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1.  Diagnostic Value of Plain Abdominal Radiography in Stroke Patients With Bowel Dysfunction 
Annals of Rehabilitation Medicine  2015;39(2):243-252.
To evaluate the diagnostic value of plain abdominal radiography in stroke patients with bowel dysfunction.
A total of 59 stroke patients were recruited and assigned into constipation or non-constipation group. Patients were interviewed to obtain clinical information, constipation score, and Bristol stool form scale. The total and segmental colon transit time (CTT) was measured using radio-opaque markers (Kolomark). The degree of stool retention was evaluated by plain abdominal radiography and scored by two different methods (Starreveld score and Leech score). The relationship between the clinical aspects, CTT, and stool retention score using plain abdominal radiography was determined.
Average constipation score was 4.59±2.16. Average Bristol stool form scale was 3.86±1.13. The total and segmental CTTs showed significant differences between the constipation and non-constipation groups. There was statistically significant (p<0.05) correlation between the total CTT and constipation score or between Starreveld score and Leech score. Each segmental CTT showed significant correlation (p<0.05) between segmental stool retention scores.
The stool retention score showed significant correlation with constipation score as well as total and segmental CTT. Thus, plain abdominal radiography is a simple and convenient method for the evaluation of bowel dysfunction in stroke patients.
PMCID: PMC4414971  PMID: 25932421
Constipation; Stroke; Abdominal radiography; Colon transit time
2.  Tolterodine extended release in the treatment of male oab/storage luts: a systematic review 
BMC Urology  2014;14:84.
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.
PMCID: PMC4230346  PMID: 25348235
Lower urinary tract symptoms; Overactive bladder; Storage LUTS; Tolterodine; Urge incontinence; Frequency; Nocturia
3.  A Prospective, Comparative Study of the Occurrence and Severity of Constipation with Darifenacin and Trospium in Overactive Bladder 
Darifenacin and trospium are the commonly used antimuscarinics in the management of overactive bladder (OAB). Constipation is the second most common treatment related side-effect. Though its incidence with the above two medications is known, data on their comparative severity and impact on patient’s well-being is lacking.
Materials and Methods:
Sixty subjects with OAB included in the study were randomized in 1:1 fashion to receive either darifenacin 7.5 mg OD or trospium extended release 60 mg OD. Treatment response was monitored using overactive bladder symptom score (OABSS). The severity of constipation was assessed using McMillan & Williams Constipation assessment scale (CAS), Bristol stool form scale and Knowles-Eccersley-Scott-Symptom (KESS) questionnaire score administered at baseline, 2 and 4 weeks of treatment.
OABSS improved significantly, -5.80 ± 3.99 (p = 0.0005) and -5.27 ± 2.98 (p = 0.0005) in darifenacin and trospium groups respectively. However, the difference between the two groups was not significant either at 2 weeks (p = 0.952) or 4 weeks (p = 0.654) of treatment. A significant decrease in stool consistency was noted with darifenacin treatment (p < 0.05), but the same was not seen with trospium (p = 0.076). There was no significant difference in scores of KESS questionnaire between baseline, 2 weeks and 4 weeks, both within the group and between the groups (p > 0.05). McMillan & Williams CAS scores increased at week 2 and week 4, in comparison with baseline scores in both darifenacin and trospium treated patients, however, the difference between the two groups was not statistically significant (p > 0.05).
Darifenacin and trospium are equally efficacious and comparable in tolerability in terms of constipation severity and its impact on patient well-being.
PMCID: PMC4413078  PMID: 25954630
Antimuscarinics; Bristol stool form scale; CAS; KESS
4.  Clinical features of constipation in general practice in Italy 
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.
PMCID: PMC4212453  PMID: 25360307
Constipation; epidemiology; general practice; Rome criteria; questionnaire
5.  Correlation between psychological stress levels and the severity of overactive bladder symptoms 
BMC Urology  2015;15:14.
The relationship between psychological stress and interstitial cystitis/bladder pain syndrome (IC/BPS) has been well described. Even though there is some overlapping of symptoms between overactive bladder (OAB) and IC/BPS, there have been very few studies that specifically investigated the relationship between psychological stress and urinary symptoms in OAB patients who do not have pelvic pain. Here we examined the relationship between psychological stress levels and the severity of overactive bladder (OAB) symptoms.
Patients diagnosed with OAB (n=51), IC/BPS (n=27), and age-matched healthy controls (n=30) participated in a case control study that inquired about their psychological stress levels using the perceived stress scale (PSS). PSS reported by the three patient groups were compared. Among OAB patients, their responses on the PSS was correlated to OAB symptoms using the following questionnaires: 1) international consultation on incontinence – urinary incontinence (ICIQ-UI), 2) international consultation on incontinence – overactive bladder (ICIQ-OAB), 3) OAB-q short form, 4) urogenital distress inventory (UDI-6), 5) incontinence impact questionnaire (IIQ-7), 6) urgency severity scale (USS), 7) numeric rating scales of urgency symptom, and 8) frequency symptom. Spearman’s correlation tests were performed to examine the relationship between psychological stress levels and the severity of OAB symptoms.
OAB patients reported psychological stress levels that were as high as IC/BPS patients (median 17.0 versus 18.0, p=0.818, Wilcoxon sum rank test), and significantly higher than healthy controls (17.0, versus 7.5, p=0.001). Among OAB patients, there was a positive correlation between perceived stress levels and urinary incontinence symptoms (ICIQ-UI, Spearman’s correlation coefficient=0.39, p=0.007), and impacts on quality of life (UDI-6, IIQ-7, OAB-q quality of life subscale; Spearman’s correlation coefficient=0.32, 0.31, 0.39, and p=0.028, 0.005, 0.029, respectively). No significant correlation was observed between perceived stress levels and urgency or frequency symptoms (ICIQ-OAB, USS, numeric ratings of urgency and frequency).
OAB patients reported psychological stress levels that were as high as IC/BPS patients, and significantly higher than healthy controls. There was a positive correlation between perceived stress levels and urinary incontinence symptoms, and its impacts on quality of life among OAB patients.
PMCID: PMC4357155  PMID: 25887525
Psychological stress; Overactive bladder; Urgency incontinence; Urinary urgency; Interstitial cystitis
6.  AB195. Correlations among improvements in overactive bladder symptom scores (OABSS) and urinary nerve growth factor levels in overactive bladder patients 
Translational Andrology and Urology  2016;5(Suppl 1):AB195.
To investigate whether the urinary nerve growth factor (NGF) levels in overactive bladder (OAB) patients is related to the improvement of overactive bladder symptom scores (OABSS) and quality of life index, following treatment of anti-muscarinic agent.
Forty-seven patients suffered from OAB and twenty normal controls were included in this study. An anti-muscarinic agent (solifenacin succinate 5 mg once a day) was administered for the OAB patients. At enrolment and after 12 weeks of treatment, the OABSS and the quality of life (QOL) score were determined. The urinary NGF/Cr level was also examined.
The urinary NGF/Cr level was higher in the OAB patients than in the controls in baseline (P<0.05). After 12 weeks treatment with anti-muscarinic agent, the OABSS-total and QOL scores were all significantly decreased (P<0.001 each) in the OAB-dry and OAB-wet patients. And the urinary NGF/Cr levels decreased in OAB-wet patients, but not in OAB-dry patients. Furthermore, treatment-related changes of urinary NGF/Cr levels were correlated well with changes in four OABSS subscales (which include daytime voiding, nighttime voiding, urgency, and urge incontinence) (P<0.001) and QOL score (P<0.001) in only OAB-wet patients, but not in OAB-dry patients.
Improvement of OAB symptoms and QOL by treatment with the anti-muscarinic agent was related to the decrease of urinary NGF/Cr level in the OAB-wet patients, but not in OAB-dry patients. Therefore, NGF/Cr level as biomarkers for assessing therapeutic outcome of OAB should be interpreted with caution.
PMCID: PMC4842740
Overactive bladder (OAB); nerve growth factor (NGF); lower urinary tracts; anti-muscarinic therapy
7.  Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study 
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.
PMCID: PMC2705818  PMID: 19348029
8.  Evaluation of the Symptom of Constipation in Indian Patients 
The exact prevalence of constipation in India is unknown. To know this, first it has to be properly defined based on stool frequency and form (as in western definition) in Indian patients, data on which is scarce. There may be difference with the western definition also.
To determine the stool frequency and form in patients consulting doctor for the complaint of constipation and compare these with the Western definition of constipation.
Materials and Methods
This was a prospective cross-sectional study on 331 consecutive patients seeking medical advice for their complaint of constipation. They were administered a questionnaire containing Rome III criteria points of functional constipation and constipation predominant irritable bowel syndrome and the Bristol stool chart to report their predominant stool form. Organic bowel diseases were excluded by further history taking, physical examination and appropriate investigations. The data on stool frequency and form thus obtained were compared with the existing Indian population data.
A total of 65% patients were above 60 years of age. The predominant stool types were 1-3 according to Bristol stool form scale present in 93.8% patients and conformed to Asian criteria of constipation by stool form. Only 67.9% patients passed Bristol Stool Scale (BSS) type 1 and 2 stool which is the western definition. 51.5% reported a frequency of 3-4 motions/week, 19.8% had normal stool frequency by Indian standard (i.e. at least 1 motion/day) and only 35.4% had constipation by Western criteria (less than 3 motions/week). Hence subjective feeling varied widely from observed rate and Western definition was invalid in about twothird of patients. Feeling of incomplete evacuation was universal and this was referred to as constipation by patients. Functional constipation was diagnosed in 69.1% (of whom most were elderly with co-morbidities) and constipation predominant irritable bowel syndrome in 13.8% by Indian standard. Only 2.1% had colonic cancer.
A stool frequency of <5 motions/week appears more appropriate in Indian definition of constipation where the subjective feeling of incomplete evacuation should also be given due weightage. Asian criteria based on stool form holds true in India.
PMCID: PMC4866155  PMID: 27190857
Bristol Stool Scale; Functional bowel disease; Irritable bowel syndrome; Rome III criteria
9.  Efficacy and safety of solifenacin succinate 10 mg once Daily: A multicenter, phase III, randomized, double-blind, placebo-controlled, parallel-group trial in patients with overactive bladder 
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.
PMCID: PMC3969973  PMID: 24692834
anticholinergic; incontinence; overactive bladder; solifenacin; urgency
10.  Relationship between overactive bladder and irritable bowel syndrome: a large-scale internet survey in Japan using the overactive bladder symptom score and Rome III criteria 
Bju International  2012;111(4):647-652.
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.
PMCID: PMC3654175  PMID: 23106867
epidemiology; internet surveillance; overactive bladder; irritable bowel syndrome
11.  New Onset of Constipation during Long-Term Physical Inactivity: A Proof-of-Concept Study on the Immobility-Induced Bowel Changes 
PLoS ONE  2013;8(8):e72608.
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.
PMCID: PMC3748072  PMID: 23977327
12.  Plain Abdominal Radiograph as an Evaluation Method of Bowel Dysfunction in Patients With Spinal Cord Injury 
Annals of Rehabilitation Medicine  2013;37(4):547-555.
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.
PMCID: PMC3764350  PMID: 24020036
Neurogenic bowel; Spinal cord injuries; Abdominal radiography; Colon transit time
Neurourology and urodynamics  2015;35(8):1017-1023.
(1) To describe the prevalence of childhood and recent trauma in patients with overactive bladder (OAB), and (2) assess the impact of traumatic events on the clinical presentation and the severity of OAB symptoms, quality of life, and psychosocial health.
Patients diagnosed with OAB (n=51) and age-matched healthy controls (n=30) were administered the Childhood Traumatic Events Scale and Recent Traumatic Events Scale, assessing exposure and perceived impact of common traumatic events. Among OAB patients, validated instruments were administered to correlate traumatic exposure to evaluate adult urinary symptoms (ICIQ-UI, ICIQ-OAB, OAB-q, UDI-6, IIQ-7, USS), mood dysregulation (HADS), sleep and fatigue (PROMIS), and psychological stress (PSS).
Childhood sexual trauma was more prevalent in patients with OAB compared to controls (29.4% vs. 6.7%, p=0.041). OAB patients also rated their childhood sexual exposure as more traumatic compared to controls (mean ratings of 1.7 vs. 0.4, p=0.050). There was no difference in childhood deaths (p=0.24), parental upheaval (p=0.87), violence (p=0.099), illness/injury (p=0.683), or any recent traumatic events between OAB and control subjects.
Childhood trauma predicted worse bladder pain (p=0.005), worse non-urologic pain (p=0.017), poorer mood (p=0.001), higher anxiety (p=0.029), higher physical symptom burden (p<0.001), and higher psychological stress (p<0.039). However, childhood trauma did not correlate with the severity of OAB symptoms (urgency, frequency, incontinence).
30% of OAB patients reported childhood sexual trauma. These patients report more pain symptoms, poorer mood, and greater somatic burden. These data highlight the potentiating role of psychosocial stressors from childhood in the adult suffering from OAB.
PMCID: PMC4942378  PMID: 26332868
14.  Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER 
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.
PMCID: PMC4265241  PMID: 24898471
15.  The Influence of an Overactive Bladder on Falling: A Study of Females Aged 40 and Older in the Community 
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.
PMCID: PMC3070226  PMID: 21468286
Urinary bladder; Overactive; Urinary incontinence; Urge; Accidental falls
16.  Short-term Effects of a Systematized Bladder Training Program for Idiopathic Overactive Bladder: A Prospective Study 
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.
PMCID: PMC3627992  PMID: 23610706
Behavior modification; Overactive urinary bladder; Quality of life
17.  Enuresis and overactive bladder in children: what is the relationship between these two conditions? 
Evaluate clinical aspects associated with the presence of nocturnal enuresis (NE) in children with a diagnosis of overactive bladder (OAB).
Material and Methods:
A data base of 200 children who were evaluated by a structured questionnaire was analysed retrospectively . OAB was defined as the presence of urinary urgency (n=183 cases) and/or daytime urinary incontinence associated with holding maneuvers (n=168 cases). Inclusion criteria were a confirmed diagnosis of OAB, age 5-16 years, and no anatomical or neurological alterations of the urinary tract. Patients were divided into enuretics and non-enuretics. The two groups were compared with respect to sex, age, skin color, presence urinary infection, urgency, urge incontinence, non-urge incontinence, pollakiuria, urinary dysfunction, nocturia, holding maneuvers, number of episodes of enuresis and bowel alterations. In a univariate analysis, the chi-square test was used to compare proportions, with p-values <0.05 being considered significant. A multivariate analysis was conducted to identify independent predictive factors.
Enuresis was diagnosed in 141/200 children. The two groups were similar with respect to sex, age and skin color. No difference was found in relation to urinary infection, non-urge incontinence, urinary dysfunction, nocturia, encopresis or constipation. The two groups were significantly different with regard to some symptoms related to OAB such as urgency (p=0.001), urge incontinency (p=0.001) and holding maneuvers (p=0.033). Following multivariate analysis, only holding maneuvers (p=0.022) remained as an independent predictive factor.
The only independent predictive factor for resolution of enuresis in children with OAB, as detected in the multivariate analysis, was holding maneuvers.
PMCID: PMC5006778  PMID: 27564293
Urinary Bladder; Enuresis; Child; Urinary Incontinence
18.  The relationship between depression and overactive bladder/urinary incontinence symptoms in the clinical OAB population 
BMC Urology  2016;16:60.
To investigate the relationship between depression and overactive bladder (OAB)/urinary incontinence symptoms among the clinical OAB population.
Patients who were diagnosed with overactive bladder (OAB) and age-matched control subjects without OAB were enrolled. Depression symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS-D). OAB/incontinence symptoms were assessed using the validated questionnaires: ICIQ-UI, ICIQ-OAB, UDI-6, IIQ-7, and OAB-q.
27.5 % of OAB patients in our study had depression (HADS ≥8), and 12 % of OAB patients had moderate to severe depression (HADS-D ≥11). OAB patients reported significantly higher HADS-D depression scores compared to age-matched controls (5.3 ± 3.9 versus 2.8 ± 3.9, p = 0.004). OAB patients with depression reported more severe incontinence symptoms (ICIQ-UI), greater bother and more impact on quality of life (UDI-6, IIQ-7) compared to OAB patients without depression (p = 0.001, 0.01, <0.001, respectively). However there were no differences in ICIQ-OAB and OAB-q. Among OAB patients, there were positive correlations between the severity of depression symptoms and OAB/incontinence symptoms (p-values <0.001 to 0.035).
27.5 % of OAB patients have depression. OAB patients with depression reported more severe urinary incontinence symptoms, greater bother and more impact on quality of life compared to those without depression. Future studies are needed to further examine the mechanistic links between depression and OAB/urinary incontinence.
PMCID: PMC5053341  PMID: 27716241
Overactive bladder; Urinary incontinence; Urinary urgency; Depression; Psychosocial
19.  Fesoterodine for overactive bladder: A review of the literature 
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.
PMCID: PMC3969610  PMID: 24688149
overactive bladder; fesoterodine; muscarinic antagonists
20.  The overlap and distinction of self-reported symptoms between interstitial cystitis/bladder pain syndrome and overactive bladder: a questionnaire-based analysis 
The Journal of urology  2014;192(6):1679-1685.
To compare the self-reported symptoms between IC/BPS and OAB based on patient-reported symptoms on validated questionnaires.
Materials and Methods
Patients diagnosed with IC/BPS (n=26) or OAB (n=53), and healthy controls (n=30), were prospectively recruited to participate in a questionnaire-based study that inquired their lower urinary tract symptoms using the following questionnaires: 1) Genitourinary pain index, 2) Interstitial cystitis symptom index and problem index, 3) International consultation on incontinence – overactive bladder, 4) International consultation on incontinence – urinary incontinence short form (ICIQ-UI), 5) Urgency severity scale, 6) numeric rating scales (NRS) of the severity of their bladder “pain, pressure, or discomfort”, and 7) NRS of severity of their urgency and 8) frequency symptoms.
In univariate analyses, IC/BPS patients reported significantly more severe pain symptoms compared to OAB. OAB patients reported significantly more severe urinary incontinence symptoms compared to IC/BPS. There were no differences in the severity of frequency and urgency between IC/BPS and OAB. Surprisingly, 33% of OAB patients reported pain or discomfort when the bladder filled, while 46% of IC/BPS patients reported urgency incontinence. In multivariate analyses, the total scores on the ICIQ-UI Short Form (p=0.01) and the severity (NRS) of bladder pain (p<0.01) distinguished OAB from IC/BPS with a sensitivity of 90.6% and a specificity of 96.1% (OAB has higher ICIQ-UI and lower pain scores on NRS).
There is considerable overlap of self-reported symptoms between IC/BPS and OAB. This overlap raises the possibility that IC/BPS and OAB represent a continuum of a bladder hypersensitivity syndrome.
PMCID: PMC4419783  PMID: 24907443
21.  Bladder sensory desensitization decreases urinary urgency 
BMC Urology  2007;7:9.
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.
PMCID: PMC1903357  PMID: 17561998
22.  Psychometric properties of the incontinence utility index among patients with idiopathic overactive bladder: data from two multicenter, double-blind, randomized, Phase 3, placebo-controlled clinical trials 
Overactive bladder is a prevalent and burdensome condition. Generic utility measures may fail to reflect its full impact on patients’ health status. The Incontinence Utility Index (IUI) is a community-based preference index derived from the Incontinence Quality of Life Questionnaire (I-QOL) developed to value health states related to urinary symptoms in patients with neurogenic detrusor overactivity. This study assessed the measurement properties of the IUI in patients with idiopathic overactive bladder (OAB).
Data were used from two clinical trials which recruited patients with OAB whose symptoms were inadequately managed with ≥1 anticholinergic medication. Psychometric evaluation included: Differential Item Functioning (DIF) analysis, concordance between I-QOL and IUI (Intraclass correlation coefficient [ICC], criterion and convergent validity according to relevant patient reported outcomes and clinical variables (Spearman’s correlation coefficient, rho), responsiveness, and agreement between utility measures (ICC and Bland-Altman method).
A total of 1,105 idiopathic OAB patients were included. Mean age (range) was 60.4 years (18–90), 87.8 % (n = 970) were female. DIF was identified in 3 items, none of which are contained in the IUI. ICC (CI95 %) was 0.944 (0.936–0.950). Statistically significant differences (p < 0.001) were found in IUI scores for patients improving according to the Treatment Benefit Scale (TBS). Moderate to strong correlations (rho > |0.6|) were found in the expected direction with daily incontinence, urgency episodes and disease-specific domains of King’s Health Questionnaire (KHQ). Low to moderate correlations (rho:<|0.6|) were found with Short Form version 2 (SF-12v2) summary components. A large effect size was found for patients reporting improvement (0.98–1.21) or great improvement (1.87–2.56) in the TBS, as well as in patients responding to treatment (1.19–2.40). Across utility measures, directional trends were consistent with OAB symptom profile, however, a lack of agreement in absolute values was observed.
The IUI presents good psychometric properties for valuing the impact of UI-related problems in idiopathic OAB patients.
Trial registration NCT00910845 and NCT00910520.
PMCID: PMC4522067  PMID: 26231052
Overactive bladder; Urinary incontinence; Utility assessment; Health-related quality of life; I-QOL
23.  Urodynamic Detrusor Overactivity in Patients with Overactive Bladder Symptoms 
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.
PMCID: PMC3070227  PMID: 21468287
Overactive bladder; Urodynamic investigation; Urinary incontinence; Detrusor overactivity
24.  Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy 
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.
PMCID: PMC2680263  PMID: 18811599
25.  Effectiveness of Retropubic Tension-Free Vaginal Tape and Transobturator Inside-Out Tape Procedures in Women With Overactive Bladder and Stress Urinary Incontinence 
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.
PMCID: PMC3797895  PMID: 24143294
Overactive urinary bladder; Stress urinary incontinence

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