Treatment Of Overactive Bladder Research Articles

The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder.

The purpose of this guideline is to provide evidence-based guidance to clinicians of all specialties on the evaluation, management, and treatment of idiopathic overactive bladder (OAB). The guideline informs the reader on valid diagnostic processes and provides an approach to selecting treatment options for patients with OAB through the shared decision-making process, which will maximize symptom control and quality of life, while minimizing adverse events and burden of disease. An electronic search employing OVID was used to systematically search the MEDLINE and EMBASE databases, as well as the Cochrane Library, for systematic reviews and primary studies evaluating diagnosis and treatment of OAB from January 2013 to November 2023. Criteria for inclusion and exclusion of studies were based on the Key Questions and the populations, interventions, comparators, outcomes, timing, types of studies and settings (PICOTS) of interest. Following the study selection process, 159 studies were included and were used to inform evidence-based recommendation statements. This guideline produced 33 statements that cover the evaluation and diagnosis of the patient with symptoms suggestive of OAB; the treatment options for patients with OAB, including Noninvasive therapies, pharmacotherapy, minimally invasive therapies, invasive therapies, and indwelling catheters; and the management of patients with BPH and OAB. Once the diagnosis of OAB is made, the clinician and the patient with OAB have a variety of treatment options to choose from and should, through shared decision-making, formulate a personalized treatment approach taking into account evidence-based recommendations as well as patient values and preferences.

Efficacy and safety of onabotulinumtoxinA for the treatment of overactive bladder in men and women: A pooled analysis.

This pooled analysis of randomized controlled studies investigated the safety and efficacy of onabotulinumtoxinA in male and female patients with overactive bladder (OAB). Data were pooled from four similarly designed trials in North America and Europe. Adults with idiopathic OAB for ≥6 months inadequately managed by at least one anticholinergic were randomized 1:1 or 2:1 to receive onabotulinumtoxinA 100 U or matched placebo in Cycle 1 and could request open-label retreatment with onabotulinumtoxinA 100 U at ≥12 weeks. Efficacy outcomes at Week 12 included the primary endpoint of mean urinary incontinence (UI) episodes per day and other variables, such as the proportion of patients with ≥50% reduction in daily UI episodes. Safety was assessed by monitoring treatment-emergent adverse events (TEAEs). Analyses by sex were descriptive. Males were further analyzed by benign prostatic hyperplasia (BPH) diagnosis status. In the pooled population (N = 1564), there were 194 males (12.4%) and 1370 females (87.6%). Mean number of baseline UI episodes per day was 4.9 in males and 5.5 in females. At Week 12, numerically greater mean reductions from baseline in number of daily UI episodes were observed with the onabotulinumtoxinA 100 U group (females: -3.0; males: -2.2) versus placebo (females: -1.1; males: -1.3). Achievement of ≥50% reduction in daily UI episodes was numerically greater with onabotulinumtoxinA 100 U (females: 64.8%; males: 61.2%) versus placebo (females: 30.6%; males: 44.8%), and numerically higher in males without BPH (onabotulinumtoxinA: 65.1%; placebo: 50.9%) versus with BPH (onabotulinumtoxinA: 54.3%; placebo: 36.6%). A total of 34.7% of males and 39.4% of females experienced at least one TEAE in the first 12 weeks during treatment Cycle 1. Urinary tract infection rate was 13.1% in females and 4.2% in males; incidence of hematuria was 6.8% in males and 1.1% in females. Incidence of urinary retention (defined as incomplete emptying, requiring catheterization) was 2.7% in females and 4.7% in males. OnabotulinumtoxinA 100 U was efficacious and well tolerated in men and women with OAB, including in males with and without BPH. No new safety findings were identified when data were analyzed by sex.

Evaluation of the efficacy of Vesusten® in patients with overactive bladder and chronic recurrent cystitis

Introduction. Numerous studies have suggested that lower urinary tract infections may be involved in the development of overactive bladder (OAB) in patients who are resistant to standard treatment. In these cases, treatment targeting all stages of disease progression could be beneficial.Objective. To evaluate the efficacy of Vesusten® in management of OAB in women with chronic recurrent cystitis.Materials & methods. The study involved 40 patients diagnosed with OAB and chronic recurrent cystitis. All patients received Vesusten® as therapy for OAB. They received 5 mg of the medication intramuscularly three times per week for a total of 10 doses. The study included three stages: a screening period lasting up to 14 days; the stage for assessing the effectiveness of therapy (42 days from the start of therapy, including the therapy period + further follow-up after the end of therapy); follow-up period — 180 days + 14 days from completion of treatment.Results. It was revealed Vesusten® clinical effectiveness on the severity of OAB symptoms and the quality of life of patients. hree weeks after the end of treatment, there was a statistically significant decrease in the severity of OAB symptoms on the Patient Perception Index of Urgency and Symptoms (PPIUS) (2.2 ± 1.0 vs 0.95 ± 1.0 points) and TUFS (28.4 ± 11.6 vs 5. 1 ± 6.4 points), a decrease in the number of urinations during the day (11.5 ± 2.2 vs 8.8 ± 2.7 episodes) and at night (3.5 ± 1.8 vs 1.4 ± 1.5 episodes) time (p < 0.001). The nighttime urination frequency decreased by more than 2.5 times, while the proportion of patients who did not wake up at night for urination increased from 10 % to 35%. Evaluation of the Overactive Bladder Questionnaire (OAB-Q) after the completion of treatment compared with the initial data showed a statistically significant improvement in quality of life related to the severity of OAB symptoms (24.8 ± 7.5 vs 15.7 + 6.4 points; p < 0.001), and with general health status (74.0 ± 31.7 vs 57.6 ± 22.1 points; p = 0.0087). The average duration of the relapse-free period, including the course of Vesusten® treatment and the follow-up period, significantly increased to 42.90 ± 9.64 weeks in comparison with the duration of the relapse-free period before patients’ inclusion in the study — 17.96 ± 7.75 weeks (p < 0.001). During the clinical study, eight women experienced exacerbations of chronic cystitis (20%).Conclusion. Study results suggest that the drug Vesusten® may be an effective treatment for OAB in combination with chronic recurrent cystitis. Based on our findings, we believe that Vesusten® can be considered as a potential treatment option for patients with chronic cystitis.

Evaluation of the efficacy of Vesusten® in patients with overactive bladder and chronic recurrent cystitis

Introduction. Numerous studies have suggested that lower urinary tract infections may be involved in the development of overactive bladder (OAB) in patients who are resistant to standard treatment. In these cases, treatment targeting all stages of disease progression could be beneficial.Objective. To evaluate the efficacy of Vesusten® in management of OAB in women with chronic recurrent cystitis.Materials & methods. The study involved 40 patients diagnosed with OAB and chronic recurrent cystitis. All patients received Vesusten® as therapy for OAB. They received 5 mg of the medication intramuscularly three times per week for a total of 10 doses. The study included three stages: a screening period lasting up to 14 days; the stage for assessing the effectiveness of therapy (42 days from the start of therapy, including the therapy period + further follow-up after the end of therapy); follow-up period — 180 days + 14 days from completion of treatment.Results. It was revealed Vesusten® clinical effectiveness on the severity of OAB symptoms and the quality of life of patients. hree weeks after the end of treatment, there was a statistically significant decrease in the severity of OAB symptoms on the Patient Perception Index of Urgency and Symptoms (PPIUS) (2.2 ± 1.0 vs 0.95 ± 1.0 points) and TUFS (28.4 ± 11.6 vs 5. 1 ± 6.4 points), a decrease in the number of urinations during the day (11.5 ± 2.2 vs 8.8 ± 2.7 episodes) and at night (3.5 ± 1.8 vs 1.4 ± 1.5 episodes) time (p < 0.001). The nighttime urination frequency decreased by more than 2.5 times, while the proportion of patients who did not wake up at night for urination increased from 10 % to 35%. Evaluation of the Overactive Bladder Questionnaire (OAB-Q) after the completion of treatment compared with the initial data showed a statistically significant improvement in quality of life related to the severity of OAB symptoms (24.8 ± 7.5 vs 15.7 + 6.4 points; p < 0.001), and with general health status (74.0 ± 31.7 vs 57.6 ± 22.1 points; p = 0.0087). The average duration of the relapse-free period, including the course of Vesusten® treatment and the follow-up period, significantly increased to 42.90 ± 9.64 weeks in comparison with the duration of the relapse-free period before patients’ inclusion in the study — 17.96 ± 7.75 weeks (p < 0.001). During the clinical study, eight women experienced exacerbations of chronic cystitis (20%).Conclusion. Study results suggest that the drug Vesusten® may be an effective treatment for OAB in combination with chronic recurrent cystitis. Based on our findings, we believe that Vesusten® can be considered as a potential treatment option for patients with chronic cystitis.

Clinical efficacy and safety analysis of type A botulinum toxin in the treatment of adolescents with refractory overactive bladder.

The objective of this study was to assess the clinical effectiveness and safety of type A botulinum toxin in the treatment of refractory overactive bladder in adolescents. We conducted a retrospective analysis of 37 adolescent patients with refractory overactive bladder who were treated at the Urology Department of Hangzhou Third People's Hospital between January 2018 and August 2023. These patients received intravesical injections of type A botulinum toxin at a concentration of 10 U/mL, with an average of 20 injection points. We recorded changes in urination diaries and urodynamic parameters both before and 1 month after treatment. After 1 month of treatment, significant improvements were observed in several parameters, when compared to the pretreatment values. These included daytime frequency of urination (11.13 ± 6.45), average single void volume (173.24 ± 36.48) mL, nighttime frequency of urination (2.43 ± 0.31), urgency episodes (3.12 ± 0.27), initial bladder capacity (149.82 ± 41.34) mL, and maximum bladder capacity (340.25 ± 57.12) mL (all P < .001). After the first treatment, 5 patients had mild hematuria, 4 patients had urinary tract infection, and 1 patient had urinary retention, which was relieved after catheterization. No serious complications or adverse reactions were observed in other patients. The follow-up period ranged from 6 to 18 months, and the duration of efficacy varied from 2 to 8 months. Eight patients who initially had treatment failure achieved symptom relief after reinjection. In adolescents with refractory overactive bladder who do not respond well to conventional drug therapy, type A botulinum toxin can be administered safely and effectively. It significantly improves lower urinary tract symptoms and enhances the quality of life for these patients.

Efficacy and safety of Vibegron for the treatment of residual overactive bladder symptoms after laser vaporization of the prostate: A single-center prospective randomized controlled trial (VAPOR TRIAL).

This study aimed to evaluate the efficacy and safety of Vibegron for the treatment of residual overactive bladder (OAB) symptoms after laser vaporization of the prostate (photo-selective vaporization of the prostate, contact laser vaporization of the prostate, and thulium laser vaporization). This randomized, open-label, parallel-group, single-center superiority trial with a 12-week observation (jRCTs071190040) enrolled male patients with OAB aged 40 years or older who had undergone laser vaporization of the prostate for not less than 12 weeks and not more than 1 year earlier. Patients were allocated to receive Vibegron 50 mg once daily or follow-up without treatment for 12 weeks. Forty-seven patients were enrolled between January 2020 and March 2023. The median age (interquartile range) was 75.5 (72.5-78.5) years for the Vibegron group and 76.5 (71.0-81.0) years for the control group. The intergroup difference in the mean change (95% confidence interval) in the 24-hour urinary frequency at 12 weeks after randomization was -3.66 (-4.99, -2.33), with a significant decrease for the Vibegron group. The Overactive Bladder Symptom Score, International Prostate Symptom Score, IPSS storage score, and Overactive Bladder Questionnaire score significantly improved for the Vibegron group. Voided volume per micturition also increased for the Vibegron group. The administration of 50 mg of Vibegron once daily for 12 weeks showed significant improvement compared with follow-up without treatment in bladder storage (OAB) symptoms after laser vaporization of the prostate for symptomatic benign prostatic hyperplasia.

Development and characterization of matrix-type drug delivery system for the treatment of Overactive Bladder

Development and characterization of matrix-type drug delivery system for the treatment of Overactive Bladder

Bladder training for treatment of overactive bladder in adults

Bladder training for treatment of overactive bladder in adults

Efficacy and Safety of Combination Therapy With Vaginal and Urethral Erbium-Doped Yttrium-Aluminum-Garnet (Er:YAG) Laser for Overactive Bladder With Urinary Incontinence.

This retrospective cohort study with propensity score (PS) matching aimed to evaluate the efficacy and safety of a combination therapy with vaginal and urethral erbium:yttrium aluminum garnet laser (VEL+UEL) (SP Dynamis; Fotona d.o.o., Ljubljana, Slovenia) in the treatment of overactive bladder with urinary incontinence (OAB-wet). The study included female OAB-wet patients aged 65 and above who were already taking OAB medication. Data obtained from electronic medical records were subjected to propensity score matching. All patients received instructions on pelvic floor exercises and were prescribed an appropriate dose of OAB medication. The VEL+UEL group (n=30) underwent three monthly laser sessions, while the control group (n=30) did not receive the treatment. Clinical outcomes were evaluated using the Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), three-day urination diary, and Vaginal Health Index Score (VHIS). Medication usage and adverse events were also assessed. Statistical analysis and R code were performed using the AI chatbot GPT-4.0. The VEL+UEL group showed significant improvements in OABSS score, ICIQ-SF score, voided volume, daytime frequency, nocturia, and VHIS after 12 months of treatment (p<0.001). Notably, 13.3% of patients transitioned from OAB-wet to OAB-dry. In contrast, the control group did not exhibit significant changes. Medication use was significantly reduced in the VEL+UEL group compared to the control group (p<0.001). No long-term side effects were reported. Combination therapy with VEL+UEL demonstrated efficacy and safety in the treatment of OAB-wet. Improvements in OAB symptoms, voided volume, frequency, nocturia, and vaginal health were observed, with a subset of patients transitioning to OAB-dry. VEL+UEL therapy offers a potential treatment option for OAB-wet, reducing medication use and improving patient outcomes. Further research is warranted to investigate the mechanism, long-term effects, safety, and cost-effectiveness of VEL+UEL therapy.

Lower urinary tract dysfunction in the central nervous system neurogenic bladder and the real-life treatment outcome of botulinum toxin A.

Neurogenic lower urinary tract dysfunction (NLUTD) is common in patients with central nervous system (CNS) lesions. Cases of cerebrovascular accidents (CVA), Parkinson's disease, dementia, and other intracranial lesions develop poor bladder control with or without urinary difficulty due to loss of cortical perception of bladder filling sensation and poor coordination of urethral sphincter relaxation during reflex micturition. Patients with CNS lesions usually have overactive bladder (OAB) symptoms, including urgency, frequency, incontinence, voiding symptoms of dysuria, large postvoid residual volume, and retention. In elderly patients with severe CNS disease the OAB symptoms are usually difficult to adequately relieve by medical treatment, and thus, their quality of life is greatly. Botulinum toxin A (BoNT-A) is currently licensed and has been applied in patients with idiopathic and neurogenic OAB due to spinal cord injury or multiple sclerosis. However, the application of BoNT-A in the treatment of urinary incontinence due to NLUTD in chronic CNS lesions has not been well-documented. Although cohort studies and case series support BoNT-A treatment for neurogenic OAB, chronic urine retention after intravesical BoNT-A injection for OAB and exacerbated urinary incontinence after urethral BoNT-A injection for voiding dysfunction have greatly limited its application among patients with NLUTD due to CNS lesions. This article reviews the pathophysiology and clinical characteristics of NLUTD in patients with CNS lesions and the clinical effects and adverse events of BoNT-A injection for patients with NLUTD. A flowchart was created to outline the patient selection and treatment strategy for neurogenic OAB.

Outcomes of para-sacral transcutaneous electric nerve stimulation in treatment of primary and refractory overactive bladder among children.

Overactive bladder (OAB) is the most prevalent lower urinary tract dysfunction among children. Refractory OAB lacks response to the first line treatments, including anticholinergic, and it is a major clinical challenge. This study aims to compare the efficacy of para-sacral transcutaneous electric nerve stimulation (PS-TENS) in the treatment of primary and refractory OAB among children. A prospective, randomized clinical study included 64 children aged 5-12 years with OAB divided equally into two groups: group (1) included 32 children with treatment-naive OAB, while group (2) included 32 children with refractory OAB who failed complete course of anticholinergics. Both groups received PS-TENS three times weekly for 12weeks. Detailed medical history, voiding diary, ultrasound, and uroflowmetry with EMG were performed at baseline and after 12 weeks of treatment. Filling cystometry was performed for children with refractory OAB before and after PS-TENS. After the end of treatment the number of children with urge incontinence decreased significantly among the two groups: from 25 to 13 and 27 to 15 for the primary and refractory groups, respectively. Micturition frequency per 24h decreased significantly among children with primary OAB. Bladder capacity increased significantly and the resting detrusor pressure decreased significantly among children with refractory OAB. PS-TENS is an effective and safe treatment option for children with OAB. The magnitude of improvement is higher among children with primary as compared to refractory OAB.

Comparative analysis of real-world adherence and persistence patterns with vibegron, mirabegron, and anticholinergics in patients with overactive bladder: A retrospective claims study.

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. 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. 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). 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.

ANALYTICAL TECHNIQUES FOR DETERMINATION OF MIRABEGRON FROM BULK, PHARMACEUTICAL FORMULATION, AND BIOLOGICAL MATRICES: A CRITICAL REVIEW

Mirabegron is a beta-3 adrenergic receptor agonist and is specified for the treatment of overactive Bladder. This review covers analytical methods aimed at the identification and quantification of mirabegron in bulk, commercial dosage forms, and Biological fluids. Using various techniques such as UV-spectroscopy, spectro-fluorimetry, planer chromatography, High Performance-Thin Layer Chromatography (HPTLC), HPLC, High-Performance Liquid Chromatography-MS/MS (HPLC-MS/MS), Ultra-Pressure Liquid Chromatography-MS/MS (UPLC-MS/MS), and capillary electrophoresis. HPLC is the most used analytical technique for the identification and quantification of mirabegron in bulk and commercial dosage forms.

The effect of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder

BackgroundMen with overactive bladder (OAB) and benign prostatic hyperplasia (BPH), will have deterioration in the quality of life.ObjectiveThe aim of this study was to evaluate the effect of combining pelvic floor muscle training with the urgency suppression technique (PFMT-st) and silodosin in comparison with silodosin in men with benign prostatic hyperplasia (BPH) and overactive bladder (OAB) after 12 weeks of treatment.Patients and methodsA total of 158 patients were randomized into two groups. The control group received oral silodosin at a daily dose of 8 mg. The experimental group was administered PFMT-st and silodosin. The evaluation methods included the number of voids and intensity of urgencies over 24 h using a micturition diary, the International Prostate Symptom Score (IPSS), the Overactive Bladder Questionnaire (OAB-q), and the patient global impression of improvement (PGI-I).Results142 of 172 (86.6%) men were assessed (70 in the control group, 72 in the experimental group). The significant changes were in favor of the experimental group (p < 0.001) in the number of voids per 24 h (− 1.95 ± 1.94 vs. − 0.90 ± 1.44), the OAB-q symptom score (− 14.25 ± 10.05 vs. − 9.28 ± 10.60), the intensity of urgencies (− 0.97 ± 0.53 vs. 0.24 ± 0.57), the IPSS (− 4.59 ± 3.00 vs. − 2.30 ± 3.63), and in the PGI-I (2.24 ± 0.79 vs. 3.60 ± 0.92).ConclusionsThe addition of PFMT-st to silodosin treatment significantly improved OAB in men with BPH. This is the first study to confirm that PFMT-st should be the first-choice treatment for OAB in BPH.

Integrated approach of white analytical chemistry and design of experiments to microwave-assisted sensitive and eco-friendly spectrofluorimetric estimation of mirabegron using 4-chloro-7-nitrobezofuran as biosensing fluorescent probe

The USFDA recently approved mirabegron, a novel once-daily β-3 adrenoceptor agonist for oral administration, as a transformative treatment for overactive bladder. Despite the existence of numerous analytical methods for the assay and bioanalysis of mirabegron, it’s perplexing that none have explored the domain of microwave-assisted sensitive spectrofluorimetric method for mirabegron estimation, even after extensive literature review. Adding to the enigma is the insistence of current analytical methods on using expensive and harmful organic solvents, posing a threat to marine life and the broader environment. Recently, the white analytical chemistry approach has been introduced to develop analytical methods that are cost-effective, environmentally friendly, and user-friendly. Consequently, a white analytical chemistry-based, sensitive, and eco-friendly spectrofluorimetric estimation of mirabegron has been initiated, using 4-Chloro-7-nitrobenzofurazan as a fluorescent biosensing probe. The development of this robust method involved a series of experiments designed to minimize solvent and time wastage. Through a combination of fractional factorial and Box-Behnken designs, researchers identified the critical variables and optimized the method to perfection. This method was validated according to the stringent ICH Q2 (R2) and USFDA guidelines, ensuring its reliability and accuracy. Once approved, this sensitive spectrofluorimetric method was tested, accurately estimating mirabegron levels in commercial formulations and rat plasma samples. To further enrich the study, a comprehensive evaluation of existing analytical methods was conducted alongside the proposed spectrofluorimetric method, using advanced tools like the AGREE calculator, GAPI software, and RGB model to assess their eco-friendliness and effectiveness in mirabegron estimation.

Lessons learned from a multi-data source research collaboration: The mirabegron post-authorization safety study program.

Many factors contribute to developing and conducting a successful multi-data source, non-interventional, post-authorization safety study (NI-PASS) for submission to multiple health authorities. Such studies are often large undertakings; evaluating and sharing lessons learned can provide useful insights to others considering similar studies. We discuss challenges and key methodological and organizational factors that led to the delivery of a successful post-marketing requirement (PMR)/PASS program investigating the risk of cardiovascular and cancer events among users of mirabegron, an oral medication for the treatment of overactive bladder. We provide context and share learnings, including sections on research program collaboration, scientific transparency, organizational approach, mitigation of uncertainty around potential delays, validity of study outcomes, selection of data sources and optimizing patient numbers, choice of comparator groups and enhancing precision of estimates of associations, potential confounding and generalizability of study findings, and interpretation of results. This large PMR/PASS program was a long-term commitment from all parties and benefited from an effective coordinating center and extensive scientific interactions across research partners, scientific advisory board, study sponsor, and health authorities, and delivered useful learnings related to the design and organization of multi-data source NI-PASS.

The AUA/SUFU Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder.

The purpose of this guideline is to provide evidence-based guidance to clinicians of all specialties on the evaluation, management, and treatment of idiopathic overactive bladder (OAB). The guideline informs the reader on valid diagnostic processes and provides an approach to selecting treatment options for patients with OAB through the shared decision-making process, which will maximize symptom control and quality of life, while minimizing adverse events and burden of disease. An electronic search employing OVID was used to systematically search the MEDLINE and EMBASE databases, as well as the Cochrane Library, for systematic reviews and primary studies evaluating diagnosis and treatment of OAB from January 2013 to November 2023. Criteria for inclusion and exclusion of studies were based on the Key Questions and the populations, interventions, comparators, outcomes, timing, types of studies and settings (PICOTS) of interest. Following the study selection process, 159 studies were included and were used to inform evidence-based recommendation statements. This guideline produced 33 statements that cover the evaluation and diagnosis of the patient with symptoms suggestive of OAB; the treatment options for patients with OAB, including non-invasive therapies, pharmacotherapy, minimally invasive therapies, invasive therapies, and indwelling catheters; and the management of patients with BPH and OAB. Once the diagnosis of OAB is made, the clinician and the patient with OAB have a variety of treatment options to choose from and should, through shared decision-making, formulate a personalized treatment approach taking into account evidence-based recommendations as well as patient values and preferences.

Percutaneous tibial nerve stimulation for the overactive bladder: A single-arm trial.

We hypothesise that PTNS is a safe and effective treatment for OAB. Overactive bladder (OAB) is estimated to affect 11.8% of women worldwide, causing diminished quality of life. Lifestyle modifications, muscarinic receptor antagonist and beta-adrenoreceptor agonist remain the mainstay of treatment but are limited by their efficacy and adverse effects. Access to third-line therapies of intravesical botulinum toxin type A or sacral neuromodulation is limited by their invasive nature. Percutaneous tibial nerve stimulation (PTNS) has emerged as a non-invasive treatment option for OAB. This study was a single-arm trial of women requesting third-line treatment for OAB. The primary treatment outcome was patient-reported visual analogue score (VAS) improvement of at least 50%. Secondary outcome measures were Urinary Distress Inventory Short Form (UDI-6) score and two-day bladder diary. Patients also provided feedback on adverse effects encountered. In the 84 women recruited, initial treatment protocol showed a success rate of 77.2% among those who completed treatment based on VAS, with a statistically significant improvement in mean UDI-6 score of 20.13 (P < 0.01, standard deviation: 12.52). Continued success following tapering protocol of 60.8% and a mean maintenance protocol of 14.2 months was achieved. No adverse effects were reported. The results from this study are in concordance with previously published literature on the effectiveness and safety of PTNS as a treatment modality for OAB. Further randomised controlled trials to evaluate the optimal treatment protocol are warranted to establish a standardised regime.

Examining the safety of mirabegron: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database.

Background: Mirabegron, the first β-3 adrenergic receptor agonist, received approval from the Food and Drug Administration (FDA) in 2012 for the treatment of overactive bladder (OAB). This pharmacovigilance study investigated the safety profile of mirabegron treatment using the US FDA Adverse Event Reporting System (FAERS) database. Methods: This study employed disproportionality analyses, including the reporting odds ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) algorithm, to quantify signals of adverse events associated with mirabegron. Results: From the first quarter of 2012 to the third quarter of 2023, a comprehensive total of 14,356,234 adverse event (AE) reports were submitted to the FDA Adverse Event Reporting System database. Within this dataset, encompassing 18,763 reports specifically associated with mirabegron, healthcare professionals notably contributed 2,902 of these reports. A total of 80 preferred terms (PTs) of interest were identified using both the ROR and information component algorithms. The most common AEs included blood pressure increased, urinary retention, atrial fibrillation, dry mouth, and tachycardia, which were consistent with the product instructions. Unexpected significant AEs, such as arrhythmia, palpitations, dementia, transient ischemic attack, Parkinson's disease, anti-neutrophil cytoplasmic antibody positive vasculitis, lip swelling, and swollen tongue, were also identified. The study findings indicated that the majority of onset time occurred within 30days (n = 358, 55.68%). However, AEs were still possible after 1year of mirabegron treatment. Conclusion: This study provided valuable evidence for the real-world safety of mirabegron, helping clinical professionals enhance their understanding of mirabegron's safety in clinical practice. It also contributed valuable evidence for further safety studies on mirabegron.

Development and characterization of 3D printed ethylene vinyl acetate (EVA) as drug delivery device for the treatment of overactive bladder

The overactive bladder is a condition characterized by a sudden urge to urinate, even with small volumes of urine present in the bladder. The current treatments available for this pathology consist on conservative approaches and the continuous administration of drugs, which when made by conventional methods has limitations related to the first pass metabolism, bioavailability, severe side effects, and low patient adherence to treatments, ultimately leading to low effectiveness. Within this context, the present work proposes the design, manufacture, and characterization of an intravesical implant for the treatment of overactive bladder pathology, using EVA copolymer as a matrix and oxybutynin as a drug. The fabrication of devices through two manufacturing techniques (extrusion and additive manufacturing by fused filament fabrication, FFF) and the evaluation of the implants through characterization tests was proposed. The usability and functionality were evaluated through simulated insertion of the device/prototype in a bladder model through catheter insertion tests. The safety and effectiveness of the devices was investigated from mechanical testing as well as drug release assays. Drug release assays presented a burst release in the first 24 h, followed by a release of 1.8 and 2.8 mg/d, totalizing 32 d. Mechanical tests demonstrated an increase in the stiffness of the specimens due to the addition of the drug, showing a change in maximum stress and strain at break. The released dose was higher than that usually presented when considering the oral administration route, showing the optimization of the development of this implant has the potential to improve the quality of life of patients with overactive bladder.