Urge Incontinence Episodes Research Articles

The peptide regulator Vezusten in the management of overactive bladder syndrome: an efficacy evaluation

Introduction. Overactive bladder (OAB) remains one of the most difficult-to-treat conditions in neurourology. The number of patients seeking help for OAB symptoms does not decrease each year, while a pathogenetic treatment has not yet been developed. This motivates the search for new approaches.Objective. To assess the efficacy of the peptide regulator Vezusten for women with idiopathic OAB based on their health condition and urodynamic assessment of bacterial detrusor overactivity (DO).Materials & methods. A prospective cohort study included 20 patients diagnosed with OAB, which was confirmed by a comprehensive urodynamic study of DO. The patients visited the clinic three times a week. Each patient received ten intramuscular injections of the peptide regulator Vezusten. Within one month after the last injection, the women were given a monitoring voiding diary, a validated Continental Society OAB Symptom Questionnaire, the Overactive Bladder Questionnaire (OAB-q), and a follow-up urodynamic study (UDS).Results. We obtained statistically significant differences in the following indicators: the number of daily urinations according to the urination diary decreased from 14.0 [13.0; 16.3] to 11.0 [8.8; 12.0] (p < 0,001), patient’s episodes of urge incontinence began to be noted for the first time (p = 0.004). At the same time, the urodynamic maximum cystometric capacity (MCC) increased from 267 [158; 332] to 320 [267; 433] ml. Subjectively, participants noted an improvement in the scores of the OAB questionnaire (OAB-q) — the score decreased from 28 [22; 30] to 19 [14; 24] (p = 0.001), and the number of episodes of nocturia decreased from 4 to 2 (p < 0.001). No side effects from therapy were observed in any of the patients.Conclusion. This study demonstrated a statistically significant improvement in subjective symptoms of OAB in DO-women treated with the peptide regulator Vezusten, but further large placebo-controlled studies are required for confirmation.

Predicting success using response after lead implantation with sacral neuromodulation for urgency incontinence.

Many women report inadequate symptom control after sacral neuromodulation (SNM), despite 50% reduction in urgency incontinence episodes (UUIE) after test stimulation. To determine the ideal percent UUIE reduction after test stimulation that predicts 24-month success. Using data from a multicenter SNM trial, we constructed receiver operating characteristic curves to identify an ideal threshold of percent UUIE reduction after test stimulation. We defined 24-month success as Patient Global Impression of Improvement of "very much better" to "better." We compared predictive accuracy of two models predicting success: (1) percent UUIE reduction alone and (2) with baseline characteristics. Of 149 women (median [IQR] baseline daily UUIE 4.7 [3.7, 6.0]), the ideal threshold for 24-month success was 72% (95% confidence interval 64,76%) UUIE reduction with accuracy 0.54 (0.42, 0.66), sensitivity 0.71 (0.56, 0.86) and specificity 0.27 (0.05, 0.55). The accuracy of the 50% reduction threshold was 0.60 (0.49, 0.71), sensitivity 0.95 (0.88, 1.0) and specificity 0.04 (0.0, 0.12). Percent reduction in UUIE was not better than chance in predicting 24-month success (concordance index [c-index] 0.47 [0.46, 0.62]); adding age, body mass index, diabetes mellitus and visual or hearing impairment the c-index was 0.68 (0.61, 0.78). Among women who received an internal pulse generator (IPG) due to ≥50% UUIE reduction after test stimulation, we found no ideal threshold that better predicted 24-month success. Percent reduction in UUIE after test stimulation poorly predicts 24-month success with or without clinical factors. Given this, re-evaluating how we determine who should receive an IPG is needed.

Open-label, randomized, post-authorization study of mirabegron in Chinese participants with overactive bladder

ObjectiveTo assess efficacy and safety of mirabegron 25 mg and 50 mg for overactive bladder in Chinese participants. MethodsParticipants ≥18 years with overactive bladder symptoms for ≥12 weeks, average ≥8 micturitions per 24 h, and ≥1 episode of Grade 3 or 4 urgency or urge incontinence per 24 h based on Patient Perception of Intensity of Urgency Scale over a 3-day micturition diary period were randomized 2:1 to open-label treatment with oral mirabegron 50 mg or 25 mg once daily for 12 weeks (15 sites in China, January 2021–March 2022). A dose escalation from 25 mg to 50 mg was permitted at weeks 4 and 8 according to investigator discretion. Primary efficacy endpoint: change from baseline to Week 12 in mean number of micturitions per 24 h in those randomized to mirabegron 50 mg. Secondary efficacy endpoints: change in mean number of micturitions at weeks 4 and 8 in the mirabegron 50 mg group and weeks 4, 8, and 12 in the mirabegron 25 mg group, change from baseline to weeks 4, 8, and 12 in Grade 3 or 4 urgency episodes on Patient Perception of Intensity of Urgency Scale, episodes of daytime incontinence, nighttime incontinence, and urgency incontinence, and Overactive Bladder Symptom Score for mirabegron 50 mg and 25 mg groups. ResultsStatistically significant reduction (p<0.001) from baseline to week 12 was observed in mean micturitions per 24 h: mirabegron 50 mg (mean and standard error: 11.71 and 0.43 at baseline, 7.80 and 0.24 at Week 12; adjusted mean change −3.73 [95% confidence interval −4.30 to −3.16]). Both doses showed statistically significant improvements in secondary efficacy endpoints at weeks 4, 8, and 12 versus baseline. Safety was consistent with mirabegron's known safety profile. ConclusionThe results support a recommended dosage of 50 mg in China.

Longitudinal Fluctuations in Treatment Response After OnabotulinumToxinA and Sacral Neuromodulation for Refractory Urgency Incontinence.

We compared fluctuations in treatment response after onabotulinumtoxinA and sacral neuromodulation for urgency incontinence using Markov models. We fit data from a randomized trial to Markov models to compare transitions of success/failure over 6 months between 200 U onabotulinumtoxinA and sacral neuromodulation. Objective failure was <50% reduction in urgency incontinence episodes from baseline; subjective failure "strongly disagree" to "neutral" to the Patient Global Symptom Control questionnaire. Of the 357 participants (median baseline daily urgency incontinence episodes 4.7 [IQR 3.7-6.0]) 61% vs 51% and 3.2% vs 6.1% reported persistent states of objective success and failure over 6 months after onabotulinumtoxinA vs sacral neuromodulation. Participants receiving onabotulinumtoxinA vs sacral neuromodulation had lower 30-day transition probabilities from objective and subjective success to failure (10% vs 14%, ratio 0.75 [95% CI 0.55-0.95]; 14% vs 21%, ratio 0.70 [95% CI 0.51-0.89]). The 30-day transition probability from objective and subjective failure to success did not differ between onabotulinumtoxinA and sacral neuromodulation (40% vs 36%, ratio 1.11 [95% CI 0.73-1.50]; 18% vs 17%, ratio 1.14 [95% CI 0.65-1.64]). Over 6 months after treatment, 2 in 5 women's symptoms fluctuate. Within these initial 6 months, women receiving onabotulinumtoxinA transitioned from success to failure over 30 days less often than sacral neuromodulation. For both treatments, there was an almost 20%-40% probability over 30 days that women returned to subjective and objective success after failure. Markov models add important information to longitudinal models on how symptoms fluctuate after urgency incontinence treatment.

A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladder.

Vibegron, a novel, potent β3 agonist, has been approved for clinical use in overactive bladder (OAB) treatment in Japan and the Unites States. We performed a bridging study to investigate the efficacy and safety of a daily 50-mg vibegron (code name JLP-2002) dose in Korean patients with OAB. A multicenter, randomized, double-blind, placebo-controlled study was conducted from September 2020 to August 2021. Adult patients with OAB with a symptom duration of more than 6 months entered a 2-week placebo run-in phase. Eligibility was assessed at the end of this phase and selected patients entered a double-blind treatment phase after 1:1 randomization to either the placebo or vibegron (50 mg) group. The study drug was administered once daily for 12 weeks and follow-up visits were scheduled at weeks 4, 8, and 12. The primary endpoint was the change in mean daily micturition at the end of treatment. The secondary endpoints included changes in OAB symptoms (daily micturition, nocturia, urgency, urgency incontinence, and incontinence episodes, and mean voided volume per micturition) and safety. A constrained longitudinal data model was used for statistical analysis. Patients who took daily vibegron had significant improvements over the placebo group in both primary and secondary endpoints, except for daily nocturia episodes. The proportions of patients with normalized micturition and resolution of urgency incontinence and incontinence episodes were significantly higher in vibegron group than in the placebo. Vibegron also improved the patients' quality of life with higher satisfaction rates. The incidence of adverse events in the vibegron and placebo groups was similar with no serious, unexpected adverse drug reactions. No abnormality in electrocardiographs was observed as well as no significant increase in postvoid residual volume. Once daily vibegron (50 mg) for 12 weeks was effective, safe, and well-tolerated in Korean patients with OAB.

Transcutaneous tibial nerve electrical stimulation versus vaginal electrical stimulation in women with overactive bladder syndrome: Is there a role for short-term interventions?

To assess the efficacy of vaginal electrical stimulation (VS) versus transcutaneous tibial nerve electrical stimulation (TTNS) in women with overactive bladder syndrome (OAB). Sixty-nine patients were randomized to receive 12 sessions of VS versus TTNS, or no treatment (control group-CG), over 6 weeks. OAB impact according to international consultation on incontinence questionnaire overactive bladder module (ICIQ-OAB), symptoms discomfort scores and voiding diaries were evaluated at baseline, 6 weeks and 1-month post-treatment. Both TTNS (mean difference = -4.2; 95% confidence interval [CI] = -6.5 to -1.9) and VS (-3.8; -6.0 to -1.6) were associated with significant reduction of ICIQ-OAB scores, as well as discomfort sensation (-3.9; -6.2 to -1,7; p < 0.001 for the TTNS and -2.8; -5.0 to -0.6; p = 0.01 for the VS) at 6 weeks when compared to CG (p < 0.001). ICIQ-OAB score remained low only in the TTNS group when compared to the CG (-3.6; -6.0 to -1.2/p = 0.00) 1 month after treatment. Discomfort symptoms improved in both active groups when compared to CG (TTNS [-3.2; -5.2 to -1.2; p < 0.001] and VS groups [-2.6; -4.7 to -0.6; p = 0.01]). No statistically differences were found in primary outcomes comparing TTNS and VS Secondary analysis showed significant improvement in urinary urgency incontinence episodes (UUI) in both TTNS and VS, but CG. UUI episodes were still reduced in the VS group and urgency in the TTNS group 1-month post-treatment. Short-term interventions (6 weeks) of TTNS and VS were both effective in treating women with OAB. TTNS provided residual effects at one-month postintervention on ICIQ-OAB score.

MP52-13 IMPROVED LOWER URINARY TRACT SYMPTOMS AND ASSOCIATED CHANGES IN MICTURITION-ASSOCIATED BRAIN ACTIVITY IN STROKE SURVIVORS FOLLOWING TRANSCUTANEOUS SPINAL CORD STIMULATION

You have accessJournal of UrologyCME1 Apr 2023MP52-13 IMPROVED LOWER URINARY TRACT SYMPTOMS AND ASSOCIATED CHANGES IN MICTURITION-ASSOCIATED BRAIN ACTIVITY IN STROKE SURVIVORS FOLLOWING TRANSCUTANEOUS SPINAL CORD STIMULATION David Chapman, Luis Alejandro Morales Ojeda, Veronica Stefania Montero Arcila, Sarah Ponce, Rita Jen, Nhi Ha, Parag Gad, Reggie Edgerton, David Ginsberg, Aidin Abedi, Kay Jann, and Evgeniy Kreydin David ChapmanDavid Chapman More articles by this author , Luis Alejandro Morales OjedaLuis Alejandro Morales Ojeda More articles by this author , Veronica Stefania Montero ArcilaVeronica Stefania Montero Arcila More articles by this author , Sarah PonceSarah Ponce More articles by this author , Rita JenRita Jen More articles by this author , Nhi HaNhi Ha More articles by this author , Parag GadParag Gad More articles by this author , Reggie EdgertonReggie Edgerton More articles by this author , David GinsbergDavid Ginsberg More articles by this author , Aidin AbediAidin Abedi More articles by this author , Kay JannKay Jann More articles by this author , and Evgeniy KreydinEvgeniy Kreydin More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003300.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Stroke survivors often experience lower urinary tract dysfunction that can be difficult to treat and profoundly impacts their quality of life. After a stroke, micturition-associated brain activity (MABA) has been shown to rely on activation of primitive brain regions including the cerebellum and periaqueductal gray with less activation of cortical regions. Transcutaneous Spinal Cord Stimulation (TSCS), a novel technique of neuromodulation, is emerging as a powerful tool with growing clinical evidence in neuro-restoration potential. The objective was to evaluate changes in brain activity using functional MRI (fMRI) and patient reported outcome measures (PROM) following twelve weeks of TSCS. METHODS: Twelve patients with de novo lower urinary tract symptoms following a stroke prospectively underwent TSCS for 24 sessions. Blood oxygen level dependent (BOLD) brain activity changes detected with fMRI were collected during maximum urgency, measured 10 seconds prior to detrusor contraction. Patients completed a voiding diary, ICIQ-OAB questionnaire, and underwent fMRI+UDS before and after TSCS. Descriptive statistics and paired t-test were used when appropriate. RESULTS: Twelve patients (5 males, 7 females) with a mean age of 52.8±9.8 years old completed the study. After completion of TSCS, patients reported a decreased perception of urge per void (1.83±0.34 vs 0.92±0.21: p<0.05), number of urge incontinence episodes (6.96±2.12 vs 4.15±1.58: p><0.05), and an increased number of urge-free voids per 24 hours (0.27±0.09 vs 2.29±0.91; p<0.05). ICIQ-OAB scores were significantly lower post stimulation (9.6 vs 4.1; p=0.001). Functional MRI detected an increase in BOLD signal in the cerebellum, cuneus, and multiple frontal areas including the inferior, medial, and middle frontal gyri following TSCS. CONCLUSIONS: Patients that completed twelve weeks of TSCS experienced a significant reduction in perceived urge per void and urgency incontinence episodes and an increase in urge-free voids per 24 hours. ICIQ-OAB scores were significantly lower in patient’s post-spinal neuromodulation. TSCS resulted in a restoration of activation of several cortical brain regions. Source of Funding: Urology Care Foundation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e707 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information David Chapman More articles by this author Luis Alejandro Morales Ojeda More articles by this author Veronica Stefania Montero Arcila More articles by this author Sarah Ponce More articles by this author Rita Jen More articles by this author Nhi Ha More articles by this author Parag Gad More articles by this author Reggie Edgerton More articles by this author David Ginsberg More articles by this author Aidin Abedi More articles by this author Kay Jann More articles by this author Evgeniy Kreydin More articles by this author Expand All Advertisement PDF downloadLoading ...

Comparison of micro-radiofrequency therapy and tolterodine for the treatment of newly diagnosed overactive bladder: A retrospective cohort study.

This study aimed to retrospectively compare the efficacy and safety of micro-radiofrequency (RF) therapy through the urethra vs. oral tolterodine tartrate in the treatment of newly diagnosed overactive bladder (OAB). In this study, 46 patients who were newly diagnosed with moderate-to-severe OAB were included; 23 of them underwent the micro-RF treatment procedure, and the other 23 patients took tolterodine. Bladder diaries were recorded 3 days before treatment and during the follow-up period on 1, 3, and 7 weeks after micro-RF therapy or oral tolterodine. Micturition parameters including daily voiding times, daily urge urinary incontinence (UI) episodes, daily urgency episodes, mean volume per micturition, post-void residual volume (PVR), maximum urine flow rate (Qmax), overactive bladder symptom score (OABSS), and quality of life (QoL) score were analyzed. All 46 patients underwent either micro-RF or oral tolterodine treatment, as well as a complete follow-up. The incidence of adverse events in the micro-RF group was 8.7% (2/23), and that in the tolterodine group was 43.5% (10/23). The following two adverse events happened in the micro-RF group: an injury to the urethra during catheterization in a man and a urinary tract infection in a woman, both of which were relieved or disappeared after day 3. The adverse effects in the tolterodine group were mainly dry mouth (4/23), dysuria (5/23), and constipation (8/23), but none of the patients withdrew from the drug therapy. Compared to pre-therapy, all parameters of both groups, including daily voiding times, daily urgency episodes, mean volume per micturition, OABSS, and QoL score, demonstrated significant improvements during follow-up in 7 weeks after therapy, except for daily UI episodes in the tolterodine group, while the above parameters showed bigger improvements in the micro-RF group than in the tolterodine group. Besides, the general treatment efficacy of micro-RF was 73.9% (17/23), which was significantly better than tolterodine (10/23, 43.5%), and the difference was 30.4% [95% CI: 3.4-57.5%, p = 0.036]. In this retrospective study, we found that micro-RF therapy is safe and more effective than oral tolterodine for newly diagnosed moderate-to-severe OAB in a short-term follow-up. Stronger evidence would be provided through a well-designed, prospective, randomized controlled trial.

Долгосрочная безопасность и эффективность троспия хлорида при лечении нейрогенного гиперактивного мочевого пузыря вследствие болезни Паркинсона – есть ли влияние на когнитивный статус?

To evaluate the efficiency of long-term use of trospium chloride (Spazmex) for the treatment of patients with neurogenic overactive bladder due to Parkinson's disease (PD) and to determine the influence of therapy on the cognitive status of patients.60 patients with PD and neurogenic overactive bladder with stages 2.5, 3 and 4 according to Hoehn-Yahr scale were included in the main group. The mean age was 58.2+/-5.7 years. All patients were prescribed trospium chloride at entry into the study, with doses titrated gradually according to clinical efficacy (30 to 90 mg). The comparison group included 15 patients with PD and neurogenic overactive bladder at stages 2,5 and 3, who received tibial neuromodulation according to the standard technique with skin electrodes. The mean age of patients was 56.4+/-4.6 years. At baseline, both groups were comparable in terms of gender, age and cognitive status (p=0.801). All patients received treatment for 52 weeks. The efficiency of therapy was assessed according to bladder diaries, while safety outcomes included postvoid residual, side effects, cognitive status according to the MoCA scale and quality of life according to the SF-Qualiveen questionnaire.clinical efficacy and satisfaction were achieved in all patients who completed the study (47 patients in the main group and 15 patients in the comparison group). Good clinical efficacy was demonstrated in both groups, since there was a decrease in the number of urinations, episodes of urgency and urinary incontinence. In addition, there was an improvement in the quality of life according to the SF-Qualiveen scale. The cognitive status during the entire follow-up period remained without significant changes in both groups.Trospium chloride is an effective drug in patients with PD. It does not affect cognitive functions during long-term use. Trospium chloride should be considered as first-line drug in those with urologic manifestations of PD.

An Acute Hip Injury Correlated With An Exacerbation Of Urinary Symptoms In A Dancer

HISTORY23-year-old female dancer sustained an acute right hip/groin injury during a rond-de-jambe movement (requiring a combination of hip abduction, extension and external rotation). She had a sensation of a pop at the time of injury, followed by difficulty with external rotation as she attempted to continue to dance. Subsequent days were characterized by bruising to the inner groin and progressive medial thigh discomfort. She concurrently experienced a significant worsening of pre-existing urinary dysfunction characterized by episodes of urge incontinence and a sensation of incomplete voiding. She then developed secondary lateral hip, sacroiliac and low back discomfort. PHYSICAL EXAMShe presented to our office 6 weeks after the initial injury. She had a normal gait and symmetric hip range of motion. Right hip exam with pain at end range of passive hip flexion, and pain also with resisted testing of hip adduction, internal rotation and external rotation. She had tenderness over the anterior hip flexor tendons and at the proximal medial thigh just inferior to the pubic ramus. She was not tender to the pubic ramus. Thomas test was negative bilaterally, but she had significant tightness of quadriceps bilaterally noted on Ely’s test. An internal exam separately completed by her urogynecologist identified tightness of the pelvic floor musculature. DIFFERENTIAL DIAGNOSIS adductor muscle strain, strain of deep hip rotator muscles (obturator externus, obturator internus), hip flexor tendonitis (as primary or secondary diagnosis), labral tear, pelvic floor muscle strain/tear/dysfunction, primary or secondary tightness of pelvic floor musculature, hormonal and/or bladder irritants affecting urinary function TESTS AND RESULTS 1. Xray pelvis/hip series: Well-formed acetabula, slight predisposition to CAM type FAI 2. Hip MRI: Shallow right acetabulum with mild uncovering of lateral femoral head, signs of possible labral tear, small partial intramuscular tear of the R obturator externus, strain of R iliopsoas muscle 3. Dynamic hip ultrasound - pending FINAL WORKING DIAGNOSIS 1.Obturator externus strain with comorbid strain of iliopsoas muscle 2.Pelvic floor dysfunction TREATMENT AND OUTCOMES 1. Dance specific PT for core and peri-pelvic stabilization 2. Pelvic floor physical therapy 3. Gradual return to dance

The Efficacy of Compression Stockings on Patients With Nocturia: A Single-Arm Pilot Study

Objectives: Behavioral treatment for nocturia includes wearing compression stockings. However, a reading of the cited literature for evidence shows that there is not enough research data to support this recommendation, and it is controversial. The present study aimed to investigate and supplement evidence on the effects of wearing compression stockings during the daytime in patients with nocturia.Methods: This was a single-arm prospective study to investigate the effects of compression stockings on nocturia for four weeks. Patients were asked to record a frequency-volume chart and complete various questionnaires at baseline and after four weeks, and also provide feedback on treatment satisfaction. The primary endpoint was a change in night-time frequency in the frequency-volume chart from the baseline to the end of treatment.Results: Thirty-four patients (19 men and 15 women; age: 72.3 ± 12.6 years) were included. Two patients dropped out because of pain associated with wearing compression stockings and one due to a refusal to wear compression stockings every day. Therefore 31 patients were analyzed. In the frequency-volume chart, night-time and 24-hour frequencies significantly decreased by 0.5 and 1.1 episodes, respectively (P = 0.004 and P = 0.035, respectively). The hours of undisturbed sleep significantly increased by 0.8 h (P = 0.013). No significant differences were observed in nocturnal or 24-h urine volumes, the number of urgency or urinary incontinence episodes, the mean or maximum voided volume, the nocturnal polyuria index, or the first night-time voided volume. The total overactive bladder symptom score significantly decreased (P = 0.006). Significant reductions were also observed in all overactive bladder symptom score subscores, except for the daytime frequency score.Conclusion: The present results suggest the effectiveness of wearing compression stockings during the day was satisfactory in most patients with nocturia, and the treatment was safely continued in patients who experienced no pain when wearing the stockings. Based on the results of this study, we believe that it is worth considering as a treatment for nocturia.

A Quasi Experiment on Outcome of Mirabegron and Solifenacin in the Treatment of Primary Over Active Bladder in A Tertiary Hospital in Dhaka, Bangladesh

Background: Overactive bladder (OAB) syndrome is a common symptom complex that affects millions of people worldwide, with an increasing prevalence with increased age in primary overactive bladder.&#x0D; Objective: The study was done to find out the efficacy and outcome of Mirabegron and solifenacin on primary overactive bladder.&#x0D; Methodology : This study was a quasi-experimental study conducted on 100 study population (Group A-50 Group B-50) in Urology Outpatient Department, Sir Salimullah Medical College Mitford Hospital, Dhaka from July 2017 to December 2018. Study population were total 100 men and women aged at least 18 &amp; up to 60 years (Group A -50 and Group B-50) with persistent primary overactive bladder (OAB) symptoms for 3 months or more were enrolled in this study. Patients were eligible for the study who were able to give a written informed consent before starting the intervention &amp; was also able to complete a voiding diary. Patients were recruited at the urology outpatient department, SSMCMH, Dhaka and were selected by the following inclusion and exclusion criteria. A data sheet was completed for each patient which included particulars of the patient, history, examination findings and baseline investigations. Half of the patients were enrolled in each group. Mirabegron group was experimental group and Solifenacin group was control group. Cases of Mirabegron group was given once daily dose of Mirabegron 25 mg and Solifenacin group was also given single dose of Solifenacin succinate 5 mg, at for 12 weeks.&#x0D; Result: The result of age distribution of the study patients belonged to age 31-40 years in group A (Mirabegron 25 mg) 21(42.0%) and 16(32.0%) in group B (Solifenacin 5 mg). The mean voided volume of each micturation at 12 week of treatment was more increased in group A (Mirabegron 25 mg) than group B (Solifenacin 5 mg). The mean change in micturition frequency per 24 hours, episodes of urgency per 24 hours, urge incontinence episodes per 24 hours and nocturia episodes per 24 hours were statistically significant (p&lt;0.05) between group A (Mirabegron 25 mg) and group B (Solifenacin 5 mg).&#x0D; Conclusion The study shows that Mirabegron is more effective than Solifenacin in the treatment of primary over active bladder and can be used in without organic and pathological diseases of urinary bladder&#x0D; Sir Salimullah Med Coll J 2022; 30: 55-60

Peroneal Electrical Transcutaneous NeuroModulation as a New Treatment for Patients with Overactive Bladder: An Initial Clinical Experience

Introduction: The aim of this study was to determine whether peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) using the URIS® neuromodulation system can be used in individuals with refractory overactive bladder (OAB). Methods: Eighteen female patients with idiopathic OAB who failed previous behavioral and pharmacological therapy were enrolled. Patients were treated with the URIS® neuromodulation system using active electrodes placed on the popliteal fossa, targeting the peroneal nerve for 30 min once a week for 12 weeks. Changes in OAB symptoms and patient-reported outcomes from baseline to the end of the study were analyzed. A nonparametric Wilcoxon signed-rank test was used to assess changes in variables. Statistical significance was defined as p ≤ 0.05. Results: We observed a significant reduction in micturition frequency (p = 0.022), number of severe urgency episodes (p < 0.001), urgency incontinence episodes (p = 0.001), and nocturia episodes (p = 0.027). A decrease in Patient Perception of Bladder Condition score (p < 0.001) was also observed. Posttreatment, 15 patients (83.3%) reported a moderate or significant reduction in their bladder bother. Throughout the study, two adverse events were recorded with no causal relationship to the study treatment. Discussion/Conclusions: Our study documented a significant reduction in all OAB symptoms and an improvement in all patient-reported outcomes in patients treated with peroneal eTNM® using the URIS® neuromodulation system.

Hengli® Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

Objective: To evaluate the efficacy and safety of Hengli® Chinese botulinum toxin type A (BTX-A; 100 U) in Chinese patients with overactive bladder. Methods: This study was a multicenter, randomized, double-blind, placebo-controlled trial in Chinese patients who were inadequately managed with anticholinergic medications. Eligible patients were randomized 2:1 to receive intradetrusor injections of Hengli® BTX-A (n = 144) or placebo (n = 72). The primary endpoint was the change in the number of daily micturition episodes at week 6 from baseline. The secondary efficacy endpoints included the average frequency of urgency and urinary incontinence (UI) episodes per day, urgency score, average micturition volume per day, OABSS, and QoL score. Results: In the Hengli® BTX-A group, there was a significantly greater reduction in the average number of micturition episodes per 24 h compared with the placebo group (3.28 vs. 1.43; p = 0.003). Moreover, there was a significantly greater improvement in the daily number of urgency episodes, micturition volume and OABSS score. An increased post-void residual urine volume, dysuria, and urinary tract infection represented adverse events (AEs) in the Hengli® BTX-A group. Most AEs were mild or moderate in severity. One patient in the BTX-A group initiated clean intermittent catheterization (CIC) during treatment. Conclusion: Hengli® BTX-A treatment was well-tolerated and resulted in significant improvements in OAB symptoms among Chinese patients inadequately managed by anticholinergics. Clinical Trial Registration: http://www.chinadrugtrials.org.cn/clinicaltrials.prosearch.dhtml, Identifier: CTR20131190.

An overactive bladder treatment: Mirabegron versus Tolterodine

Background: Overactive bladder (OAB), as described by the International Continence Society (ICS), is characterized by complex symptoms, which include urinary urgency (strong, sudden need to urinate that is difficult to delay) with or without urge incontinence that is usually associated with frequency (abnormally frequent urination) and nocturia (excessive urination at night).1 The objective of this study is to assess the efficacy of mirabegron and tolterodine, comparing both drugs by International Prostate Symptom Score (IPSS), micturition episodes per 24 hours, nocturia, urgency, urge incontinence after 12 weeks of intervention among patients who presented with predominantly storage lower urinary tract symptoms (LUTS).2,3METHODS: This is a prospective observational study conducted on 40 patients with overactive bladder over a period of 15 months, from January 2019 to March 2020. 20 patients received Mirabegron 50 mg (tablet) once daily (Group-M) and the other 20 patients received Tolterodine 4 mg (tablet) once daily (Group-T). RESULTS: The difference in urinary frequency episodes per 24 hours after 12 weeks in the Group-M was 2.75 ± 1.41, while that among Group-T was 1.15 ± 1.04 with significant p-value &lt; 0.05. The difference of nocturia episodes after 12 weeks in the Group-M was 1.45 ± 0.88, while that in Group-T was 0.7 ± 0.65 with significant p-value &lt; 0.05. The difference of urgency episodes after 12 weeks in Group-M was 1.65 ± 0.99, while that among Group-T was 1 ± 0.79 with significant p-value &lt; 0.05. The difference of urge incontinence episodes after 12 weeks was not statically significant between the two groups (Table 1). The difference of IPSS after 12 weeks in the Group-M was 5.7 ± 3.65, while that among Group-T was 3.85 ± 1.27 with significant p-value &lt; 0.05 (Table 2). CONCLUSION: Mirabegron improved urinary urgency, total number of micturition episodes/24 hours, nocturia, IPSS score more than Tolterodine in over active bladder patients. There was no statistical difference between Mirabegron and Tolterodine in terms of urinary incontinence episodes.

Rehabilitation methods for patients with severe extragenital pathology after reconstructive plastic surgery for various types of urinary incontinence

In recent years, the frequency of operations for genital prolapse and urinary incontinence has been steadily increasing. Neurogenic disorders of urination can be the first manifestations of the disease of extragenital pathology. Neurogenic bladder is bladder dysfunction (lethargy or spasticity) caused by neurogenic damage. Any disease in which the afferent or efferent innervation of the bladder is damaged can lead to a neurogenic bladder.Purpose. To study the features of urinary disorders in women with severe extragenital diseases and to improve the methods of rehabilitation of patients after reconstructive plastic surgery for various types of urinary incontinence.Materials and methods. 153 patients aged 50-70 years (mean age 55.1 ± 6.3 years) and duration of postmenopause from 2 to 5 years (7.6 ± 4.1 years) were examined at the outpatient department of the of Moscow Regional Research Institute of Obstetrics and Gynecology, Russian Federation, who applied for various manifestations of urination disorders. All patients were offered the method of biofeedback in combination with electrical stimulation of the pelvic floor muscles as a treatment. When overactive detrusor therapy was detected, therapy was combined with medicamentous (solifenacin 5 mg [Vesicar] or myrobegron 50 mg [Betmiga] in the morning) in combination with estriol (cream or suppositories) 0.5 mg intravaginally 2 times a week. In the presence of symptoms of climacteric syndrome in the absence of contraindications, menopausal hormonal therapy was prescribed.Results. Subjectively, 150 (98.1 %) patients noted an improvement in their condition, 3 (1.9 %) patients did not notice the effect of treatment. The results showed a significant improvement in all OABSS and bladder diary scores, including frequency of urination during the day and at night, urgency and number of urge incontinence episodes, and urine volume. Analysis of the -hour pad test showed that the volume of urine lost, which averaged 16.5 g before treatment, was negative after treatment in patients who noted the effect. In 2 patients who did not notice the effect, no changes were found. Investigation of the intraurethral pressure profile in 23 (17.6 %) women before treatment revealed insufficiency of the internal sphincter of the urethra, leading to urinary incontinence during stress. After treatment, in 19 (82.6 %) patients, the insufficiency of the internal sphincter was not determined. In 3 (13.0 %) patients, intraurethral pressure remained in the range of 60 to 80 cm of water column and did not lead to urinary incontinence during stress. In 1 (4.3 %) patient, the insufficiency of the urethral closure persisted, which required repeated surgery.Conclusions. In patients with severe extragenital diseases against the background of vulvovaginal atrophy, an overactive bladder and a mixed form of urinary incontinence prevail. Extragenital pathology of various origins, especially concerning various parts of the central nervous system, obesity and diabetes significantly worsens the course of urination disorders in both conservative and surgical and combined treatment and requires additional treatment methods: pelvic floor muscle training, biofeedback therapy in combination with electrical stimulation of the pelvic floor muscles, local hormonal therapy, the use of M-anticholinergics, B-adrenomimetics.

Effectiveness and safety of tibial nerve stimulation versus anticholinergic drugs for the treatment of overactive bladder syndrome: a meta-analysis.

This meta-analysis aimed to evaluate the efficacy and safety of tibial nerve stimulation (TNS) and anticholinergic drugs (ACDs) for the treatment of overactive bladder syndrome (OAB). Qualified studies up to November 3, 2020 were retrieved from PubMed, Embase, the Cochrane Library and Web of Science. Pooled mean differences (MDs) were calculated to evaluate the improvement of micturition frequency per day, nocturia per night, urinary urgency episodes per day, incontinence episodes per day, and voided volume each time. Odd ratios (ORs) were used to assess the discontinuation rate. A total of 6 RCTs including 291 patients were included. Comparing with those receiving ACDs, patients receiving TNS had a significantly better improvement of urge incontinence episodes (MD =-1.11; 95% CI: -1.66, -0.55; P<0.001), but had comparable effect on micturition (MD =-0.75; 95% CI: -1.78, 0.28; P=0.16), nocturia (MD =-1.11; 95% CI: -2.93, 0.72; P=0.23), urgency (MD =-0.57; 95% CI: -1.93, 0.79; P=0.41) and voided volume (MD =11.61; 95% CI: -3.95, 27.18; P=0.14). Moreover, TNS group had a significantly lower discontinuation rate (OR =0.13; 95% CI: 0.03, 0.51; P=0.003) during the trials. TNS is as effective as ACDs for treating OAB, but with better performance on the decrease of urge incontinence episodes. Besides, TNS appears to be more tolerable than ACDs.

Transcutaneous tibial nerve home stimulation for overactive bladder in women with Parkinson's disease: A randomized clinical trial.

This study aims to investigate the efficacy of transcutaneous tibial nerve home stimulation for overactive bladder (OAB) in women with Parkinson's disease (PD). The current study is a prospective, randomized, double-blind, sham-controlled trial. Home intervention was carried out andassessments were conducted at a tertiary hospital in South Brazil. Women with PD and OAB symptoms were included in the study. Patients were randomly divided into two groups: (1) stimulation and (2) sham. Both groups underwent intervention at home for 12 weeks. Patients were evaluated at baseline and at 12 weeks (end of intervention),30- and 90-day follow-up. The primary outcome was the mean reduction in the number ofurgency incontinence episodes, and secondary outcomes included daytime and nighttime urinary frequency, urinary urgency episodes, use of pad (reported in a 24-h bladder diary), OAB-V8 andKing's Health Questionnaire scores, and maintenanceof symptom relief after discontinuation of the intervention. In total, 30 consecutive patients completed the study (15/group). The stimulation group showed a reduction in nighttime urinary frequency (0.9 ± 0.6), urinary urgency (1.0 ± 1.2), urgency incontinence episodes (0.5 ± 0.6), use of pads (1.3 ± 1.2), and OAB-V8 (1.3 ± 1.2)and King's Health Questionnaire scores. In a 30-day and 90-day follow-up, 8 (53.3%) and 5 (33.3%) stimulation patients, respectively, reported fullmaintenance of symptom relief after discontinuation of the intervention. Stimulation patients presented a statistically significant improvement of symptoms as compared with sham patients (p = .001). Transcutaneous tibial nerve home stimulation can be used in clinical practice as an effective nonpharmacological resource for the reduction of OAB symptoms in women with PD, and the resulting relief seems to persistin the follow-up (30 and 90 days).

Cost-Effectiveness Analysis and Budget Impact: Antimuscarinics and Mirabegron for the Treatment of Patients With Urge Urinary Incontinence: The Brazilian Public Health System Perspective

ObjectivesThe Brazilian public health system does not cover pharmacotherapy for urge urinary incontinence (UUI). The aim of this study was to estimate the cost-effectiveness and budget impact of providing tolterodine, solifenacin, oxybutynin (OXY), darifenacin, and mirabegron for the treatment of UUI in Brazilian public health system. MethodsA cost-effectiveness analysis with budget impact was performed. Six scenarios were assessed: in one scenario, all 5 therapeutic alternatives approved for coverage, and in the remaining 5 scenarios, only 1 alternative is approved for adoption for all patients. Clinical data were derived from a rapid systematic review conducted in several databases. One-way sensitivity analysis was also performed. The time horizon was 12 months. ResultsThe cost-effectiveness analysis showed that patients treated with OXY had the lowest incremental cost-effectiveness ratio (ICER) per outcomes assessed (change in urinary incontinence episodes (UIE): R$1180.08; change in urge incontinence episodes: R$757.85 and change in micturition frequency: R$907.75), corresponding to a budget impact of R$17.9 billion over 5 years. The change in effectiveness measures was the parameter that most influenced the results of the ICER per patient-year. ConclusionThe results of the study have shown that OXY and solifenacin had the lowest ICER per patient-year and the lowest budget impact when compared with other drugs.

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

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. 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. 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. Imidafenacin demonstrated efficacy and safety in the treatment of OAB in Taiwanese patients.