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      Efficacy and safety of pelvic floor magnetic stimulation combined with mirabegron in female patients with refractory overactive bladder: a prospective study

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          Abstract

          Objective

          To observe the efficacy and safety of pelvic floor magnetic stimulation (PFMS) combined with mirabegron in female patients with refractory overactive bladder (OAB) symptoms.

          Patients and methods

          A total of 160 female patients with refractory OAB symptoms were prospectively randomized into two groups. Eighty cases in the combination group accepted PFMS and mirabegron therapy and 80 cases as control only accepted mirabegron therapy (The clinical trial registry number: ChiCTR2200070171). The lower urinary tract symptoms, OAB questionnaire (OAB-q) health-related quality of life (HRQol), symptom bother score and OABSS between two groups were compared at the 1st, 2nd and 4th week ends.

          Results

          All of 160 patients were randomly assigned to two groups, of which 80 patients were included in the combination group and 80 in the mirabegron group. The incidences of LUTS, including urgency, frequent urination, and incontinence episodes, in the 2nd week and the 4th week after combination treatment were significantly lower than those in the mirabegron group ( p < 0.05). The incidence of drug-related adverse events between two groups was similar, and there was no statistically significant difference ( p > 0.05). With respect to secondary variables, the OAB-q HRQol score in the combination group was statistically superior in comparison with that in the mirabegron group between the 2nd week and the 4th week ( p < 0.05). This was consistent with the primary outcome. Meanwhile, from the second to fourth week, the OAB-q symptom bother score and OABSS in the combination group were both lower than in the mirabegron group ( p < 0.05).

          Conclusion

          Combination therapy of PFMS and mirabegron demonstrated significant improvements over mirabegron monotherapy in reducing refractory OAB symptoms for female patients, and providing a higher quality of life without increasing bothersome adverse effects.

          Clinical Trial Registration

          https://www.chictr.org.cn/, ChiCTR-INR-22013524.

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          Most cited references23

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          An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction.

          Next to existing terminology of the lower urinary tract, due to its increasing complexity, the terminology for pelvic floor dysfunction in women may be better updated by a female-specific approach and clinically based consensus report. This report combines the input of members of the Standardization and Terminology Committees of two international organizations, the International Urogynecological Association (IUGA), and the International Continence Society (ICS), assisted at intervals by many external referees. Appropriate core clinical categories and a subclassification were developed to give an alphanumeric coding to each definition. An extensive process of 15 rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). A terminology report for female pelvic floor dysfunction, encompassing over 250 separate definitions, has been developed. It is clinically based with the six most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Female-specific imaging (ultrasound, radiology, and MRI) has been a major addition while appropriate figures have been included to supplement and help clarify the text. Ongoing review is not only anticipated but will be required to keep the document updated and as widely acceptable as possible. A consensus-based terminology report for female pelvic floor dysfunction has been produced aimed at being a significant aid to clinical practice and a stimulus for research.
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            Urothelial signaling.

            The urothelium, which lines the inner surface of the renal pelvis, the ureters, and the urinary bladder, not only forms a high-resistance barrier to ion, solute and water flux, and pathogens, but also functions as an integral part of a sensory web which receives, amplifies, and transmits information about its external milieu. Urothelial cells have the ability to sense changes in their extracellular environment, and respond to chemical, mechanical and thermal stimuli by releasing various factors such as ATP, nitric oxide, and acetylcholine. They express a variety of receptors and ion channels, including P2X3 purinergic receptors, nicotinic and muscarinic receptors, and TRP channels, which all have been implicated in urothelial-neuronal interactions, and involved in signals that via components in the underlying lamina propria, such as interstitial cells, can be amplified and conveyed to nerves, detrusor muscle cells, and ultimately the central nervous system. The specialized anatomy of the urothelium and underlying structures, and the possible communication mechanisms from urothelial cells to various cell types within the bladder wall are described. Changes in the urothelium/lamina propria ("mucosa") produced by different bladder disorders are discussed, as well as the mucosa as a target for therapeutic interventions.
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              Prevalence, risk factors, and impact on health related quality of life of overactive bladder in China.

              To evaluate the prevalence, associated risk factors and the impact on health related quality of life (HRQoL) of overactive bladder (OAB) among men and women aged ≥18 years in China, using the 2002 International Continence Society (ICS) definition. The population-based, cross-sectional field survey was conducted between June 2009 and February 2010 in China using questionnaires regarding demographics, the prevalence and the HRQoL. A stratified random sample of men and women aged ≥18 years residing in China who were representative of the general populations was selected for demographic questionnaires first. The individuals meeting the diagnostic criteria of OAB (urgency occurring once a week or more) were further interviewed through King's health questionnaire (KHQ) to estimate the impact of OAB on HRQoL. Data were stratified by city, age cohort, and gender. A total of 21,513 individuals were contacted to participate in the survey, and 14,844 individuals (7,614 men, 7,230 women) with complete data were included in this study. The prevalence of OAB was 6.0%, OAB(dry) 4.2%, and OAB(wet) 1.8%. The prevalence varied slightly among six geographical regions of China. Nocturia was the most common OAB symptom besides urgency. Advanced age, higher BMI, lower education level, manual worker, alcohol consumption, and married were associated risk factors for OAB in men. Advanced age, lower education level, manual worker, alcohol consumption, married, menopause, more parities and vaginal delivery were potential risk factors for OAB in women. The symptoms of OAB had a detrimental effect on HRQoL, especially on Coping Measures, Sleep/Energy, General Health Perceptions, and Severity of Urinary Problems. The prevalence of OAB in China is lower than that of most previous reports. Many known risk factors are associated with OAB. The symptoms of OAB have a detrimental effect on HRQoL. Efforts need to be made to improve public and professional education about the problems of OAB and decrease the unnecessary burden of this condition. Copyright © 2011 Wiley Periodicals, Inc.
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                Author and article information

                Contributors
                Role: Role:
                URI : https://loop.frontiersin.org/people/1801602/overviewRole:
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                Journal
                Front Neurosci
                Front Neurosci
                Front. Neurosci.
                Frontiers in Neuroscience
                Frontiers Media S.A.
                1662-4548
                1662-453X
                10 April 2024
                2024
                : 18
                : 1373375
                Affiliations
                [1] 1Department of General Surgery, The Second Hospital of Nanjing, Affiliated Hospital to Nanjing University of Chinese Medicine , Nanjing, Jiangsu, China
                [2] 2Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University , Nanjing, Jiangsu, China
                [3] 3Department of Urology, Liaocheng People’s Hospital , Liaocheng, Shandong, China
                [4] 4Department of Clinical Medicine, Kangda College of Nanjing Medical University , Lianyungang, Jiangsu, China
                Author notes

                Edited by: Guangyuan Zhang, Southeast University, China

                Reviewed by: Zhao Kai, Affiliated Hospital of Nanjing University of Chinese Medicine, China

                Hongzhou Cai, Nanjing Medical University, China

                Qi-lin Xi, The First Affiliated Hospital of Soochow University, China

                *Correspondence: Rong-zhen Tao, 18915973028@ 123456163.com

                These authors have contributed equally to this work

                Article
                10.3389/fnins.2024.1373375
                11040079
                38660220
                87ed6cc9-3b8a-43bd-b011-7148d7876239
                Copyright © 2024 Liang, Tang, Lin, Tang, Liu, Zhou and Tao.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 01 February 2024
                : 28 March 2024
                Page count
                Figures: 2, Tables: 3, Equations: 0, References: 23, Pages: 8, Words: 4435
                Funding
                The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This work was supported by the key project of scientific research development fund of Kangda College of Nanjing Medical University in China (no.KD2022KYJJZD077).
                Categories
                Neuroscience
                Clinical Trial
                Custom metadata
                Autonomic Neuroscience

                Neurosciences
                refractory overactive bladder,pelvic floor magnetic stimulation,mirabegron,combination therapy,incontinence

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