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.     

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,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.     

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.     

Clinical Impact of Solifenacin on Generic and Symptom‐Specific Quality of Life for Females with Overactive Bladder: Using the Overactive Bladder Symptom Score and Rand Medical Outcomes Study 36‐Item Health Survey

Objectives: We evaluated the effectiveness of antimuscarinic treatment on disease‐specific and generic quality of life (QoL) in females with clinically diagnosed overactive bladder (OAB) by prospectively analyzing improvements in the overactive bladder symptom score (OABSS) and the Rand Medical Outcomes Study 36‐Item Short Form Health Survey (SF‐36). Methods: We prospectively recruited newly diagnosed female patients with OAB. Pretreatment disease‐specific symptoms were documented, and generic QoL questionnaires were administered. All subjects received solifenacin 5 mg/day for >8 weeks. Symptoms and general health‐related QoL (HRQoL) were assessed using the OABSS and SF‐36, respectively. Other objective variables, such as maximum urinary flow rate and postvoid residual urine volume, were also evaluated. Results: Seventy‐eight subjects met all inclusion criteria and no exclusion criteria. After 8 weeks, the mean OABSS decreased by approximately 50% compared with baseline (from 9.1 ± 2.8 to 4.5 ± 3.6). All individual scores in OABSS improved after administration of solifenacin. Before treatment, the scores of the study subjects in all SF‐36 domains were significantly worse than the age‐ and gender‐adjusted Japanese national norms (P < 0.01), except the vitality (VT) scale. Intra‐group comparisons between age groups showed worse mental health (MH) scores in all age groups. In the OAB group, three mean SF‐36 scales (physical function [PF], VT, and MH) significantly improved after treatment. Conclusion: Treatment of OAB with solifenacin is associated with significant improvement in generic HRQoL and disease‐specific symptoms at 8 weeks after drug administration. Particularly for generic HRQoL as measured by the SF‐36, solifenacin treatment effectively improves three SF‐36 scores: PF, VT, and MH.     

Randomized Controlled Trial to Treat Benign Prostatic Hyperplasia with Overactive Bladder Using an Alpha‐blocker Combined with Anticholinergics

Objectives: TAABO was a randomized, controlled trial to evaluate the efficacy and safety of combination therapy of tamsulosin (TAM) with propiverine (PROP) in men with both benign prostatic hyperplasia and overactive bladder. Methods: It enrolled men 50 years or older who had an international prostate symptom score (IPSS) of 8 or higher, an urgency item score of 1 or higher, and a quality of life (QOL) score of 2 or higher. After 8 weeks of TAM 0.2 mg/day, patients who met the inclusion criteria (8 micturitions per 24 h and 1 urgency per 24 h, evaluated by bladder diary) and were eligible for 12‐weeks of continued Treatment II. Five hundred and fifteen patients were enrolled. Thereafter, 214 patients were assigned randomly to receive either TAM alone (n = 67), TAM plus PROP 10 mg (n = 72), or TAM plus PROP 20 mg (n = 75) in Treatment II. The primary efficacy end point was a change in micturitions per 24 h documented in the bladder diary. The change from baseline in urgency episodes per 24 h, IPSS, IPSS/QOL subscore, urinary flow rate and postvoid residual volume were assessed as secondary efficacy measures. Results: A total of 141 men (47 TAM, 49 TAM plus PROP 10 mg, and 45 TAM plus PROP 20 mg patients) were assessed by week 12. Compared with the TAM, TAM plus PROP 10 mg patients experienced significantly fewer micturitions (P = 0.0261), urgencies (P = 0.0093) per 24 h, lower IPSS storage (P = 0.0465), and IPSS urgency (P = 0.0252) subscores. Conclusions: These results suggest that combining TAM and 10 mg of PROP for 12 weeks provides added benefit for men with both benign prostatic hyperplasia and overactive bladder.     

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.     

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.     

Tolterodine: A Safe and Effective Treatment for Older Patients with Overactive Bladder

OBJECTIVE: To investigate the clinical safety and efficacy of two dosages of tolterodine in older patients with symptoms attributable to overactive bladder. DESIGN: Randomized, double-blind, placebo-controlled, parallel-group, multinational, phase III study. SETTING: Incontinence, older care, urological, and urogynecological clinics in the United Kingdom, France, and the Republic of Ireland. PARTICIPANTS: One hundred and seventy-seven older patients (age > or =65 years) with symptoms of urinary urgency, increased frequency of micturition (> or =8 micturitions/24 hours), and/or urge incontinence (> or =1 episode/24 hours). INTERVENTION: Tolterodine 1 mg or 2 mg twice daily (bid), or placebo, for 4 weeks. MEASUREMENTS: Safety and tolerability were evaluated through spontaneously reported adverse events, electrocardiogram, and blood pressure measurements. Efficacy was assessed using micturition diary variables: mean change from baseline in frequency of micturition and number of incontinence episodes/24 hours. RESULTS: The mean age of the patient population was 75 years. Overall, > or =87% of patients completed the study. Neither dosage of tolterodine was associated with serious drug-related adverse events during the study. No cardiac arrythmogenic events were noted. Dry mouth (mild to moderate intensity) was the most common adverse event in both the placebo and tolterodine treatment groups. Three percent of patients in the tolterodine 2 mg bid group discontinued treatment because of dry mouth, compared with 2% of placebo-treated patients. Compared with placebo, statistically significant decreases in micturition frequency were apparent in both tolterodine treatment groups. Furthermore, patients treated with tolterodine 2 mg bid had statistically significant decreases in urge incontinence episodes/24 hours and increases in volume voided per micturition compared with placebo. CONCLUSION: Tolterodine (taken for 4 weeks) is safe and shows efficacy, particularly at a dosage of 2 mg bid, in the treatment of older patients with urinary symptoms attributable to overactive bladder.