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PurposeTo test the efficacy, duration and safety of 100 U of botulinum toxin type A (BoNT/A) in women affected by idiopathic detrusor overactivity (IDO) and the effectiveness of subsequent injections.MethodsIn this double centre, prospective study conducted from March 2008 to March 2010, we selected women affected by IDO who failed to respond to various antimuscarinic agents, reported intolerable anticholinergic side-effects or contraindication to their use, also without any response to tibial stimulation. Medical history, physical examination, standard urodynamic examination, urinalysis, urine culture, a 4-day voiding diary and a quality of life questionnaire were requested for all patients. A total amount of 100 U of BoNT/A were injected into the detrusor muscle. A second injection of BoNT/A was suggested to patients who experienced a relapse of initially improved symptoms.ResultsWe enrolled a total number of 68 women. All patients showed significant improvement in urodynamic parameters, clinical features and quality of life, after the first injection of Botox® until the 9 months of follow-up. Even after the second injection, with a follow-up of 3 months, we obtained results comparable with the first injection. Side-effects include an increase in post-void residual volume, dysuria and urinary infections.ConclusionsWe considered the dose of 100 U of Botox®, for treatment of IDO, as an efficacious and safe solution compared to other therapeutic options, without serious and lasting adverse effects for women, even after a second injection.

Introduction and Hypothesis Overactive bladder (OAB) affects 11–17% of the female population. First-line treatment with lifestyle modifications and second-line therapy with medications are often limited by inadequate efficacy or pharmacological side effects. This study was aimed at assessing the effect of 100 U onabotulinumtoxin A treatment on idiopathic OAB (iOAB) as a second-line treatment. Methods This prospective follow-up study involved 94 women who received onabotulinumtoxin A treatment at a dose of 100 U as a second-line treatment for iOAB at the Department of Obstetrics and Gynecology, Oulu University Hospital, Finland, between May 2018 and December 2023. The impact of the treatment on iOAB symptoms was evaluated 3 months after administration using self-reported symptoms and the following internationally validated questionnaires: Visual Analogue Scale (VAS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6). Postoperative complications were assessed. Results The follow-up data were obtained from 74 (78%) patients, of whom 66 (95.7%) reported a good outcome and 3 (4.3%) reported a poor outcome. Incontinence episodes, the number of incontinence pads needed, and daily micturitions were significantly reduced. For all questionnaires, the total scores decreased significantly after the treatment (VAS 8.27 ± 1.78 vs 3.50 ± 3.08, p  < 0.001; IIQ-7 72.14 ± 20.55 vs 28.73 ± 29.40, p  < 0.001; UDI-6 55.01 ± 18.86 vs 29.66 ± 22.03, p  < 0.001). Postoperative urinary tract infection occurred in 9 patients (9.6%), whereas urinary retention occurred in 6 patients (6.4%). Conclusions Onabotulinumtoxin A (100 U) demonstrates good effectiveness in the second-line treatment of female iOAB.

Despite the efficacy of onabotulinumtoxinA, its safety profile remains a concern. This meta-analysis reviewed the major adverse events (AEs) associated with intravesical onabotulinumtoxinA treatment in patients with neurogenic detrusor overactivity (NDO) and idiopathic overactive bladder (iOAB). Randomized controlled trials (RCTs) conducted between January 2000 and December 2022 were searched for adult patients administered different onabotulinumtoxinA dosages or onabotulinumtoxinA vs. placebo. Quality assessment was performed using the Cochrane Collaboration tool, and statistical analysis was performed using Review Manager version 5.3. A total of 26 RCTs were included in the analysis, including 8 on NDO and 18 on iOAB. OnabotulinumtoxinA vs. placebo significantly increased the urinary tract infection (UTI) incidence in patients with NDO (relative risk, or RR, 1.54) and iOAB (RR, 2.53). No difference in the RR with different onabotulinumtoxinA dosages was noted. Urinary retention was frequent with onabotulinumtoxinA use in the NDO (RR, 6.56) and iOAB (RR, 7.32) groups. Similar observations were made regarding the risks of de novo clean intermittent catheterization (CIC). The risk of voiding difficulty increased with onabotulinumtoxinA use in patients with iOAB. Systemic AEs of onabotulinumtoxinA, including muscle weakness (RR, 2.79) and nausea (RR, 3.15), were noted in patients with NDO; most systemic AEs had a low incidence and were sporadic.

Introduction and hypothesis This study aims to compare the effectiveness of intravaginal electrical stimulation (IVES) with regard to quality of life (QoL) and clinical parameters related to incontinence in women with idiopathic overactive bladder (iOAB) naive or refractory to treatment with pharmacological agents (PhA). Methods In this prospective trial, PhA-naive women were included in Group 1 ( n = 24) and women with PhA-resistant iOAB were included in Group 2 ( n = 24). IVES was performed 3 days a week, with a total of 24 sessions for 8 weeks. Every session lasted 20 minutes. Women were evaluated for the severity of incontinence (24-hour pad test), pelvic floor muscle (PFM) strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and the number of pads), symptom severity (OAB-V8), quality of life (IIQ-7), treatment success (positive response rate), cure/improvement rate, and treatment satisfaction. Results A statistically significant improvement was found in all parameters for each group at the 8th week compared to the baseline values ( p < 0.05). At the 8th week, there were no statistically significant differences in the severity of incontinence, PFM strength, incontinence episodes, nocturia, number of pads, QoL, treatment satisfaction, cure-improvement, or positive response rates between the two groups ( p > 0.05). It was found that the frequency of voiding and symptom severity parameters were significantly more improved in Group 1 than in Group 2 ( p < 0.05). Conclusions Although IVES was more effective in PhA-naive women with iOAB, it also appears to be an effective treatment in the management of women with PhA-resistant iOAB. Clinical trial registration This study was registered with ClinicalTrials.gov under no. NCT05416450.

PurposeThis study assessed the efficacy and safety of onabotulinumtoxinA according to injection site for treatment of overactive bladder.MethodsA systematic literature review located randomized controlled trials of onabotulinumtoxinA treatment for neurogenic detrusor overactive bladder and idiopathic overactive bladder in adults. We searched MEDLINE, EMBASE, and the Cochrane Controlled Trials Register using the Ovid platform. Meta-analysis was based on Cochrane Review Methods.ResultsEight studies (419 participants) were included. Trigone-including injection demonstrated a significant improvement in symptom score (SMD = − 0.53, 95% CI − 1.04 to − 0.02, P = 0.04, I2 = 78%), higher complete dryness rates (OR = 2.19 patients, 95% CI 1.32–3.63, P = 0.002, I2 = 41%), and lower frequency of incontinence episodes (WMD = − 0.85 per day, 95% CI − 1.55 to − 0.16, P = 0.02, I2 = 87%) in patients. Comparing trigone-including injection to trigone-sparing injection, lower detrusor pressure (WMD = − 2.55 cm H2O, 95% CI − 4.16 to − 0.95, P = 0.002, I2 = 0%) and higher volume at first desire to void (WMD = 17.54 ml, 95% CI 1.00–34.07, P = 0.04, I2 = 0%) were observed with trigone-including injection. Between intradetrusor and suburothelial injection sites, there were no differences in efficacy or safety regarding the incidence of vesicoureteral reflux, hematuria, general weakness, bladder discomfort, large post-void residual, and urinary tract infection.ConclusionTrigone-including onabotulinumtoxinA injection has superior efficacy to trigone-sparing injection without increased complications. The depth of injection does not influence the efficacy or safety of onabotulinumtoxinA.

The aim of this study was to determine the safety and effectiveness of mirabegron in children with refractory overactive bladder (OAB) for improving urinary symptoms. We conducted a search strategy in MEDLINE (OVID), EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), and LILACS from inception to September 2023. We performed a systematic review of studies evaluating the effectiveness of improving urinary symptoms and the safety of mirabegron at any dose in children and adolescents with idiopathic refractory OAB. We searched the interception to September 2023. The risk of bias was assessed using the Cochrane risk of bias tool for clinical trials and the MINORS tool for non-randomized studies. We included three studies in the analysis. All of them included children and adolescents receiving mirabegron as monotherapy at different doses. Also, none of them reported a control group. Improvement and safety rates were high in every study in objective and subjective measurements. Compliance was also high in all studies. Most of the evaluated items had a low risk of bias within and across studies. Mirabegron as monotherapy appears to be a safe and effective alternative for children with refractory idiopathic OAB or those who are intolerant to antimuscarinic therapy.

Urinary incontinence (UI) is a common and refractory complication for patients with neurogenic detrusor overactivity (NDO) or idiopathic overactive bladder (IOAB). To evaluate the effect of Botulinum toxin A (BTX-A) based on different dosages strategy for UI. The MEDLINE, Ovid EMbase, The Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Internet (CNKI), and WanFang database were searched for relevant published randomized controlled trials (RCTs) between 1969 to September 31, 2018. All database were searched to identify relevant randomized controlled trials (RCTs) that investigated the clinical benefit of BTX-A for management of UI in patients with NDO and IOAB. This meta-analysis involved 19 original studies. The BTX-A was superior to placebo in reducing episodes of UI for NDO patients in all subgroups of different dosages for different durations, and also reduced maximum detrusor pressure in all kinds of 200U and 300U at 6 weeks. However, it increased post void residual in different dosages of 200U at 2 weeks. For IOAB patients, compared to placebo, BTX-A increased detrusor compliance for different dosages of 200U and 300U at 12 and 36 weeks, but it increased risk of urinary tract infections at other dosages. This meta-analysis indicated that BTX-A 200U and 300U are more effective than placebo in the treatment of NDO, with minimal, local, and manageable adverse events. Furthermore, BTX-A 300U and 200U could also improve detrusor compliance of IOAB. However, more RCTs would still be necessary to explore the effect of BTX-A on management of UI in NDO and IOAB patients.

Introduction and hypothesis The aim of this study is to compare the effectiveness of transcutaneous tibial nerve stimulation (TTNS) on quality of life (QoL) and clinical parameters related to incontinence in pharmacological agents (PhAs) naive and refractory women with idiopathic overactive bladder (iOAB). Methods In this prospective nonrandomized clinical trial, women with resistance to PhAs were included in the first group ( n =21), PhA-naive women were included in the second group ( n =21). TTNS was performed 2 days a week, a total of 12 sessions for 6 weeks. Every session lasted 30 min. Women were evaluated for the severity of incontinence (Pad test), 3-day voiding diary (voiding frequency, nocturia, incontinence episodes, and number of pads), symptom severity (Overactive Bladder Questionnaire-V8), quality of life (Incontinence Impact Questionnaire-7), treatment satisfaction, positive response, and cure-improvement rates. Results A statistically significant improvement was found in all parameters for each group at the 6th week compared with the baseline values ( p <0.05). It was found that the severity of incontinence, incontinence episodes, symptom severity, treatment satisfaction, and QoL parameters were significantly improved in PhA-naive group compared with the PhA-resistant group at the 6th week ( p <0.05). There were no statistically significant differences in the frequency of voiding, nocturia, and number of pads between the two groups ( p >0.05). Positive response rates, the primary outcome measure, were statistically significantly higher in the PhA-naive group than in the PhA-resistant group. Conclusions Although TTNS is more effective in PhA-naive women with iOAB, it appears to be an effective therapy that can also be used in the management of PhA-resistant women with iOAB.

To evaluate the clinical outcomes of two different doses of BTX-A in patients with refractory idiopathic overactive bladder. Thirty nine patients with refractory idiopathic overactive bladder from 1/1/2008 till 30/3/2009 were evaluated in a tertiary care hospital. Patients were evaluated using urodynamic studies, voiding diary, UDI-6 and IIQ-7 questionnaires prior to being prospectively randomized (alternate randomization) to the BTX-A applications and three months after treatment. Voiding diary and residual volume were followed two weeks later. All patients received intradetrusorial injections of BTX-A (Botox, Allergan, Irvine, CA) of 100u or 200u under cystoscopic control on an outpatient basis. The primary endpoint was assessed for the improvement of urodynamic parameters and adverse events at three months after the initial treatment. Secondary end points included urinary frequency, urgency and UUI episodes as assessed by voiding diary and QoL. Eleven patients were enrolled to each arm of the study. There were no significant differences in demographic characteristics between the two groups. Urodynamic assessment at the end of the third month showed significant improvement in urodynamic variables in both groups. There was no statistically significant difference in urodynamic parameters and in the voiding diary between the two groups. QOL was significantly improved in both groups with no statistically significant difference between the different doses. Only three patients developed acute urinary retention. BTX-A at 100u and 200u appears to improve symptoms, urodynamic parameters and QoL with no statistical significance between the two groups.

Patients with overactive bladder (OAB) may experience significant reduction in quality of life attributable to their voiding symptoms. Patients who are refractory to first‐ and second‐line intervention with behavioral modification and oral medications can be offered intravesical injections of botulinum toxin A (BTX‐A) as third‐line therapy. BTX‐A inhibits the release of acetylcholine at the neuromuscular junction in bladder detrusor muscle. Level 1 evidence demonstrates the benefit of intravesical BTX‐A for patients with overactive bladder. BTX‐A is well tolerated with the most common side‐effects being urinary tract infection and urinary retention. We further describe the mechanism of action, indications for treatment, adverse outcomes, and technical considerations for the usage of BTX‐A in the management of OAB.