Cross-sectional survey. Clinical examinations and interview.
Overall discontinuation rate of antimuscarinic therapy in children is comparable to what has been reported in adult patients with OAB. However, children seem to persist on the medication for a longer duration before adherence rates start declining. The low rate of persistence highlights the need to identify the reasons for discontinuation of therapy in children in order to obtain better persistence rates.
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Overall, half of the total population achieved FR, and continued success was observed in more than half of full responders irrespective of the groups. Thus, adding EA treatment to pharmacotherapy is an effective second-line therapeutic strategy for children with PRNE.
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OROS technology has evolved over the last 30 years, resulting in four systems: the elementary osmotic pump; the two-layer osmotic push-pull tablet; the advanced longitudinally compressed tablet multilayer formulation; and, the L-OROS system. OROS technology is employed for drug delivery in many therapeutic areas including: cardiovascular medicine, endocrinology, urology, and central nervous system (CNS) therapeutics. Two calcium channel blockers utilizing OROS technology for the treatment of hypertension are nifedipine and verapamil. Glipizide extended-release is used for the treatment of type 2 diabetes. Doxazosin is used for the treatment of benign prostatic hyperplasia, and oxybutynin for overactive bladder. Most recent developments are with drugs that affect the CNS, including the use of methylphenidate for treatment of attention deficit hyperactivity disorder, paliperidone extended-release and OROS hydromorphone, which are under clinical development for schizophrenia and chronic pain, respectively.
A gas chromatographic-mass spectrometric method is described for the quantitative analysis of plasma oxybutynin. Deuterated oxybutynin served as the internal standard and its synthesis is described. Chromatographic separation on a methylsilicone capillary column avoided the thermal decomposition observed using a packed column. Electron-impact ionization and selected-ion monitoring of the alpha-cleavage fragments of drug and internal standard permitted quantitation of oxybutynin down to 0.25 ng/ml of plasma. At the 2 ng/ml level the accuracy and precision are 4 and 10%, respectively, and improved at higher drug concentrations. Application of the method to the pharmacokinetics of oral oxybutynin in man demonstrated rapid absorption and elimination of the drug.
Before treatment, the mean maximum flow rate (Qmax) was 21.0 +/- 3.2 mL/sec, the mean International Prostate Symptom Score (I-PSS) score was 12.9 +/- 4.2, the mean I-PSS Quality of Life (IPSS QoL) score was 3.6 +/- 1.2. At the first check-up performed after 3 months, we could observe that the I-PSS and QoL scores were 12.6 +/- 4.3 and 3.8 +/- 1.3 in the group who received placebo; the scores decreased to 11.1 +/- 3.2 and to 3.1 +/- 1.0, respectively, in the 15 patients treated with oxybutynin and decreased to 6.1 +/- 2.6 and 1.3 +/- 1.1, respectively, in the 13 patients who underwent acupuncture reflexotherapy. At 1-year follow-up, these parameters were practically similar. The voiding diaries allowed us to deduce that the average number of daytime voidings decreased by 8% in patients who received oxybutynin and decreased by 20% in 13 patients who underwent reflexotherapy; the average number of nocturnal micturitions decreased by approximately 20% and 60%, respectively, in patients who received oxybutynin and reflexotherapy.
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Oxybutynin was effective in the treatment of persistent plantar hyperhidrosis, resulting in a better quality of life in women who had undergone thoracoscopic sympathectomy.
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Trospium chloride and oxybutynin, judged in terms of objective urodynamic parameters, are of substantially equal value as parasympathetic antagonists. However, assessment of tolerance in terms of adverse drug effects showed that TCl had certain advantages.
Breakfast did not change the AUC of oxybutynin but increased the AUC of N-desethyloxybutynin by about 20%. The Cmax of oxybutynin and N-desethyloxybutynin were two-fold higher when the drug was administered after breakfast compared to the fasting state.
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Indiana Medicaid claims data were merged with data from the Minimum Data Set (MDS). Repeated-measures analyses were performed to assess the effects of dual therapy on change in cognitive function measured using the MDS Cognition Scale (MDS-COGS; scored 0-10) and change in activity of daily living (ADL) function using the seven ADL items in the MDS (scored 0-28). Potential covariates included age, sex, race, number of medications, and Charlson Comorbidity Index score.
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The intravesical application of oxybutynin was a well tolerated and efficacious therapy. The topical oxybutynin therapy dosage (A) was efficient in 66% of our selected patients, the escalating dosage titration (B) could increase the efficiency to 87%.
Spinal Cord Injury Unit, Yonsei Rehabilitation Hospital, Seoul, Korea.
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The psychometric properties and clinical validity of the KHQ Japanese version were confirmed in this study population, and were similar between males and females. The KHQ's good reliability was evidenced by Cronbach's alpha coefficients of >0.60, indicating reasonable consistency except for the personal relationship domain in males (0.47) and severity (coping) measure domain in females (0.59). Discriminant, convergent, and construct validity of the KHQ were also good, with the factor analysis identifying those factors which the KHQ was intended to measure. Finally, KHQ domains were generally responsive to clinical efficacy variables; the KHQ also showed statistically significant sensitivity to change in patients' perception of bladder condition in all domains, except General Health Perception.
To examine the factors of intravesical oxybutynin influencing the cystometrogram in normal conscious rats at various pH levels and concentrations of oxybutynin.
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Oxybutinin treatment can be long, but UD and VUR improvement run parallel in most cases. The rare discrepant cases point towards a multifactorial ethology in this condition.
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There was statistical correlation between HDSS and QLQ and between HDSS and SEQ before treatment and after 5 weeks. Additionally, HDSS was reproducible and sensitive to clinical changes after the treatment period.
The present study was undertaken to characterize in vivo muscarinic receptors in peripheral tissues (urinary bladder, submaxillary gland, colon, stomach, heart) of mice, and further to evaluate bladder-selectivity of anticholinergic agents to treat overactive bladder. Following i.v. injection of [3H]QNB in mice, the radioactivity in peripheral tissues was exclusively detected as the unchanged form. The in vivo specific [3H]QNB binding in particulate fraction of tissue homogenates of mice showed a pharmacological specificity which characterized muscarinic receptors. Binding parameters (Kd and Bmax) for in vivo specific [3H]QNB binding differed between mouse tissues. Oral administration of oxybutynin attenuated significantly in vivo specific [3H]QNB binding in all tissues of mice. From ratios of AUCurinary bladder/AUCother tissues of time-dependent muscarinic receptor occupancy, oral oxybutynin has been shown to exert little urinary bladder selectivity. Following oral administration of propiverine, there was a significant reduction of in vivo specific [3H]QNB binding in the urinary bladder, colon and submaxillary gland, but not in the stomach and heart. From the ratios of AUCurinary bladder to AUCsubmaxillary gland or AUCheart, it has been shown that oral propiverine exerts higher selectivity to muscarinic receptors in the urinary bladder than in the submaxillary gland and heart. Similarly, tolterodine displayed high selectivity to muscarinic receptors in the urinary bladder than in the submaxillary gland. Thus, the present study has demonstrated that [3H]QNB may be a useful ligand for in vivo characterization of muscarinic receptor binding of anticholinergic agents to treat overactive bladder. Propiverine and tolterodine have exhibited in vivo selectivity of muscarinic receptor in the mouse urinary bladder rather than in the submaxillary gland, and such receptor binding specificity may be the reason of lower incidence of dry mouth.
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Children with attention deficit hyperactivity disorder disproportionately experience voiding dysfunction and persistent nocturnal enuresis due to a combination of sphincter and detrusor overactivity and nocturnal polyuria. The different treatment approaches to nocturnal enuresis often fail in these patients. Therefore, we performed a prospective study to compare the efficacy of combination therapy with desmopressin and oxybutynin vs the tricyclic antidepressant imipramine in patients with attention deficit hyperactivity disorder who have nocturnal enuresis.
Repeated discrete outcome variables such as count measurements often arise in pharmacodynamic experiments. Count measurements can only take nonnegative integer values; this and correlation between repeated measurements from an individual make the design and analysis of repeated-count data special. Sample size/power calculation is an important part of clinical trial design to ensure adequate power for detecting significant effect, and it is often based on the procedure for analysis. This paper describes an approach for calculating sample size/power for population pharmacokinetic/pharmacodynamic experiments involving repeated-count measurements modeled as a Poisson process based on mixed-effects modeling technique. The noncentral version of the Wald chi(2) test is used for testing parameter/treatment significance. The approach was applied to two examples and the results were compared to results obtained from simulations in NONMEM. The first example involves calculating the power of a design to detect parameter significance between two groups: placebo and treatment group. The second example involves characterization of the dose-efficacy relationship of oxybutynin using a mixed-effects modeling approach. Weekly urge urinary incontinence episodes (a discrete count variable) is the primary efficacy variable and is modeled as a Poisson variable. A prospective study based on two different formulations of oxybutynin was designed using published population pharmacokinetic/pharmacodynamic model. The results of simulation studies showed good agreement between the proposed method and NONMEM simulations.
The 6607 patients with OAB, with a substantial proportion with elevated HR at baseline, were more likely to have CV comorbidities (39% vs 21%; P < 0.001) and previous exposure to medications with antimuscarinic effects (33% vs 17%; P < 0.001) than the non-OAB patients. Rate of CV comorbidities (40% vs 38%; P = 0.326) did not differ between treated and untreated patients with OAB. However, there was a difference in previous exposure to medications with antimuscarinic effects (37% vs 29%; P < 0.001); 39.1% of patients with OAB had a HR of >80 beats/min before starting antimuscarinic treatment.
To compare the effects of pelvic floor muscle training combined with another active treatment versus the same active treatment alone in the management of women with urinary incontinence.
Intravesical oxybutynin is used to control bladder overactivity in patients who are refractory to or cannot tolerate oxybutynin given orally. Although it is clinically effective, the mode of action of intravesical oxybutynin remains unclear. We tested the influence of intravesical oxybutynin on single fiber pelvic nerve afferents from the rat bladder.
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Traditional suburethral slings are surgical operations used to treat women with symptoms of stress urinary incontinence.
OTG3% 84 mg/day was well tolerated and effective in improving urge incontinence or mixed UI symptoms with a predominance of UI in adults with overactive bladder.
Twenty-four patients with sensory urgency, and 53 patients with motor urgency were treated with oxybutynin (6 mg/day) for 4 weeks and subjective and objective efficacies were evaluated. Subjective parameters were quantified with urge score (grade 0-3) and daily numbers of voiding and incontinence. Objective efficacies were evaluated with pre-/ postcomparison of cystometric parameters.
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We have separated the local inhibitory effects of antimuscarinic agents during the storage phase from a decrease in voiding pressure. Intravesical instillation of antimuscarinic agents at clinically meaningful concentrations also suppressed carbachol-induced bladder overactivity. Antimuscarinic agents may be effective in treating overactive bladder, not only by suppression of muscarinic receptor-mediated detrusor muscle contractions, but also by blocking muscarinic receptors in bladder-afferent pathways.
This observational study of recorded side effects showed that, except for stroke and hypertension, patients who were treated with an inhaled anticholinergic drug appeared to be at higher risk of developing neurovascular or cardiovascular side effects, than those treated with an oral drug. However, physicians should also be aware that oral anticholinergic drugs may have similar adverse impacts on health. Further studies on the association between anticholinergic drugs and cardiovascular and neurovascular side effects are recommended.
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To evaluate the protective effect of intravesical oxybutynin on the ultrastructure of rabbits with detrusor overactivity (DO). Seventeen North Folk male rabbits were distributed into three groups: GI (n = 5) used as control, GII (n = 5), and GIII (n = 5) with DO. One animal from GII and one from GIII were excluded because they did not develop DO. In GIII, the animals were treated with daily intravesical application of 0.5 mg/Kg of oxybutynin for 30 days. Bladder weight was significantly higher in animals from GII and GIII as compared to GI. After 30 days, cystometric study revealed that vesical capacity was significantly decreased in GII and GIII. Detrusor pressure was significantly higher in GII. Electron microscopy showed increase of intercellular space, cell junctions and caveolae areas asymmetries, mitochondria and cellular degeneration in GII, while in GIII, these alterations have improved after a 30-day treatment. Animals treated with intravesical oxybutynin presented ultrastructural aspect similar to normal.
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At baseline, 586 (23.1%) reported that overactive bladder had an impact on their sex life. Coital incontinence in 569 (22.8%) decreased after treatment to 438 (19.3%). Effects of overactive bladder on subjects' sex lives improved in 19.1% (worsened in 11.2%), and the effect on relationships with partners improved in 19.6% (worsened in 11.9%). Reduced interest in sex, reported by 52.1% at baseline, improved significantly. (all P < .0001).