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PubMed2006

Efficacy, tolerability and safety of darifenacin, an M(3) selective receptor antagonist: an investigation of warning time in patients with OAB.

This double-blind, randomised placebo-controlled, multicentre study evaluated the efficacy, tolerability and safety of 12 weeks' treatment with controlled release darifenacin 15 mg once daily (qd), in 445 patients with overactive bladder (OAB). The primary endpoint was warning time (time from first sensation of urgency to voiding), and secondary endpoints included urge incontinence episodes and volume voided. Darifenacin treatment resulted in numerical increases in warning time, but these were not significant compared with placebo -- highlighting difficulties in assessing this parameter. Significant improvements were seen with darifenacin vs. placebo in urge incontinence episodes/week, volume voided and quality of life (QoL). Darifenacin was associated with increases in urgency-free time (UFT; time between any void to the next urgency event) vs. placebo. Treatment was well tolerated; the most commonly reported adverse events were the typical antimuscarinic effects of dry mouth and constipation, both infrequently leading to discontinuation. This study demonstrated the difficulty in measuring warning time, due in part to its subjective nature; the authors believe further investigation is warranted to allow urgency to be better defined. Further investigation of UFT is required to determine its role in evaluating urgency. The study confirmed that darifenacin 15 mg qd is an effective and well-tolerated treatment for OAB, which improves QoL.

Adult↗

PubMed2005

Questionnaire survey on female urinary frequency and incontinence.

BACKGROUND: Urinary incontinence is a well-known bothersome symptom in women, which may cause physical and psychological problems. We conducted a questionnaire survey on female urinary incontinence to investigate the disease's impact on the quality of life (QoL), the reasons women don't seek medical attention and the information they wished to obtain. PATIENTS AND METHODS: From March to October 2002, a member of the Professional Women's Coalition for Sexuality and Health distributed a questionnaire about urinary frequency and urinary incontinence to women who were attending the lectures hosted by the group. RESULTS: We analysed 262 questionnaires: 158 people belonged to the Stress Urinary Incontinence (SUI) Group, 36 to the Overactive Bladder (OAB) Group, 22 to the Urinary Frequency (UF) Group and 18 to the Normal Group. 'Going out' was most influenced in all three groups with symptoms in their daily life. Compared with the Normal or SUI Group, the QoL in those belonging to the OAB and UF Groups was more deteriorated. The medical institution check-up rate in the SUI Group was the lowest at 7.1%, bringing down the overall consultation rate to 13.5%. More than 70% of respondents who didn't have a check-up said that they did not think it was a problem serious enough to require consultation. CONCLUSIONS: Urinary incontinence and frequency impairs women's QoL. It is important to provide information on these diseases and to provide medical treatments that cater to the needs of individual patients.

Adult↗

PubMed2005

Effectiveness of an anti-inflammatory drug, loxoprofen, for patients with nocturia.

AIM: There is increasing evidence that non-steroidal anti-inflammatory drugs are effective for the treatment of nocturia. In this study, we attempted to investigate the role of loxoprofen sodium (loxoprofen) in the therapeutic management of patients with nocturia. METHODS: Fifteen benign protastatic hyperplasia and/or overactive bladder patients (13 males and 2 females, 71.1 +/- 1.5 years old) with three or more voids per night were involved. These patients had received standard drug therapy. Although these patients had received standard drug therapy for more than half a year, they had still three or more episodes of nocturia. The patients took a single dose of 60 mg of loxoprofen at night prior to sleep. Before and 1 week after the initiation of this therapy, the effects of this treatment were assessed by frequency volume chart and a questionnaire. RESULTS: In the questionnaire, seven patients answered as excellent, six patients demonstrated improvement of their symptoms, two patients did not show a significant change in their symptoms and no patients demonstrated a deterioration in the symptoms. In frequency volume chart, total void per day, total void per night, total urine volume per day, total night urine volume per day and single voided volume in the night before and after this treatment were 9.97 +/- 0.81 and 8.99 +/- 0.74 per day, 3.82 +/- 0.25 and 1.82 +/- 0.27 per night, 1349 +/- 81 and 1258 +/- 91 mL per day, 567 +/- 46 and 325 +/- 51 mL per night, and 143 +/- 13 and 149 +/- 10 mL, respectively. CONCLUSION: Loxoprofen can be effective and useful for patients with nocturia. Our data suggest that the main mechanism of this effect is to decrease urine production during a night's sleep.

Aged↗

PubMed2000

Mixed symptomatology.

Mixed symptomatology, i.e. both stress and urge incontinence, is reported by patients, either of their own accord or in response to a questionnaire. Our understanding of motor urge incontinence, detrusor instability, stress incontinence and sensory urge incontinence is changing. Detrusor instability is now known to be a urodynamic observation of uncertain clinical significance. Symptoms reported by patients are not equivalent to a urodynamic diagnosis but the problem seems to be more in the urodynamics than in the symptoms. Evidence shows that sensory urge incontinence and motor urge incontinence are probably gradations of the same condition. The relationship between stress incontinence and an overactive bladder is complex. For example, neither detrusor instability nor urge incontinence appear to adversely influence the outcome of surgical treatment for stress incontinence; however, this treatment does not have a good success rate. At present, it is not clear whether this poor outcome reflects a lack of efficacy of the operations used, or their application to inappropriate patients.

Female↗

PubMed2003

The prevalence of nocturia and its effect on health-related quality of life and sleep in a community sample in the USA.

OBJECTIVE: To evaluate the prevalence of nocturia and its effects, with and without concomitant overactive bladder (OAB, i.e. urgency, frequency, urge incontinence and nocturia), on health-related quality of life (HRQoL) and sleep. SUBJECTS AND METHODS: A national survey was conducted in the USA to assess the prevalence of OAB and nocturia. A nested case-control study was conducted among respondents with OAB symptoms and age- and gender-matched controls, with participants completing a series of questionnaires on HRQoL (OAB-q, Short Form-36, and Medical Outcomes Study (MOS) sleep scale). Descriptive analyses, t-tests, analysis of variance with post hoc comparisons and multivariate regressions were used to analyse the data. RESULTS: In all, 5204 people participated in the survey, with 919 in the nested case-control study. The sample population had a mean age of 45.8 years, was 52.6% female and 80% Caucasian. In the community sample, 31% reported > 1 void/night and 14.2% reported > 2 voids/night. The prevalence of nocturia increased with age, with no gender differences. For OAB cases, 66.8% reported > 1 void/night and 42.2% reported > 2. In the case-control cohort there were significant HRQoL differences (P < 0.01), with increasing episodes of nocturia in all OAB-q subscales except social interaction. The amount of sleep per night was significantly correlated with the sleep, concern and social interaction OABq subscale scores. The number of nocturia episodes/night was also significantly (P = 0.02) associated with the number of hours of sleep/night. CONCLUSION: Nocturia is widely prevalent and increases with age, affecting men and women equally. Incremental increases in the number of voids/night have further negative effects on sleep, symptom bother, and HRQoL.

Age Distribution↗

PubMed2005

A critical review of diagnostic criteria for evaluating patients with symptomatic stress urinary incontinence.

The first paper in this section is a review by several highly respected authors of diagnostic criteria for evaluating patients with symptomatic stress urinary incontinence, and is followed by a review of the role of urgency and its measurement in the overactive bladder symptom syndrome, with emphasis on current concepts and future prospects. These are two important papers, which point the reader in the direction of a greater understanding of these conditions. The concept of alpha-blockade before a trial without catheter after acute urinary retention is revisited by authors from the UK, who used tamsulosin in a randomized controlled trial. They found that it is appropriate to recommend tamsulosin for such use in this condition.

Female↗

PubMed2005

An investigation of dose titration with darifenacin, an M3-selective receptor antagonist.

OBJECTIVES: To evaluate the efficacy, tolerability and safety of a flexible-dosing strategy with darifenacin, an M(3)-selective receptor antagonist, in patients with symptoms of overactive bladder (OAB). PATIENTS AND METHODS: In this multicentre double-blind 12-week study, 395 patients (aged 22-89 years; 84% female) with OAB symptoms for >6 months were randomized (2 : 1) and received once-daily treatment with darifenacin controlled-release tablets 7.5 mg (268 patients) or matching placebo (127). After 2 weeks of treatment, the efficacy, safety and tolerability were assessed and the dose increased to 15 mg once daily (pseudo-increase for placebo recipients) if additional efficacy was required by both the patient and physician. In the week before clinic visits (at 2 and 12 weeks), patients recorded incontinence episodes (primary efficacy endpoint) and several secondary efficacy variables in an electronic daily diary. Safety and tolerability were evaluated from withdrawal rates and adverse-event reports. RESULTS: The treatment groups had comparable baseline characteristics. Similar proportions of darifenacin (59%) and placebo (68%) recipients increased the dose at 2 weeks; at 12 weeks patients on darifenacin (overall group) had a significantly greater reduction in the median number of incontinence episodes per week than had those on placebo, at - 8.2 (-62.9%) and - 6.0 (-48.1%), respectively (P = 0.035). There were also significant improvements in voiding frequency (P = 0.001), bladder capacity (volume voided; P = 0.036), frequency of urgency (P < 0.001), severity of urgency (P = 0.013) and number of significant leaks/week (i.e. incontinence episodes needing a change of clothing or pads, per week; P = 0.010) for darifenacin over placebo. Subset analysis suggested that some patients (those remaining on darifenacin 7.5 mg) were more sensitive to darifenacin than those who increased the dose, based on both efficacy and adverse events. Continued treatment with 7.5 mg for 'sensitive' patients, and an increased dose (to 15 mg) for remaining patients, resulted in comparable outcomes by 12 weeks. The most common treatment-related adverse events were mild-to-moderate dry mouth and constipation, which led to discontinuation in < 3.0% of darifenacin-treated patients and < 1.0% of the placebo group. Central nervous system and cardiovascular adverse events were comparable to those with placebo. CONCLUSIONS: Darifenacin appears to be an effective, well-tolerated and flexible treatment for patients with OAB, allowing individualized dosing according to patient needs.

Adult↗

PubMed2005

Validation of the urgency perception scale.

OBJECTIVE: To ascertain the validity and responsiveness of the Urgency Perception Scale (UPS) as an indicator of perceived urinary urgency. PATIENTS AND METHODS: The UPS was developed to assess perceived urinary urgency in clinical studies evaluating the efficacy of the antimuscarinic drug, tolterodine, for treating the overactive bladder (OAB) syndrome. Secondary analyses of clinical and patient assessment data from three clinical studies of tolterodine were conducted to evaluate the UPS. Construct validity was assessed by correlations between the UPS and patient voiding diary variables and other patient assessments, including: perception of bladder condition; perception of treatment benefit; the Medical Outcomes Study Short-Form 36 health survey; the King's Health Questionnaire; the OAB Questionnaire; and the Overall Treatment Effect scale. RESULTS: The UPS correlated well with the patients' perception of bladder condition (correlation coefficients - 0.29 to - 0.46; all P < 0.001) and with the voiding diary variables, especially incontinence episodes (-0.30 to - 0.41) and pad usage (-0.25 to - 0.38; all P < 0.001). An improvement in UPS score at the end of treatment was consistently reflected by significant improvements among all voiding variables. CONCLUSION: Urinary urgency is a central symptom of OAB and is particularly bothersome because of its unpredictability and consequent impact on daily life. The UPS is a valid scale by which urinary urgency can be assessed subjectively, and provides a useful tool for research into urinary urgency.

Aged↗

PubMed2005

Towards a better understanding of involuntary detrusor activity.

UNLABELLED: There is a wide spectrum of topics covered in this section. The ever-present problem of nocturia is further explored by authors from Sweden, with interesting conclusions. In addition, several papers describe various issues relating to the surgical correction of stress urinary incontinence. Finally, authors from Switzerland describe their use of sacral magnetic stimulation in non-inflammatory chronic pelvic pain syndrome. OBJECTIVES: To compare the measured variables of involuntary detrusor activity (IDA) during ambulatory cystometry (AC) in women with and with no overactive bladder symptoms, and to evaluate the correlation between these variables and symptom severity. PATIENTS AND METHODS: In all, 61 symptomatic and 39 asymptomatic women completed the Bristol Female Lower Urinary Tract Symptoms Questionnaire (BFLUTS-Q) and underwent AC. Measured variables of IDA (amplitude, duration, bladder volume and symptoms) were compared in the two cohorts. RESULTS: IDA was detected in 47 of 61 symptomatic women (77%) and in 17 of 36 (47%) controls (P < or = 0.01). The maximum IDA (defined as the highest amplitude contraction in any fill-void cycle) occurred at significantly lower volumes (328 vs 450 mL, P < or = 0.05), was of higher amplitude (26 vs 12 cm H(2)O, P = 0.14) and longer duration (83 vs 14 s, P < or = 0.05) in symptomatic women than in controls. There was coincident incontinence in 22 (36%) symptomatic women and no controls (P < or = 0.01). Discriminatory levels for clinically relevant IDA were established, and when applied retrospectively, classified 35 of 61 symptomatic women (55%) and one control (3%) as having such IDA. The correlation between symptom severity (measured by the BFLUTS-Q) and urodynamics was higher when these criteria were applied (r = 0.52 vs 0.38, P < or = 0.01). CONCLUSION: There are quantifiable differences between IDA found during AC in symptomatic and asymptomatic women. The measured variables of IDA may be useful to determine its clinical relevance, which may be indicated by contractions associated with leakage or contractions of >30 s occurring at bladder volumes of <300 mL.

Adult↗

PubMed2005

Nocturnal enuresis at 7.5 years old: prevalence and analysis of clinical signs.

OBJECTIVE: To determine the prevalence of nocturnal enuresis (NE) in a large cohort of children at 7.5 years old, and to examine the frequency of variables such as gender, severity, associated elimination problems, and clinical signs within the identified group. SUBJECTS AND METHODS: Of an original cohort of 13 971 infants alive at 12 months, 11 251 who were still active in the Avon Longitudinal Study of Parents and Children (ALSPAC) survey, were followed at 91 months. The mother or main carer was given a questionnaire which asked, amongst other items, about the presence and frequency of bedwetting, other elimination problems, and signs related to the wetting behaviour; 8269 (73.5%) questionnaires were returned and 8151 contained information on the frequency of bedwetting. RESULTS: In all, 1260 children (15.5%) at 7.5 years wet the bed, but most wet once or less a week, and only 215 (2.6%) met the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) criteria of NE (wetting at least twice a week). A higher prevalence was reported in boys than girls and 266 children (3.3%) had both daytime wetting and bedwetting, with 189 (2.3%) having both daytime soiling and bedwetting. Daytime urgency increased with severity of bedwetting and occurred in 28.9% of children with NE. CONCLUSION: At 7.5 years old the incidence of bedwetting is high, but only 2.6% of this large population-based sample wet at a frequency meeting the definition of NE. Although a small percentage of children had both daytime wetting and bedwetting, the evidence suggests that these are discrete problems. Amongst children with NE, indicators of bladder overactivity were present, supporting the view of heterogeneity and the importance of individual assessment in deciding on appropriate treatment.

Chi-Square Distribution↗

PubMed2005

Role of muscarinic receptor antagonists in urgency and nocturia.

The overactive bladder (OAB) syndrome is defined as urgency, with or without urgency incontinence, usually accompanied by frequency and nocturia. Muscarinic receptor antagonists are the most established form of treatment for OAB, but until recently their effectiveness was only confirmed for symptoms of incontinence and frequency. In recent studies, selected muscarinic antagonists, including darifenacin, solifenacin, tolterodine and trospium, significantly reduced the number of urgency episodes per day relative to placebo. While some data raise the possibility that certain of these agents may be more effective than others in this regard, this variability in their effect on urgency needs to be confirmed in future studies. Moreover, it remains to be determined whether counting the number of urgency episodes or assessing the subjective intensity of the sensation of urgency more adequately reflects patient needs and therapeutic efficacy. For nocturia, muscarinic receptor antagonists have only inconsistently shown statistically greater effects than placebo. This inconsistency may relate to the multifactorial nature of nocturia, which even in patients with OAB can have many causes, not all of which may respond/be sensitive to muscarinic receptor antagonism.

Age Factors↗

PubMed2005

Nocturia in relation to sleep, health, and medical treatment in the elderly.

Nocturia is a common condition in the elderly that profoundly influences general health and quality of life. It appears to predict a higher risk of death. One consequence of nocturia is sleep deterioration, with increased daytime sleepiness and loss of energy and activity. Accidents, e.g. falls, are increased both at night and during the day in elderly persons with nocturia. Nocturia is caused by nocturnal polyuria, reduced voided volumes, or a combination of the two. Nocturnal polyuria can be caused by numerous diseases, e.g. diabetes insipidus, diabetes mellitus, congestive heart failure, and sleep apnoea. A disorder of the vasopressin system, with very low or undetectable vasopressin levels at night, is manifested as an increased nocturnal urine output, which in the most extreme cases reaches 85% of the 24-h diuresis: the prevalence of low or undetectable vasopressin levels at night has been estimated to be 3-4% in those aged >or= 65 years. Treatment of nocturia may include avoiding excessive fluid intake and use of diuretic medication in the afternoon rather than the morning, oral desmopressin at bedtime in cases of nocturnal polyuria, and antimuscarinic agents in the case of overactive bladder or impaired storage capacity of the bladder.

Age Factors↗

PubMed2006

Short- and long-term efficacy of solifenacin treatment in patients with symptoms of mixed urinary incontinence.

OBJECTIVE: To evaluate urinary symptom relief in women with mixed urinary incontinence (MUI) treated for up to 52 weeks with solifenacin succinate for overactive bladder (OAB), as MUI is a complex and distressing condition reported by about a third of incontinent women, and with confirmed efficacy in OAB-related urge incontinence, anticholinergic agents are a reasonable therapeutic option for such women. PATIENTS AND METHODS: Patients with OAB (mean of > or = 8 voids/24 h, plus > or = 1 incontinence episode or > or = 1 urgency episode/24 h) were pooled from four studies. A subgroup of 1041 patients reporting MUI at baseline were evaluated over 12 weeks in a double-blind, placebo-controlled study, and up to a further 40 weeks in 433 in an open-label solifenacin treatment (5 mg and 10 mg). Voiding frequency, episodes of incontinence and urgency, and volume voided per void, were collected from voiding diaries completed during the 3 days before each study visit. RESULTS: Patients with a history of MUI treated with solifenacin for up to 12 weeks had statistically significant reductions in voiding frequency and episodes of incontinence and urgency vs placebo. In all, 43% and 49% (at 5 mg and 10 mg, respectively) of patients with a history of MUI regained continence after 12 weeks, vs 33% with placebo. Among patients in the open-label study with mixed symptoms, 52% reported regaining continence, and 34% reported resolution of symptomatic urgency based on diary reporting at study end. Sustained improvements in quality of life and high satisfaction ratings accompanied symptom improvements. CONCLUSIONS: Significant reductions in OAB-related frequency, incontinence and urgency were reported after 12 weeks of solifenacin treatment in patients with a history of MUI. Symptom improvement in this subgroup was maintained during long-term treatment. These findings support the therapeutic potential of solifenacin for treating symptoms of MUI and the need to re-evaluate classically defined MUI.

Adolescent↗

PubMed2006

Bothersome lower urinary tract symptoms 1 year after first delivery: prevalence and the effect of childbirth.

OBJECTIVE: To assess the severity of both stress urinary incontinence (SUI) and overactive bladder (OAB) symptoms during and after the first pregnancy, using a self-reported health-related quality-of-life questionnaire, and to assess the effect of pregnancy and childbirth on bothersome lower urinary tract symptoms (LUTS) persisting at 1 year after the first childbirth. PATIENTS AND METHODS: In a prospective cohort study, 344 women completed four self-reported questionnaires. Urogenital symptoms were assessed with the Urogenital Distress Inventory (UDI), assessing if a urogenital symptom is present and the amount of bother it causes, measured on a 4-point Likert scale, i.e. 'not at all', 'slightly', 'moderately' and 'greatly bothered'. Bothersome LUTS were defined as reporting moderate or great bother from the symptom, and as not bothersome if it was absent or present with none or only a slight degree of self-reported bother. In the analysis we used three of the five subscales from the UDI; UI, OAB and obstructive voiding, where each subscale has a range of 0 (no symptom) to 100 (all symptoms present with the highest degree of bother). RESULTS: Of the 344 women, 83 (24.2%) reported having a moderate to greatly bothersome frequency symptom at 36 weeks of gestation. After childbirth there was a statistically significant decline in the prevalence of bothersome frequency to 38 (9.6%) women (P < 0.001). Bothersome SUI was present in 53 (15.4%) women at 36 weeks of gestation, and in 36 (10.5%) at 1 year after childbirth. Fifty-eight (16.9%) women reported having moderate to greatly bothersome urge UI (UUI) and at 1 year after childbirth, 51 (14.8%) were still bothered by it. After univariate and multivariate analysis, the predictive factors for the presence of bothersome SUI were greater maternal age (32.5 vs 30.3 years old at delivery) and the presence of bothersome SUI at 12 weeks of gestation. Bothersome UUI was significantly associated with a lower educational level (odds ratio 0.08, 95% confidence interval 0.02-0.36). Women after a Caesarean delivery had more bothersome UUI and women after a spontaneous vaginal delivery developed more bothersome SUI (neither statistically significant, possibly because there were too few samples). During pregnancy, all UDI subscale scores increased significantly and after childbirth all scores decreased significantly vs 36 weeks of gestation. However, the score on the UI subscale remained significantly higher at 1 year after birth than at 12 weeks of gestation, whereas the scores on the OAB and obstructive voiding subscales were lower at 1 year after birth than at 12 weeks of gestation. Nevertheless, the scores for UI and obstructive voiding were low, indicating little bother. CONCLUSION: Most women are not bothered by their LUTS after their first delivery. As the prevalence of bothersome symptoms was highest at 36 weeks of gestation, they are probably part of a normal pregnancy. However, OAB symptoms can be perceived as bothersome. Physiotherapy and bladder training can be offered to women with bothersome LUTS. Bothersome SUI in early pregnancy and a greater maternal age were predictive of bothersome SUI at 1 year after first childbirth. A Caesarean delivery seemed to be protective for bothersome SUI at 1 year after birth, but bothersome UUI was more prevalent after a Caesarean than a vaginal delivery. More research with a larger sample is needed to allow definite statements about the effect of the mode of delivery and bothersome UI symptoms.

Adult↗

PubMed2004

A randomised controlled trial comparing abdominal and vaginal prolapse surgery: effects on urogenital function.

OBJECTIVE: To compare the effects of vaginal hysterectomy (combined with anterior and/or posterior colporraphy) and abdominal sacro-colpopexy (with preservation of the uterus) on urogenital function. DESIGN: Randomised trial. SETTING: Three teaching hospitals in The Netherlands. POPULATION: Eighty-two patients undergoing surgical correction of uterine prolapse stages II-IV. METHODS: Participating patients completed the urogenital distress inventory (UDI), before and at six weeks, six months and one year after surgery, to measure discomfort of prolapse and micturition symptoms. Domain scores of the UDI (ranging from 0 to 100, higher scores indicating more discomfort) were compared between groups at all time points. Findings at pelvic examination, number of doctor visits within the first year after surgery because of pelvic floor symptoms and performed or planned surgery of recurrent genital prolapse were also compared. MAIN OUTCOME MEASURE: Domain scores of the UDI at one year after surgery. RESULTS: At one year after surgery, scores on the discomfort/pain domain (mean difference 7.1, 95% confidence interval [CI] 1.1-13.2), overactive bladder domain (mean difference 8.7, 95% CI 0.5-16.9) and obstructive micturition domain (mean difference 10.3, 95% CI 0.6-20.1) of the UDI were significantly higher in the abdominal group than in the vaginal group. Findings at pelvic examination were similar in both groups. Doctor visits because of pelvic floor symptoms were more frequent in the abdominal group than in the vaginal group. Re-operation was performed or planned in 9 of the 41 patients who underwent abdominal surgery and in 1 of the 41 patients who underwent vaginal surgery (odds ratio [OR] = 11.2, 95% CI 1.4-90.0). CONCLUSIONS: Our findings suggest that vaginal hysterectomy with anterior and/or posterior colporraphy is preferable to abdominal sacro-colpopexy with preservation of the uterus as surgical correction in patients with uterine prolapse stages II-IV.

Colpotomy↗

PubMed2004

How much is enough and who says so?

BACKGROUND: One of the challenges of health-related quality of life research is to translate statistically significant health-related quality of life changes into interpretable clinical or medically important ones. OBJECTIVE: To calculate the minimal important difference of the King's Health Questionnaire, a condition-specific health-related quality of life questionnaire for the assessment of men and women with lower urinary tract dysfunction. METHODS: The King's Health Questionnaire was administered to patients suffering from overactive bladder enrolled in two multinational studies. Minimal important differences were calculated using an anchor-based approach with both a global rating of patient-perceived treatment benefit and one of perceived disease impact. A distribution-based method using effect size was calculated for comparison purposes. RESULTS: Minimal important difference values varied slightly with each method. Using the anchor-based approach, the King's Health Questionnaire minimal important difference ranged between 5-10 points when the calculation factored out patients who reported no change and 6-12 points for patients who experienced a small improvement. The effect size method indicated a minimal important difference of 5 to 6 points for a small effect and 10 to 15 points for a medium effect. CONCLUSIONS: In the case of the King's Health Questionnaire, the anchor-based approaches and the distribution-based approach provide similar results. A change from baseline of at least 5 points on King's Health Questionnaire domains indicates a change that is meaningful to patients and is indicative of a clinically meaningful improvement in health-related quality of life after treatment. Convergence of the estimates using different approaches should give us confidence in the values derived for the quality of life domains measured by the King's Health Questionnaire.

Female↗

PubMed2006

Muscarinic receptor subtypes in neuronal and non-neuronal cholinergic function.

1 Muscarinic M1-M5 receptors mediate the metabotropic actions of acetylcholine in the nervous system. A growing body of data indicate they also mediate autocrine functions of the molecule. The availability of novel and selective muscarinic agonists and antagonists, as well as in vivo gene disruption techniques, has clarified the roles of muscarinic receptors in mediating both functions of acetylcholine. 2 Selective M1 agonists or mixed M1 agonists/M2 antagonists may provide an approach to the treatment of cognitive disorders, while M3 antagonism, or mixed M2/M3 antagonists, are approved for the treatment of contractility disorders including overactive bladder and chronic obstructive pulmonary disease. Preclinical data suggest that selective agonism of the M4 receptor will provide novel anti-nociceptive agents, while therapeutics-based upon agonism or antagonism of the muscarinic M5 receptor have yet to be reported. 3 The autocrine functions of muscarinic receptors broadly fall into two areas - control of cell growth or proliferation and mediation of the release of chemical mediators from epithelial cells, ultimately causing muscle relaxation. The former particularly are involved in embryological development, oncogenesis, keratinocyte function and immune responsiveness. The latter regulate contractility of smooth muscle in the vasculature, airways and urinary bladder. 4 Most attention has focused on muscarinic M1 or M3 receptors which mediate lymphocyte immunoresponsiveness, cell migration and release of smooth muscle relaxant factors. Muscarinic M4 receptors are implicated in the regulation of keratinocyte adhesion and M2 receptors in stem cell proliferation and development. Little data are available concerning the M5 receptor, partly due to the difficulties in defining the subtype pharmacologically. 5 The autocrine functions of acetylcholine, like those in the nervous system, involve activation of several muscarinic receptor subtypes. Consequently, the role of these subtypes in autocrine, as well neuronal cholinergic systems, significantly expands their importance in physiology and pathophysiology.

Acetylcholine↗

PubMedDate not supplied

The validation of patient-rated global assessments of treatment benefit, satisfaction, and willingness to continue--the BSW.

OBJECTIVE: This study evaluated the validity of three single-item, patient-rated, interviewer-administered, global assessments of treatment benefit, satisfaction with treatment and willingness to continue treatment, collectively referred to as the BSW. METHODS: The BSW, micturition diaries, the Overactive Bladder Questionnaire (OAB-q) and the King's Health Questionnaire (KHQ) were included in part or in total in three OAB clinical trials. Discriminant validity for full and dichotomized responses was assessed with anovas models and correlations were used to evaluate construct validity. RESULTS: The BSW demonstrated significant differences among the majority of the response levels on all measures of micturitions in all studies. The BSW also demonstrated discriminant validity with the OAB-q and the KHQ. BSW measures demonstrated significant differences among the change scores for all subscales of the OAB-q and the majority of the KHQ domains with both full and dichotomized responses. Patients who were dissatisfied with treatment and those unwilling to continue treatment also reported significantly worse OAB-q and KHQ scores compared with those who were satisfied with treatment or willing to continue treatment. BSW measures were moderately correlated with the micturition variables, moderate to strongly correlated with the OAB-q and weak to moderately with the KHQ, providing support for the construct validity of the BSW measures. CONCLUSIONS: The BSW is a useful tool to capture patients' global impressions of three key elements of treatment outcome: a perceived benefit, satisfaction with treatment, and the willingness to continue treatment, and can facilitate patient-physician communication as well as be informative to researchers.

Aged↗