Overactive bladder (OAB)/ storage lower urinary tract symptoms (LUTS) have a high prevalence affecting up to 90% of men over 80 years. The role of sufficient therapies appears crucial. In the present review, we analyzed the mechanism of action of tolterodine extended-release (ER) with the aim to clarify its efficacy and safety profile, as compared to other active treatments of OAB/storage LUTS.
A wide Medline search was performed including the combination of following words: “LUTS”, “BPH”, “OAB”, “antimuscarinic”, “tolterodine”, “tolterodine ER”. IPSS, IPSS storage sub-score and IPSS QoL (International Prostate Symptom Score) were the validated efficacy outcomes. In addition, the numbers of urgency episodes/24 h, urgency incontinence episodes/24 h, incontinence episodes/24 h and pad use were considered. We also evaluated the most common adverse events (AEs) reported for tolterodine ER.
Of 128 retrieved articles, 109 were excluded. The efficacy and tolerability of tolterodine ER Vs. tolterodine IR have been evaluated in a multicenter, double-blind, randomized placebo controlled study in 1529 patients with OAB. A 71% mean reduction in urgency incontinence episodes was found in the tolterodine ER group compared to a 60% reduction in the tolterodine IR (p < 0.05). Few studies evaluated the clinical efficacy of α-blocker/tolterodine combination therapy. In patients with large prostates (prostate volume >29 cc) only the combination therapy significantly reduced 24-h voiding frequency (2.8 vs. 1.7 with tamsulosin, 1.4 with tolterodine, or 1.6 with placebo). A recent meta-analysis evaluating tolterodine in comparison with other antimuscarinic drugs demonstrated that tolterodine ER was significantly more effective than placebo in reducing micturition/24 h, urinary leakage episodes/24 h, urgency episodes/24 h, and urgency incontinence episodes/24 h. With regard to adverse events, tolterodine ER was associated with a good adverse event profile resulting in the third most favorable antimuscarinic. Antimuscarinic drugs are the mainstay of pharmacological therapy for OAB / storage LUTS; several studies have demonstrated that tolterodine ER is an effective and well tolerated formulation of this class of treatment.
Tolterodine ER resulted effective in reducing frequency urgency and nocturia and urinary leakage in male patients with OAB/storage LUTS. Dry mouth and constipation are the most frequently reported adverse events.
Lower urinary tract symptoms; Overactive bladder; Storage LUTS; Tolterodine; Urge incontinence; Frequency; Nocturia
Definition and diagnosis of constipation remain challenging, partly due to different perceptions of the disease by doctors and patients.
To evaluate prevalence and features of constipation among individuals seen in general practice, by comparing different diagnostic instruments.
Standardized questionnaires and the Bristol stool form scale were distributed to all subjects attending 10 general practitioners for any reason in a 2-week period. The questionnaires investigated constipation defined according to: (1) self-perception (yes/no); (2) a visual analogue scale; (3) Rome III Criteria.
The prevalence of constipation in 1306 subjects (790 female, 516 male) resulted: (1) 34% self-reported; (2) 28% by visual analogue scale; (3) 24% by Rome Criteria. Constipation was more frequent in females. A high frequency of symptoms of obstructed defecations was observed with differences among patients with self-reported constipation with or without Bristol stool type 1–2.
Prevalence of constipation among individuals attending their GP ranges between 24 and 34%, according to the different definitions adopted. Symptoms of obstructed defecations are frequent. The combination of self-evaluation and the Bristol stool type scale is potentially useful to identify subgroups of patients with different clinical features in general practice.
Constipation; epidemiology; general practice; Rome criteria; questionnaire
To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder (OAB) who were dissatisfied with previous tolterodine treatment.
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.
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.
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.
Background: Solifenacin succinate is an antimuscarinic drug with reported efficacy and tolerability at a recommended starting dose of 5 mg QD in patients with overactive bladder (OAB).
Objective: The objective of this trial was to investigate the efficacy, safety, and tolerability of solifenacin 10 mg QD in patients with OAB.
Methods: In this multicenter, Phase III, double-blind, placebo-controlled, parallel-group trial, patients aged ≥18 years with OAB were randomized at a 1:1 ratio to receive solifenacin 10 mg or placebo QD for 12 weeks. The patients were instructed to complete a micturition diary for the 3 days preceding each scheduled visit (weeks 4, 8, and 12). The primary end point was the change from baseline in the mean number of micturitions per 24 hours; secondary end points included the mean change from baseline in the number of episodes per 24 hours of urgency, incontinence, nocturnal voiding, and nocturia and the mean volume voided per micturition. Tolerability was monitored through adverse events (AEs), vital sign measurements, ECGs, laboratory assessments, and physical examination.
Results: A total of 672 patients were randomized and received ≥1 dose of study drug (solifenacin, n = 340; placebo, n = 332). The mean (SE) decrease from baseline to study end in the number of micturitions per 24 hours was significantly greater in the solifenacin group compared with the placebo group (−3.0 [0.2] vs −1.5 [0.2], respectively; P < 0.001). The mean decrease in the number of episodes of incontinence was significantly greater in the solifenacin group compared with the placebo group (−2.0 [0.2] vs −1.1 [0.2]; P < 0.001), as was the mean decrease in the number of episodes of urgency (−4.1 [0.2] vs −2.1 [0.2]; P < 0.001). Of the patients with ≥1 incontinence episode per 24 hours at baseline, significantly more patients in the solifenacin group achieved complete continence at study end than did patients in the placebo group (119/225 [52.9%] vs 80/237 [33.8%]; P < 0.001). The change from baseline to study end in the mean volume voided per micturition increased significantly in the solifenacin group compared with the placebo group (47.2 vs 2.7 mL; P < 0.001). Most AEs were mild or moderate in intensity. The AEs that were most commonly reported in the solifenacin-treated group were anticholinergic in nature: dry mouth (91 [26.8%] vs 13 patients [3.9%] in the placebo group; P < 0.001); constipation (58 [17.1%] vs 11 [3.3%]; P < 0.001); and blurred vision (12 [3.5%] vs 4 [1.2%]; P < 0.05). Serious AEs (SAEs) were reported for 5 patients in the solifenacin group and 3 patients in the placebo group. In the solifenacin group, 2 patients experienced chest pain, 1 had cellulitis, 1 had dehydration, and 1 had colonic obstruction; only 1 SAE (colonic obstruction) was judged to be possibly related to the study drug. In the placebo group, 1 patient had chest pain, 1 had bacterial meningitis, and 1 had hemopericardium.
Conclusions: This study found that solifenacin 10 mg QD for 12 weeks was associated with significantly reduced symptoms of OAB, including the frequency of micturition, and episodes of urgency and of incontinence. With solifenacin, the volume voided per micturition increased by 47.2 mL, and 53% of patients with ≥1 incontinence episode per 24 hours at baseline achieved complete continence. This efficacy was accompanied by a favorable safety and tolerability profile.
anticholinergic; incontinence; overactive bladder; solifenacin; urgency
What's known on the subject? and What does the study add?
There is known to be an association between overactive bladder (OAB) and irritable bowel syndrome (IBS).The study investigates the association between OAB and IBS using an internet-based survey in Japan. It is the first to investigate the prevalence and severity of OAB in the general population using the OAB symptom score questionnaire.
To investigate the association between overactive bladder (OAB) and irritable bowel syndrome (IBS) by using an internet-based survey in Japan.
Subjects and Methods
Questionnaires were sent via the internet to Japanese adults.The overactive bladder symptom score was used for screening OAB, and the Japanese version of the Rome III criteria for the diagnosis of IBS was used for screening this syndrome.
The overall prevalence of OAB and IBS was 9.3% and 21.2%, respectively.Among the subjects with OAB, 33.3% had concurrent IBS.The prevalence of OAB among men was 9.7% and among women it was 8.9%, while 18.6% of men and 23.9% of women had IBS.Concurrent IBS was noted in 32.0% of men and 34.8% of women with OAB.
Taking into account a high rate of concurrent IBS in patients with OAB, it seems to be important for physicians to assess the defaecation habits of patients when diagnosing and treating OAB.
epidemiology; internet surveillance; overactive bladder; irritable bowel syndrome
The pathophysiological mechanisms underlining constipation are incompletely understood, but prolonged bed rest is commonly considered a relevant determinant.
Our primary aim was to study the effect of long-term physical inactivity on determining a new onset of constipation. Secondary aim were the evaluation of changes in stool frequency, bowel function and symptoms induced by this prolonged physical inactivity.
Ten healthy men underwent a 7-day run-in followed by 35-day study of experimentally-controlled bed rest. The study was sponsored by the Italian Space Agency. The onset of constipation was evaluated according to Rome III criteria for functional constipation. Abdominal bloating, flatulence, pain and urgency were assessed by a 100mm Visual Analog Scales and bowel function by adjectival scales (Bristol Stool Form Scale, ease of passage of stool and sense of incomplete evacuation). Daily measurements of bowel movements was summarized on a weekly score. Pre and post bed rest Quality of Life (SF-36), general health (Goldberg’s General Health) and depression mood (Zung scale) questionnaires were administered.
New onset of functional constipation fulfilling Rome III criteria was found in 60% (6/10) of participants (p=0.03). The score of flatulence significantly increased whilst the stool frequency significantly decreased during the week-by-week comparisons period (repeated-measures ANOVA, p=0.02 and p=0.001, respectively). Stool consistency and bowel symptoms were not influenced by prolonged physical inactivity. In addition, no significant changes were observed in general health, in mood state and in quality of life at the end of bed rest
Our results provide evidence that prolonged physical inactivity is relevant etiology in functional constipation in healthy individuals. The common clinical suggestion of early mobilization in bedridden patients is supported as well.
To assess fesoterodine 8 mg efficacy over time and vs. placebo in subjects with overactive bladder (OAB) who responded suboptimally to tolterodine extended release (ER) 4 mg.
In a 12-week, double-blind trial, subjects with self-reported OAB symptoms for ≥ 6 months, mean of ≥ 8 micturitions and ≥ 2 to < 15 urgency urinary incontinence (UUI) episodes/24 h, and suboptimal response to tolterodine ER 4 mg (defined as ≤ 50% reduction in UUI episodes during 2-week run-in) were randomised to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks) or placebo once daily. Change from baseline to week 12 in UUI episodes (primary end-point) was analysed in step-wise fashion: first, baseline vs. week 12 for fesoterodine; if significant, then change from baseline to week 12 for fesoterodine vs. placebo.
By week 12, subjects receiving fesoterodine 8 mg had significantly greater improvement from baseline vs. placebo in UUI episodes, urgency episodes and scores on the Patient Perception of Bladder Control, Urgency Perception Scale and OAB Questionnaire Symptom Bother and Health-Related Quality of Life scales and domains (all p < 0.05). 50% and 70% UUI responder rates were also significantly higher with fesoterodine 8 mg vs. placebo at week 12 (p < 0.05). Dry mouth (placebo, 4%, 12/301; fesoterodine, 16.6%, 51/308) and constipation (placebo, 1.3%, 4/301; fesoterodine, 3.9%, 12/308) were the most frequent adverse events.
Subjects who responded suboptimally to tolterodine ER 4 mg showed significant improvements in UUI and other OAB symptoms and patient-reported outcomes, with good tolerability, during treatment with fesoterodine 8 mg vs. placebo.
To evaluate the usefulness of plain abdominal radiography as an evaluation method for bowel dysfunction in patients with spinal cord injury (SCI).
Forty-four patients with SCI were recruited. Patients were interviewed about their clinical symptoms, and the constipation score and Bristol stool form scale were assessed. The colon transit time (CTT) was measured by using radio-opaque markers (Kolomark). The degree of stool retention and the presence of megacolon or megarectum were evaluated using plain abdominal radiographs. We examined the relationship between clinical aspects and CTT and plain abdominal radiography.
The constipation scores ranged from 1 to 13, and the average was 4.19±3.11, and the Bristol stool form scale ranged from 1 to 6, with an average of 4.13±1.45. CTTs were 19.3±16.17, 19.3±13.45, 15.32±13.15, and 52.42±19.14 in the right, left, rectosigmoid, and total colon. Starreveld scores were 3.4±0.7, 1.8±0.86, 2.83±0.82, 2.14±1, and 10.19±2.45 in the ascending, transverse, descending, rectosigmoid, and total colon. Leech scores were 3.28±0.7, 2.8±0.8, 2.35±0.85, and 8.45±1.83 in the right, left, rectosigmoid, and total colon. The number of patients with megacolon and megarectum was 14 (31.8%) and 11 (25%). There were statistically significant correlations between the total CTT and constipation score (p<0.05), and Starreveld and Leech scores (p<0.05). Significant correlations were observed between each segmental CTT and the segmental stool retention score (p<0.05).
Plain abdominal radiography is useful as a convenient and simple method of evaluation of bowel dysfunction in patients with SCI.
Neurogenic bowel; Spinal cord injuries; Abdominal radiography; Colon transit time
An overactive bladder (OAB) affects a person's quality of life. Patients who suffer from OAB run to the toilet frequently to prevent incontinence, and this behavior increases their risk of falling and fear of falling. This study evaluated the influence of OAB on falls and concern about falling in females aged 40 and over living in urban and rural communities.
We conducted a population-based cohort study using King's Health Questionnaire (KHQ), the Korean version of Falls Efficacy Scale-International (KFES-I) and a questionnaire regarding falls, in females aged 40 and over in Guri city and Yangpyeong county. The data from 514 responders were analyzed. The definition of OAB was 'moderately' or 'a lot' of urgency, or urge incontinence in KHQ. Falls was defined as experience of falls in the last year. High fear of falling was defined as a score of 24 or over in KFES-I. The factors were analyzed by the exact chi-square test and Student's t-test. The multivariate logistic regression model was adopted in order to examine the effects of OAB on falls and concern about falling.
Of the 514 responders, 98 fitted the criterion of OAB. Eighty-nine (17.3%) of the responders had experienced falls in the last year: twenty-seven (27.5%) in the group with OAB and 62 (14.9%) in the group without OAB. There was a significant association between falls and OAB (odds ratio [OR], 1.76; 95% confidence interval [CI], 1.00 to 3.08; P=0.0485), and between high fear of falling and OAB (OR, 2.72; 95% CI, 1.42 to 5.20; P=0.0024).
Urgency and symptoms of urge incontinence increase the risk of falls in women aged 40 or older in the community. Early diagnosis and proper treatment may prevent falls and improve quality of life in OAB patients.
Urinary bladder; Overactive; Urinary incontinence; Urge; Accidental falls
This study was to investigate whether a systematized bladder training (BT) program is effective for patients with idiopathic overactive bladder (OAB).
A prospective study was conducted on 105 patients with OAB from March 2009 to November 2011. We developed a 30 minutes BT program, which consisted of first, refraining from going to the bathroom after feeling an urge to void, second, in order to stop thinking about voiding, ceasing action and thought temporarily, and third, performing pelvic floor exercises 5 to 6 times. Before and after BT, the patients filled out voiding diaries as well as the following questionnaires; International Consultation on Incontinence Questionnaire for overactive bladder (ICIQ-OAB), International Prostate Symptom Score (IPSS), overactive bladder questionnaire (OAB-q), the short form 36-item health survey (SF-36) questionnaire, the work productivity and activity impairment questionnaire, and a patients' perception of treatment benefit (PPTB).
A final analysis was performed from on 85 patients (38 male, 47 female) with idiopathic OAB. After the first BT, the results of the ICIQ-OAB showed improvement in frequency, nocturia, and urgency (P<0.05), and all domains of IPSS questionnaires showed significant improvement (P<0.05). Among the SF-36 domains, the role-physical domain showed significant improvement after the first BT, and the general health domain showed significant improvement after the second. The voiding diaries showed statistically significant changes in maximal voided volume after the first BT, and nocturia index and nocturnal polyuria index after the second BT. According to the PPTB questionnaire, the perceived usefulness of BT increased after each session, and almost all of the patients replied that BT improved their symptoms.
Our results demonstrated that BT was effective in improving many OAB related symptoms and quality of life in patients with idiopathic OAB. More clinical application of BT could be implemented in the future.
Behavior modification; Overactive urinary bladder; Quality of life
Background: Overactive bladder (OAB) is a chronic condition affecting both men and women, with prevalence increasing with age. Antimuscarinics form the cornerstone of treatment of OAB. Fesoterodine, a nonselective muscarinic-receptor antagonist, was approved by the US Food and Drug Administration in late 2008 for once daily, oral administration in the treatment of OAB to relieve the symptoms of urinary urge incontinence, urgency, and frequency.
Objective: The aim of this review was to provide an overview of the mechanism of action of and clinical trial data for fesoterodine, and to discuss the present status of fesoterodine in the management of OAB.
Methods: The MEDLINE and Google Scholar databases were searched (June 1, 1999–December 1, 2009) using the terms fesoterodine, overactive bladder, and muscarinic antagonists. Full-text articles in English were selected for reference, and articles presenting the mechanism of action, pharmacokinetics, and data from clinical trials were included. The parameters measured were tolerability, efficacy, and health-related quality of life (HRQoL). Trials involving animals and Phase I studies were excluded.
Results: The initial literature search yielded 48 papers. A total of 20 articles fulfilled the inclusion criteria. In two 12-week, randomized, multicenter, Phase III clinical trials involving patients with increased micturition frequency and urgency and/or urinary urge incontinence (n = 836 and 1132 in each trial), both fesoterodine 4 and 8 mg were associated with significantly improved symptoms of OAB (frequency of micturition, urgency, and urge incontinence) compared with placebo (P < 0.05). In a post hoc analysis of pooled data of the Phase III trials, HRQoL improved significantly with both doses. In a 12-week, Phase Illb trial, fesoterodine 4 and 8 mg led to treatment satisfaction in ∼80% of patients (of 516 enrolled) who were initially unsatisfied with their previous treatment.
Conclusion: A review of the literature suggests that fesoterodine is an efficacious and well-tolerated treatment option for patients with OAB.
overactive bladder; fesoterodine; muscarinic antagonists
Bladder desensitization has been investigated as an alternative treatment for refractory detrusor overactivity. Most open and controlled clinical trials conducted with intravesical RTX showed that desensitization delays the appearance of involuntary detrusor contractions during bladder filling and decreases the number of episodes of urgency incontinence.
Urgency is being recognised as the fundamental symptom of overactive bladder (OAB), a symptomatic complex which recent epidemiological studies have shown to affect more than 10% of the Western population. As anti-muscarinic drugs, the first line treatment for OAB, are far from being able to fully control urgency, the opportunity to test other therapeutic approaches is created. The present work was, therefore, designed as an exploratory investigation to evaluate the effect of bladder desensitization on urinary urgency.
Twenty-three OAB patients with refractory urgency entered, after given informed consent, a 30 days run-in period in which medications influencing the bladder function were interrupted. At the end of this period patients filled a seven-day voiding chart where they scored, using a 0–4 scale, the bladder sensations felt before each voiding. Then, patients were instilled with 100 ml of 10% ethanol in saline (vehicle solution) and 30 days later a second seven-day voiding chart was collected. Finally, patients were instilled with 100 ml of 50 nM RTX in 10% ethanol in saline. At 1 and 3 months additional voiding charts were collected.
At the end of the vehicle and 3 months period patients were asked to give their subjective impression about the outcome of the treatment and about the willingness to repeat the previous instillation.
At the end of the run-in period the mean number of episodes of urgency per week was 71 ± 12 (mean ± SEM). After vehicle instillation, the mean number of episodes of urgency was 56 ± 11, but only 4 patients (17%) considered that their urinary condition had improved enough to repeat the treatment. At 1 and 3 months after RTX the number of episodes of urgency decreased to 39 ± 9 (p = 0.002) and 37 ± 6 (p = 0.02), respectively (p indicates statistical differences against vehicle). The percentage of patients with subjective improvement after RTX and willing to repeat the instillation at a later occasion was 69%.
In OAB patients with refractory urgency bladder desensitization should be further investigated as an alternative to the standard management. Additionally, the specific effect of RTX on TRPV1 receptors suggests that urothelium and sub-urothelial C-fibers play an important role to the generation of urgency sensation.
To evaluate the relationship between urodynamic detrusor overactivity (DO) and overactive bladder (OAB) symptoms in men and women.
We reviewed the records of adult males and females who attended a tertiary referral center for urodynamic evaluation of OAB syndrome symptoms with the presence or absence of DO. DO was calculated for symptoms alone or in combination.
The overall incidence of DO was 76.1% and 58.7% in male and female OAB patients, respectively. Of men 63% and 61% of women with urgency (OAB dry) had DO, while 93% of men and 69.8% of women with urgency and urgency urinary incontinence (OAB wet) had DO. Of women, 58% who were OAB wet had stress urinary incontinence symptoms with 26.4% having urodynamic stress incontinence. 6% of men and 6.5% of women with OAB symptoms had urodynamic diagnosis of voiding difficulties with postvoid residual greater than 100 mL. Combination of symptoms is more accurate in predicting DO in OAB patients. The multivariate disease model for males included urge urinary incontinence (UUI) and urgency while for females it included UUI and nocturia.
There was a better correlation in results between OAB symptoms and the urodynamic diagnosis of DO in men than in women, more so in OAB wet than in OAB dry. Combination of symptoms of the OAB syndrome seems to have a better correlation with objective parameters from the bladder diary, filling cystometry, and with the occurrence of DO.
Overactive bladder; Urodynamic investigation; Urinary incontinence; Detrusor overactivity
Introduction and objective:
Patient perception of overactive bladder (OAB) treatment outcomes can be a useful indicator of benefit and may help drive persistence on treatment, which is known to be poor in OAB. It remains unclear whether OAB patients dissatisfied with one antimuscarinic can achieve satisfaction with another and supporting data are limited. This study investigated patient-reported outcomes and clinical parameters during darifenacin treatment in OAB patients who expressed dissatisfaction with prior extended-release (ER) oxybutynin or tolterodine therapy (administered for ≥ 1 week within the past year).
This open-label study was conducted in darifenacin-naïve OAB patients. Patients received 7.5 mg darifenacin once daily with the possibility of up-titrating to 15 mg after 2 weeks, for up to 12 weeks. Efficacy parameters included the Patient’s Perception of Bladder Condition (PPBC), patient satisfaction with treatment, micturition frequency and number of urgency and urge urinary incontinence (UUI) episodes. Adverse events (AEs) were also recorded.
In total, 497 patients were treated (84.1% women). Darifenacin treatment resulted in statistically significant improvements in PPBC scores, micturition frequency, urgency and UUI episodes from baseline at 12 weeks. The improvements were similar for patients previously treated with oxybutynin ER or tolterodine ER. More than 85% of patients expressed satisfaction with darifenacin. As noted in other studies, the most common AEs were dry mouth and constipation, but these infrequently resulted in treatment discontinuation, which was low overall.
In this study, PPBC score and OAB symptoms were significantly improved, and satisfaction was high during treatment with darifenacin (7.5/15 mg) in patients who were dissatisfied with the previous antimuscarinic treatment.
We compared the effectiveness of the retropubic tension-free vaginal tape (TVT) and the transobturator inside-out tape (TVT-O) in treating symptoms of overactive bladder (OAB) in women with stress urinary incontinence (SUI).
Women with urodynamic SUI and OAB (mean urgency episodes ≥1 and frequency ≥8/24 hours on a 3-day voiding diary) were assigned to the TVT or TVT-O group. Preoperative measures were based on a urodynamic study, 3-day voiding diary, the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTSSF), and the urgency perception scale (UPS). At 12 postoperative months, the 3-day voiding diary, symptoms questionnaire, patient satisfaction, and standing stress test were assessed. The primary endpoint was change in the number of urgency episodes/24 hours from baseline to 12 months.
In this group of 132 women, 42 received TVT and 90 received TVT-O. The mean urgency episodes/24 hours decreased from 6.3±5.5 to 1.6±3.2 in the TVT group and from 5.1±4.4 to 1.8±3.0 in the TVT-O group. The mean percent change was significantly greater after TVT than after TVT-O (73% vs. 60%, P=0.049). All subscales of BFLUTSSF and UPS were significantly improved using either method, with significantly greater improvement seen in the quality of life (QoL) domain after TVT (P=0.002). There were no significant differences in the cure and satisfaction rates between the two groups.
Intervention with the TVT or the TVT-O significantly improved symptoms of OAB in women with SUI and OAB. Urgency and QoL significantly improved after TVT compared with that after TVT-O.
Overactive urinary bladder; Stress urinary incontinence
Objectives. To prospectively examine the efficacy and safety of propiverine hydrochloride in patients with overactive bladder (OAB) symptoms who poorly responded to previous treatment with solifenacin, tolterodine or imidafenacin. Methods. Patients aged ≥20 with persisting OAB symptoms (≥6 in OAB symptom score (OABSS)) even after at least 4-week treatment using solifenacin, tolterodine or imidafenacin were enrolled. Propiverine 20 mg/day was administered for 12 weeks to 70 patients who desired the further improvement of OAB symptoms and 3 who had intolerable adverse events of previous drugs. The OABSS and postvoid residual urine volume (PVR) were determined before and at 4 and 12 weeks of treatment. Results. Of 73 patients enrolled (29 males and 44 females, median age 71 years), 52 completed the protocol treatment. The OABSS was significantly improved by propiverine treatment (9.0 at baseline, 6.2 at 4 weeks, 6.3 at 12 weeks (P < 0.001)). The scores of OAB symptoms (nighttime frequency, urgency and urge incontinence) except daytime frequency also improved significantly. No increase in PVR was observed. The most frequent adverse event was dry mouth (13.7%), followed by constipation (6.8%). Conclusions. Propiverine is useful to improve OAB for patients who poorly respond to solifenacin, tolterodine or imidafenacin.
Constipation is often inadequately assessed and underdiagnosed in patients with advanced cancer. Many studies use patient-reported constipation as an outcome.
The aim was to compare the accuracy of patient-reported constipation as compared with the modified Rome III (ROME) criteria and to determine the agreement between patient-reported constipation, physician assessment of constipation, and objective assessment of constipation by modified ROME criteria among outpatients with advanced cancer.
Patients with advanced cancer attending a supportive care clinic were screened. Constipation was assessed using the modified ROME criteria, patient report (yes or no and rated 0-10; 10 = worst possible symptom), and physician assessments (yes or no and rated 0-10).
One hundred patients were enrolled and 50 of 100 (50%) patients met the modified ROME criteria for constipation. Disagreement between ROME criteria and the patient report (yes/no) was found in 33 patients (33%), and between ROME criteria and the physician assessment (yes/no) in 39 (39%). The best combination of sensitivity (0.84) and specificity (0.62) was found with scores ≥ 3/10 for patient-reported constipation.
We found a high frequency of constipation. The limited agreement with modified ROME criteria suggests that a patient’s self-report as yes or no is not useful for clinical practice. Patient self-rating on a 0 to 10 scale (score of three or greater) seems to be the best tool for constipation screening among this population. More research is needed to identify the best way to assess constipation in advanced cancer patients
Constipation; assessment; Rome criteria; advanced cancer; palliative care
The purpose of this study is to compare changes in voiding pattern after midurethral sling surgery (MUS) between the stress urinary incontinence (SUI) group and the overactive bladder (OAB)+SUI group.
Materials and Methods
From January 2008 to February 2011, a retrospective survey was conducted of 225 female patients who had been diagnosed with SUI and undergone MUS. The subjects were divided into the SUI group and the OAB+SUI group. Changes in the overactive bladder symptom score (OABSS) and American Urological Association-Symptom Index (AUA-SI) before and three months after the MUS were compared.
Of the 225 patients, 165 patients (73.3%) were classified as SUI group, and 60 patients (26.7%) were classified as OAB+SUI group. The mean age of the subjects was 54.7 years (range, 31-80 years), and the mean age of patients was 53.9 years (range, 34-80 years), and 56.8 years (range, 31-78 years) in the SUI group and OAB+SUI group. In SUI group, voiding symptom and storage symptom among the AUA-SI were significantly increased (p<0.05). OABSS were slight increased, but was statistically insignificant (p=0.847). In OAB+SUI group, voiding symptom score and OABSS showed a significant increase (p<0.05), but storage symptom score showed an insignificant increase (p=0.790).
OAB may occur in approximately 18% of SUI patients who undergo MUS surgery, and voiding dysfunctions with deteriorated voiding symptom and storage symptom may also occur. The deteriorated OAB was shown in 45% of SUI patients with OAB after the surgery.
Midurethral sling; Overactive bladder; Stress urinary incontinence; Urge incontinence
Overactive bladder (OAB) is subtyped into OAB-wet and OAB-dry, based on the presence or absence, respectively, of urgency incontinence. In order to better understand patient and physician perspectives on symptoms among women with OAB-wet and OAB-dry, we conducted patient focus groups and interviews with experts in urinary incontinence.
Materials and Methods
Five focus groups totaling 33 patients with OAB symptoms, including three groups of OAB-wet and 2 groups of OAB-dry patients, were conducted. Topics addressed patients’ perceptions of OAB symptoms, treatments, and outcomes. Twelve expert interviews were then conducted in which experts were asked to describe their views on OAB-wet and OAB-dry. Focus groups and expert interviews were transcribed verbatim. Qualitative data analysis was performed using Grounded Theory methodology, as described by Charmaz.
During the focus groups sessions, women screened as OAB-dry shared the knowledge that they would probably leak if no toilet is available. This knowledge was based on a history of leakage episodes in the past. Those few patients with no history of leakage had a clinical picture more consistent with painful bladder syndrome than OAB. Physician expert interviews revealed the belief that many patients labeled as OAB–dry may actually be mild OAB-wet.
Qualitative data from focus groups and interviews with experts suggest that a spectrum exists between very mild OAB-wet and severe OAB-wet. Scientific investigations are needed to determine if urgency without fear of leakage constitutes a unique clinical entity.
focus groups; qualitative research; urge urinary incontinence; grounded theory; overactive bladder
Constipation is a common side effect of antimuscarinic treatment for overactive bladder (OAB). This review evaluates the incidence and impact of constipation on the lives of patients with OAB being treated with darifenacin.
Constipation data from published Phase III and Phase IIIb/IV darifenacin studies were reviewed and analyzed. Over 4000 patients with OAB (aged 18–89 years; ≥80% female) enrolled in nine studies (three Phase III [data from these fixed-dose studies were pooled and provide the primary focus for this review], three Phase IIIb, and three Phase IV). The impact of constipation was assessed by discontinuations, use of concomitant laxatives, patient-reported perception of treatment, and a bowel habit questionnaire.
In the pooled Phase III trials, 14.8% (50/337) of patients on darifenacin 7.5 mg/day and 21.3% (71/334) on 15 mg/day experienced constipation compared with 12.6% (28/223) and 6.2% (24/388) with tolterodine and placebo, respectively. In addition, a few patients discontinued treatment due to constipation (0.6% [2/337], 1.2% [4/334], 1.8% [4/223], and 0.3% [1/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively), or required concomitant laxatives (3.3% [11/337], 6.6% [22/334], 7.2% [16/223], and 1.5% [6/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively). Patient-reported perception of treatment quality was observed to be similar between patients who experienced constipation and those who did not. During the long-term extension study, a bowel habit questionnaire showed only small numerical changes over time in frequency of bowel movements, straining to empty bowels, or number of days with hard stools.
While constipation associated with darifenacin was reported in ≤21% of the patient population, it only led to concomitant laxative use in approximately one-third of these patients and a low incidence of treatment discontinuation. These data suggest that constipation did not impact patient perception of treatment quality.
antimuscarinics; tolerability; overactive bladder
To investigate the agreement between Rome III and Rome II criteria for diagnosing functional constipation (FC) and to evaluate the accuracy of each constipation symptom for FC diagnosis.
Patients with chronic constipation underwent rigorous biochemical and endoscopic/imaging tests to exclude organic and metabolic diseases. The questionnaires including general information, constipation symptoms, and the most troublesome constipation symptoms were completed in a face-to-face survey. The accuracy of constipation symptoms for FC diagnosis was examined using the likelihood ratio.
Among 184 patients (43 males and 141 females) with chronic constipation, 166 (90.2%) met Rome II criteria and 174 (94.6%) met Rome III criteria for FC, while 166 met both criteria. There was a good diagnostic agreement between the two sets of criteria, with a kappa value of 0.69 and the overall agreement rate was 95.7% (P < 0.001). Based on Rome III criteria, the most accurate symptom for FC diagnosis was sensation of anorectal blockage, followed by straining during defecation and infrequent bowel movements. The most troublesome symptoms reported by patients were lumpy or hard stools, straining during defecation, sensation of incomplete evacuation. More patients indicated that ‘the symptoms in the past 3 months’ was better than ‘those within the past one year’ to reflect their constipation (36.7% vs 6.0%, P < 0.001).
There is good agreement between Rome III and Rome II criteria for FC diagnosis. Rome III criteria are more practical than Rome II criteria for Chinese patients.
constipation; diagnosis; questionnaires; Rome II criteria; Rome III criteria
To determine how variable stool consistency is in patients with irritable bowel (IBS) and assess the relationship between stool consistency and gastrointestinal symptoms.
Individuals with a physician diagnosis of IBS were recruited by advertisement. Enrollment questionnaires included the Rome III Diagnostic Questionnaire and IBS Symptom Severity Scale. Then 185 patients meeting Rome criteria for IBS rated the consistency (using the Bristol Stool Scale) of each bowel movement (BM) for 90 days and whether the BM was accompanied by pain, urgency, or soiling. Each night they transferred BM ratings from a paper diary to an internet form and also reported the average daily intensity of abdominal pain, bloating, bowel habit dissatisfaction, and life interference of bowel symptoms. Only the longest sequence of consecutive days of diary data was used in analysis (average of 73 days).
Patients were 89% female with average age 36.6 years. 78% had both loose/watery and hard/lumpy stools; the average was 3 fluctuations between these extremes per month. The proportion of loose/watery stools correlated r=.78 between the first and second months and the proportion of hard/lumpy stools correlated r=.85 between months. Loose/watery stools were associated with more BM-related pain, urgency, and soiling than hard/lumpy or normal stools; however, IBS-C patients had significantly more BM-unrelated abdominal pain, bloating, dissatisfaction with bowel habits, and life interference than IBS-D. Questionnaires overestimated the frequency of abnormal stool consistency and gastrointestinal symptoms compared to diaries.
Stool consistency varies greatly within individuals. However, stool patterns are stable within an individual from month to month. The paradoxical findings of greater symptom severity after individual loose/watery BMs vs. greater overall symptom severity in IBS-C implies different physiological mechanisms for symptoms in constipation compared to diarrhea. Daily symptom monitoring is more sensitive and reliable than a questionnaire.
Introduction and hypothesis
The Actionable Bladder Symptom Screening Tool (ABSST) was initially developed to identify patients with multiple sclerosis (MS) who could benefit from lower urinary tract assessment and treatment. Assessment of the measurement properties of the ABSST, including its ability to identify patients experiencing bladder symptoms related to overactive bladder (OAB), was undertaken in a general female population.
One hundred women completed the ABSST, OAB Questionnaire Short Form (OAB-q SF), and a patient global impression of severity (PGI-S) scale. Half of the sample had urgency urinary incontinence (UUI), while the other half did not. Descriptive statistics, reliability, and validity were examined, as was sensitivity and specificity of the previous cut-off score established in MS.
Fifty-three women with UUI/OAB and 47 controls took part (71.0 % Caucasian). Patients with UUI/OAB were older (54.6 vs 40.4 years), had a higher body mass index (31.1 vs 26.4 kg/m2), and more comorbid conditions. The Cronbach’s alpha reliability of ABSST was 0.90. High correlations with OAB-q SF Symptom Bother and Health Related Quality of Life (r = 0.83 and −0.81 respectively) supported concurrent validity. Using the PGI-S severity scores as a reference, the ABSST was able to distinguish patients with differing severity levels (known-group validity). Physician assessment of the need for further evaluation/treatment showed sensitivity (79 %) and specificity (98 %), supporting a cut-off score of ≥3.
The previous MS ABSST scoring algorithm was validated in a non-neurogenic female population. ABSST is a reliable, valid, and sensitive tool for screening women with UUI/OAB.
Overactive bladder; Reliability; Sensitivity; Specificity; Urgency urinary incontinence; Validity
To better understand experts’ perceptions of the definition of overactive bladder (OAB), the evaluation of OAB, and treatment of OAB. OAB is defined by the International Continence Society as “urinary urgency, with or without urge urinary incontinence, usually with frequency and nocturia.” Under the current definition, people with very different clinical conditions fall under the OAB umbrella. With the goal of improving the care for women with OAB, we sought to better understand experts’ perceptions of OAB as it is presently defined.
Twelve interviews with leading urologic, gynecologic, and geriatric practitioners in urinary incontinence and OAB were performed. Questions were asked about their perception and agreement with the current definition of OAB. Interviews were audiotaped and transcribed verbatim. Grounded theory methodology was used to analyze the data.
Overall, there was a great deal of variability in defining and managing OAB. Four categories of definitions were derived from the qualitative analysis: current definition is adequate, OAB is a constellation of symptoms, should include the fear of leakage, and OAB is a marketing term. While there is some consensus on evaluation, several areas demonstrate disagreement over elements of the evaluation. Experts also felt that OAB is a chronic condition, with variability of symptoms, and it has no cure. Managing patient expectation is essential, as OAB is challenging to treat. A focus was placed on behavioral therapy.
There was disagreement among experts over the definition and work-up of OAB. However, experts agree that OAB is a chronic condition with a low likelihood of cure.
overactive bladder; urgency; urge incontinence; diagnosis; evaluation; management; definition
To determine the baseline clinical characteristics associated with dose escalation of solifenacin in patients with overactive bladder (OAB).
We analyzed the data of patients with OAB (micturition frequency ≥8/day and urgency ≥1/day) who were treated with solifenacin and followed up for 24 weeks. According to our department protocol, all the patients kept voiding diaries, and OAB symptom scores (OABSS) were monitored at baseline and after 4, 12, and 24 weeks of solifenacin treatment.
In total, 68 patients (mean age, 60.8±10.0 years) were recruited. The dose escalation rate by the end of the study was 41.2%, from 23.5% at 4 weeks and 17.6% at 12 weeks. At baseline, the dose escalator group had significantly more OAB wet patients (53.6% vs. 20.0%) and higher total OABSS (10.2±2.4 vs. 7.9±3.5, P=0.032) than the nonescalator group. OAB wet (odds ratio [OR], 4.615; 95% confidence interval [CI], 1.578-13.499; P<0.05) and total OABSS (OR, 1.398; 95% CI, 1.046-1.869; P<0.05) were found to be independently associated with dose escalation.
Patients who have urgency urinary incontinence and high total OABSS have a tendency for dose escalation of solifenacin.
Overactive urinary bladder; Muscarinic antagonists; Solifenacin