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2,166 result(s) for "overactive bladder"
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Invasive urodynamic investigations in the management of women with refractory overactive bladder symptoms (FUTURE) in the UK: a multicentre, superiority, parallel, open-label, randomised controlled trial
Overactive bladder is a common problem affecting women worldwide, with a negative effect on their social and professional lives. Before considering invasive treatments, guidelines recommend urodynamics to identify detrusor overactivity. However, the clinical-effectiveness and cost-effectiveness of urodynamics has never been robustly assessed in this cohort of women. We aimed to compare the clinical-effectiveness and cost-effectiveness of urodynamics plus comprehensive clinical assessment (CCA) versus CCA only in the management of women with refractory overactive bladder symptoms. We did a multicentre, superiority, parallel, open-label, randomised controlled trial in 63 UK hospitals. Women aged 18 years or older with refractory overactive bladder or urgency predominant mixed urinary incontinence, with failed conservative management and being considered for invasive treatment, were randomly assigned (1:1) to urodynamics plus CCA versus CCA only. Assignment used an internet-based application with stratified random permuted blocks and site and baseline diagnosis as stratum. Primary outcome was participant-reported success at the last follow-up timepoint, measured by the Patient Global Impression of Improvement at 15 months after randomisation. Primary economic outcome was incremental cost per quality-adjusted life-year (QALY) gained modelled over the participants lifetime. Analysis was based on the intention-to-treat principle. This study is registered with ISRCTN registry (ISRCTN63268739). Between Nov 6, 2017, and March 1, 2021, 1099 participants were randomly assigned to urodynamics plus CCA (n=550) or CCA only (n=549). At the final follow-up timepoint, participant-reported success rates of “very much improved” and “much improved” were not superior in the urodynamics plus CCA group (117 [23·6%] of 496) versus the CCA-only group (114 [22·7%] of 503; adjusted odds ratio 1·12 [95% CI 0·73–1·74]; p=0·60). Serious adverse events were low and similar between groups. Incremental cost-effectiveness ratio was £42 643 per QALY gained. The cost-effectiveness acceptability curve showed urodynamics had a 34% probability of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY gained, which reduced further when extrapolated over the patient's lifetime. In women with refractory overactive bladder or urgency predominant mixed urinary incontinence, the participant-reported success in the urodynamics plus CCA group was not superior to the CCA-only group, and urodynamics was not cost-effective at the £20 000 per QALY gained threshold. UK National Institute for Health and Care Research Health Technology Assessment Programme.
A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus
In patients with idiopathic normal-pressure hydrocephalus responsive to CSF drainage, shunting improved gait and balance at 3 months, but not cognition or incontinence, and was associated with some procedure-related risks.
Comparative study on the Impact of Transcranial Magnetic stimulation and Bio-feedback on overactive bladder in multiple sclerosis patients: a Randomized Clinical Trial
Background Overactive bladder (OAB) is a common clinical presentation in patients with multiple sclerosis. Objectives The purpose of this study was to compare the effects of transcranial magnetic stimulation (TMS) and biofeedback on overactive bladder in patients with multiple sclerosis. Methods This research included 45 individuals with multiple sclerosis of both sexes. We randomly divided them into three equal groups (A, B, and C). Patients in group A got biofeedback training and pelvic floor exercise (PFME); patients in group B had transcranial magnetic treatment and PFME; and patients in group C had PFME. Urodynamic measurements were utilized to determine bladder parameters (detrusor pressure at maximum flow rate, bladder volume at initial desire to empty, maximum cystometric capacity, detrusor pressure, and maximum flow rate) for all groups before and after a six-week training interval (the end of therapy). Results There was a statistically significant improvement in all urodynamic measurement parameters within the groups (Groups A, B and C). Except for the maximal cystometric capacity and detrusor pressure were non-significant improvement in B before and after therapy. However, there was no significant difference between the three groups following therapy. Conclusion Transcranial magnetic stimulation and biofeedback improved bladder function in patients with multiple sclerosis. These approaches have a high level of safety and effectiveness, but EMG biofeedback has superiority.
Comparison of the effects of transcranial direct current stimulation and transcutaneous tibial nerve stimulation on the urgency and frequency of women with overactive bladder syndrome: study protocol of a randomized clinical trial
Background Overactive bladder syndrome is common, with a prevalence of 12–17% among adults. Posterior tibial nerve stimulation is the primary nonpharmacological and conservative treatment for overactive bladder syndrome. While several human brain imaging studies have shown the involvement of supraspinal centers in bladder control, a literature review has found that no research has specifically investigated cortical stimulation through transcranial direct current stimulation as a treatment for overactive bladder syndrome in women. Therefore, this study aims to assess the potential benefits of transcranial direct current stimulation (tDCS) and compare them with the effects of posterior tibial nerve stimulation on overactive bladder syndrome. Methods/design The random allocation method will be used to divide the participants into two groups. Group 1 ( n  = 19) will undergo pelvic floor muscle training and transcutaneous tibial nerve stimulation. Group 2 ( n  = 19) will undergo pelvic floor muscle training and transcranial direct current stimulation. The transcranial direct current stimulation for group 2 will consist of 12 sessions occurring thrice a week, each lasting for 20 min. Anodal tDCS will be administered to FPz targeting the medial prefrontal cortex (mPFC) for 12 sessions, with the cathode electrode positioned between Oz and inion at an intensity of 2 mA for 20 min. Discussion It is believed that utilizing an approach involving non-invasive electrical stimulation of the cortex could lead to a more efficient treatment for individuals with overactive bladder. Additionally, it is theorized that combining the effects of tDCS and pelvic floor muscle training could present an innovative technique for alleviating the negative impacts of overactive bladder syndrome. Ultimately, this new method could provide help for patients who have not responded to conventional therapy. Trial registration Iranian Registry of Clinical Trials (IRCT) ID: IRCT20090301001722N26, registration date: May 17, 2023. https://en.irct.ir/ .
The impact of urodynamics on treatment and outcomes in women with an overactive bladder: a longitudinal prospective follow-up study
Introduction and hypothesisThe aim of this study was to establish if the management of women with overactive bladder (OAB) and patient-reported outcomes differed based on the findings of urodynamics (UDS).MethodsA prospective, longitudinal observational study conducted in urogynaecology clinics in 22 UK hospitals participating in the Diagnostic Accuracy of Bladder Ultrasound Study (BUS). A total of 687 women with OAB symptoms or urgency-predominant mixed urinary incontinence were recruited into a diagnostic study that used UDS as the reference standard. Detailed clinical history and International Consultation on Incontinence OAB Short Form (ICIQ-OAB sf) questionnaire responses were obtained before the UDS test was carried out. These questionnaires were subsequently collected at a mean of 7 and 20 months, along with patient global impression of improvement and details on medical and surgical treatments. The relationship between UDS diagnosis and treatment was examined using a multinomial regression model; logistic and repeated measures regressions were used to examine other outcomes.ResultsWe recruited 687 women and the response rate was 69% at 20 months. Treatment subsequent to UDS was highly associated with diagnosis (p < 0.0001). Women who received treatment concordant with their UDS findings were more likely to report an improvement in bladder symptoms (57% vs 45%; p = 0.02) and ICIQ-OAB sf scores (0.5 points, 95%CI: 0.1 to 0.9; p = 0.02).ConclusionsUrodynamics influenced treatment decisions made by clinicians in determining treatment pathways in women presenting with OAB. Women treated based on UDS diagnoses appear to have greater reductions in symptoms than those who do not.
Comparison of mirabegron and vibegron for clinical efficacy and safety in female patients with overactive bladder: a multicenter prospective randomized crossover trial
Purpose To compare the efficacy and safety of mirabegron and vibegron in female OAB patients. Methods We conducted a multicenter, prospective, randomized crossover study of female patients with OAB. The patients were assigned to Group MV (mirabegron for 8 weeks, followed by vibegron for 8 weeks) or group VM (vibegron for 8 weeks, followed by mirabegron for 8 weeks). The primary endpoint was the change in OABSS from baseline, and the secondary endpoint was the change in FVC parameters. After completion of the study, each patient was asked which drug was preferable. Results A total of 83 patients were enrolled (40 and 43 in groups MV and VM, respectively). At 8th and 16th week, 33 and 29 in Group MV and 34 and 27 in Group VM continued to receive the treatment. The change in PVR was not significantly different between treatment with mirabegron and vibegron. The changes in OABSS, nighttime frequency, mean, and maximum voided volume were similar between mirabegron and vibegron. The mean change in the daytime frequency was greater in the vibegron than in the mirabegron. Of the 56 patients, 15 (27%) and 30 (53%) preferred mirabegron and vibegron, respectively. The remaining 11 patients (20%) showed no preference. The change in the urgency incontinence score during vibegron was better in patients who preferred vibegron to mirabegron. Conclusion The efficacies of mirabegron and vibegron in female patients was similar. The patients’ preference for vibegron could depend on the efficacy of vibegron for urgency incontinence.
Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study
PurposeThis multicenter, randomized, double-blind, placebo-controlled phase 2 study evaluated the efficacy and safety of TAC-302, a novel drug that restores neurite outgrowth, in patients with detrusor underactivity (DU) and overactive bladder (OAB).MethodsAfter 2–4 weeks of observation, patients were randomized 2:1 to receive oral TAC-302 200 mg or placebo twice daily for 12 weeks. The primary endpoint was detrusor contraction strength, estimated by bladder contractility index (BCI) for males and projected isovolumetric pressure 1 (PIP1) for females. Secondary endpoints included changes in bladder voiding efficiency (BVE) and safety.ResultsSeventy-six patients were included (TAC-302, n = 52; placebo, n = 24). The mean (standard deviation [SD]) BCI for males was 64.6 (16.6) at baseline and 75.2 (21.1) at week 12 (p < 0.001) with TAC-302 (n = 27), and 61.3 (16.6) and 60.5 (16.7) (p = 0.82) with placebo (n = 11). The respective mean (SD) PIP1 for females was 18.8 (6.6) and 29.4 (9.4) (p < 0.001) with TAC-302 (n = 15), and 20.6 (7.5) and 25.5 (9.6) (p = 0.14) with placebo (n = 7). TAC-302 significantly increased BCI in males and BVE in both sexes. TAC-302 efficacy on OAB was not clearly shown. The incidences of adverse events (AEs), serious AEs, and AEs leading to dose interruption were similar between groups; no adverse drug reactions occurred.ConclusionConsidering the significant effects on BCI in males and BVE in both sexes, TAC-302 may benefit patients with DU.RegistrationClinicalTrials.gov Identifier NCT03175029 registered 6/5/2017.
Resistance exercise alleviates overactive bladder by attenuating detrusor oxidative stress via peroxynitrite reduction
Overactive bladder (OAB) remains challenging to treat due to drug intolerance and limited efficacy of behavioral therapies. The mechanistic basis by which exercise improves bladder function is poorly understood. Here, we established a clinically translatable resistance exercise model using graded treadmill loading (5–15% body weight [BW], 10–30 min/day) in a cyclophosphamide (CYP)-induced OAB rat model to identify the optimal therapeutic intensity and delineate redox-related mechanisms. Functional (urodynamics, urine spot test), MRI imaging, histological, immunofluorescence, and untargeted metabolomic analyses were integrated to assess detrusor remodeling and oxidative stress modulation across 11 experimental groups. ModeratSTREe resistance exercise (10% BW, 20 min/day) significantly increased bladder capacity (0.45 ± 0.17 mL–1.28 ± 0.44 mL) and prolonged voiding interval (2.13 ± 0.64 min–6.35 ± 0.93 min; p  < 0.001). MRI and histology confirmed reversal of detrusor hypertrophy. Immunofluorescence demonstrated reduced 3-nitrotyrosine accumulation, indicating decreased peroxynitrite (ONOO⁻)-mediated nitrative stress. Metabolomic profiling revealed extensive reprogramming of glutathione metabolism, arginine biosynthesis, and glycine–serine pathways, restoring redox balance and antioxidant capacity. Integration of metabolic and histological data defined a mechanistic framework, “resistance exercise–peroxynitrite reduction–oxidative stress attenuation–detrusor remodeling.” In conclusion, our findings identify peroxynitrite reduction and detrusor remodeling as key mechano-redox pathways through which resistance training improves bladder compliance and detrusor relaxation. These results highlight resistance exercise as a clinically feasible, non-pharmacological strategy with translational potential for improving outcomes in patients with OAB.
Efficacy of the combination of transcutaneous tibial nerve stimulation and mirabegron in women with overactive bladder in a prospective randomized controlled trial
The management of overactive bladder (OAB) in women encompasses a range of strategies, from behavioral modifications to pharmacotherapy and nerve stimulation techniques. This prospective, randomized, controlled trial evaluates the efficacy of the combination of TTNS and mirabegron in symptom improvement over three months in women diagnosed with OAB. The study was designed as a randomized controlled trial. A total of 40 patients were prospectively randomized into two groups. Twenty patients in the combination group accepted TTNS and mirabegron therapy, and the other 20 patients as control only accepted mirabegron therapy. Primary outcomes were changes from baseline in the lower urinary tract symptoms. The severity of symptoms and quality of life (QoL) were assessed using the validated OAB questionnaire (OAB-q). TTNS reduced the clinical symptoms of OAB, and the difference was statistically significant at all study sites ( p  < 0.05). Regarding secondary outcomes, the OAB-q symptom bother score was lower in the combination group than in the mirabegron group ( p  < 0.05). The OAB-q score in the combination group was statistically superior to that in the mirabegron group ( p  < 0.05). The incidence of complications was not statistically significant between the two groups.The combination of TTNS and mirabegron represents a promising therapeutic strategy for women with overactive bladder, significantly improving symptoms and quality of life with a favorable safety profile. Further research with a larger sample size and long-term follow-up is warranted to confirm these findings and explore the underlying mechanisms of this combination therapy’s efficacy.
Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial
Background Neurogenic detrusor overactivity (NDO) is a serious and common complication after spinal cord injury, affecting patients’ quality of life seriously. Therefore, we developed this research protocol to evaluate the efficacy of repetitive functional magnetic stimulation (rFMS) in the sacral nerve in patients with neurogenic detrusor overactivity (NDO) after suprasacral spinal cord injury (SCI) and provide more options for rFMS in treating NDO after suprasacral SCI. Methods This study is a single-center, randomized, parallel-group clinical trial. We will recruit the patients with NDO after suprasacral SCI in the Rehabilitation Department of the Affiliated Hospital of Southwest Medical University from September 2022 to August 2023. They will be assigned to the rFMS group and the sham stimulation group randomly. The sample size is 66, with 33 patients in each group. The rFMS group will receive real rFMS treatment of the sacral nerve (100% stimulation intensity, 5 Hz, 20 min each time, five times a week), and the sham group will receive sham stimulation. Both groups will receive similar treatment strategies, including medication, standard urine management, acupuncture treatment, and health education. The bladder compliance (bladder capacity/detrusor pressure) and pudendal nerve electromyography will be evaluated at baseline, 8th week of treatment. The residual volume of the bladder and bladder diary will be recorded once a week during 8 weeks of treatments. SCI-QOL and NBSS will be evaluated at baseline, the 4th and 8th week of treatment. In addition, the above assessments will be followed up at 8 weeks after the end of treatment. Discussion It is expected that the bladder function, symptoms, and quality of life might be significantly improved after rFMS of the sacral nerve. Trial registration The China Clinical Trials Registry has approved this study, registration number: ChiCTR2100045148. Registered on April 7, 2021.