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 evaluate the risk factors for overactive bladder (OAB) in a population aged 40 years and over in the community.
Materials and Methods
We conducted a community-based survey of OAB in a population aged 40 years and over in Guri City and Yangpyeong County, South Korea, by use of the overactive bladder symptom score (OABSS) questionnaire. A total of 926 subjects were included in the final analysis. The definition of OAB was more than 2 points for the urgency score and 3 points for the sum of scores. In addition, the subjects were asked about age, dwelling place, marital status, educational status, behavioral factors (smoking, drinking, etc), and medical history. Categorical variables were analyzed by using the logistic regression model and were adjusted for age by using the logistic regression model.
Overall OAB prevalence was 14.1% (130/926), made up of 49/403 males (12.2%) and 81/523 females (15.5%). OAB prevalence increased with age (p<0.0001). Risk factors for OAB were educational status (age-adjusted p=0.0487), stroke (p=0.0414), osteoporosis (p=0.0208), asthma (p=0.0091), rhinitis (p=0.0008), and cataract. Other factors (dwelling place, marital status, smoking, drinking, hypertension, diabetes, hyperlipidemia, myocardial infarction, angina, tuberculosis, atopic dermatitis, hepatitis B, and depression) were not associated with OAB.
The prevalence of OAB in our study was about 14.1% and the risk factors for OAB were educational status, stroke, osteoporosis, asthma, rhinitis, and cataract. Knowledge of these risk factors may help in the diagnosis and treatment of OAB.
Overactive bladder; Risk factors
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
In this review, we discuss the treatment of refractory overactive bladder (OAB) that has not adequately responded to medication therapy and we propose an appropriate care pathway to the treatment of OAB. We also attempt to address the cost of OAB treatments.
Materials and Methods:
A selective expert review of the current literature on the subject of refractory OAB using MEDLINE was performed and the data is summarized. We also review our experience in treating refractory OAB. The role and outcomes of various treatment options for refractory OAB are discussed and combined therapy with oral anticholinergics is explored. Emerging remedies including intravesical botulinum toxin injection and pudendal neuromodulation are also reviewed, along with conventional surgical options.
In general behavioral therapy, pelvic floor electrical stimulation, magnetic therapy and posterior tibial nerve stimulation (PTNS), have shown symptom decreases in 50-80% of patients with OAB. Depending on the study, combination therapy with oral anticholinergics seems to improve efficacy of behavioral therapy and PTNS in approximately 10-30%. In multicenter, long-term randomized controlled trials, sacral neuromodulation has been shown to improve symptoms of OAB and OAB incontinence in up to 80% of the patients treated. Studies involving emerging therapies such as pudendal serve stimulation suggest that there may be a 15-20% increase in efficacy over sacral neuromodulation, but long-term studies are not yet available. Another emerging therapy, botulinum toxin, is also showing similar success in reducing OAB symptoms in 80-90% of patients. Surgical approaches, such as bladder augmentation, are a last resort in the treatment of OAB and are rarely used at this point unless upper tract damage is a concern and all other treatment options have been exhausted.
The vast majority of OAB patients can be managed successfully by behavioral options with or without anticholinergic medications. When those fail, neuromodulation or intravesical botulinum toxin therapies are successful alternatives for most of the remaining group. We encourage practitioners responsible for the care of OAB patients to gain experience with these options. More research is needed to assess the cost-effectiveness of various OAB treatments
Behavioral therapy; botulinum toxin type A; electrical stimulation; overactive bladder; urinary incontinence; urologic surgical procedures
Bladder wall thickness has been reported to be associated with overactive bladder (OAB) in women. Diabetic women have an increased risk for OAB syndrome and may have an increased risk for bladder wall thickness.
A total of 235 female patients aged 40 to 75 years were categorized into four groups. The first group consisted of women free of urgency or urge urinary incontinence. The second group included nondiabetic women with idiopathic OAB. The third group consisted of women with diabetes and clinical OAB, and women with diabetes but without OAB constituted the fourth group. Bladder wall thickness at the anterior wall was measured by ultrasound by the suprapubic approach with bladder filling over 250 mL.
The diabetic (third group) and nondiabetic (second group) women with OAB had significantly greater bladder wall thickness at the anterior bladder wall than did the controls. However, the difference was not significant between the diabetic (third group) and the nondiabetic (second group) women with OAB. Women with diabetes but without OAB (fourth group) had greater bladder wall thickness than did the controls but this difference was not significant. Additionally, the difference in bladder wall thickness between diabetic women with (third group) and without (fourth group) OAB was not significant.
This is the first study to show that bladder wall thickness is increased in diabetic women with and without OAB. Additionally, nondiabetic women with OAB had increased bladder wall thickness. Further studies may provide additional information for diabetic and nondiabetic women with OAB, in whom the etiopathogenesis of the disease may be similar.
Overactive urinary bladder; Urinary bladder; Diabetes mellitus
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
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
To investigate the association between overactive bladder (OAB) and C-reactive protein (CRP) in a population-based sample of men and women.
SUBJECTS AND METHODS
Epidemiological survey of urological symptoms among men and women aged 30–79 years. A multi-stage stratified cluster design was used to randomly sample 5503 adults from the city of Boston. Analyses were conducted on 1898 men and 1854 women with available CRP levels.
The International Continence Society defines OAB as ‘Urgency with or without urge incontinence, usually with frequency and nocturia.’ OAB was defined as: (1) urgency, (2) urgency with frequency, and (3) urgency with frequency and nocturia.
Odds ratios (OR) and 95% confidence intervals (95% CI) of the CRP and OAB association were estimated using logistic regression.
Prevalence of OAB increased with CRP levels in both men and women.
In men, adjusted ORs (95% CI) per log10(CRP) levels were 1.90 (1.26–2.86) with OAB defined as urgency, 1.65 (1.06–2.58) with OAB defined as urgency and frequency, and 1.92 (1.13–3.28) with OAB defined as urgency, frequency and nocturia.
The association was more modest in women with ORs (95% CI) of 1.53 (1.07–2.18) for OAB as defined urgency, 1.51 (1.02–2.23) for OAB defined as urgency and frequency, and 1.34 (0.85–2.12) for OAB defined as urgency, frequency and nocturia.
Results show a consistent association of increasing CRP levels and OAB among both men and women.
These results support our hypothesis for the role of inflammation in the development of OAB and a possible role for anti-inflammatory agents in its treatment.
C-reactive protein; epidemiology; inflammation; overactive bladder
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
Overactive bladder (OAB) is a manifestation of urgency, regardless of urge incontinence, due to involuntary bladder contraction during the storage period. There is a close association between constipation and OAB, but constipation cannot be readily diagnosed. The aims of this study were to evaluate the prevalence of constipation in OAB and the consequent therapeutic effects according to the diagnostic criteria for constipation.
We collected clinical data from 40 children (mean age, 71±22 months) with chief complaints of urgency, frequency, and incontinence. A voiding questionnaire and a 2-day voiding diary were collected, and urinalysis, the Bristol stool scale, and plain abdominal radiography were performed. Constipation was defined as conditions satisfying at least one of the following criteria: Rome III diagnostic criteria, Bristol stool scale types I/II, or a Leech score higher than 8 points as determined by plain radiography. Lower urinary tract symptoms, defecation symptoms, and the bladder volume of patients were examined, and the therapeutic outcomes by constipation diagnostic criteria were evaluated.
Of the 40 OAB patients, 25 had constipation. Among them, 6 had reduced functional bladder capacity (24%; P>0.05). Regarding treatment, in patients who satisfied only one diagnostic criterion, the symptoms improved in 76.9%, 76.9%, and 69.6% of patients meeting the Rome III criteria, Bristol stool scale, and Leech score, respectively (P<0.05). Among the 8 patients satisfying all three criteria, 75% responded to treatment (P<0.05).
The prevalence of constipation in OAB is high. Constipated patients recruited by use of the Rome III criteria, Bristol scale, and Leech score alone and together showed similar outcomes on OAB improvement after the treatment of constipation, which implies that each criterion has the same strength and can be applied comprehensively and generally.
Overactive urinary bladder; Pediatrics; Constipation
With the ultimate goal of improving the quality of care provided to aging women with overactive bladder, we sought to better understand aging women’s experience with overactive bladder (OAB) symptoms and the care they receive.
Women seen in outpatient female urology clinics were identified by ICD-9 codes for OAB and recruited. Patients with painful bladder syndrome, mixed stress and urge incontinence, prolapse, or recent pelvic surgery were excluded. Patient focus groups were conducted by trained non-clinician moderators incorporating topics related to patients’ perceptions of OAB physiology, symptoms, diagnostic evaluation, treatments, and outcomes. Qualitative data analysis was performed using grounded theory methodology.
Five focus groups totaling 33 women with OAB were conducted. Average patient age was 67 years (range 39–91). Older women with OAB lacked knowledge about the physiology of their disease and had poor understanding regarding the rationale for many diagnostic tests, including urodynamics and cystoscopy. The results of diagnostic studies often were not understood by older patients. Many women were dissatisfied with the care they had received. This lack of knowledge and understanding was more apparent among the elderly women in the group.
Findings demonstrated a poor understanding of the physiology of overactive bladder and the rationale for various diagnostic modalities and treatments. This was associated with dissatisfaction with care. There is a need for better communication with older women experiencing OAB symptoms about the physiology of the condition.
Focus groups; qualitative research; aging; urinary incontinence; grounded theory
To compare urgency symptoms in women with interstitial cystitis/bladder pain syndrome (IC/BPS) and overactive bladder (OAB).
Materials and Methods
Women with diagnoses of IC/BPS (n = 194) and OAB (n = 85) were recruited from the clinical practices of Urologists (n = 8) and Gynecologists (n = 16) with recognized expertise in the diagnosis and management of these conditions. Subjects completed a comprehensive telephone survey about their current symptoms. The questionnaire included 11 questions about urinary urgency. Responses were compared between the two groups.
Urgency was commonly reported as a symptom by women with both conditions (81% IC/BPS and 91% OAB). Compared with IC/BPS, urgency in OAB more often resulted in leakage, and was perceived to be more of a problem. In IC/BPS, the urgency was primarily reported as due to pain, pressure, or discomfort, while in OAB the urgency was more commonly due to fear of leakage. However, approximately 40% of women with OAB also report urgency due to pain, pressure, or discomfort. Similar proportions of both groups (~60%) indicated that the urgency occurred “suddenly” instead of more gradually over a period of minutes or hours.
Urgency symptoms differed in women diagnosed with IC/BPS versus those diagnosed with OAB, but there was significant overlap. This suggests that “urgency” is not a well-defined and commonly understood symptom that can be utilized to clearly discriminate between IC/BPS and OAB. These findings reinforce the clinical observation that it is often challenging to differentiate between these two conditions.
sensations; specificity; symptoms
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.
We aimed to estimate the prevalence of overactive bladder (OAB) in Korea, to assess the variation in prevalence by sex and age, and to measure the impact of OAB on quality of life.
A population-based, cross-sectional telephone survey was conducted between April and June 2010 with a questionnaire regarding the prevalence of OAB, demographics, and the impact of OAB on quality of life. A geographically stratified random sample of men and women aged ≥30 years was selected.
The overall prevalence of OAB was 22.9% (male, 19%; female, 26.8%). Of a total of 458 participants with OAB, 37.6% and 19.9% reported moderate or severe impact on their daily life and sexual life (5.6% and 3.5%, respectively, in participants without OAB). Anxiety and depression were reported by 22.7% and 39.3% of participants with OAB, respectively (9.7% and 22.8%, respectively, in participants without OAB). Only 19.7% of participants with OAB had consulted a doctor for their voiding symptoms, but 50.7% of respondents with OAB were willing to visit a hospital for the management of their OAB symptoms.
This study confirmed that OAB symptoms are highly prevalent in Korea, and many sufferers appear to have actively sought medical help. OAB has severe effects on daily and sexual life as well as psychological health.
Overactive urinary bladder; Prevalence; Demography
Overactive bladder (OAB) represents a disorder with overall increasing prevalence in the American population. However, gender-specific characteristics of OAB and how it relates to the general practitioner are not well described. We sought to determine the distribution and characteristics of OAB in women in a primary care setting.
Self-administered questionnaires were distributed to patients visiting a family medicine outpatient center. The modified questionnaire included eight questions on evidence of lower urinary tract symptoms (LUTS, OAB-validated 8-question screener [OAB-V8]), two questions on stress urinary incontinence, and one question on incomplete emptying. The questionnaire included demographic characteristics and relevant medical and surgical history. Body mass index was calculated based on weight and height. Chi-square test and risk ratio analysis were used to analyze the relationship between OAB and other independent variables.
Of 1025 questionnaires administered, 386 were completed. Patients ranged from 16 to 97 years, the majority were African American (78.2%), and 49.7% were premenopausal while 50.3% were postmenopausal. OAB was present in 46.4% of premenopausal women and 41.7% of postmenopausal women. OAB was significantly associated with overweight status (body mass index 25.0–29.9, P = 0.042) and obesity (body mass index ≥30, P < 0.001). Overall, obese women were twice as likely to have OAB (relative risk = 1.99, 1.31–3.04) than women with normal weight. OAB was not shown to correlate with race, cigarette use, history of hysterectomy, or parity.
OAB was evident in 44% of all female patients surveyed, which is much higher than previously reported estimates. In addition, overweight women were more likely to have OAB. Increased awareness of OAB in the primary care setting should be considered for women’s general health.
overactive bladder; incontinence; women; primary care
Overactive bladder (OAB) is a common condition affecting the elderly. The mainstay of treatment for OAB is medical therapy with anticholinergics. However, adverse events have been reported with this class of drugs including cognitive changes.
To investigate the effect of an anticholinergic medication on cognitive function in postmenopausal women being treated for OAB.
Prospective cohort study conducted from January to December 2010, with 12-week follow-up after medication initiation.
Urogynecology clinic at one academic medical center.
Women age 55 or older seeking treatment for OAB and opting for anticholinergic therapy were recruited.
Baseline cognitive function was assessed via the Hopkins Verbal Learning Test – Revised Form (HVLT-R) (and its 5 subscales), the Orientation, Memory & Concentration (OMC) short form, and the Mini-Cog evaluation. After initiation of trospium chloride extended release, cognitive function was reassessed at Day 1, Week 1, Week 4 and Week 12. Bladder function was assessed via three condition-specific quality of life questionnaires. Secondary outcomes included change in bladder symptoms, correlation between cognitive and bladder symptoms, and overall medication compliance.
Main Outcome Measure
Change in HVLT-R score at Week 4 after medication initiation, compared to baseline (pre-medication) score.
Of 50 women enrolled, 35 completed the assessment. Average age was 70.4 years and 77.1% had previously taken anticholinergic medication for OAB. At enrollment 65.7% had severe overactive bladder and 71.4% had severe urge incontinence. Cognitive function showed an initial decline on Day 1 in HVLT-R total score (p=0.037), HVLT-R Delayed Recognition subscale (p=0.011) and HVLT-R Recognition Bias subscale (p=0.01). At Week 1 the HVLT-R Learning subscale declined from baseline (p=0.029). All HVLT-R scores normalized by Week 4. OMC remained stable throughout. The Mini-Cog nadired at a 90.9% pass rate at Week 4. OAB symptoms did not improve until Week 4, based on questionnaire scores (p<0.05).
Cognitive function exhibited early changes after initiation of trospium chloride but normalized within four weeks. Cognitive changes occurred weeks prior to OAB symptom improvement. Surveillance for cognitive changes with anticholinergic use should be part of OAB management.
Anticholinergic; Cognitive Function; Elderly; Overactive Bladder
Psychometric properties of the overactive bladder questionnaire (OAB-q) were recently examined. However, since the cross-cultural adaptation of a non-English version of the OAB-q has never been demonstrated, we evaluated the psychometric properties of a Korean version of the OAB-q in a Korean population with OAB.
A prospective cohort study involving 116 women with 58 OAB and 58 control subjects was performed and convergent validity was assessed. Total and subscale OAB-q scores of the control and OAB groups were compared to their sensitivity to score changes before and after administering anti-cholinergic medication for 12 weeks. Short form 36 and King's health questionnaire (KHQ) were also used for comparison or correlation.
Assessment of face validity showed that the Korean version of the OAB-q was reasonable with OAB-q subscale scores being significantly different between the control and patient groups. Significant correlation (range, -0.29 to -0.81) was found between the OAB-q scores and KHQ results for the OAB patients. Cronbach's alpha coefficients (range, 0.77 to 0.95) indicated excellent internal consistency and test-retest analysis involving 35 OAB patients showed that each questions as well as subscale scores were reproducible. Each score of OAB-q also showed statistically significant sensitivity to changes following anti-muscarinic treatment for OAB (n=27, P<0.001 except for social, P=0.059).
The Korean version of the OAB-q is a valid and reliable instrument to measure outcomes in Korean patients with OAB.
Overactive urinary bladder; Quality of life; Questionnaires; Psychometrics
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.
Limited utility data on patients suffering from overactive bladder (OAB) are available in the literature. The objectives of this study were to estimate utility values in patients with OAB using the generic EQ-5D questionnaire and the OAB-5D disease specific questionnaire, to investigate the relationship between utilities and symptoms, and to evaluate the sensitivity of the two instruments to changes in symptom severity.
Analyses were based on pooled data from three large multicenter randomized 12-week placebo-controlled trials (SCORPIO, ARIES, CAPRICORN). Patients completed a micturition diary, EQ-5D and OAB-q (a quality of life questionnaire from which OAB-5D is derived) at baseline and at weeks 4, 8 and 12. Time trade-off tariffs elicited from UK population were applied to obtain utilities from both instruments. Repeated measures regressions were used to estimate EQ-5D and OAB-5D utilities by micturition frequency and incontinence severity level. As a test of sensitivity of the instruments, utility changes from baseline to week 12 were estimated by symptomatic response (improvement, stable or worsening).
The sample included 4427 patients. Mean utilities (± standard deviation) across all visits were 0.82 (±0.21) for EQ-5D and 0.86 (±0.09) for OAB-5D. Correlation between EQ-5D and OAB-5D was 0.34 (p < 0.0001). Both OAB-5D and EQ-5D utilities increased as OAB symptoms improved. Utility values were similar for severe levels of symptoms, but higher with OAB-5D than with EQ-5D for mild cases. Micturitions and incontinence had similar impact on EQ-5D utilities, but micturitions had greater impact on OAB-5D utilities than incontinence. Changes from baseline in OAB-5D utilities differed significantly according to symptomatic response. Changes in EQ-5D utilities were not significantly associated with changes in micturition frequency and weakly associated with changes in incontinence severity among patients with mild symptoms at baseline.
This study showed that both EQ-5D and OAB-5D can detect changes in severity of OAB, especially in severe cases. However, OAB-5D is more sensitive than EQ-5D in measuring differences between treatments in milder cases. Both OAB-5D and EQ-5D–although leading to different results–may be useful to derive utilities from clinical trial data and perform cost-effectiveness analyses.
Clinical Trials NCT00689104, NCT00662909, NCT00912964.
Health-related quality of life; Overactive bladder; EQ-5D; OAB-5D; Quality-adjusted life-years; Utility assessment
Treatment options for overactive bladder (OAB) with urinary urge incontinence (UUI) refractory to oral antimuscarinics include: botulinum toxin type A (BoNTA), sacral neuromodulation (SNM), and augmentation cystoplasty (AC). A standard treatment success metric that can be used in both clinical and economic evaluations of the above interventions has not emerged. Our objective was to conduct a literature review and synthesis of published measures of treatment success for OAB with UUI interventions and to identify a treatment success outcome.
We performed a literature review of primary studies that used a definition of treatment success in the OAB with UUI population receiving BoNTA, SNM, or AC. The recommended success outcome was compared to generic and disease-specific health-related quality-of-life (HRQoL) measures using data from a BoNTA treatment study of neurogenic incontinent patients.
Across all interventions, success outcomes included: complete continence (n = 23, 44%), ≥ 50% improvement in incontinence episodes (n = 16, 31%), and subjective improvement (n = 13, 25%). We recommend the OAB with UUI treatment success outcome of ≥ 50% improvement in incontinence episodes from baseline. Using data from a neurogenic BoNTA treatment study, the average change in the Incontinence Quality of Life questionnaire was 8.8 (95% CI: -4.7, 22.3) higher for those that succeeded (N = 25) versus those that failed (N = 26). The average change in the SF-6D preference score was 0.07 (95% CI: 0.02, 0.12) higher for those that succeeded versus those that failed.
A treatment success definition that encompasses the many components of underlying OAB with UUI symptoms is currently not practical as a consequence of difficulties in measuring urgency. The treatment success outcome of ≥ 50% improvement in incontinence episodes was associated with a clinically meaningful improvement in disease-specific HRQoL for those with neurogenic OAB with UUI. The recommended success definition is less restrictive than a measure such as complete continence but includes patients who are satisfied with treatment and experience meaningful improvement in symptoms. A standardized measure of treatment success will be useful in clinical and health economic applications.
Overactive bladder (OAB) is a bothersome condition affecting the quality of life, financial constraint on the individual, and community. Anticholinergic drugs cannot be used for long term due to adverse side effects. Botulinum toxin has recently shown promising and encouraging result in management of OAB.
Aim was to study the safety, efficacy, tolerability, and duration of effect of 200 units of botulinum toxin in refractory idiopathic detrusor overactivity.
Materials and Methods
Thirty-nine female patients (average age of 52 years) clinically and urodynamically diagnosed as idiopathic OAB were injected 200 units of botulinum toxin-A mixed with 20 ml of normal saline, intradetrusally at the rate of 1 mL at each site for 20 such sites sparing the trigone and ureteric orifices. Follow up at 3rd, 6th, 9th, and 12th month with clinical and urodynamical questionnaire was done.
There were 4 dropouts and 35 patients were evaluated, of which 30 patients (85.7%) showed improvement in clinical features like frequency, urgency, nocturia, and incontinence within 1 week of injection, which lasted for mean period of 7 months (varying from 6 to 9 months). Volume at first desire to void improved from median baseline of 104-204 ml and maximum cystometric capacity of bladder increased from mean baseline value of 205-330 ml. The detrusor pressure decreased by 49% from the baseline and postresidual urine volume increased by 30% of maximum cystometric capacity of bladder. There was no adverse effect on our patient.
Intradetrusor injection of Botox-A in management of refractory overactive idiopathic bladder is not only safe and well tolerated, but also very effective with practically no side effects.
Anticholinergic; botulinum toxin; overactive bladder
Previous studies demonstrate that tolterodine extended release (ER) significantly improves urgency urinary incontinence (UUI) episodes. Instruments that measure patient-reported outcomes (PROs) provide additional information that is valuable for assessing whether clinical improvements are meaningful to the patient. This study determined the correlation of changes in bladder diary variables and other PROs in subjects with overactive bladder (OAB).
Subjects with OAB, urinary frequency, and UUI were treated with 4 mg once-daily tolterodine ER or placebo for 12 weeks. Subjects completed 7-day bladder diaries, the Patient Perception of Bladder Condition (PPBC), and the King's Health Questionnaire (KHQ) at baseline and week 12. Only subjects who reported at least some minor bladder-related problems at baseline (PPBC score ≥ 3) were included in this analysis.
Reductions in UUI episodes per week were significantly greater in the tolterodine ER group (n = 500) compared with the placebo group (n = 487) at week 12 (-71% vs -33%, P < 0.0001). A significantly greater percentage of subjects in the tolterodine ER group reported improvement on the PPBC versus placebo (58% vs 45%, P < 0.0001), and 7 of 10 KHQ domains were significantly improved versus placebo (all P < 0.05). Significant correlations were found for median percentage changes in UUI episodes with changes in PPBC scores (r = 0.35,P < 0.0001) and the 7 improved KHQ domains (r = 0.16–0.32, P ≤ 0.0011). Changes in PPBC scores and all KHQ domains were significantly correlated (r = 0.13–0.38, P ≤ 0.009) in the tolterodine ER group. Correlations among endpoints in the placebo group were similar to those observed in the tolterodine ER group.
Improvement in UUI episodes after 12 weeks of treatment with tolterodine ER or placebo was correlated with improvements in patients' perception of their bladder-related problems and health-related quality of life. Correlations were moderate in magnitude but statistically significant, suggesting that PROs are important and relevant measures for evaluating OAB treatment.
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.
Overactive bladder (OAB) is a medical syndrome defined by symptoms of urgency, with or without urge urinary incontinence (any involuntary loss of urine), usually with frequency and nocturia. Although anticholinergic agents have been the first-line treatment for OAB for many years, the efficacious pharmacologic management of this condition has been compromised by concerns regarding tolerability. Flavoxate was the first anticholinergic and antispasmodic agent approved by the Food and Drug Administration (FDA) to treat symptoms of OAB but is not routinely used today since newer agents are more effective. The more recent drugs, oxybutynin and tolterodine, have appeared to be equally efficacious in treating the symptoms of OAB in clinical trials; however, tolterodine has proven to be better tolerated with fewer adverse effects. In 2004, the FDA approved the three newest agents for the class: darifenacin, solifenacin, and trospium. Compared with oxybutynin and tolterodine, these agents have a more favorable side effect profile, which can enhance tolerability and patient compliance. Side effects are reduced in part because of the drugs' greater tissue selectivity for inhibiting the bladder muscle contraction over other anticholinergic receptors in the body. In recent clinical trials, darifenacin, solifenacin, and trospium have shown superiority to placebo and efficacy comparable to that of oxybutynin and tolterodine.
Research has focused on treatment of overactive bladder (OAB) symptoms in women with the goal of cure. The objective of this study was to assess women’s perceptions of their OAB symptoms, treatment experience, and outcomes by conducting patient focus groups.
Women seen in our academic center female urology referral clinics were identified by ICD-9 codes for OAB symptoms and recruited to participate in one of five focus groups, totaling 33 patients. Non-clinician moderators conducted the focus group sessions incorporating topics related to patients’ perceptions of OAB symptoms, treatments, and outcomes. Data analysis was performed using grounded theory methodology.
Qualitative analysis yielded several preliminary themes: impact of OAB on quality of life, strategies to control wetness, medications and side effects, and triggers. The majority of focus group participants reported only a partial response to medication and other physician-recommended treatments for OAB. They therefore developed self-reliant personalized strategies to improve their quality of life. These strategies included fluid restriction, preventive toileting, and, most importantly, the use of incontinence pads.
The majority of the women who participated in the focus groups reported only a partial response to medical and other treatments for OAB. As a result, they developed personalized self-management strategies to improve their quality of life. Although most studies addressing the treatment of OAB aim at curing the condition, such a strategy may be unrealistic. Applying a chronic care model that uses a patient-centered symptom management approach to OAB may optimize patient outcomes and improve quality of life.
focus groups; qualitative research; urinary incontinence; grounded theory