BACKGROUND: Vibegron is a selective β3-adrenergic receptor agonist that was approved by the US Food and Drug Administration in December 2020 for the treatment of overactive bladder in adults. This retrospective study assessed US pharmacy claims data to evaluate the real-world adherence and persistence of vibegron compared with mirabegron and with anticholinergics.
METHODS: This analysis used the Optum Research Database to identify adults with ≥1 pharmacy claim for vibegron, mirabegron, or an anticholinergic from April 1, 2021, to August 31, 2022. Patients had ≥ 90 days of continuous commercial or Medicare medical and pharmacy coverage preindex and ≥ 60 days of continuous pharmacy coverage postindex. Two independent propensity-score models matched patients treated with (1) vibegron versus mirabegron and (2) vibegron versus anticholinergics on key variables such as demographics and clinical characteristics, index copay, days\' supply, and time of entry into analysis (index quarter). Adherence was measured by proportion of days covered (PDC) from index to the end of follow-up and was defined as PDC ≥ 80%. Persistence was defined as days to discontinuation of index medication (first 30-day gap) or end of follow-up.
RESULTS: The matched vibegron and mirabegron cohorts included 4921 and 9842 patients, respectively, and the matched vibegron and anticholinergic cohorts included 4676 and 9352 patients, respectively. Patients receiving vibegron had greater mean PDC versus patients receiving mirabegron (0.67 vs. 0.64, respectively; p < 0.001) or anticholinergics (0.67 vs. 0.58; p < 0.001). A greater percentage of patients receiving vibegron were adherent versus those receiving mirabegron (49.0% vs. 45.1%, respectively; p < 0.001) or anticholinergics (49.1% vs. 38.5%; p < 0.001). Persistence was longer with vibegron compared with both mirabegron (median [95% CI], 171 [159-182] vs. 128 [122-137] days, respectively; p < 0.001) and anticholinergics (172 [159-183] vs. 91 [91] days; p < 0.001).
CONCLUSIONS: In this retrospective analysis of pharmacy claims data, patients receiving vibegron exhibited significantly higher adherence and demonstrated longer persistence in comparison to matched patient cohorts receiving either mirabegron or anticholinergics.

BACKGROUND: Vibegron is a β3-adrenergic receptor agonist approved for overactive bladder (OAB). This analysis assessed real-world adherence and persistence with vibegron in patients with OAB, along with demographics and clinical characteristics associated with adherence and persistence.
METHODS: This retrospective study used the Optum Research Database to identify patients treated with vibegron from April 2021 to August 2022 (identification period). Patients had ≥ 60 days of continuous pharmacy coverage in a commercial or Medicare Advantage plan following the index fill (follow-up). Adherence was assessed as proportion of days covered (PDC) from index to end of follow-up and was defined as PDC ≥ 80%. Persistence was measured as days to discontinuation of therapy (30-day gap) or end of follow-up. Data for adherence and persistence are presented descriptively. Characteristics associated with adherence and persistence were analyzed using multivariable models among patients with medical and pharmacy benefits during the 90 days before index (baseline).
RESULTS: Overall, 9992 patients had a vibegron claim during the identification period; 9712 had ≥ 2 months of follow-up. Mean (SD) age was 74.2 (10.7) years; 68.2% were female. Mean (SD) PDC was 0.64 (0.34). Median (95% confidence interval) persistence was 142 (132-153) days. Of the 5073 patients who were ≥ 18 years old with continuous baseline pharmacy and medical benefits ≥ 90 days before index, 2497 (49.2%) were adherent. Patients were more likely to be adherent and persistent if they received a greater days\' supply for the index fill and had baseline medication count ≥ 6. Patients were more likely to discontinue if their index copay was > $45.
CONCLUSIONS: Nearly half of the patients initiating vibegron were adherent. Factors associated with adherence and persistence were more likely to be related to prescribing practices than patient characteristics. These results suggest it may be best to follow up with patients approximately 4 to 5 months after initiating treatment with vibegron.
Vibegron is a newer drug for treating overactive bladder. Vibegron was safe and worked well in clinical trials. However, there is no information on use of vibegron in a real-world population that is not a clinical trial. This study looked at how consistently and how long patients took vibegron after starting it. It also looked at what was common in patients who took vibegron consistently. To do this, the study used pharmacy prescription data from April 2021 to August 2022. It examined adherence to the study medication for each patient. Adherence is how many days patients had medication on hand compared to how long they were followed. The study also looked at persistence to the study medication. Persistence is how long a patient takes a medication before they stop taking it. Researchers then examined if there were reasons a patient may or may not take vibegron as prescribed. The study included prescription data for 9712 patients. The average age was 74 years and 68% of patients were female. Patients had their medication 64% of the time (adherence). On average, patients took their medication for 142 days before stopping (persistence). Patients had better adherence and persistence if they received a larger supply of medication at the pharmacy when first prescribed the medication and if they had more medications overall. Patients’ age and gender did not affect adherence and persistence. Vibegron may be a good option for patients with overactive bladder. Follow-up with a provider may be considered 4 to 5 months after starting vibegron.

The global cesarean delivery rate is high and continues to increase. A bladder catheter is usually placed for the cesarean delivery because a distended bladder is assumed to be at higher risk of injury during surgery and to compromise surgical field exposure. Preliminary data suggest that self bladder emptying (no catheter) at cesarean delivery may have advantages and be safe.
This study aimed to compare the effects of self bladder emptying and indwelling Foley bladder catheterization for planned cesarean delivery on the rate of postpartum urinary retention and maternal satisfaction.
A randomized controlled trial was conducted in a tertiary university hospital from January 10, 2022 to March 22, 2023. A total of 400 participants scheduled for planned cesarean delivery were randomized: 200 each to self bladder emptying or indwelling Foley catheter. The primary outcomes were postpartum urinary retention (overt and covert) and maternal satisfaction with allocated bladder care. Analyses were performed using t test, Mann-Whitney U test, chi-square test, or Fisher exact test, as appropriate. Logistic regression was used to adjust for differences in characteristics.
Postpartum urinary retention rates were 1 per 200 (0.6%) and 0 per 200 (P>.99) (a solitary case of covert retention) and maternal satisfaction scores (0-10 visual numerical rating scale), expressed as median (interquartile range) were 9 (8-9.75) and 8 (8-9) (P=.003) in the self bladder emptying and indwelling Foley catheter arms, respectively. Regarding secondary outcomes, time to flatus passage, satisfactory ambulation, urination, satisfactory urination, satisfactory breastfeeding, and postcesarean hospital discharge was quickened in the self bladder emptying group. Pain scores at first urination were decreased and no lower urinary tract symptom was more likely to be reported with self bladder emptying. Surgical field view, operative blood loss, duration of surgery, culture-derived urinary tract infection, postvoid residual volume, and pain score at movement were not different. There was no bladder injury.
Self bladder emptying increased maternal satisfaction without adversely affecting postpartum urinary retention. Recovery was enhanced and urinary symptoms were improved. The surgeon was not impeded at operation. No safety concern was found.

Spinal cord injury often results in chronic loss of micturition control, which is featured by bladder hyperreflexia and detrusor sphincter dyssynergia. Previous studies showed that treatment of capsaicin reduces non-voiding bladder contractions in multiple animal injury models and human patients. However, its underlying neural mechanisms remain largely unknown. Here, by injecting a RetroAAV into the bladder wall, we specifically targeted TRPV1+, a capsaicin receptor, bladder afferent neurons. Morphometric analysis revealed borderline increase of the soma size and significant spinal axon sprouting of TRPV1+ bladder afferent neurons post a complete T8 spinal cord crush. We further demonstrated that chronic chemogenetic inhibition of these DRG neurons improved micturition recovery after SCI by increasing voiding efficiency and alleviating bladder hyperreflexia, along with reduced morphological changes caused by injury. Our study provided novel insights into the structural and functional changes of TRPV1+ bladder afferent post SCI and further supports the clinical use of capsaicin as an effective treatment to improve bladder functions in patients with SCI.

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

This study aims to activate the external urethral sphincter (EUS), which plays a critical role in micturition control, through optogenetics and to determine its potential contribution to the stabilization of sensitized micturition activity. The viral vector (AAV2/8-CMV-hChR2(H134R)-EGFP) is utilized to introduce light-gated ion channels (hChR2/H134R) into the EUS of wild-type C57BL/6 mice. Following the induction of sensitized micturition activity using weak acetic acid (0.1%) in anesthetized mice, optical stimulation of the EUS muscle tissue expressing channel rhodopsin is performed using a 473 nm laser light delivered through optical fibers, and the resulting changes in muscle activation and micturition activity are examined. Through EMG (electromyography) measurements, it is confirmed that optical stimulation electrically activates the EUS muscle in mice. Analysis of micturition activity using cystometry reveals a 70.58% decrease in the micturition period and a 70.27% decrease in the voiding volume due to sensitized voiding. However, with optical stimulation, the micturition period recovers to 101.49%, and the voiding volume recovered to 100.22%. Stimulation of the EUS using optogenetics can alleviate sensitized micturition activity and holds potential for application in conjunction with other micturition control methods.

OBJECTIVE: This study was conducted to determine the effect of listening to the sound of running water during urodynamics on the patient\'s anxiety and parameters in the pressure-flow study.
METHODS: The population of the study, which was planned in the nonrandomized experimental study design, consisted of patients who will undergo urodynamics in the Urology Department of a city hospital in Istanbul between September 2022 and January 2023, and the sample consisted of 60 patients, 30 of which were in the experimental group and 30 in the control group. During the pressure-flow study, the patients in the experimental group listened to the sound of running water from a smartphone, while the patients in the control group did not undergo any intervention during urodynamics. The level of anxiety in both groups before, during and after urodynamics was evaluated with the visual analogue scale. During the pressure-flow study, it was evaluated whether the patients emptied on command, and the maximum flow rate (Qmax) and the detrusor pressure at the maximum flow rate (PdetQmax) were measured. Bladder outlet obstruction index (PdetQmax-2Qmax) and bladder contractility index (Pdetqmax+5Qmax) were calculated using these values.
RESULTS: During the pressure-flow study, in the experimental group patients who listened to the sound of running water from a smartphone; anxiety level mean scores during and after urodynamics were found to be statistically significantly lower than the control group patients (P < 0.001). The mean bladder contractility index score in the experimental group patients was statistically significantly higher than the control group patients (P < 0.001), and the cases of urinating with a catheter during the pressure-flow study were statistically significantly higher than the control group patients (P < 0.001).
CONCLUSIONS: Listening to the sound of running water during urodynamics had a positive effect on reducing anxiety in patients and micturating during pressure-flow study.

OBJECTIVE: Assessing brainstem function in humans through typical neuroimaging modalities has been challenging. Our objective was to evaluate brain and brainstem activation patterns during initiation of voiding in healthy males and females utilizing a 7 Tesla magnetic resonance imaging (MRI) scanner and a noninvasive brain-bladder functional MRI (fMRI) protocol.
METHODS: Twenty healthy adult volunteers (10 males and 10 females) with no history of urinary symptoms were recruited. Each volunteer underwent a clinic uroflow and postvoid residual assessment and was asked to consume water prior to entering the scanner. Anatomical and diffusion tensor images were obtained first, followed by a blood oxygenation level dependent (BOLD) resting-state fMRI (rs-fMRI) during the empty bladder. Subjects indicated when they felt the urge to void, and a full bladder rs-fMRI was obtained. Once completed, the subjects began 5 voiding cycles, where the first 7.5 seconds of each voiding cycle was identified as \"initiation of voiding.\" BOLD activation maps were generated, and regions of interests with a t-value greater than 2.1 were deemed statistically significant.
RESULTS: We present 5 distinct regions within the periaqueductal gray (PAG) and pontine micturition center (PMC) with statistically significant activation associated with an initiation of voiding in both men and women, 3 within the PAG and 2 within the PMC. Several additional areas in the brain also demonstrated activation as well. When comparing males to females, there was an overall lower BOLD activation seen in females throughout all regions, with the exception of the caudate lobe.
CONCLUSIONS: Our study effectively defines regions within the PAG and PMC involved in initiation of voiding in healthy volunteers. To our knowledge, this is the first study investigating differences between male and female brainstem activation utilizing an ultra-high definition 7T MRI.

Introduction: The medial preoptic area (mPOA) participates in thermoregulatory control and blood pressure modulation as shown by studies with electrical stimulation of this area or cobalt chloride injection, a non-selective synapse inhibitor. This study aimed to investigate whether angiotensin II (Ang II) and GABA could act or not in the mPOA to mediate the cardiovascular and micturition control pathways. Methods: Female Wistar rats were submitted to stereotaxic surgery for implantation of a guide cannula into the mPOA 7 days prior to the experiments. Afterwards, the animals were isoflurane- anesthetized and submitted to the catheterization of the femoral artery and vein and urinary bladder cannulation for mean arterial pressure (MAP), heart rate (HR), and intravesical pressure (IP) recordings, respectively. After the baseline MAP, HR, and IP recordings for 15 min, Ang II (0.1 nM, 1 μL), losartan (AT-1 receptor antagonist, 100 nM, 1 μL), GABA (50 mM, 1 μL) or saline (1 μL) were injected into the mPOA, and the variables were measured for additional 30 min. In a different group of rats, the AT-1 receptor, angiotensin II converting enzyme (ACE), and GABAa receptor gene expression was evaluated in mPOA samples by qPCR. The data are as mean ± SEM and submitted to One-way ANOVA (Tukey posttest) or paired Student t-test (P <0.05). Results: The injection of Ang II into the mPOA evoked a significant hypotension (-37±10 mmHg, n = 6, p = 0.024) and bradycardia (-47 ± 20 bpm, p = 0.030) compared to saline (+1 ± 1 mmHg and +6 ± 2 bpm, n = 6). A significant increase in IP was observed after Ang II injection into the mPOA (+72.25 ± 17.91%, p = 0.015 vs. -1.80 ± 2.98%, n = 6, saline). No significant changes were observed in MAP, HR and IP after the losartan injection in the mPOA compared to saline injection. Injection of GABA into the mPOA evoked a significant fall in MAP and HR (-68 ± 2 mmHg, n = 6, p < 0.0001 and -115 ± 14 bpm, n = 6, p = 0.0002 vs. -1 ± 1 mmHg and +4 ± 2 bpm, n = 6, saline), but no significant changes were observed in IP. The AT-1 receptor, ACE and GABAa receptor mRNA expression was observed in all mPOA samples. Discussion: Therefore, in female rats, Ang II mediated transmission in the mPOA is involved in the cardiovascular regulation and in the control of central micturition pathways. A phasic control dependent on AT-1 receptors in the mPOA seems to be involved in the regulation of those cardiovascular and intravesical 3 parameters. In contrast, GABAergic transmission in the mPOA participates in the pathways of cardiovascular control in anesthetized female rats, nevertheless, this neurotransmission is not involved in the micturition control.

The central nervous system (CNS) regulates lower urinary tract reflexes using information from sensory afferents; however, the mechanisms of this process are not well known. Pressure and volume were measured at the onset of the guarding and micturition reflexes across a range of infusion rates to provide insight into what the CNS is gauging to activate reflexes.
Female Sprague Dawley rats were anesthetized with urethane for open outlet cystometry. A set of 10 infusion rates (ranging 0.92-65.5 mL/h) were pseudo-randomly distributed across 30 single-fill cystometrograms. Bladder pressure and external urethral sphincter electromyography were used for the determination of the onset of the micturition and guarding reflexes, respectively. The bladder volume at the onset of both reflexes was estimated from the total infusion rate during a single fill.
In response to many single-fill cystometrograms, there was an increased volume the bladder could store without a significant increase in pressure. Volume was adjusted for this effect for the analysis of how pressure and volume varied with infusion rate at the onset of the micturition and guarding reflexes. In 25 rats, the micturition reflex was evoked at similar volumes across all infusion rates, whereas the pressure at micturition reflex onset increased with increasing infusion rates. In 11 rats, the guarding reflex was evoked at similar pressures across infusion rates, but the volume decreased with increasing infusion rates.
These results suggest that the CNS is interpreting volume from the bladder to activate the micturition reflex and pressure from the bladder to activate the guarding reflex.