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PubMed2004

Cost-effectiveness analysis of extended-release formulations of oxybutynin and tolterodine for the management of urge incontinence.

INTRODUCTION: Oxybutynin and tolterodine are two drugs widely used for the management of overactive bladder and urge urinary incontinence. The once-daily, extended-release formulations benefit from being well tolerated and efficacious. However, their costs, compared with generic immediate-release (IR) oxybutynin, are significantly greater. This study compared the cost effectiveness of oxybutynin extended-release (Oxy-XL), tolterodine extended-release (Tol-ER), tolterodine immediate-release (Tol-IR) and oxybutynin immediate-release (Oxy-IR). STUDY DESIGN: A cost-effectiveness model. METHODS: A systematic review that identified appropriate randomised clinical trials provided evidence on efficacy. Empirical models of drug effects (number of incontinent-free weeks) and persistence (proportion of patients still on therapy) were constructed in order to determine clinical effectiveness which was combined with cost data (direct medical costs to the UK NHS, year 2001 values) to calculate the drugs' cost-effectiveness from the perspective of the NHS. Univariate sensitivity analyses were conducted to test the robustness of the results. PATIENTS: Hypothetical cohort of patients with urge incontinence associated with overactive bladder. MAIN OUTCOME MEASURES AND RESULTS: The incremental cost per incontinent-free week for Oxy-IR (versus no treatment) ranged from pound sterling 2.58 to pound sterling 16.59. Oxy-XL and Tol-ER were more effective than Oxy-IR but at additional costs per incontinent-free week. Tol-IR did not appear to be a cost-effective option as it was less effective and more costly than the extended-release formulations. Uncertainty surrounding the health and cost consequences of early discontinuation affected these results, although the model results were robust to parameter uncertainty. CONCLUSION: Oxy-IR, Oxy-XL and Tol-ER appear to be cost-effective options for the management of urge incontinence from the NHS perspective. A decision among the treatments depends on the acceptable cost per additional incontinent-free week.

Adult↗
PubMed2006

Management of incontinence for family practice physicians.

Family practice physicians are likely to encounter urinary incontinence and overactive bladder (OAB) in their patients. An informed family practice physician can generally accurately diagnose the cause and type of incontinence in patients with a properly focused physical examination and, if necessary, auxiliary testing. Accurate diagnosis can lead to effective treatment when physicians are familiar with available treatment options, including pharmacologic, surgical, behavioral therapies, and catheterization.

Family Practice↗
PubMed2005

Epidemiology of prolapse and incontinence questionnaire: validation of a new epidemiologic survey.

The epidemiology of prolapse and incontinence questionnaire (EPIQ) was developed to screen for female pelvic floor disorders (PFD). Content and face validity, reliability, internal consistency and criterion validity of the EPIQ to detect the presence of pelvic organ prolapse (POP), stress urinary incontinence (SUI), overactive bladder (OAB) and anal incontinence (AI) is presented. Cronbach's alpha; Spearman's, kappa, intraclass correlations, factor analysis and Chi-Squared tests were used for analysis. Questions related to PFD proved internally consistent (alpha = 0.91) and reproducible (correlations >0.70) for all but three items on the EPIQ. Positive and negative predictive values of the EPIQ to detect PFD were: POP = 76% and 97%, SUI = 88% and 87%, OAB = 77% and 90% and AI = 61% and 91% respectively. EPIQ is a psychometrically validated screening instrument that may identify women at high risk of having pelvic floor disorders in large undiagnosed populations.

Adult↗
PubMed2004

In vitro and in vivo characterization of a novel naphthylamide ATP-sensitive K+ channel opener, A-151892.

1. Openers of ATP-sensitive K(+) channels are of interest in several therapeutic indications including overactive bladder and other lower urinary tract disorders. This study reports on the in vitro and in vivo characterization of a structurally novel naphthylamide N-[2-(2,2,2-trifluoro-1-hydroxy-1-trifluoromethyl-ethyl)-naphthalen-1-yl]-acetamide (A-151892), as an opener of the ATP-sensitive potassium channels. 2. A-151892 was found to be a potent and efficacious potassium channel opener (KCO) as assessed by glibenclamide-sensitive whole-cell current and fluorescence-based membrane potential responses (-log EC(50)=7.63) in guinea-pig bladder smooth muscle cells. 3. Evidence for direct interaction with KCO binding sites was derived from displacement of binding of the 1,4-dihydropyridine opener [(125)I]A-312110. A-151892 displaced [(125)I]A-312110 binding to bladder membranes with a -log Ki value of 7.45, but lacked affinity against over 70 neurotransmitter receptor and ion channel binding sites. 4. In pig bladder strips, A-151892 suppressed phasic, carbachol-evoked and electrical field stimulus-evoked contractility in a glibenclamide-reversible manner with -log IC(50) values of 8.07, 7.33 and 7.02 respectively, comparable to that of the potencies of the prototypical cyanoguanidine KCO, P1075. The potencies to suppress contractions in thoracic aorta (-log IC(50)=7.81) and portal vein (-log IC(50)=7.98) were not substantially different from those observed for suppression of phasic contractility of the bladder smooth muscle. 5. In vivo, A-151892 was found to potently suppress unstable bladder contractions in obstructed models of unstable contractions in both pigs and rats with pED(35%) values of 8.05 and 7.43, respectively. 6. These results demonstrate that naphthylamide analogs exemplified by A-151892 are novel K(ATP) channel openers and may serve as chemotypes to exploit additional analogs with potential for the treatment of overactive bladder and lower urinary tract symptoms.

Acetamides↗
PubMed2003

Prevalence and correlations of anal incontinence and constipation in Taiwanese women.

Anal incontinence and constipation are not only physically and psychologically disabling symptoms but also a significant social and public health problem. The epidemiology of anal incontinence and constipation from community-bases remains largely unknown, especially in Asian women. This study is a continuation of a previous survey taken on the epidemiology of urinary incontinence and overactive bladder in Taiwanese women by using a second questionnaire (correlation coefficient for symptoms, r=0.87; P<0.05). We evaluated the prevalence and potential risk factors associated with anal incontinence and constipation in the general population. Of the 1,584 (2.92%) women sampled, 1,253 (79.1%) were successfully interviewed at home. The prevalence of fecal incontinence and flatus incontinence was 35 (2.8%) and 107 (8.6%), respectively. There were 306 (24.5%) participants who reported constipation. However, according to the current medical criteria for constipation, the prevalence of constipation was only 2.7%. The prevalence of anal incontinence did not increase after the age of 65 years (9.7%, including 3.5% of elderly women with fecal incontinence and 6.2% of elderly women with flatus incontinence). The prevalence of constipation significantly increased in the women aged 65 years and over (self-reported prevalence: 32.4%, fitted in medical criteria for constipation: 8.3%). Our results demonstrated that constipation shares some of the same risk factors, namely, symptoms of uterovaginal prolapse, prior gynecologic surgery, and overactive bladder that predispose women to the occurrence of anal incontinence. The questionnaire needs a higher discriminatory capacity, and a longitudinal study should be conducted to clarify this conflict further.

Activities of Daily Living↗
PubMed2005

Phosphodiesterase inhibitors in female sexual dysfunction.

Based on the increasing knowledge on both the physiology of penile erection and the pathophysiology of erectile dysfunction, selective phosphodiesterase (PDE) inhibitors have been successfully introduced in the oral treatment of male erectile dysfunction. Because of their central role in smooth muscle tone regulation, PDEs remain an attractive target for drug development in urology. Since the distribution and functional significance of PDE isoenzymes vary in different tissues, selective inhibitors of the isoenzymes have the potential to exert at least partially specific effects on the target tissue. Currently, PDE inhibitors are under investigation with potential uses in urinary stone disease, overactive bladder and the so-called benign prostatic syndrome. The convincing clinical data on the use of the orally active PDE5 inhibitors sildenafil (VIAGRA), vardenafil (LEVITRA) and tadalafil (CIALIS) in the treatment of erectile dysfunction are accompanied by boosting research activities on intracellular signal transduction and PDE characterisation in female genital tissues with the aid of immunohistochemistry and immunocytochemistry and molecular biology. The expression of various PDE isoforms in the human clitoris, vagina and labia minora was shown by means of immunohistochemistry and RT-PCR analyses and it was concluded from functional studies that an increase in cGMP or cAMP might be involved in the regulation of female genital blood flow and the control of genital non-vascular smooth muscle. As a consequence, the efficacy and safety of the PDE5 inhibitor sildenafil in the treatment of symptoms of female sexual dysfunction (FSD), including female sexual arousal disorders (FSAD), have been evaluated. Although the experiences from these early clinical studies have so far not been conclusive, they suggest that, after appropriate evaluation of patients, inhibition of PDE5 might be of benefit for selected individuals with FSAD. Such research efforts will possibly allow the identification of efficacious and diagnostic tools for erectile dysfunction and of even more selective drugs in its therapy.

Female↗
PubMed2005

Newer pharmacologic options in management of overactive bladder syndrome.

PURPOSE OF REVIEW: Urinary incontinence is an under-reported epidemic that currently affects an estimated 13 million people in the United States, of whom about 11 million are women, according to the National Institute of Diabetes and Digestive and Kidney Diseases (Publication No. 02-4132). Because many patients are unaware of curative options and perceive it to be an inevitable outcome of advancing age, they fail to report their symptoms and increase their risk of developing associated co-morbid disease. Failure to diagnose and treat this condition increases financial burdens on individuals, their families and health care organizations. RECENT FINDINGS: Pharmacologic therapy of urge incontinence previously had limited treatment success because efficacious drugs were poorly tolerated, resulting in low patient compliance. Tolerance and effectiveness continue to be improved due to innovative new drugs and alternative delivery systems. SUMMARY: The goal of this review is to update the clinician on the efficacy and the tolerability of established and investigational pharmacologic modalities of therapy.

Animals↗
PubMed2005

Overactive bladder in women: symptom impact and treatment expectations.

OBJECTIVE: The objectives of this survey were to understand (1) the effects of overactive bladder (OAB) and urinary incontinence (UI) on women's lives and to understand (2) women's needs and expectations of health care providers and treatment related to these disorders. METHODS: Women (N = 1046) with self-reported symptoms of UI completed a survey via electronic mail about the impact of urinary symptoms, health care provider interactions, treatment practices and expectations, and co-morbid conditions. RESULTS: The majority of women rated urinary symptoms such as frequency (61%), urgency (80%), nocturia (72%), and UI (69%-88% by type of incontinence) as moderately or extremely bothersome. Over half of women with UI (55%) had not sought medical treatment, but instead used a variety of non-medical coping mechanisms for symptom management. More than one third of women (37%) would prefer that their health care provider initiate discussion about urinary symptoms. Approximately half of the women with UI in this survey desired a greater than 70% reduction in incontinence episodes in order to consider treatment effective. CONCLUSION: Women are making an effort to cope with disruptive symptoms of OAB. However, a communication gap between health care providers and patients with urinary symptoms may be a barrier to appropriate medical therapy. Health care providers should routinely query patients about urinary symptoms. In addition to choosing a medical treatment that can produce a meaningful reduction in symptoms, health care providers should set expectations for patients and monitor patient satisfaction with the prescribed treatment regimen.

Adult↗
PubMed2005

Trospium chloride: an anticholinergic quaternary ammonium compound for the treatment of overactive bladder.

The International Continence Society has defined overactive bladder (OAB) as urinary urgency, with or without urge urinary incontinence, usually with urinary frequency and nocturia. Approximately 17% of men and women in the US report OAB symptoms, which can affect quality of life. Trospium chloride, which has recently been introduced in the US as Sanctura, has been prescribed for > 10 years in Europe as, for example, Spasmo-lyt, Regurin and Spasmex. Trospium chloride has been shown to be effective in relieving OAB symptoms, and has a favourable safety profile, showing < 1% difference for all adverse events compared with placebo, except for dry mouth, constipation and headache. Metabolic drug-drug interactions are unlikely, given that trospium chloride is not metabolised by cytochrome P450 isozymes. The fast-acting efficacy of trospium chloride, coupled with its good safety profile and tolerability, make it an important new option for treatment of OAB.

Benzilates↗
PubMed2005

Solifenacin in overactive bladder syndrome.

Solifenacin is a bladder-selective, muscarinic (M(1) and M(3)) receptor antagonist. In animal studies, the selectivity of solifenacin for the bladder over the salivary glands was greater than that of tolterodine, oxybutynin, darifenacin or atropine. In large, 12-week, randomised, double-blind, multicentre clinical trials, solifenacin 5 and 10mg once daily improved symptoms of overactive bladder syndrome (OAB) [urinary urgency, frequency, incontinence and nocturia] and increased functional bladder capacity to a significantly greater extent than placebo. Solifenacin 5 or 10mg once daily was noninferior to tolterodine extended release (ER) 4mg daily for improving urinary frequency and had significantly greater efficacy than tolterodine ER for improving other symptoms of OAB (episodes of urgency, incontinence and urge incontinence) and increasing functional bladder capacity. At least half of all patients receiving solifenacin who were incontinent at baseline were continent by study end in the three comparative studies reporting this parameter. Health-related quality of life was significantly improved with once-daily solifenacin 5 or 10mg versus placebo, as assessed in two 12-week double-blind studies; the improvement was maintained during a 40-week extension study. Solifenacin was generally well tolerated; the most frequently reported adverse events were dry mouth, constipation and blurred vision.

Humans↗
PubMed2006

Botulinum toxin: a potential alternative to current treatment of neurogenic and idiopathic urinary incontinence due to detrusor overactivity.

OBJECTIVE: To analyze and report the current data on the treatment of both neurogenic and idiopathic detrusor overactivity with Botulinum toxin. METHODS: Literature review using Pub-Med and Medline from 1990 until June 30, 2006. RESULTS: Case series of patients with neurogenic detrusor dysfunction (NDD) and idiopathic detrusor overactivity (IDO) range from 15 to 200 patients with follow up from 12 to 36 weeks post-treatment. Significant improvements in cystometric bladder capacity, reflex volume at first urge to void, and bladder compliance are seen in nearly all patients. Approximately 50% of NDD patients achieved urinary continence and almost all had improvement in bladder control up to 36 weeks following treatment. Patients with IDO with urgency alone or with incontinence also had urodynamic as well as symptom improvement. Approximately 75% of patients with IDO and incontinence are dry at 12 weeks post-treatment. Urgency disappears on average in two thirds of patients. Quality of life scores also shows significant improvement for all groups. CONCLUSION: Botulinum toxin-A has emerged as a promising option for the treatment of neurogenic and refractory idiopathic detrusor overactivity. Studies to date have shown that not only is this treatment effective at decreasing urinary symptoms and incontinence, as well as improving potentially dangerous urodynamic measures, but it is also minimally invasive, reversible and safe. Questions over proper dosing and dilution, number of injection sites, and re-injection rates remain to be answered.

Botulinum Toxins↗
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

Localization of the urge to void in patients with painful bladder syndrome.

AIMS: Our aim was to describe the location of urinary urgency or bladder discomfort in patients with painful bladder syndrome (PBS) and controls. METHODS: Patients with symptomatic diagnoses of PBS, overactive bladder (OAB) syndrome, stress urinary incontinence (SUI), and asymptomatic controls were asked to indicate the location of their urinary urge/urgency/discomfort on a body map. RESULTS: We present results for 30 PBS patients, 25 OAB patients, 15 SUI patients, and 15 asymptomatic controls. In asymptomatic subjects and those with SUI, the urge to void was localized to the suprapubic region only. More than half (53%) of patients with PBS and a minority (20%) of those with OAB localized their urinary urgency/discomfort to both suprapubic and vulvar/urethral locations. Some patients with PBS also localized their urinary discomfort to other body sites including low back, upper and lateral buttocks, lower abdomen, and upper thighs. CONCLUSIONS: In most patients with PBS and some with OAB, complaints of bladder discomfort or urgency may refer to sensations that are localized at sites other than suprapubic. The etiology of widespread sensation may include an expansion of dermatomes of referral of bladder sensation, and/or the presence of associated somatic abnormalities.

Adult↗
PubMed2003

Therapeutic efficacy of extended release oxybutynin chloride, and immediate release and long acting tolterodine tartrate in children with diurnal urinary incontinence.

PURPOSE: We compare the tolerability and efficacy of extended release oxybutynin chloride, and immediate release and long acting tolterodine tartrate in children with nonneurogenic diurnal urinary incontinence and symptoms of overactive bladder. MATERIALS AND METHODS: Children with a history of diurnal urinary incontinence were arbitrarily assigned to extended release oxybutynin, immediate release tolterodine or long acting tolterodine. The dose was titrated until effective (onset of complete diurnal urinary continence), maximal recommended dosage was achieved or bothersome anticholinergic side effects developed. An independent observer recorded the dose used, anticholinergic side effects and efficacy of therapy (incidence of urinary frequency, urgency, posturing and urinary incontinence). RESULTS: The study included 86 girls and 46 boys. There were no statistically significant differences among the 3 treatment groups regarding the presence of peripheral or central nervous system anticholinergic side effects. Extended release oxybutynin and long acting tolterodine were significantly more effective at reducing daytime urinary incontinence than immediate release tolterodine (p <0.01 and 0 <0.05, respectively). Extended release oxybutynin was significantly more effective then long acting tolterodine for complete resolution of diurnal incontinence (p <0.05). CONCLUSIONS: Extended release oxybutynin and long acting tolterodine are more effective than immediate release tolterodine in decreasing diurnal urinary incontinence. Extended release oxybutynin chloride is more effective than either immediate or long acting tolterodine for control of daytime urinary incontinence and urinary frequency.

Adolescent↗
PubMed2005

Urodynamic properties and neurotransmitter dependence of urinary bladder contractility in the BK channel deletion model of overactive bladder.

Overactive bladder and incontinence are major medical issues, which lack effective therapy. Previously, we showed (Meredith AL, Thornloe KS, Werner ME, Nelson MT, and Aldrich RW. J Biol Chem 279: 36746-36752, 2004) that the gene mSlo1 encodes large-conductance Ca2+-activated K+ (BK) channels of urinary bladder smooth muscle (UBSM) and that ablation of mSlo1 leads to enhanced myogenic and nerve-mediated contractility and increased urination frequency. Here, we examine the in vivo urodynamic consequences and neurotransmitter dependence in the absence of the BK channel. The sensitivity of contractility to nerve stimulation was greatly enhanced in UBSM strips from Slo-/- mice. The stimulation frequency required to obtain a 50% maximal contraction was 8.3 +/- 0.9 and 19.1 +/- 1.8 Hz in Slo-/- and Slo+/+ mice, respectively. This enhancement is at least partially due to alterations in UBSM excitability, as muscarinic-induced Slo-/- contractility is elevated in the absence of neuronal activity. Muscarinic-induced Slo-/- contractility was mimicked by blocking BK channels with iberiotoxin (IBTX) in Slo+/+ strips, whereas IBTX had no effect on Slo-/- strips. IBTX also enhanced purinergic contractions of Slo+/+ UBSM but was without effect on purinergic contractions of Slo-/- strips. In vivo bladder pressure and urine output measurements (cystometry) were performed on conscious, freely moving mice. Slo-/- mice exhibited increased bladder pressures, pronounced pressure oscillations, and urine dripping. Our results indicate that the BK channel in UBSM has a very significant role in urinary function and dysfunction and as such likely represents an important therapeutic target.

Animals↗
PubMed1996

Electrical pelvic floor stimulation: a possible alternative treatment for reflex urinary incontinence in patients with spinal cord injury.

The present study demonstrates the clinical experience of pelvic floor stimulation using percutaneous implantable electrodes and implantable electrical stimulator for the treatment of reflex urinary incontinence in patients with spinal cord injury. Pelvic floor stimulation was carried out on six paraplegic patients who had urinary incontinence from an overactive bladder. After the percutaneous implantation of a pair of electrodes, chronic stimulation was carried out by employing an implanted receiver or an external pulse regulator. Within 4 to 16 weeks of electrical stimulation urinary incontinence was improved in four of the six patients. In two of these six patients, incontinence was completely abolished subjectively. Urodynamic investigations demonstrated an increased volume at the first unstable contraction (P < 0.01) in all of the patients. Inhibition of detrusor overactivity was obtained from this procedure. The stimulation effect appeared to be constant during chronic stimulation. This new procedure probably provides a stable and reliable stimulation effect for long term treatment, and may be an alternative treatment for previous external electrical pelvic floor stimulation.

Adult↗
PubMed2001

The standardization of terminology for researchers in female pelvic floor disorders.

The lack of standardized terminology in pelvic floor disorders (pelvic organ prolapse, urinary incontinence, and fecal incontinence) is a major obstacle to performing and interpreting research. The National Institutes of Health convened the Terminology Workshop for Researchers in Female Pelvic Floor Disorders to: (1) agree on standard terms for defining conditions and outcomes; (2) make recommendations for minimum data collection for research; and (3) identify high priority issues for future research. Pelvic organ prolapse was defined by physical examination staging using the International Continence Society system. Stress urinary incontinence was defined by symptoms and testing; 'cure' was defined as no stress incontinence symptoms, negative testing, and no new problems due to intervention. Overactive bladder was defined as urinary frequency and urgency, with and without urge incontinence. Detrusor instability was defined by cystometry. For all urinary symptoms, defining 'improvement' after intervention was identified as a high priority. For fecal incontinence, more research is needed before recommendations can be made. A standard terminology for research on pelvic floor disorders is presented and areas of high priority for future research are identified.

Fecal Incontinence↗