result in new, worsened, and in some persisting LUTS. CONCLUSIONS: The workshop discussed the interaction between the virus and the immune system, covering current evidence supporting theories underlying the causes of acute and chronic LUTS related to COVID-19 infection. Research questions for further investigation were suggested and identified.

Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN): An introduction to the Urinary Urgency Phenotyping Protocol LURN II.

AIMS: The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) is undertaking a new cohort study in LURN II including cases and controls. METHODS: This new cohort was enrolled to specifically study urinary urgency and urgency urinary incontinence, lower urinary tract symptoms (LUTSs) that are often difficult to treat due to a lack of understanding of their phenotypes and pathophysiologies. RESULTS: This paper will focus on the motivation for the second iteration of LURN and highlight the new research techniques and plans for more thorough phenotyping of this population. CONCLUSIONS: This paper will outline the gaps in understanding in treating LUTSs, specifically urinary urgency.

Effect of Dietary Choline Consumption on the Development of Urinary Urgency Incontinence in a Longitudinal Cohort of Women.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to determine whether differences in the cumulative dietary intake of choline, is associated with the risk of developing urge urinary incontinence (UUI). METHODS: This was an analysis within the Nurses' Health Study (NHS) I and II. The main exposure was the cumulative daily intake for each choline-containing compound obtained from a detailed daily food frequency questionnaire. The primary outcome was UUI, defined as urine loss with a sudden feeling of bladder fullness or when a toilet is inaccessible, occurring >1/month. Cox proportional hazards regression models were used to calculate multivariate-adjusted relative risks and 95% confidence intervals (CIs) for the association between total choline and choline derivatives and risk of UUI. Fixed effects meta-analyses of results from NHSI and NHSII were performed for postmenopausal women only to obtain a pooled estimate of the impact of choline consumption on UUI. RESULTS: There were 33,273 participants in NHSI and 38,732 in NHSII who met all the criteria for inclusion in the analysis. The incidence of UUI was 9.41% (n=3,139) in NHSI and 4.25% (n=1,646) in NHSII. After adjusting for confounders choline was not found to be associated with UUI in postmenopausal women. However, in premenopausal women, relative to the lowest quartile, the highest quartile of consumption of total choline (aRR = 0.79, 95% CI: 0.64-0.99), free choline (aRR = 0.74, 95% CI: 0.58-0.94), and phosphocholine (aRR = 0.77, 95% CI: 0.61-0.96) were associated with a reduced risk of UUI. CONCLUSIONS: Increased dietary choline consumption was associated with a reduced risk of UUI among premenopausal women.

Long-Term Outcomes of the Altis® Single-Incision Sling: Up to 10 Years' Follow-up.

INTRODUCTION AND HYPOTHESIS: Single-incision slings (SIS) have emerged as a less invasive alternative to conventional slings for stress urinary incontinence (SUI) treatment. However, long-term efficacy and safety results remain uncertain owing to a lack of studies. MATERIAL AND METHODS: A retrospective review of 155 patients treated with Altis® for SUI between February 2012 and June 2017, held in 2022, as a continuation of a prospective study in which all patients (197) were reviewed for 2 years after surgery (1, 6, 12, and 24 months). Preoperative demographic data, comorbidities, and pressure-flow studies were also recorded. Continence status and satisfaction rates were assessed using the International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) and the Patient Global Impression of Improvement (PGI-I) respectively. The assessment in the 2022 retrospective review was performed via a telephone survey. RESULTS: Mean follow-up time after surgery was 85.3 months (82.5-88.1). In 2022, complete continence was present in 75.4% of the patients. The presence of urinary urgency conditioned the ICIQ-SF score (10.9 vs 1.7 points, p < 0.01), with the ICIQ-SF = 0 in 84.5% of the patients with no associated urgency. Satisfaction assessed by the PGI-I was high, with 84.6% of the patients showing improvement. De novo urgency was present in 37,9% of the patients by 2022. Urinary tract infections were the most frequent complication (9.7%), with only 5 documented cases of mesh erosion. CONCLUSIONS: Altis® SIS is a safe and effective device for SUI treatment, with satisfaction rates comparable with those of the conventional slings. Persistence or development of urinary urgency influences the results.

Development and validation of models predicting treatment patterns in women with urinary urgency and/or urgency incontinence: A Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study.

PURPOSE: To develop a tool to predict a woman's treatment pattern for bothersome urinary urgency (UU) and/or UU incontinence over 1 year after presenting for care at urology or urogynecology clinics. METHODS: The Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study enrolled adult women with bothersome UU and/or UU incontinence using the lower urinary tract symptoms (LUTS) Tool who were seeking care for LUTS. Treatments for UU and/or urgency incontinence were ordered from least to most invasive. Ordinal logistic and Cox proportional hazard regression models were fit to predict the most invasive level of treatment during follow-up and overactive bladder (OAB) medication discontinuation, respectively. Binary logistic regression was performed to predict sling treatment during the study follow-up. Clinical tools were then created using the models listed above to predict treatment pattern over 12 months. RESULTS: Among 349 women, 281 reported UU incontinence, and 68 reported UU at baseline. The highest level of treatment during the study was as follows: 20% no treatment, 24% behavioral treatments, 23% physical therapy, 26% OAB medication, 1% percutaneous tibial nerve stimulation, 3% onabotulinumtoxin A, and 3% sacral neuromodulation. Slings were placed in 10% (n = 36) of participants before baseline and in 11% (n = 40) during study follow-up. Baseline factors associated with predicting the most invasive level of treatment included baseline level of treatment, hypertension, UU incontinence severity, stress urinary incontinence (SUI) severity, and anticholinergic burden score. Less severe baseline depression and less severe UU incontinence were associated with OAB medication discontinuation. UU and SUI severity were associated with sling placement during the study period. Three tools are available to predict: (1) highest level of treatment; (2) OAB medication discontinuation; and (3) sling placement. CONCLUSIONS: OAB treatment prediction tools developed in this study can help providers individualize treatment plans and identify not only patients at risk for treatment discontinuation but also patients who may not be escalated to potentially beneficial OAB treatments, with the goal to improve clinical outcomes for patients suffering from this chronic and often debilitating condition.

Reduced versus standard intradetrusor OnabotulinumtoxinA injections for treatment of overactive bladder.

BACKGROUND: Intradetrusor onabotulinumtoxinA injection is an effective advanced treatment for overactive bladder. While the effective dosages have been well studied, very little data exist on treatment efficacy using differing injection techniques. The objective of this study was to determine whether the efficacy of a reduced injection technique of 5 injection sites was noninferior to the standard technique of 20 injection sites of intradetrusor onabotulinumtoxinA for treatment of overactive bladder. METHODS: In this randomized noninferiority trial, men and women seeking treatment of overactive bladder with intradetrusor onabotulinumtoxinA injections were randomized to receive 100 units administered via either a reduced injection technique of 5 injection sites or a standard injection technique of 20 injection sites. Subjects completed a series of standardized questionnaires at baseline and at 4-12 weeks postprocedure to determine symptom severity and treatment efficacy. The primary outcome was treatment efficacy as determined by Overactive Bladder Questionnaire-Short Form with a noninferiority margin of 15 points. Secondary outcomes were incidence of urinary tract infection and urinary retention requiring catheterization. RESULTS: Data from 77 subjects were available for analysis with 39 in the control arm (20 injections) and 38 in the study arm (5 injections). There was a significant improvement in both arms from baseline to follow-up in Overactive Bladder Questionnaire-Short Form and International Consultation on Incontinence Questionnaire scores (p < 0.001). Overall treatment success was 68% with no statistically significant difference between arms. A significant difference between arms was found on the Overactive Bladder Questionnaire-Short Form quality of life survey favoring the control arm (confidence interval [CI]: 0.36-20.5, p = 0.04). However, there were no significant differences between arms in the remaining validated questionnaires. The study arm did not demonstrate noninferiority to the control arm. Subjects in the study arm were significantly more likely to express a willingness to undergo the procedure again (odds ratio = 3.8, 95% CI: 1.42-10.67, p = 0.004). Adverse events did not differ between arms. CONCLUSIONS: A reduced injection technique for administration of intradetrusor onabotulinumtoxinA demonstrates similar efficacy to the standard injection technique but did not demonstrate noninferiority. Subjects preferred the reduced injection technique over the standard technique. A reduced injection technique is a safe and effective alternative to the standard technique.

Assessing the effectiveness of antimicrobial pouch use for infection prevention in sacral neuromodulation.

INTRODUCTION AND HYPOTHESIS: Sacral neuromodulation (SNM) is a commonly performed procedure for various conditions. Infection rates range as high as 10% and often require operative explantation with resultant increased cost and morbidity. Pouches impregnated with antibiotic have been utilized in cardiovascular procedures with decreasing infectious complications. TYRX is an antibiotic pouch utilizing minocycline and rifampin manufactured by Medtronic. The objective of this study is to investigate the utility of antimicrobial pouches for patients undergoing SNM. METHODS: We retrospectively analyzed our patients undergoing SNM using an antimicrobial pouch and compared them with a historic cohort. Additional variables of interest included post-operative infection, diagnosis of diabetes, weight, and revision case or virgin implant. RESULTS: A total of 170 cases were identified, ranging from March 2017 to November 2022. Overall infection rate was 2.9% with 0 in the antimicrobial pouch cohort (0%) versus 5 in the historic cohort (5.5%; p = 0.04). Groups were similar in terms of body habitus. The group receiving an antimicrobial pouch was noted to be older with a higher percentage of female patients. 85 patients received an antimicrobial pouch and 85 did not. Of the infections, 4 occurred in revision cases (6.9%) and 1 in a virgin implant (0.9%; p = 0.03). No difference was noted in infection rate with regard to a diagnosis of diabetes or body habitus. CONCLUSION: The use of antimicrobial pouches in SNM is associated with a decreased rate of infectious complications. Revision cases displayed a higher rate of infectious complications.

Predictors of persistent overactive bladder following surgery for advanced pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Reliable risk factors for persistent urgency following pelvic organ prolapse (POP) surgery are still unclear. We aimed to identify preoperative parameters related to persistent postoperative urgency in a cohort of women following surgery for POP stage 3-4 with concomitant overactive bladder (OAB). METHODS: In this retrospective analysis, women with POP stage 3-4 and OAB who underwent POP repair during November 2012-December 2020 were included. Preoperative evaluation included history, Pelvic Organ Prolapse Quantification (POP-Q), multi-channel urodynamic studies and Pelvic Floor Distress Inventory (PFDI-20). Surgical procedures included: anterior and posterior colporrhaphy, sacrospinous ligament suspension, anterior vaginal wall mesh repair and robotic-assisted laparoscopic sacrocolpopexy. At the 12-month follow-up, urogynecological history, POP-Q evaluation, cough stress test and the PFDI-20 questionnaire were repeated. RESULTS: One hundred seventy-three patients were included in the analysis. Resolution of urgency was observed in 56% of women. Variables associated with persistent postoperative urgency included body mass index (BMI) (27 kg/m2 vs 25.7 kg/m2, p = 0.04), preoperative increased daytime frequency (46.39% vs 61.84%, p = 0.05), urgency urinary incontinence (UUI) (51.46% vs 80.26%, p = 0.0001), detrusor overactivity (DO) (40.2% vs 61.84%, p = 0.009) and lower maximum flow rate on UDS (13.9 ml/s vs 15 ml/s, p = 0.04). Multivariate analysis confirmed preoperative DO (OR: 12.2 [95% CI: 1.4-16.6]; p = 0.01), preoperative UUI (OR 3.8 [95% CI: 1.3-11.0]; p = 0.008) and BMI > 25 kg/m2 (OR 1.8 [95% CI: 1.1-7.2]; p = 0.04) as predictive factor for persistent urgency. CONCLUSIONS: In women with advanced POP and OAB, being overweight, preoperative UUI and DO are related to persistent postoperative urgency. These findings will guide our future preoperative counseling and reinforce the role of UDS in POP management.

Urologic view in the management of genitourinary syndrome of menopause.

Genitourinary syndrome of menopause (GSM) has a variety of effects on the urinary system and is an important consideration in the care provided to perimenopausal and postmenopausal patients when addressing urinary pathology. Here we discuss the common pathologies of the urinary system related to GSM including lower urinary tract symptoms and recurrent urinary tract infections. Female sexual dysfunction is not to be excluded as a critical part of a urologist's management of GSM but will be discussed elsewhere in this issue.

Role of Protopine and Nuciferine in the Management of Nocturia, Urgency, and Dysuria in Pre- and Postmenopausal Women: A Prospective Pilot Study.

OBJECTIVES: Nocturia was commonly treated with drugs burdened with high costs and numerous side effects; in fact, more than 70% of patients drop out of long-term treatment. Protopine and nuciferine are two alkaloids that have different effects on the neurotransmitter receptors involved in the regulation mechanism of the onset of urinary stimuli. The aim of the study was to evaluate the efficacy in controlling primarily nocturia and secondarily urgency and dysuria after 3 months of treatment with combination therapy of protopine and nuciferine syrup. DESIGN: This is a prospective cohort study in which all patients were diagnosed with overactive bladder syndrome (OAB) and the presence of the following symptoms: nocturia, urgency, and dysuria. Thirty patients were administered 10 mL/die (16.6 mg of nuciferine, 0.09 mg of protopine) of syrup for 3 months. Patients were evaluated at baseline (T0) with the International Consultation on Incontinence Questionnaire (ICIQ), Visual Analogue Scale (VAS) for the evaluation of dysuria, Patient Perception of Intensity of Urgency Scale (PPIUS) and at 3 months (T1) with the Patients' Global Impression of Change (PGI-C) scale, PPIUS, VAS, and ICIQ. PARTICIPANTS: Women with diagnosis of OAB; the presence of nocturia, urgency, and dysuria symptoms agreeing to undergo treatment and compiling informed consent; and the absence of contraindications to the use of active ingredients were included in the study. SETTING: Patients were recruited at T0 during the visit to the Uro-Gynecology clinic of the University of "Campus Bio-Medico" and visited again 3 months (T1) after the initiation of therapy. METHODS: We explored survey data by descriptive statistics: in particular, continuous values (i.e., ICIQ) have been summarized by mean and standard deviation of discrete ordinal values (i.e., VAS, PPIUS, and bladder diary parameters at T0 and T1) by median, minimum, and maximum reported scores. Where we could assume normality in distribution, assessed by the Shapiro-Wilk test and the evaluation of the QQ plot, we compared the observation of T0 and T1 with the paired Student's t test; otherwise, we tested differences in distribution with the paired Mann-Whitney U test. RESULTS: Thirty patients completed a 3-month therapy. The ICIQ and VAS questionnaires for the assessment of dysuria, both, reported an improvement in dysuria at T1 (p < 0.001). The PPIUS questionnaire reported an improvement in urinary urgency at T1 (p < 0.001). The PGI-C scale in T1 indicated an improvement in symptoms: 93% for nocturia, 70% for urinary urgency, and 63% for dysuria. LIMITATIONS: The weaknesses of this study are the small number of patients; as a pilot study, the study design was not randomized with a placebo and without blinding; and the short follow-up. CONCLUSIONS: Protopine and nuciferine can be an interesting alternative to primarily treat and reduce nocturia episodes, in addition to improving OAB-related urgency and dysuria.

Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS).

INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). METHODS: RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. RESULTS: Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman's rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. CONCLUSIONS: Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.

Non-Hunner's Interstitial Cystitis Is Different from Hunner's Interstitial Cystitis and May Be Curable by Uterosacral Ligament Repair.

BACKGROUND: The posterior fornix syndrome (PFS) was first described in 1993 as a predictably occurring group of symptoms: chronic pelvic pain (CPP), urge, frequency, nocturia, emptying difficulties/urinary retention, caused by uterosacral ligament (USL) laxity, and cured by repair thereof. SUMMARY: Our hypothesis was that non-Hunner's interstitial cystitis (IC) and PFS are substantially equivalent conditions. The primary objective was to determine if there was a causal relationship between IC and pelvic organ prolapse (POP). The secondary objective was to assess whether other pelvic symptoms were present in patients with POP-related IC and if so, which ones? How often did they occur? A retrospective study was performed in 198 women who presented with CPP, uterine/apical prolapse (varying degrees), and PFS symptoms, all of whom had been treated by posterior USL sling repair. We compared their PFS symptoms with known definitions of IC, CPP, and bladder symptoms. To check our hypothesis for truth or falsity, we used a validated questionnaire, "simulated operations" (mechanically supporting USLs with a vaginal speculum test to test for reduction of urge and pain), transperineal ultrasound and urodynamics. KEY MESSAGES: 198 patients had CPP and 313 had urinary symptoms which conformed to the definition for non-Hunner's IC. The cure rate after USL sling repair was CPP 74%, urge incontinence 80%, frequency 79.6%, abnormal emptying 53%, nocturia 79%, obstructive defecation 80%. Our findings seem to support our hypothesis that non-Hunner's IC and PFS may be similar conditions; also, non-Hunner IC/BPS may be a separate or lesser disease entity from "Hunner lesion disease". More rigorous scientific investigation, preferably by RCT, will be required.

Effects of intravesical prostaglandin E2 on bladder function are preserved in capsaicin-desensitized rats.

Prostaglandin E2 (PGE2) instilled into the bladder generates symptoms of urinary urgency in healthy women and reduces bladder capacity and urethral pressure in both humans and female rats. Systemic capsaicin desensitization, which causes degeneration of C-fibers, prevented PGE2-mediated reductions in bladder capacity, suggesting that PGE2 acts as an irritant (Maggi CA, Giuliani S, Conte B, Furio M, Santicioli P, Meli P, Gragnani L, Meli A. Eur J Pharmacol 145: 105-112, 1988). In the present study, we instilled PGE2 in female rats after capsaicin desensitization but without the hypogastric nerve transection that was conducted in the Maggi et al. study. One week after capsaicin injection (125 mg/kg sc), rats underwent cystometric and urethral perfusion testing under urethane anesthesia with saline and 100 µM PGE2. Similar to naïve rats, capsaicin-desensitized rats exhibited a reduction in bladder capacity from 1.23 ± 0.08 mL to 0.70 ± 0.10 mL (P = 0.002, n = 9), a reduction in urethral perfusion pressure from 19.3 ± 2.1 cmH2O to 10.9 ± 1.2 cmH2O (P = 0.004, n = 9), and a reduction in bladder compliance from 0.13 ± 0.020 mL/cmH2O to 0.090 ± 0.014 mL/cmH2O (P = 0.011, n = 9). Thus, changes in bladder function following the instillation of PGE2 were not dependent on capsaicin-sensitive pathways. Further, these results suggest that urethral relaxation/weakness and/or increased detrusor pressure as a result of decreased compliance may contribute to urinary urgency and highlight potential targets for new therapies for overactive bladder.

Altered gut microbiome associated with overactive bladder and daily urinary urgency.

PURPOSE: To explore associations between the gut microbiome and overactive bladder (OAB) with daily urinary urgency among individuals reporting this diagnosis within a single community. METHODS: This cross-sectional study surveyed 1113 individuals who participated in the Iwaki Health Promotion Project in Japan. OAB was defined as urinary urgency at least once per week and an Overactive Bladder Symptom Score (OABSS) of ≥ 3. OAB with urinary urgency at least once a day was defined as daily urgency. The gut microbiomes were assessed by next-generation sequencing of 16S rRNA genes extracted from fecal samples. The participants were divided into two groups: OAB-daily urgency and non-OAB. Cases were selected for inclusion on the basis of 1:1 propensity score matching; we assigned 58 individuals to each group (23 men and 35 women) for our analysis. RESULTS: Individuals reporting OAB with daily urinary urgency demonstrated a lower bacterial diversity between individuals (Bray-Curtis distance 0.48 vs. 0.53, P < 0.001); the results cluster differently in the non-OAB groups. The relative abundance of genus Bifidobacterium was significantly lower among those reporting daily urgency (2.41% vs. 4.23%, P = 0.014). By contrast, the relative abundance of genus Faecalibacterium (9.25% vs. 6.26%, P = 0.006) was significantly higher in this group. CONCLUSION: We observed significant differences in gut microbial contents and specific bacterial genera in association with OAB with daily urgency. Further study will be necessary to assess causal relationships between the gut microbiome and OAB.

Cardiovascular safety of vibegron, a new ß3-adrenoceptor agonist, in older patients with overactive bladder: Post-hoc analysis of a randomized, placebo-controlled, double-blind comparative phase 3 study.

AIMS: To examine the safety and efficacy of vibegron, a new ß3-adrenoceptor agonist, in patients aged ≥65 years, with a focus on the effects on cardiovascular system and overactive bladder (OAB) symptoms. METHODS: A post-hoc subgroup analysis was performed of a randomized, placebo-controlled, double-blind comparative phase 3 study of vibegron, including those assigned to receive either vibegron 50 mg (V50), vibegron 100 mg (V100), or placebo for 12 weeks. Subjects were stratified into two subgroups based on age: a <65-year subgroup and a ≥65-year subgroup. Safety (changes in systolic and diastolic blood pressure, pulse rate, and residual urine volume) and efficacy (changes in the numbers of micturitions, urgency episodes, urgency urinary incontinence [UUI] episodes, and the voided volume/micturition) were assessed in the subgroups treated with vibegron vs. placebo. RESULTS: There were no significant differences in the cardiovascular outcomes (blood pressure and pulse rate), nor in the changes in residual urine volume, between the V50/100 and placebo groups in the <65-year or ≥65-year subgroup after 12-week treatment. Adverse events were slightly increased in the ≥65-year subgroup. In the efficacy analysis, V50/100 demonstrated similar efficacy in the <65-year and ≥65-year subgroups; an increasing trend in the voided volume/micturition was observed in subjects aged ≥65 years compared to subjects aged <65 years. CONCLUSIONS: Vibegron was suggested to be similarly effective in patients ≥65 and <65 years and to have minimal influence on cardiovascular parameters.

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented. METHODS: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented. RESULTS: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred. CONCLUSIONS: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

Association between female urinary urgency and aponeurotic ptosis: Results from a community-based cross-sectional study in Japan.

AIMS: To investigate the relationship between urinary urgency (UU) and aponeurotic ptosis (AP) in a health promotion project. METHODS: This cross-sectional study analyzed 658 women in Aomori, Japan. The presence of UU was evaluated using the Overactive Bladder Symptom Score. The distance from the light reflex on the cornea to the upper eyelid (margin reflex distance-1 [MRD-1]) was measured. AP was defined as MRD-1 of less than 2.0 mm. The daily salt intake amount was estimated using the dietary questionnaire. Daily salt intake was defined as excessive if it was 10 g/day or higher. Independent factors of UU and AP were analyzed via multivariable logistic regression model. RESULTS: The number of women with UU and AP was 193 and 65, respectively. Similar background differences were observed in age, cardiovascular disease history, renal function, hypertension, diabetes mellitus, dyslipidemia, and daily salt intake between participants with UU and those with AP. Participants with UU had a higher prevalence of AP (19% vs. 6.2%) than those without. Moreover, more than 50% of the women with AP experienced UU. Multivariable logistic analysis on UU showed that age (≥65 years), diabetes mellitus, daily salt intake (≥10 g/day), and AP (odds ratio, 2.07, p = .014) were independent factors. Multivariable analysis on AP revealed that age (≥65 years), hypertension, daily salt intake (≥10 g/day), and UU were independent factors. CONCLUSIONS: AP was an independent indicator of UU, in addition to excessive daily salt intake. Women with AP may tend to intake excessive salt and experience UU.

Can patients independently identify their urinary incontinence symptoms?

INTRODUCTION AND HYPOTHESIS: The objective of our study is to compare patient self-reported urinary incontinence symptoms based on the International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) question number 6 (When does urine leak?) with physician-assessed interpretation of the patient's urinary incontinence symptoms. METHODS: This trial is a cross-sectional study of patients who presented to a tertiary urogynecology center with symptoms of urinary incontinence between January 2014 and August 2016. We compared patient-reported symptoms on the ICIQ-SF with physician interpretation of urinary complaints during their initial visit. The urinary incontinence symptoms included stress urinary incontinence (SUI), urgency urinary incontinence (UUI), insensible urine loss, nocturnal enuresis, and post-micturition dribbling. RESULTS: A total of 432 patients with a mean age of 61 were included in this evaluation. The most common urinary incontinence symptoms according to the physician were UUI (n = 357, 83%), followed by SUI (n = 308, 71%). Of the patients who were diagnosed by a physician with the symptom of UUI, only 61% self-identified as having this symptom based on the ICIQ-SF, and for SUI, only 66% self-identified as having SUI symptoms based on the ICIQ-SF. Overall UUI (κ = 0.30) appears to have poor agreement, as does nocturnal enuresis (κ = 0.39), when compared with physician historical assessment. CONCLUSION: There is a discrepancy between patient-reported urinary incontinence symptoms on the ICIQ-SF and physician-assessed symptoms. Symptomatology entered into electronic medical records by patients is often inaccurate. Physician validation is essential in understanding the underlying the precise symptomatology.

The Bladder at Night during Hospitalisation: Towards optimal care for elderly patients with nocturia.

OBJECTIVE: This study aimed to describe the characteristics of nocturia in older hospitalised patients and to explore knowledge, beliefs and experiences associated with night toileting while in hospital in order to identify unmet care needs. METHODS: A multisite mixed methods cross-sectional study of older hospitalised adults who were admitted for ≥2 days was conducted using a standardised researcher-administered questionnaire. An additional cohort 16 older hospitalised adults with nocturia >twice per night were interviewed to understand the experience and impact of nocturia during hospitalisation. RESULTS: Nocturia was experienced by 260 out of 308 participants. In-hospital nocturia was significantly correlated with nocturia in the month preceding admission, high diurnal voiding frequency and nocturnal urinary urgency. Bother was attributed to multiple nocturia episodes. Participants had poor knowledge and understanding of nocturia and believed the symptom to be a normal occurrence; only 20% had discussed management with staff. Disrupted sleep and fear of falling were common in older immobile participants with nocturia. CONCLUSION: Nocturia is highly prevalent in hospitalised older people. Toileting multiple times at night bothers patients, disrupts sleep, heightens a fear of falling yet is rarely addressed in ward management plans. A screening process to identify, assess, provide education and intervene for nocturia has the potential to improve wellbeing, safety at night and to address risk factors.