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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.

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.

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/ .

Objective. The purpose of this study is to assess the effectiveness of pelvic floor muscle training and extracorporeal magnetic innervation in treatment of urinary incontinence in women with stress urinary incontinence. Methods. The randomized controlled trial enrolled 128 women with stress urinary incontinence who were randomly allocated to either one out of two experimental groups (EG1 or EG2) or the control group (CG). Subjects in the experimental group 1 (EG1) received 12 sessions of pelvic floor muscle training, whereas subjects in the experimental group 2 (EG2) received 12 sessions of extracorporeal magnetic innervation. Subjects in the control group (CG) did not receive any therapeutic intervention. The following instruments were used to measure results in all study groups at the initial and final assessments: Revised Urinary Incontinence Scale (RUIS), Beck Depression Inventory (BDI-II), General Self-Efficacy Scale (GSES), and King’s Health Questionnaire (KHQ). Results. In both experimental groups, a statistically significant decline in depressive symptoms (BDI-II) and an improvement in urinary incontinence severity (RUIS) and quality of life (KHQ) were found in the following domains: “social limitations,” “emotions,” “severity measures,” and “symptom severity scale.” Moreover, self-efficacy beliefs (GSES) improved in the experimental group that received ExMI (EG2). No statistically significant differences were found between all measured variables in the control group. Comparative analysis of the three study groups showed statistically significant differences at the final assessment in the quality of life in the following domains: “physical limitations,” “social limitations,” “personal relationships,” and “emotions.” Conclusion. Pelvic floor muscle training and extracorporeal magnetic innervation proved to be effective treatment methods for stress urinary incontinence in women. The authors observed an improvement in both the physical and psychosocial aspects.

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.

Background Men with overactive bladder (OAB) and benign prostatic hyperplasia (BPH), will have deterioration in the quality of life. Objective The 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 methods A 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). Results 142 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). Conclusions The 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.

Background Urgency is a complaint of sudden, compelling desire to pass urine, which is difficult to defer, caused by involuntary contraction of the detrusor muscle during the bladder-filling stage. To enable detrusor inhibition, electrotherapy resources such as transcutaneous tibial nerve stimulation (TTNS) and parasacral transcutaneous electrical stimulation (PTES) have been used. The objective this study is to publish the study protocol that aims to investigate whether urgency decreases after treatment with both of the techniques. Methods This randomized controlled clinical trial will include 99 women, aged more than 18 years old, with urgency (score ≥ 8 in the Overactive Bladder-Validated 8-Question Awareness Tool [OAB-V8]). Women will be randomly allocated into three groups: TTNS, PTES, and placebo. The following questionnaires will be applied: the Anamnesis Record, the Incontinence Questionnaire Overactive Bladder, the King’s Health Questionnaire, the 24-Hour Voiding Diary, and the OAB-V8, at four different time points: at baseline prior to the first session, at the 6th session, the 12th session and at follow-up. The current used for the transcutaneous electrical stimulation will be a symmetrical balanced biphasic pulsed current, for 12 sessions, twice a week, for 20 minutes. Qualitative variables will be displayed as frequency and percentage, quantitative variables as mean and standard deviation. Comparison of urgency severity among groups will be performed with a repeated measures ANOVA, considering the effect of the three groups and the four evaluations, and interactions among them. Discussion The present study aims to contribute evidence for a more in-depth discussion on electrode positioning for electrostimulation used in urgency treatment. It should be emphasized that, based on the possibility of confirming the hypothesis that urgency will decrease in a similar way after both treatments (TTNS and PTES), the PTES will be used as an option for positioning the electrodes alternatively to the tibial nerve region in special populations, such as amputees or people with severe lower limb sensory impairment. Trial registration Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-9rf33n , date of registration: 17 May 2018.

Objectives To evaluate the efficacy and safety of a non-invasive low-frequency tibial nerve stimulator (TNS-01) vs sham control in relieving the symptoms of overactive bladder (OAB) patients. Patients Participants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly. Methods The subjects were 1:1randomized (block randomization with a block size of 4) to either active treatment (TNS-01 group) or sham treatment (sham group). Based on the randomization, the subject will be given either an active or sham device system (systems will only differ in the Instructions for Use and electrode size/shape). During the 12-week study period, all participants underwent three 30-min intervention sessions weekly. The primary endpoint was the change in Overactive Bladder Symptom Score (OABSS) at week 12 from the baseline. Results Of the 109 recruited OAB patients. In the TNS-01 group, the OABSS change from baseline at week 12 was significantly higher than that in the sham group (2.83 ± 2.53 vs 1.62 ± 2.59, p  = 0.02). The absolute and percent changes of average UUI episodes per day from baseline at week 8 in the TNS-01 group were significantly lower from those in the sham group (0.11 ± 1.33 vs 0.68 ± 2.14, p  = 0.01; − 27.82% ± 167.33% vs 87.18% ± 25.20%, p  = 0.04). One treatment-related adverse event (hematuria) was reported by one patient (1.8%) in the sham group. Conclusions The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation. Trial registration number: NCT04999657.

Introduction and Hypothesis This study was aimed at evaluating the therapeutic effects of a modified intravesical botulinum toxin injection technique (fewer injection sites under local anesthesia), in comparison with the conventional technique for patients with idiopathic detrusor overactivity, considering the urodynamic parameters. Methods In this double-blinded randomized clinical trial, 78 adult females with idiopathic detrusor overactivity were divided into two groups: conventional and modified groups. In the conventional method, patients received intradetrusor botulinum toxin injection at 20 sites under general or spinal anesthesia in a trigone-sparing fashion. In the modified group, injections were performed at five intradetrusor sites beyond the trigone, using local anesthetics. The primary end point was the comparison of urodynamic parameters in both groups following the procedure. The secondary endpoints were assessing the safety and tolerability of the modified method compared with the conventional method. Results There were no significant differences between the two treatment groups in terms of urodynamic parameters before the intervention ( p  > 0.05). After the intervention, no significant differences in urodynamic parameters were observed between the two treatment methods. All patients in the modified-method group could tolerate the procedure well. Conclusion The innovation of reducing the number of injection sites and concurrently using local anesthetics was shown to be as effective as the conventional method in terms of improving urodynamic parameters, tolerability, and safety in patients with idiopathic detrusor overactivity.

Background 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. Methods 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 12 weeks. 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. Results 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 24 h decreased significantly among children with primary OAB. Bladder capacity increased significantly and the resting detrusor pressure decreased significantly among children with refractory OAB. Conclusions 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.