Randomized,Single‐Blind,Parallel Study of the Effectiveness and Safety of Solifenacin versus Propiverine in the Treatment of Overactive Bladder

Objectives: To compare the effectiveness and safety of solifenacin versus propiverine in the treatment of overactive bladder (OAB), in a single‐blind, randomized parallel study. Methods: Sixty‐six patients with OAB (14 men and 52 women) were randomly assigned to groups: solifenacin (5 mg/day) or propiverine (20 mg/day) and treated for 8 weeks. The primary outcome variable was mean change from baseline to end of treatment in urgency of the OAB symptom score (OABSS). Secondary outcomes were bladder diary variables: change over 24 h in the mean number of voids (daytime and nighttime), episodes of micturition urgency and incontinence, and mean volume voided. Patients also completed total OABSS and the King's Health questionnaires. Results: Group backgrounds were comparable except for the male to female proportion; 11:22 for solifenacin (n = 33) versus 3:30 for propiverine (n = 33). Adverse events were 6 of 29 (21%) for solifenacin versus 14 of 26 (54%) for propiverine (P = 0.017). Three patients were withdrawn for voiding difficulty (one in solifenacin and two in propiverine) and one patient for dry mouth (propiverine group). Change in OABSS urgency score was ?2.3 ± 1.4 for solifenacin (n = 28) versus ?1.3 ± 1.7 for propiverine (n = 23), (P = 0.0169). Total OABSS and other individual scores, and voiding diary parameters for both drugs showed improvements; however, between‐group difference was not established. Conclusion: Although both solifenacin 5 mg and propiverine 20 mg were effective in the treatment of OAB, solifenacin appeared to be more effective and tolerable.     

Efficacy and Safety of Propiverine and Solifenacin for the Treatment of Female Patients with Overactive Bladder: A Crossover Study

Objectives: To evaluate the clinical efficacy and tolerability of propiverine and solifenacin in female patients with overactive bladder (OAB). Methods: A prospective nonrandomized crossover study of propiverine 20 mg and solifenacin 5 mg was conducted. Female OAB patients were assigned alternately to treatment with propiverine for 8 weeks then solifenacin for 8 weeks (Group P‐S) or solifenacin for 8 weeks then propiverine for 8 weeks (Group S‐P). At baseline, 8th week and 16th week, symptoms were assessed using overactive bladder symptom score (OABSS). Results: A total of 121 patients were enrolled. Overall, 38 patients (31.4%) discontinued or dropped out and 83 patients were available for analysis (39 in Group P‐S and 44 in Group S‐P). In both groups, the total score and each score of OABSS were significantly improved after 8 weeks compared with baseline. In only Group P‐S (changing over from propiverine to solifenacin), urgency score in the 16th week was further improved significantly compared with the 8th week. The most bothersome symptom at baseline was urgency incontinence (50.6%), followed by urgency (37.3%). Even after symptom improvement, more than half of the patients were bothered by urgency or urgency incontinence. The incidence of adverse events of moderate and severe grade was higher during propiverine treatment than solifenacin (11.1% vs 2.9%, P = 0.039). Conclusion: Propiverine 20 mg and solifenacin 5 mg were effective for treating female OAB patients. Urgency was further improved after switching from propiverine to solifenacin, but not after switching from solifenacin to propiverine. Solifenacin was better tolerated than propiverine.     

Efficacy of Propiverine in Improving Symptoms and Quality of Life in Female Patients with Wet Overactive Bladder

Objectives: The present prospective study was conducted to assess the effects of propiverine hydrochloride in improving symptoms and quality of life (QoL) in female patients with wet OAB. Methods: Propiverine was administered orally for 8 weeks to 58 female patients who had urgency incontinence. Prior to administration, and at 4 and 8 weeks after administration, symptoms and QoL of the patients were assessed using a micturition diary, the International Consultation on Incontinence Questionnaire‐Short Form (ICIQ‐SF), and the King's Health Questionnaire (KHQ). In addition, the relationships between changes in frequency of urinary incontinence or amount of urine leakage following treatment and changes in each domain of the KHQ were investigated by multiple regression analysis. Results: After administration of propiverine, the mean numbers of daily micturitions, incontinence episodes, and urgency episodes assessed on the basis of the micturition diary significantly improved in comparison to the baseline: from 11.7 to 9.6 for daily micturitions, from 2.8 to 1.1 for incontinence episodes, and from 5.9 to 2.3 for urgency episodes in 8 weeks. The mean of the ICIQ‐SF total scores significantly decreased, from 8.4 to 4.6 points at 4 weeks and to 3.6 points at 8 weeks. The mean scores for three individual items in the ICIQ‐SF, namely, frequency of incontinence episodes, amount of leakage, and impact on everyday life also significantly improved. The KHQ scores significantly improved at both 4 and 8 weeks post‐administration in all domains except personal relationships. In the multiple regression analysis, improvement in frequency of incontinence was significantly related to the domain of severity measure of the KHQ, while improvement in amount of leakage was significantly related to the domains of general health perception and social limitations. Conclusion: Propiverine hydrochloride contributed to improvements not only in symptoms but also in QoL in female patients with wet OAB.     

Who Would Benefit from Solifenacin Add‐On Therapy to Tamsulosin for Overactive Bladder Symptoms Associated with Benign Prostatic Hyperplasia?

Objectives: We evaluated the types of patient factors that influence the efficacy and safety of solifenacin add‐on therapy to tamsulosin in men with overactive bladder (OAB) associated with benign prostatic hyperplasia (BPH). Methods: A total of 130 BPH patients with persistent OAB symptoms despite undergoing alpha1‐adrenagic antagonist monotherapy were enrolled in this study. Their OAB symptoms persisted after monotherapy consisting of tamsulosin 0.2 mg once daily for more than 8 weeks, followed by subsequent solifenacin 5 mg once daily. The patient backgrounds were assessed, as were the changes in their International Prostate Symptom score (IPSS), Quality of Life (QOL) index, and Overactive Bladder Symptom Score (OABSS) before and 8 weeks after the administration of solifenacin. Results: Total IPSS, QOL index, and OABSS improved significantly following solifenacin administration. Multivariate analyses revealed prostate volume was the only predictor that contributed to the improvement of total IPSS. In patients with prostate volume <30 mL, the improvement in total IPSS (?3.5) was superior to that for prostate volume >30 mL (?0.5; P = 0.002). The data also demonstrated that diabetes mellitus was an independent factor preventing OABSS improvement. In patients with diabetes mellitus, OABSS was not sufficiently improved (?0.6) compared to patients without diabetes (?2.1; P < 0.001). Conclusion: Solifenacin add‐on therapy to tamsulosin showed efficacy and good tolerability in BPH patients with OAB symptoms. The findings also indicated that patients with a relatively small prostate and without diabetes mellitus would receive more benefit from this therapy.     

Efficacy,Safety and Tolerability of Fesoterodine in Asian Patients with Overactive Bladder

Objectives: To assess the efficacy, safety, and tolerability of fesoterodine 4 and 8 mg once daily (QD) compared with placebo in Asian subjects with overactive bladder (OAB) after 12 weeks of treatment. Methods: This phase II, dose‐finding study consisted of a 2‐week placebo run‐in period followed by a 12‐week, randomized, double‐blind, placebo‐controlled, treatment period. Eligible subjects were aged ≥20 years with ≥8 micturitions per 24 h and ≥1 urgency urinary incontinence (UUI) episodes per 24 h reported in a 3‐day diary. The subjects were randomized to receive placebo, fesoterodine 4 mg, or fesoterodine 8 mg QD for 12 weeks. Results: Of 1232 subjects who entered the placebo run‐in period, 951 received double‐blind treatment. The mean number of UUI episodes per 24 h at baseline was 2.2 among the three treatment groups. The two fesoterodine groups showed statistically significant decreases from baseline in the mean number of UUI episodes per 24 h at week 12 (primary endpoint) compared with placebo. Most all‐causality adverse events (e.g. dry mouth and constipation) were mild or moderate. The percentage of subjects with severe adverse events was low and similar among the treatment groups (placebo, 1.3%; fesoterodine 4 mg, 1.9%; fesoterodine 8 mg, 1.0%). Conclusion: Fesoterodine 4 and 8 mg QD were significantly better than placebo in improving OAB symptoms. Overall, the two fesoterodine dosing regimens were well tolerated. These results suggest that fesoterodine 4 and 8 mg QD are effective and well‐tolerated treatments for OAB in Asian subjects.     

Comparison of Outcome Assessments in Patients with Overactive Bladder Receiving Anticholinergics

Objectives: Patient‐reported outcomes (PRO) reflect treatment benefits from the patient's perspective, and are a subjective method of evaluating the efficacy of overactive bladder (OAB) treatment. We examined the changes in voiding diaries and health‐related quality of life (HRQL) according to patient‐perceived treatment benefits in patients with OAB receiving propiverine. Methods: Thirty‐two patients (mean age ± S.D: 55.1 ± 14.1 years) with OAB were treated with 20 mg propiverine once daily for 12 weeks. The 3‐day voiding diary and the Korean version of the Overactive Bladder Questionnaire (OABq), which includes an eight‐item bothersome symptom scale, as well as 25 HRQL items, were assessed at baseline and at 12 weeks. Finally, patient perception of treatment benefit was evaluated as “no benefit,”“little benefit,” or “much benefit” after treatment. Results: According to patients' perceptions of treatment benefits, 16 (50%) patients perceived “much benefit” from their treatment (group A) and 16 (50%) patients perceived “little benefit” or “no benefit” from their treatment (group B). In both groups, there were significant improvements in the micturation parameters, OABq bothersome symptoms, and total HRQL score after 12 weeks of treatment (P < 0.05). Although there were no significant differences in the voiding diary parameters between the two groups, patients in group A showed significant improvement of the OABq bothersome symptom and total HRQL score compared to group B (P < 0.05). Conclusion: Anticholinergic treatment improves both OAB symptoms and HRQL, and patients' perceptions of treatment benefits correlate better with the OABq than with the voiding diary parameters.     

Recent Advances in Intravesical Treatment of Overactive Bladder

The traditional medication for overactive bladder (OAB) is antimuscarinic agent, which targets muscarinic receptors. Recent investigations have revealed that muscarinic receptors are present in the urothelium and suburothelial sensory fibers, as well as in the detrusor. Urothelial dysfunction and abnormality of sensory receptor expression or transmitter release in suburothelial nerves could contribute to OAB refractory to antimuscarinics. Intravesical treatment to inhibit abnormal receptor expression or transmitter release in the sensory nerve terminals in the suburothelial space might provide beneficial therapeutic effects in the treatment of OAB. Intravesical resiniferatoxin (RTX) instillation and intravesical botulinum toxin A (BoNT‐A) injection are two promising treatment alternatives for refractory OAB. RTX at a high dose may cause undesired adverse events, such as hematuria, bladder pain or autonomic dysreflexia. RTX at a low concentration can decrease sensory urgency without influencing detrusor contractility; multiple instillations of low‐dose RTX may be required to achieve adequate desensitization of OAB. BoNT‐A, however, has a beneficial effect on detrusor contractility and causes large post‐void residual after injection in some patients. Therefore, careful dosage and injection site adjustment is mandatory to achieve satisfactory results using intravesical therapy.     

Depression and age as predictors of patient-reported outcome in a multidisciplinary rehabilitation programme for chronic musculoskeletal pain

Background. The recommended treatment for chronic musculoskeletal pain is multidisciplinary, with a cognitive approach. The aim of this study was to investigate health‐related quality of life (HRQoL) outcome after a multidisciplinary treatment with a cognitive approach. Methods. A total of 131 subjects who participated in a multidisciplinary rehabilitation programme (2005–2008) were studied at baseline and after six months, using the Short Form Short Form 36‐item Health Survey questionnaire (SF‐36) as primary outcome (HRQoL), and the Hospital Anxiety and Depression Scale (HAD) and pain as secondary outcomes and possible baseline predictors for HRQoL. Results. Complete data were available for 97 subjects (85 women, mean age [SD] 44.6 [9.7] years). The SF‐36 subscales physical function (PF), general health (GH), vitality (VT), social function (SF) and mental health (MH), the visual analogue scale for pain and the HAD improved significantly (p < 0.05) at follow‐up compared with baseline. A pre‐treatment probable depression (HAD score ≥11) was associated with a favourable outcome of the SF‐36 subscales PF (odds ratio [OR] 5.6; p = 0.01), VT (OR 4.3; p = 0.02) and MH (OR 3.6; p = 0.02). A probable anxiety (HAD score ≥11) was associated with a favourable outcome of PF (OR 2.6; p = 0.05). There was an even stronger association for younger subjects (20–45 years), with probable depression scores at baseline and a favourable HRQoL outcome at follow up. Conclusion. This multidisciplinary rehabilitation programme, using a non‐pharmacological cognitive approach, seemed to yield a better outcome concerning HRQoL measures in younger subjects with higher depression scores at baseline. This information is important for clinics when tailoring a multidisciplinary rehabilitation programme for patients with musculoskeletal chronic pain. Copyright © 2010 John Wiley & Sons, Ltd.     

Twelve Months Follow‐up of Injection of OnabotulinumtoxinA into Vesical Submucosa for Refractory Non‐neurogenic Overactive Bladder

Objective: The aim of the present study was to assess the effects of onabotulinumtoxinA injection for refractory non‐neurogenic overactive bladder (OAB) for 12 months. Methods: For patients with persistent urgency urinary incontinence (UUI) more than once a week despite taking anti‐cholinergic agents or incapability to continue the agents because of adverse effects, 100 units of onabotulinumtoxinA was injected at 30 sites in the sub‐epithelial bladder wall. Efficacy was assessed every month up to 12 months after injection, using a three‐day frequency‐volume chart (FVC) and postvoid residual urine (PVR), three questionnaires, and a simple score of Global Response Assessment (GRA). Failure was defined as when GRA was negative and additional treatment was administered. Results: Nine men and eight women aged 67 ± 12 years were included. On FVC, frequencies of urgency, UUI and daytime urination significantly decreased up to the 11th month. PVR significantly increased at the first and second months but no patient required catheterization. The total scores of Overactive Bladder Symptom Score and International Consultation on Incontinence Questionnaire Short Form were significantly decreased for 10 and eight months, respectively. The score of GRA was significantly improved for eight months. The median time to failure was 11.0 months. Conclusion: This study suggests that onabotulinumtoxinA submucosal injection is promising for refractory non‐neurogenic OAB. It is anticipated that the treatment is effective for eight to nine months and approximately 40% of the patients do not require anticholinergics at the 12th month postoperatively.     

Does the Number of Previous Vaginal Deliveries Affect Overactive Bladder Symptoms and their Response to Treatment?

Objectives: To explore associations between the number of vaginal deliveries (primary aim) or gender (secon‐ dary aim) and overactive bladder (OAB) symptoms as well as their response to treatment with a muscarinic antagonist. Methods: Preplanned secondary analysis of an observational study of solifenacin in OAB patients. Episode frequencies of OAB symptoms, pad use and scores on OAB rating scales were documented in 4450 patients before and after a 12–14 week treatment period with solifenacin 5 or 10 mg. Results: Women without, and with one, two or more than two vaginal deliveries and men were similar in their baseline characteristics. All groups also exhibited rather similar reductions in symptoms and improvements in rating scales upon treatment. Conclusion: These data indicate that solifenacin, and perhaps other muscarinic receptor antagonists, are similarly suitable for the treatment of OAB symptoms in both genders, irrespective of previous vaginal deliveries.     

琥珀酸索利那新治疗良性前列腺增生术后膀胱过度活动症的临床疗效观察

目的 探讨琥珀酸索利那新治疗良性前列腺增生(BPH)术后并发膀胱过度活动症(OAB)的临床疗效和安全性.方法 115例接受BPH手术的患者中,治疗组(n=58)术后第4d睡前口服索利那新治疗20 d,对照组(n=57)术后服用莨菪碱片,观察患者在拔出导尿管前后排尿情况,并以尿动力学检查、国际前列腺症状评分(IPSS)和膀胱过度活动症评分(OABSS)评价患者排尿情况.结果 治疗组IPSS评分由28.3分下降到11.3分,OABSS评分由(14.2±1.2)分下降到(2.9±0.7)分(P＜0.01).对照组IPSS评分由27.3分下降到11.8分(P＜0.01),OABSS评分由(14.2±1.6)分下降到(11.3±1.1)分,治疗前后差异无统计学意义(P＞0.05).结论 BPH术后正确地使用索利那新,能缓解膀胱过度活动给患者带来的痛苦症状,有利于患者的术后康复.     

Defining Causes for Overactive Bladder Symptoms in Women

Objectives: The aim of the present study was to determine the causes for overactive bladder (OAB) symptoms in women visiting a urological clinic. Methods: We prospectively recruited female patients with OAB symptoms between December 2008 and February 2010. All patients were interviewed for their detailed personal and medical history. All patients completed a 3‐day frequency‐volume chart. Symptom severity was evaluated using the International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS) questionnaires. All patients underwent either conventional pressure‐flow urodynamic studies or video‐urodynamic studies. On the basis of these evaluations, patients were assigned to one of the following categories: idiopathic OAB, stress urinary incontinence (SUI)‐associated, neurogenic bladder, or bladder outlet obstruction (BOO). Results: A total of 108 female patients were recruited into the study. The mean age of the patients was 63.75 ± 14.02 years (range: 23–89). Detrusor overactivity was demonstrated in 55 patients (51%). The differential diagnosis was idiopathic OAB in 51 women (47.2%), SUI‐associated in 46 (42.6%), neurogenic bladder in 13 (12.0%) and BOO in 7 (6.5%). Conclusion: Our study suggests that the causes for OAB symptoms could be defined in half of the women visiting a urological clinic. Among them, SUI was the most common. Moreover, OAB symptoms in women might relate to BOO. Detailed history taking and sophisticated urodynamic studies are required for a substantial group of female patients with OAB symptoms to make the correct diagnosis and provide optimal therapy.     

Prevalence of xerostomia with or without overactive bladder symptoms

Overactive bladder (OAB) occurs idiopathic or secondary to a neurological cause. In addition, OAB may also occur due to xerostomia, because it causes excessive drinking of water. If xerostomia is one of the causes of OAB, treating xerostomia may be effective. This study aimed to investigate the prevalence of xerostomia with or without overactive bladder symptoms. A web-based questionnaire was administered to investigate the prevalence of xerostomia with or without overactive bladder symptoms. The survey included questions concerning age, gender, medical history, medications, OAB symptoms by the Overactive Bladder Symptom Score (OABSS), and xerostomia by the Dry Mouth Scale (DMS). From the analysis, a total of 21 (13.0%) participants were identified as having OAB. The prevalence of xerostomia was six (28.6%) in the OAB group and 14 (10.0%) in the non-OAB group. OABSS and DMS were significantly higher in the OAB group than in the non-OAB group. Urgency score and urgency incontinence score of OABSS were substantially higher in xerostomia participants than non-xerostomia participants. The adjusted odds ratio of OAB showed DMS total score, xerostomia symptoms, accompanying symptoms, and other symptoms that were all significantly associated with OAB. These results suggested that OAB subjects, even untreated subjects, had xerostomia. It may be beneficial for clinicians to perform dry mouth management in parallel with careful choice pharmacotherapy for the wellness of OAB patients.     

Efficacy of Synthetic Suburethral Slings in Female Urinary Stress Incontinence with Overactive Bladder

Objectives: The aim of the present study was to investigate the efficacy of synthetic suburethral slings in female stress urinary incontinence (SUI) patients with overactive bladder (OAB). Methods: From May 2002 to April 2005, a total of 295 women with SUI underwent suburethral sling procedure. Of the 295 women, only those who were followed up for at least 12 months were included in the study, yielding 236 patients. The patients were divided into three groups: pure SUI; SUI with OAB dry; and SUI with OAB wet. Telephone questionnaires by were used to evaluate the postoperative improvement of SUI and storage symptoms. Results: There were significant differences in preoperative symptom score, quality of life (QoL) score, and preoperative voided volume among the three groups. There were no significant differences among the three groups in terms of the cure rate for the stress component (group 1, 88.6%; group 2, 86.2%; group 3, 86.7%; P = 0.943). Eighty percent of group 1 patients improved in frequency, but two patients (2.3%) complained of de novo urgency. In group 2, 81.5 and 82.7% improved in frequency and urgency, respectively, but one patient (1.7%) complained of de novo urge incontinence. In group 3, 76.9 and 84.4% improved in frequency and urge incontinence, respectively. Conclusion: Suburethral slings are simple, safe and highly effective in treating SUI with OAB.     

Summary of Anticholinergic Pharmacotherapy Available for Overactive Bladder

The International Continence Society definition of overactive bladder syndrome (OAB) is “urgency, with or without urge incontinence, usually with frequency and nocturia.” OAB syndrome is a very common condition, estimated to affect 12% to 22% of women and men in Europe and 16% to 17% in the United States. The muscarinic receptor antagonists are first-line pharmacotherapy in treatment of OAB. In North America, six antimuscarinic drugs are marketed for treating OAB: oxybutynin, tolterodine, fesoterodine, trospium, darifenacin, and solifenacin. In our review, we summarize the pharmacology, efficacy, and adverse events of commonly used anticholinergic agents.     

Overactive Bladder in Female Patients with Chronic Diseases Visiting Primary Care Doctors: Effect of Age on Prevalence and Bothersomeness

Objectives: We evaluated the effects of age on the prevalence and bothersomeness of overactive bladder (OAB) in female patients with chronic diseases visiting primary care doctors. Methods: We used the pooled data of the SURPRISE survey in which 121 doctors and 1388 female patients aged 40 years or older responded to questionnaires. Results: The OAB prevalence rate in patients was estimated by doctors to be 9.5%. However, the OAB prevalence rate according to patients, as defined by the OAB symptom score, was 22.3%. The rate was increased with age. The number of patients with OAB was much higher than estimated by doctors. Approximately 25% of patients were dissatisfied with their present urinary condition. The rate was increased with age. Dissatisfaction with present urinary condition was strongly correlated with severe urgency score in all age groups. In elderly patients, contribution of urgency incontinence and nocturia to dissatisfaction was also increased. Thirteen percent of patients were receiving treatment for their OAB. However, 15.8% were untreated, regardless of having OAB, suggesting that treated patients comprise less than half of all OAB patients. This tendency was observed in all age groups. In the correlation between satisfaction with pharmacological treatment and each OAB symptom, contribution of urgency to satisfaction with pharmacological treatment was the highest. Conclusion: Urgency is the most bothersome symptom and shows the highest contribution to treatment satisfaction. In elderly patients, urgency incontinence and nocturia are proportionally greater problems. Management of urgency is essential for improving quality of life and satisfaction with treatment in OAB patients.     

Treatment Outcome of Overactive Bladder Patients Receiving Antimuscarinic Therapy for More than One Year

Objectives

Details on the therapeutic effects of long‐term antimuscarinic therapy have not been reported. Thus, the aim of this study is to evaluate the detailed long‐term therapeutic effect of antimuscarinic therapy.

Methods

All consecutive patients who visited the urologic outpatient clinics of a medical center for treatment of overactive bladder syndrome and received antimuscarinic therapy of 12 months or more were retrospectively reviewed. All medical records, including the Overactive Bladder Symptom score (OABSS), the modified Indevus Urgency Severity Scale and the International Prostate Symptoms score (IPSS) questionnaires, and uroflowmetry parameters were reviewed at each visit.

Results

A total of 140 patients had received 12 months or more of antimuscarinic therapy. Sustained therapeutic effects were observed by persistent decreases of IPSS‐storage score, IPSS‐total score and OABSS score. Moreover, the maximum flow rate did not change over time. A temporary increase in postvoid residual volume and decrease in voiding efficiency were found, but these parameters improved over long‐term visits. Side‐effects were observed in 81 patients (57.9%) and included dry mouth (n = 58, 41.4%), constipation (n = 48, 34.3%) and blurred vision (n = 4, 2.9%); all side‐effects were tolerable. Patients aged 75 years or more (n = 94) had a higher comorbidity rate (n = 46, 48.9%) before treatment but generally exhibited similar therapeutic effects as overall patients; elderly patients could also tolerate side‐effects.

Conclusion

Sustained therapeutic effects were observed in patients who received 12 months or more of antimuscarinic therapy, even in elderly patients. In addition, side‐effects in patients receiving long‐term therapy were also common but tolerable.     

Mirabegron versus vibegron in previously untreated female patients with overactive bladder: A randomized,single-clinic,open-label trial

Objectives

This study aimed to assess the efficacy and safety of mirabegron compared with vibegron (both 50 mg once daily) in Japanese female patients with symptoms of overactive bladder (OAB).

Methods

This prospective, 12-week, two-arm, parallel-group, open-label randomized trial (UMIN000038288) was conducted at a single clinic from December 2019 to September 2022. The primary efficacy outcome measure was the change in mean total overactive bladder symptom scores (OABSSs) from baseline to end of treatment (EOT) (Week 12). The secondary efficacy outcome measures were changes in mean International Prostate Symptom Score from baseline to EOT, the ratio of patients who achieved a minimal clinically important change (MCIC) of total OABSS, and individual domains of the King's Health Questionnaire. Safety assessments, such as adverse events (AEs), postvoid residual volume, and patient-reported incidences, were recorded at every visit.

Results

There was no statistically significant adjusted mean difference between mirabegron and vibegron in terms of the primary outcome of the mean change from baseline to EOT in the total OABSS. The difference in the percentage of patients in the mirabegron and vibegron groups achieving an MCIC on the total OABSS was not statistically significant but appeared to be clinically important. The incidence of treatment-related AEs was significantly higher for the vibegron group (38.5%) than the mirabegron group (19.1%) (p = .047).

Conclusions

These results showed that both drugs were effective in female OAB patients, with no significant differences in terms of efficacy. However, the safety of vibegron requires further investigation.     

Effect of the Amount of Hours Spent Studying on the Prevalence of Overactive Bladder in College Women

Objectives: We conducted a questionnaire survey to access whether the amount of hours spent studying has an effect on the prevalence of OAB in college women. Methods: A total of 126 (63%; mean: 23.2 years) of 200 women participants completed the questionnaire. They were divided into two groups: group A (weekly studying hour >40 h) consisted of medical female students and group B (weekly studying hour <25 h) consisted of French literature woman students. The factors related to OAB were analyzed by the chi‐squared test. Results: Of 126 respondents, the prevalence of OAB was prevalent in 38 (30.2%) women. There was significant difference in prevalence between the two groups: 7.0% for group A and 42.2% for group B. In group B, OAB prevalence was 66.7% for ≤2 h, 41.2% for 2–≤4 h, 46.5% for 4–≤6 h, and >6 h was 23.5%. This survey showed that there is no relationship between the amount of hours spent studying and OAB. Conclusion: Although the amount of hours spent studying had no association with OAB in college women, OAB prevalence showed a decreasing pattern as the quantity of studying hour increases. Consequently, it is thought that the attitude toward study has more association with OAB than the quantity of studying hours.     

Potential Primary Endpoint for Exploratory Clinical Trial in Patients with Overactive Bladder: A Systematic Literature Review

Objectives

To identify a potential primary endpoint in an early‐phase exploratory trial among key overactive bladder (OAB) symptoms.

Methods

Placebo‐controlled double‐blinding trials in patients with OAB were extracted for systematic literature review. The correlation between key OAB symptoms recorded in bladder diaries and coefficient of variation (CV) in each study were assessed.

Results

Forty‐one controlled trials were extracted for the present review. Mean number of urgency episodes in 24 h was substantially associated with mean number of urgency incontinence episodes in 24 h, mean volume voided per micturition, and mean number of micturitions in 24 h (Spearman's r = 0.725, ?0.661, and 0.657, respectively). Mean number of micturitions in 24 h was also substantially associated with mean volume voided per micturition (Spearman's r = ?0.674). Mean number of incontinence episodes in 24 h was substantially associated with mean number of urgency incontinence episodes in 24 h and mean volume voided per micturition (Spearman's r = 0.840 and ?0.628, respectively). The median CV of mean volume voided per micturition in each trial was the smallest among all endpoints.

Conclusions

Our findings suggest that volume voided per micturition is a useful symptom for evaluating OAB candidate compounds in a small sample size and represents an effective primary endpoint, especially in exploratory clinical trials.