Radiofrequency as the New Opportunity in Treating Overactive Bladder and Urge Urinary Incontinence-A Single-Arm Pilot Study.

Background and Objectives: Until now, overactive bladder (OAB) with or without urge urinary incontinence (UUI) has been treated mainly in two ways: with behavioral methods and patient education, or using antimuscarinic drugs and/or beta-3 adrenergic receptor agonists. Unfortunately, these drugs may cause side effects in some women or are insufficiently effective, so patients abandon them. Therefore, in this pilot study, radiofrequency was evaluated as a new option in the treatment of OAB and UUI. Materials and Methods: Nineteen patients were enrolled in this pilot study using radiofrequency (RF), where the level of OAB and UUI was assessed using the validated ICIQ-OAB questionnaire. RF was applied four times for 20 min, once a week. Two weeks after treatment, the level of OAB and UUI was reassessed and processed statistically and the treatment effect evaluated. Results: Using the ICIQ-OAB, the severity of OAB and UUI was assessed: 0-3 mild symptoms; 4-7 moderate symptoms; 8-11 severe symptoms; 12-16 very severe symptoms. Before treatment, 10.5% of patients had mild symptoms, 21.1% moderate symptoms, 63.2% severe symptoms and 5.3% very severe symptoms. After treatment, 42.9% had mild symptoms, 50% moderate symptoms and 7% severe OAB and UUI symptoms. All four main symptoms-frequency, nocturia, urgency and incontinence-decreased statistically significantly, with the best results being found in urgency (p = 0.002). Conclusions: Based on this pilot study, RF seems a very promising method in the treatment of OAB and UUI. To extend our initial findings, it is necessary to perform a prospective, randomized and placebo-controlled study in order to obtain reliable results and to determine for how long one set of treatment maintains the results obtained immediately after the end of that treatment. In this way, we may determine how often the treatment needs to be repeated, if necessary, and when.

Seminal papers in urology: two-year outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for refractory urgency urinary incontinence: a Randomized Trial.

In this critical review, we explore the study design, strengths and limitations of the paper: "Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial." The paper reports 24 month follow-up data of the landmark ROSETTA trial. This multi-centre, open-labelled parallel randomised trial allocated females 1:1 to receive Sacral Neuromodulation (SNM) or OnabotulinumtoxinA(BTX) 200 units (U). The primary outcome was change in mean daily urinary urgency incontinence episodes (UUIE) over 24 months. The study did not demonstrate a difference between treatments (-3.88 vs. -3.50 episodes per day), however women treated with BTX were more satisfied; but reported higher rates of UTI. The two treatments provide comparable third-line treatment options for patients with refractory urgency urinary incontinence.

Investigation of intradetrusor onabotulinum toxin A efficacy and safety in older adults with urge urinary incontinence.

PURPOSE: Intradetrusor onabotulinum toxin A (BTX-A) has been demonstrated to be an effective treatment option for overactive bladder (OAB). However, concerns about frailty and frequent injections may deter its use in the elderly. This study aims to assess the safety, efficacy, and treatment duration of BTX-A in managing OAB in elderly women. METHODS: We retrospectively reviewed female patients aged 70 and above who were diagnosed with OAB with predominant urge urinary incontinence and underwent intravesical BTX-A treatment. We collected demographic and clinical data, with repeat BTX-A injections re-administered upon patient-reported symptom recurrence. RESULTS: Twenty-one female patients, median age 77 (range 71-92), were included. The median time between the first and second injection was 185 (84-448) days, 186 (105-959) days between the second and third injection, and increased to 206.5 (84-256) days between the third and fourth injection. However, the median interval trended downward after the fourth injection (Fig. 1). Patients with four or more injections had a shorter median interval between injections, 154 days, compared to those with fewer injections, 210 days. Two patients (6.9%) experienced urinary retention after the initial treatment, with 1 (2.2%) among a total of 46 subsequent treatments (Table 3). There were ten (13.3%) episodes of UTIs within 2 weeks of treatment. Patients reported improvement in symptoms following 93.3% of the injections. CONCLUSION: This real-world study demonstrates that BTX-A effectively controls OAB symptoms in elderly women, with just two injections annually. BTX-A appears safe and efficacious for treating OAB in elderly females.

Impact of microbiota and host immunologic response on the efficacy of anticholinergic treatment for urgency urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Studies within the past decade have suggested associations among composition of the urinary microbiota, local immune responses, and urinary incontinence symptoms. To investigate these relationships, we evaluated the structure of the urinary microbiome, local inflammatory markers, and patient responses prior to and at 6-weeks after treatment with anticholinergic medication for urgency urinary incontinence (UUI). METHODS: Using a prospective pilot study, we enrolled women who presented with UUI symptoms and were prescribed treatment with anticholinergics. Catheterized urine samples were collected from participants at their baseline and 6-week follow-up visits for microbiological (standard and 16S rRNA gene phylotyping analyses) and cytokine analysis along with the UDI-6 questionnaire and 2-day bladder diary. RESULTS: Patients were Caucasian, post- menopausal, with a median age of 64 and median BMI of 30.1 kg/m2. Among the patients, 75% had UUI symptoms for less than 2 years, but with a frequency of at least a few times a week or every day. Most women were prescribed 10 mg oxybutynin ER daily at enrollment. Patients had varied urinary microbiota by culture and 16S phylotyping, with species of Lactobacillus being the most common, in six samples, in addition to taxa associated with Enterococcus, Staphylococcus, and mixed flora. Cytokine levels showed no differences before and after treatment with anticholinergics, nor correlation with urinary bacteria or microbiome composition. CONCLUSIONS: Our pilot study suggests factors in addition to the urinary microbiome and local immune responses may be involved in patients' response to anticholinergics for UUI.

What Are the Short-term Benefits and Potential Harms of Therapeutic Modalities for the Management of Overactive Bladder Syndrome in Women? A Review of Evidence Under the Auspices of the European Association of Urology, Female Non-neurogenic Lower Urinary Tract Symptoms Guidelines Panel.

CONTEXT: Overactive bladder syndrome (OAB) is highly prevalent among women and has a negative impact on their quality of life. The current available treatments for OAB symptoms include conservative, pharmacological, or surgical modalities. OBJECTIVE: To provide an updated contemporary evidence document regarding OAB treatment options and determine the short-term effectiveness, safety, and potential harms of the available treatment modalities for women with OAB syndrome. EVIDENCE ACQUISITION: The Medline, Embase, and Cochrane controlled trial databases and clinicaltrial.gov were searched for all relevant publications up to May 2022. The risk of bias assessment followed the recommended tool in the Cochrane Handbook for Systematic Reviews of Interventions, and quality of evidence was assessed using the modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. A meta-analysis was performed where appropriate. EVIDENCE SYNTHESIS: Antimuscarinics and beta-3 agonists were significantly more effective than placebo across most outcomes, with beta-3 agonists being more effective at reducing nocturia episodes and antimuscarinics causing significantly higher adverse events. Onabotulinumtoxin-A (Onabot-A) was more effective than placebo across most outcomes, but with significantly higher rates of acute urinary retention/clean intermittent self-catheterisation (six to eight times) and urinary tract infections (UTIs; two to three times). Onabot-A was also significantly better than antimuscarinics in the cure of urgency urinary incontinence (UUI) but not in the reduction of mean UUI episodes. Success rates of sacral nerve stimulation (SNS) were significantly higher than those of antimuscarinics (61% vs 42%, p = 0.02), with similar rates of adverse events. SNS and Onabot-A were not significantly different in efficacy outcomes. Satisfaction rates were higher with Onabot-A, but with a higher rate of recurrent UTIs (24% vs 10%). SNS was associated with 9% removal rate and 3% revision rate. CONCLUSIONS: Overactive bladder is a manageable condition, with first-line treatment options including antimuscarinics, beta-3 agonists, and posterior tibial nerve stimulation. Second-line options include Onabot-A bladder injections or SNS. The choice of therapies should be guided by individual patient factors. PATIENT SUMMARY: Overactive bladder is a manageable condition. All patients should be informed and advised on conservative treatment measures in the first instance. The first-line treatment options for its management include antimuscarinics or beta-3 agonists medication, and posterior tibial nerve stimulation procedures. The second-line options include onabotulinumtoxin-A bladder injections or sacral nerve stimulation procedure. The therapy should be chosen based on individual patient factors.

Heterogeneity of placebo effects on urinary incontinence in overactive bladder syndrome: A meta-analysis of Japanese placebo-controlled clinical trials.

OBJECTIVES: The effect sizes, changes over time, and heterogeneity of placebo effects on frequency of urination for voiding disorders in Japanese clinical trials have been published. This study evaluated the characteristics of placebo effects on overall and urge incontinence in overactive bladder patients. METHODS: A meta-analysis of Japanese placebo-controlled clinical trials was conducted to determine placebo effects on the daily frequency of overall (n = 16) and urge (n = 11) incontinence and identify factors that should be considered in clinical trials. RESULTS: The between-study heterogeneity variance of placebo effects for overall and urge incontinence at 8 weeks was estimated as I2 = 70.3% and 64.2%, and the prediction interval for the ratio of means ranged from g = 0.31-0.91 and 0.32-0.81, respectively. Subgroup analysis using the random-effects model showed placebo effects in overall incontinence (p = 0.08) and urge incontinence (p < 0.0001). The ratio of means (95% confidence interval) of urge incontinence frequency from baseline to 4 (n = 10), 8 (n = 10), and 12 (n = 7) weeks were 0.65 (0.57, 0.74), 0.51 (0.42, 0.62), and 0.48 (0.36, 0.64), respectively, for the random-effects model. Regression analysis did not reveal any significant factors that influenced placebo effects. CONCLUSIONS: This meta-analysis confirmed the characterization of placebo effects on overall and urge incontinence, which demonstrates heterogeneity between trials. The impact of population, follow-up period, and endpoints on placebo effects should be considered when designing clinical trials for overactive bladder syndrome.

Treatment patterns in women with urinary urgency and/or urgency urinary incontinence in the symptoms of Lower Urinary Tract Dysfunction Research Network Observational Cohort Study.

BACKGROUND: Limited epidemiological data exist describing how patients engage with various treatments for overactive bladder (OAB). To improve care for patients with OAB, it is essential to gain a better understanding of how patients interface with OAB treatments longitudinally, that is, how often patients change treatments and the pattern of this treatment change in terms of escalation and de-escalation. OBJECTIVES: To describe treatment patterns for women with bothersome urinary urgency (UU) and/or urgency urinary incontinence (UUI) presenting to specialty care over 1 year. STUDY DESIGN: The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) study enrolled adult women with bothersome UU and/or UUI seeking care for lower urinary tract symptoms (LUTS) between January 2015 and September 2016. An ordinal logistic regression model was fitted to describe the probabilities of escalating or de-escalating level of treatment during 1-year follow-up. RESULTS: Among 349 women, 281 reported UUI and 68 reported UU at baseline. At the end of 1 year of treatment by a urologist or urogynecologist, the highest level of treatment received by participants was 5% expectant management, 36% behavioral treatments (BT), 26% physical therapy (PT), 26% OAB medications, 1% percutaneous tibial nerve stimulation, 3% intradetrusor onabotulinum toxin A injection, and 3% sacral neuromodulation. Participants using BT or PT at baseline were more likely to be de-escalated to no treatment than participants on OAB medications at baseline, who tended to stay on medications. Predictors of the highest level of treatment included starting level of treatment, hypertension, UUI severity, stress urinary incontinence, and anticholinergic burden score. CONCLUSIONS: Treatment patterns for UU and UUI are diverse. Even for patients with significant bother from OAB presenting to specialty clinics, further treatment often only involves conservative or medical therapies. This study highlights the need for improved treatment algorithms to escalate patients with persistent symptoms, or to adjust care in those who have been unsuccessfully treated.

Surgical Effect Observation and Treatment Strategy Analysis of Pseudo Urgency Syndrome.

Background and Objectives: pseudo urgency syndrome among patients with mixed incontinence (MUI) causes and the corresponding treatment strategies is explored. Materials and Methods: A total of 40 patients with MUI are treated with transobturator tape (TOT) and/or solifenacin succinate. Further, 30 patients with simple stress urinary incontinence (SUI) that were treated with transobturator tape (TOT) from the period of December 2018 to August 2020 are retrospectively analyzed; then, their clinical characteristics and therapeutic effects were summarized and analyzed. Results: The effective rates of SUI symptoms in MUI and simple SUI groups were 85% and 90%, respectively; further, the difference was noted as not statistically significant (P > 0.05). Among the 40 patients with MUI, 12 patients had unstable bladder contraction, and the other 28 patients showed normal bladder compliance. The treatment effectiveness rates of SUI symptoms in patients with unstable bladder contraction and normal bladder compliance were 83.3% and 85.7%, respectively; further, no significant difference was noted (P > 0.05). However, the effective rates of urge urinary incontinence (UUI) were 50% and 85.7%, respectively, however the difference was noted as statistically significant (P < 0.05). Conclusions: Most of the UUI symptoms in MUI patients may be "pseudo urgency syndrome" caused by the worry about the leakage of urine, rather than a real sense of UUI that is caused by excessive bladder excitement. Direct surgical treatment in patients with MUI can improve the symptoms of urinary incontinence, and the effect is more obvious in patients with urinary frequency who have normal bladder compliance according to urodynamics.

Prasterone in the treatment of mild to moderate urge incontinence: an observational study.

OBJECTIVE: To assess the effects of prasterone compared with hyaluronic acid on symptoms of mild to moderate urinary urgency in women with genitourinary syndrome of menopause. METHODS: This is an observational prospective cohort study. A total of 58 postmenopausal women were enrolled (from December 2019 to May 2021). Overactive Bladder Screener questionnaire, Patient Global Impression of Improvement questionnaire, International Consultation on Incontinence Questionnaire-Short Form, and International Quality of Life questionnaire were used. RESULTS: Fifty-eight women, 29 (50%) and 29 (50%), were treated with prasterone and hyaluronic acid for 12 weeks, respectively. At the end of the study, 26 (89.7%) versus 3 (10.3%) women reported an improvement (Patient Global Impression of Improvement score ≤3) of the symptoms in the prasterone versus hyaluronic acid group. According to the International Consultation on Incontinence Questionnaire-Short Form, no statistically significant difference was recorded before treatment between the prasterone and hyaluronic acid groups (median, 12 [6-12] vs 11 [8-12]; P = 0.8). Conversely, a statistically significant difference was recorded after treatment between the two groups (median, 8 [5-11] vs 10 [8-11]; P = 0.03). According to the International Quality of Life, a statistically significantly lower median score was recorded in the prasterone compared with the hyaluronic acid group, before (73 [interquartile range {IQR}, 55-81] vs 89 [IQR, 67-94]; P < 0.01) and after (78 [IQR, 65-86] vs 87 [IQR, 72-99]; P = 0.04) treatment. CONCLUSIONS: The current observational study supports the hypothesis that prasterone might improve the severity of urinary urge incontinence in this set of women. However, these results need to be confirmed in further studies with a controlled design and a larger population.

Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence.

OBJECTIVE: The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation. METHODS: This was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline. RESULTS: Participants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%-90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%-95%) of participants were considered responders with 36% (95% CI, 20%-57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study. CONCLUSIONS: The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.

Predicting outcomes after intradetrusor onabotulinumtoxina for non-neurogenic urgency incontinence in women.

AIMS: Develop models to predict outcomes after intradetrusor injection of 100 or 200 units of onabotulinumtoxinA in women with non-neurogenic urgency urinary incontinence (UUI). METHODS: Models were developed using 307 women from two randomized trials assessing efficacy of onabotulinumtoxinA for non-neurogenic UUI. Cox, linear and logistic regression models were fit using: (1) time to recurrence over 12 months, (2) change from baseline daily UUI episodes (UUIE) at 6 months, and (3) need for self-catheterization over 6 months. Model discrimination of Cox and logistic regression models was calculated using c-index. Mean absolute error determined accuracy of the linear model. Calibration was demonstrated using calibration curves. All models were internally validated using bootstrapping. RESULTS: Median time to recurrence was 6 (interquartile range [IQR]: 2-12) months. Increasing age, 200 units of onabotulinumtoxinA, higher body mass index (BMI) and baseline UUIE were associated with decreased time to recurrence. The c-index was 0.63 (95% confidence interval [CI]: 0.59, 0.67). Median change in daily UUIE from baseline at 6 months was -3.5 (IQR: -5.0, -2.3). Increasing age, lower baseline UUIE, 200 units of onabotulinumtoxinA, higher BMI and IIQ-SF were associated with less improvement in UUIE. The mean absolute error predicting change in UUIE was accurate to 1.6 (95% CI: 1.5, 1.7) UUI episodes. The overall rate of self-catheterization was 17.6% (95% CI: 13.6%-22.4%). Lower BMI, 200 units of onabotulinumtoxinA, increased baseline postvoid residual and maximum capacity were associated with higher risk of self-catheterization. The c-index was 0.66 (95% CI: 0.61, 0.76). The three calculators are available at http://riskcalc.duke.edu. CONCLUSIONS: After external validation, these models will assist clinicians in providing more accurate estimates of expected treatment outcomes after onabotulinumtoxinA for non-neurogenic UUI in women.

The effect of a counseling and training program on the treatment of women with overactive bladder.

Anticholinergic drugs and behavioral interventions are effective methods for the treatment of OAB and UUI. This randomized controlled, prospective, and quasi-experimental study determined the effect of healthy lifestyle behavior training, based on the Health Promotion Model (HPM), on the treatment of women with Overactive Bladder (OAB). The study sample included intervention and control groups with a sample size of 100 women diagnosed with OAB who received pharmacological treatment and agreed to participate in the study. The data were collected using an Introductory Information Form, Urinary Diary, OAB Questionnaire (OAB-V8), King's Health Questionnaire (KHQ), Healthy Life Style Behavior Scale II (HLSB II), Brief Symptom Inventory (BSI), and 24-hour Pad Test. The intervention group was administered a 45-minute training program based on Pender's HPM. There was a statistically significantly higher level of decrease in urgency (z = -3,259;p = 0,001), nocturia (z = -3,691;p < 0,001), urge urinary incontinence (z = -2,391;p = 0,017), and urinary frequency (χ2 = 17,420;p < 0,001) in the intervention group during the posttest period. The study found a significant decrease in the total posttest scores of the women in the intervention group on the OAB-V8 (t = -6.955;p < 0.001), KHQ (t = -5.354;p < 0.001), and BSI (t = -6.463;p < 0.001) scales whereas a statistically significant increase was found in their total score on the HLSB II (t = 9.139;p < 0.001) scale. The study concluded that HLSB training, which was prepared based on HPM, reduced OAB symptoms among women, improved the quality of their lives, changed their HLSBs, and positively affected their psychological symptoms.

Evaluation of the relationship of cholinergic metabolites in urine and urgency urinary incontinence.

INTRODUCTION AND HYPOTHESIS: To investigate differences in urine cholinergic metabolites in women with urinary urgency incontinence (UUI) and responders (R) and non-responders (NR) to anti-cholinergic medications (AC). METHODS: Patients with UUI and age-matched controls were evaluated pre- and post-treatment using OABSS, UDI-6 and IIQ-7. Controls were defined as having a cumulative OABSS of zero. Patients with UUI were treated with AC and followed for 12 weeks. Responders were those with a > 50% decrease in the total OABSS score. Urine samples were collected from all participants for evaluation. Metabolite detection was accomplished using commercial assay kits. Wilcoxon-rank sum test and Fisher's exact test were used to express differences between groups. Spearman's rho correlation coefficient was used to determine the relationship between acetylcholine (Ach), choline (Ch), acetylcholinesterase (AchE) and questionnaire scores. RESULTS: We recruited 39 with UUI and 33 controls. We found concentrations of Ch [29.0 (IQR: 24.2-42.5) µmol vs. 15.2 (IQR: 7.5-24.1) µmol] and Ach [65.8 (IQR: 30.4-101.8) nmol and 33.1 (IQR: 11.9-43.8) nmol] were higher in the UUI group compared to controls (p = 0.003 and p < 0.001, respectively] and no differences in AchE concentrations. In the UUI group, 43.6% responded to AC after 12 weeks of therapy. There were no differences in Ch or AchE levels between R and NR; Ach levels were higher in the R group [82.1 nmol (IQR: 54.8-118.1) vs. 50.3 nmol (IQR: 29.9-68.2), p = 0.007]. Ch and Ach were positively associated with pre-treatment OABSS parameters. CONCLUSIONS: Urine Ach is higher in responders to anti-cholinergic therapy, and urine cholinergic metabolites were higher in the UUI patients compared to controls.

A Prospective Study to Investigate the Effect of Fesoterodine Treatment on Quality of Life, Anxiety, and Depression in Urge-Type Urinary Incontinence.

PURPOSE:   Urinary incontinence (UI) is a fundamental health problem, can occur at any age but is especially common in older women. Depression and anxiety are also considerable problems for the elderly. UI is one of the geriatric syndromes that are thought to be related to depression and quality of life (QOL). MATERIALS AND METHODS: This prospective study was conducted for a period of 2 months from February 2020 to April 2020. Women who applied to the outpatient clinic of geriatrics with UI symptoms were taken into the study. The type of UI was determined by using the 3 Incontinence Questions (3IQ). Only patients with urge incontinence were included in the study. Patients were evaluated for QOL, anxiety, depression, disability, and geriatric syndromes before and after treatment. Data analysis was done by using SPSS version 22. RESULTS: The study population was 42 women; the mean age was 69.7 +/- 4.3 years.  QoL, anxiety, and depression symptoms, and ADL were revealed to be improved after treatment. ICIQ-SF, I-QOL, and HADs scores were associated with UI treatment when evaluated with one-way MANOVA (F [4, 79] =3.25, p=0.00, Wilk's Λ=0.859, partial η2=0.14). CONCLUSION: UI is a common problem in the elderly. Patients usually hesitate to tell this complaint to even doctors. That situation affects their physical and psychological condition negatively. In this study, we reached that anticholinergic treatment (fesoterodine) improved ADL, QoL, and psychological symptoms. Those findings represented us that proper treatment of UI is critical for healthy aging.

Combination therapy with botulinum toxin and bulking agent-An efficient, sustainable, and safe method to treat elderly women with mixed urinary incontinence.

AIMS: To evaluate the efficacy, sustainability and safety of combined botulinum toxin and polyacrylamide hydrogel (PAHG) therapy to treat urgency and stress components of therapy-refractory mixed urinary incontinence (MUI) in an elderly study population. METHODS: Fifty-five women with therapy-refractory MUI were treated with botulinum toxin and PAHG in one surgical procedure. Urgency urinary incontinence (UUI) and stress urinary incontinence (SUI) outcomes were separately assessed after 4 and 12 months by objective UUI episodes/24 h and cough test, subjective impact of UUI and SUI on quality of life, and subjective International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). MUI outcome was calculated by combining UUI and SUI outcomes. Complications were monitored throughout the study. RESULTS: At 4 months, objective cure rates were 73%, 53%, and 42%, and subjective cure rates were 71%, 52%, and 50% for SUI, UUI, and MUI. At 12 months, objective cure rates were 73%, 56%, 50% and subjective cure rates were 78%, 42%, and 40% for SUI, UUI, and MUI. The ICIQ-UI SF score decreased by 9.0 and 8.7 points after 4 and 12 months. All complications were transient and included 22% clean intermittent catheterization immediately after surgery, 33% postvoid residual volumes >100 ml at 14 days, and 13% symptomatic urinary tract infection within the first postoperative month. CONCLUSIONS: The combination of botulinum toxin and PAHG is effective, sustainable and safe to treat therapy-refractory MUI, even in an elderly and frail study population. Patients benefit from the short surgical procedure without the need for general anaesthesia or discontinuation of anticoagulation.

Comparison of 100 U With 200 U of Intradetrusor OnabotulinumToxinA for Nonneurogenic Urgency Incontinence.

OBJECTIVES: The objective of this study was to compare efficacy and adverse events between 100 U and 200 U of onabotulinumtoxinA for 6 months in women with nonneurogenic urgency incontinence. METHODS: This is a secondary analysis of 2 multicenter randomized controlled trials assessing efficacy of onabotulinumtoxinA in women with nonneurogenic urgency incontinence; one compared 100 U to anticholinergics and the other 200 U to sacral neuromodulation. Of 307 women who received onabotulinumtoxinA injections, 118 received 100 U, and 189 received 200 U. The primary outcome was mean adjusted change in daily urgency incontinence episodes from baseline over 6 months, measured on monthly bladder diaries. Secondary outcomes included perceived improvement, quality of life, and adverse events. The primary outcome was assessed via a multivariate linear mixed model. RESULTS: Women receiving 200 U had a lower mean reduction in urgency incontinence episodes by 6 months compared with 100 U (-3.65 vs -4.28 episodes per day; mean difference, 0.63 episodes per day [95% confidence interval (CI), 0.05-1.20]). Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32 [95% CI, 0.14-0.75]) and smaller improvement in severity score (adjusted mean difference, 12.0 [95% CI, 5.63-18.37]). Upon subanalysis of only women who were treated with prior anticholinergic medications, these differences between onabotulinumtoxinA doses were no longer statistically significant. There was no statistically significant difference in adverse events in women receiving 200 U (catheterization, 32% vs 23%; adjusted odds ratio, 1.4 [95% CI, 0.8-2.4]; urinary tract infection, 37% vs 27%; adjusted odds ratio, 1.5 [95% CI, 0.9-2.6]). CONCLUSIONS: A higher dose of onabotulinumtoxinA may not directly result in improved outcomes, but rather baseline disease severity may be a more important prediction of outcomes.

A double-blind, randomized, placebo-controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan.

OBJECTIVE: This study evaluated the efficacy and safety of imidafenacin 0.1 mg twice daily vs placebo for Taiwanese patients with overactive bladder (OAB) after a 12-week oral administration. METHODS: This randomized, double-blind, placebo-controlled, two-arm, parallel-group, prospective study enrolled 118 patients across 11 study sites in Taiwan. Subjects were randomized to imidafenacin or placebo in a 2:1 ratio and entered the 12-week treatment period. At the subsequent visits, efficacy outcome measures and safety assessments were collected for analysis. The primary efficacy outcome was the change in the mean number of micturitions per day. Secondary endpoints included mean changes from baseline in urgency episodes and urge incontinence episodes per day and mean volume voided per micturition. Safety outcomes were also collected and compared between groups. RESULTS: A total of 78 and 40 patients were allocated to the imidafenacin and placebo groups, respectively. Among them, 100 patients (imidafenacin, 65 and placebo, 35) completed the trial. Compared with placebo, imidafenacin was significantly better at reducing the number of micturitions per day (-1.29 ± 2.23 vs -0.46 ± 3.49, P = .0171) and reducing the mean number of urge incontinence episodes (-0.15 ± 0.52 vs 0.04 ± 0.50, P = .0386) at week 12. Adverse events were reported in 35 subjects (44.9%) and 16 (40%) in the imidafenacin and placebo groups, including constipation (n = 3, 4), dry mouth (n = 11, 2), and urinary tract infection (n = 7, 4), respectively. One patient in the imidafenacin group had mild dysuria. CONCLUSION: Imidafenacin demonstrated efficacy and safety in the treatment of OAB in Taiwanese patients.

The First Injection: Rates of Urinary Retention in Women With Urgency Incontinence Treated With Intravesical OnabotulinumtoxinA Injection.

OBJECTIVE: The aim of the study was to describe the rate of symptomatic and asymptomatic urinary retention and catheterization in women undergoing initial intravesical onabotulinumtoxinA (BnTA) injection for urgency urinary incontinence (UUI). METHODS: This retrospective chart review included women receiving initial 100 U of BnTA injection for UUI for 5 years. Straight-catheterized postvoid residuals (PVRs) were performed 2 weeks after the injection. Women without the sensation of incomplete bladder emptying, worsened urgency, inability to void, or suprapubic pain but with PVR of greater than 300 mL were characterized as having asymptomatic retention, whereas women with a PVR of greater than 150 and any of these symptoms were diagnosed with symptomatic retention. RESULTS: One hundred eighty-seven 187 patients received initial BnTA injection. The majority were postmenopausal (89%) and white (82%) with a mean age of 65 years and body mass index of 30 kg/m2. One-third of the cohort underwent baseline urodynamic studies. At 2 weeks after injection, 163 patients (87%) followed up, and 17 (10%) had either asymptomatic or symptomatic retention (2% and 8%, respectively). There were no differences in demographic or pretreatment urodynamic parameters in women with and without retention except that women who had previous anti-stress urinary incontinence procedures were more likely to experience retention (53% vs 18%, P = 0.002) despite similar baseline PVRs. CONCLUSION: We demonstrated that the rate of retention requiring catheterization after 100 U BnTA may be as high as 10% although only 5% develop PVRs for 300 mL and only 2% have asymptomatic retention for 300 mL.