Urgency Episodes (urgency + episode)

Distribution by Scientific Domains


Selected Abstracts


Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 4 2009
J.-J. Wyndaele
Summary Aims:, To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder (OAB) who were dissatisfied with previous tolterodine treatment. Methods:, This was a 12-week, open-label, flexible-dose study of adults with OAB (, 8 micturitions and , 3 urgency episodes per 24 h) who had been treated with tolterodine (immediate- or extended-release) for OAB within 2 years of screening and reported dissatisfaction with tolterodine treatment. Subjects received fesoterodine 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on the subject's and physician's subjective assessment of efficacy and tolerability. Subjects completed 5-day diaries, the Patient Perception of Bladder Condition (PPBC) and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12 and rated treatment satisfaction at week 12 using the Treatment Satisfaction Question (TSQ). Safety and tolerability were assessed. Results:, Among 516 subjects treated, approximately 50% opted for dose escalation to 8 mg at week 4. Significant improvements from baseline to week 12 were observed in micturitions, urgency urinary incontinence episodes, micturition-related urgency episodes and severe micturition-related urgency episodes per 24 h (all p < 0.0001). Approximately 80% of subjects who responded to the TSQ at week 12 reported satisfaction with treatment; 38% reported being very satisfied. Using the PPBC, 83% of subjects reported improvement at week 12 with 59% reporting improvement , 2 points. Significant improvements from baseline (p < 0.0001) exceeding the minimally important difference (10 points) were observed in OAB-q Symptom Bother and Health-Related Quality of Life (HRQL) scales and all four HRQL domains. Dry mouth (23%) and constipation (5%) were the most common adverse events; no safety issues were identified. Conclusion:, Flexible-dose fesoterodine significantly improved OAB symptoms, HRQL, and rates of treatment satisfaction and was well tolerated in subjects with OAB who were dissatisfied with prior tolterodine therapy. [source]


Defining overactive bladder as hypersensitivity,

NEUROUROLOGY AND URODYNAMICS, Issue S6 2007
Osamu Yamaguchi
Abstract Overactive bladder (OAB), according to the International Continence Society (ICS) definition, is a symptom syndrome, with urgency as the cornerstone symptom. However, the word ,urgency' and its definition continue to be the subject of much debate and confusion. It is generally difficult for patients to differentiate urgency from normal urge, particularly when the desire to void is strong. To investigate the micturition behavior associated with OAB, we conducted a Patient Trust Study in 21 intelligent (i.e., to be ,trusted') female patients who could clearly and accurately discriminate between urgency and urge. The results showed that in 43% of patients seeking medical care, urgency episodes occurred less than once/day, and some patients had days without urgency. Our patients deferred voiding until bladder sensation was relatively strong, suggesting that coping was not common among these patients. Four of the 21 patients studied experienced spontaneous resolution of several urgency episodes. At volumes exceeding 40% of the maximum bladder volume (MBV), urgency episodes occurred frequently and independently of the bladder volume, indicating that 40% of the MBV may be a threshold of bladder volume to induce urgency. A linear relationship was observed between bladder volume and increasing bladder sensation. However, compared with normal subjects, urge sensation increased markedly at any given bladder volume among patients with OAB in our study. This hypersensitivity was observed in our patients regardless of urgency episodes. We therefore hypothesized that OAB may be more accurately defined as a hypersensitivity disorder rather than a syndrome characterized by urgency. Neurourol. Urodynam. 26:904,907, 2007. © 2007 Wiley-Liss, Inc. [source]


The responsiveness of the OAB-q among OAB patient subgroups,

NEUROUROLOGY AND URODYNAMICS, Issue 2 2007
Karin S. Coyne
Abstract Aims Although the majority of patients with overactive bladder (OAB) are continent, most patient-reported outcome measures for OAB were designed for patients with urinary incontinence. The overactive bladder questionnaire (OAB-q) was developed to assess symptom bother and HRQL among both continent and incontinent OAB patients; however, the responsiveness of the OAB-q among continent patients has not been evaluated. The purpose of this analysis was to assess the responsiveness of the OAB-q among OAB patient subgroups with a focus on continent patients. Methods Post-hoc analyses were conducted from two 12-week trials of tolterodine for the treatment of OAB. Patients completed the OAB-q and daily bladder diaries (assessing frequency, urgency, and incontinence episodes) at baseline, 4 weeks, and 12 weeks. Three patient subgroups were identified on the basis of continence status at all three timepoints: (1) continent; (2) incontinent; and (3) incontinent at baseline and continent by Week 12 (ITC). General linear models were used to compare changes from baseline, and Spearman correlations assessed the association between OAB-q changes and bladder diary changes. Effect sizes were computed separately for each group. Results A total of 262 continent, 552 incontinent, and 397 ITC patients were included in this analysis. Continent patients tended to be younger than incontinent patients, and patients were predominantly female, although continent patients had the highest percentage of male patients in both studies. Compared with continent patients, patients who were incontinent at baseline tended to have greater symptom bother and lower HRQL at baseline. All OAB-q change scores were consistently greatest for the ITC group (12.1,33.9), and greater for continent patients (10.8,28.6) than for incontinent patients (7.6,20.1). All three groups of patients experienced reductions in frequency and urgency episodes, and these changes were significantly correlated with changes in the OAB-q scales. Among all three groups, effect sizes were in the moderate-to-large range for all OAB-q subscales except Social Interaction. Conclusions The OAB-q is highly responsive to change between continent and incontinent patients with OAB, and is a valid tool for measuring treatment outcomes among continent OAB patients. Neurourol. Urodynam. 26:196,203, 2007. © 2006 Wiley-Liss, Inc. [source]


Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head-to-head placebo-controlled trial

BJU INTERNATIONAL, Issue 1 2010
Sender Herschorn
Study Type , Therapy (RCT) Level of Evidence 1b OBJECTIVE To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended-release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB). PATIENTS AND METHODS In this 12-week double-blind, double-dummy, placebo-controlled, randomized clinical trial, eligible patients reported OAB symptoms for ,3 months and recorded ,8 voids and ,1 urgency urinary incontinence (UUI) episode per 24 h in 3-day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); tolterodine ER 4 mg; or placebo (with sham dose escalation for tolterodine ER and placebo). Endpoints were changes from baseline to week 12 in UUI episodes (primary endpoint), total and nocturnal voids, urgency episodes, severe urgency episodes, and frequency-urgency sum per 24 h; mean voided volume per void (MVV); and the OAB questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS). Safety and tolerability were assessed and summarized over the 12-week study period. RESULTS Fesoterodine (636 patients) significantly improved UUI episodes at week 12 (primary endpoint) compared with tolterodine ER (641 patients; P = 0.017) and placebo (313 patients; P < 0.001). Fesoterodine also produced significantly greater improvements than tolterodine ER in MVV (P = 0.005). Fesoterodine significantly improved all diary endpoints compared with placebo (P < 0.001), except for nocturnal voids (P = 0.327). Tolterodine ER significantly improved all diary endpoints vs placebo (P < 0.001), except for nocturnal voids (P = 0.506) and MVV (P = 0.103). Diary dry rates (the proportion of patients reporting no UUI episodes at endpoint among those with one or more UUI episodes at baseline) were significantly higher with fesoterodine (64%) than with tolterodine ER (57%; P = 0.015) and placebo (45%; P < 0.001). Improvements in PPBC, UPS and OAB-q scale and domain scores at week 12 were all significantly better with fesoterodine than placebo (all P < 0.001) and tolterodine ER (all P < 0.05) except for the OAB-q Sleep domain vs tolterodine ER (P = 0.081). Dry mouth and constipation rates were 28% and 5% in the fesoterodine group, 16% and 4% in the tolterodine ER group, and 6% and 3% with placebo, respectively. Discontinuations due to treatment-emergent adverse events were 6%, 4% and 2% in the fesoterodine, tolterodine ER, and placebo groups, respectively. CONCLUSION In patients with OAB, fesoterodine 8 mg showed superior efficacy over tolterodine ER 4 mg and placebo in reducing UUI episodes (primary endpoint) and in improving most patient-reported outcome measures. Both active treatments were well tolerated. [source]