LB18 Long lasting therapy for recurrent urinary tract infections in women (original) (raw)
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European Urology, 2004
Objective: To evaluate the efficacy and tolerability of tolterodine in children with an overactive bladder, treated in a single incontinence centre. Materials and methods: A retrospective analysis of a database of a total of two hundred and fifty-six patients (175 boys and 81 girls, age range 3 years to 17 years, mean age 8.33 years) with urodynamically confirmed bladder overactivity was performed. All children received tolterodine tartrate (dose range of 0.5-4 mg orally). In group I (n ¼ 205) tolterodine tartrate replaced anticholinergic drugs (AC) (oxybutinin chloride or oxyphencyclimin hydrochloride). A subgroup of patients switched because of intolerance due to serious adverse events (60.4%) or because of lack of improvement in micturition variables (39.6%). In group II tolterodine was prescribed as initial therapy (n ¼ 51). Tolerability was assessed by a standardised questionnaire on adverse events at every outdoor clinic visit. Efficacy assessment was based on micturition diary variables, mean change of maximum bladder capacity and number of incontinence episodes/24 h. Results: The mean treatment time was 9.32 months with a range from 1.5 months to 23.4 months. The final dose was 0.1 mg/kg orally daily divided into two doses. In group I central nervous system disorders (81%) were the most common adverse events, 26.2% showed flushing, 12.2% accommodation problems and 25.2% had gastrointestinal complaints (constipation, encopresis, abdominal pain). Withdrawal of the non-selective antimuscarinic drug resulted in total recovery from adverse events.
Indian journal of physiology and pharmacology
To examine the efficacy, safety and tolerability of tolterodine in children with overactive bladder in comparison with standard treatment i.e. oxybutynin as demonstrated in randomized clinical trials and other studies. A systematic search was done to screen the studies evaluating the effect of tolterodine in children with non-neurogenic overactive bladder. Results of studies were pooled and compared. Efficacy was determined from micturition diaries and dysfunctional voiding symptoms score. Safety and tolerability were assessed from the reported treatment emergent adverse events. A total of six randomized clinical trials and 11 other studies of tolterodine in children with urinary incontinence were included in the present systematic review. The dose of tolterodine used in different settings ranged from '0.5 to 8 mg/day' instead of '0.5 to 8 mg/kg per day' and the duration of studies ranged from 2 weeks to 12 months. Both extended and immediate release preparations of ...
The overactive bladder in children: a potential future indication for tolterodine
BJU International, 2001
Objective To determine the safety, efficacy and pharmacokinetics of tolterodine in children with an overactive bladder. Patients and methods Thirty-three children (20 boys and 13 girls, aged 5-10 years) with an overactive bladder and symptoms of urgency, frequency and/or urge incontinence were enrolled in an open, dose-escalation study. Patients were treated with oral tolterodine 0.5 mg (n=11), 1 mg (n=10) or 2 mg (n=12) twice daily for 14 days. The primary safety endpoint was the change in residual urinary volume, as determined by ultrasonography. In addition, voiding diary variables (frequency and incontinence episodes) and pharmacokinetics were evaluated. Other safety endpoints included laboratory variables, electrocardiogram recordings and reported adverse events. Results There were no safety concerns in terms of the change in residual urinary volume for any of the three dosage groups; values were comparable with baseline after 2 weeks of treatment for all three dosages. Adverse events were reported by 20 patients (six on 0.5 mg, five on 1 mg, and nine on 2 mg). Most adverse events were not considered to be drug-related; of the 13 possibly related events, 10 occurred in those taking 2 mg. Headache was the most commonly reported adverse event. No serious adverse events were reported and there were no general safety concerns. There was an improvement in voiding diary variables in all treatment groups after 2 weeks of treatment, although the efficacy was greatest in those taking 1 mg and 2 mg. Pharmacokinetic findings were consistent with dose linearity over the range 0.5-2 mg. Conclusion The results support the use of 1 mg twice daily as the optimal dose of tolterodine for treating children aged 5-10 years with an overactive bladder.
Efficacy of tolterodine as a first-line treatment for non-neurogenic voiding dysfunction in children
Bju International, 2005
OBJECTIVETo assess the effect of antimuscarinic treatment with tolterodine combined with behavioural modification as a first-line treatment, before invasive investigation, in children with non-neurogenic voiding dysfunction but no obvious anatomical or neurogenic cause.To assess the effect of antimuscarinic treatment with tolterodine combined with behavioural modification as a first-line treatment, before invasive investigation, in children with non-neurogenic voiding dysfunction but no obvious anatomical or neurogenic cause.PATIENTS AND METHODSThe study comprised 44 children presenting with voiding dysfunction (30 girls and 14 boys, mean age 7 years, range 5–14); all had a noninvasive evaluation consisting of a history, urine analysis, renal and bladder ultrasonography and physical examination, with specific emphasis on the voiding pattern. Anticholinergic treatment with tolterodine (1 mg twice daily) was started in all patients; they were also informed about conservative management, including timed voiding, double voiding and relaxation of the pelvic floor during voiding. At the start and after 3 months, the dysfunctional voiding symptom score (DVSS) was completed twice by all patients.The study comprised 44 children presenting with voiding dysfunction (30 girls and 14 boys, mean age 7 years, range 5–14); all had a noninvasive evaluation consisting of a history, urine analysis, renal and bladder ultrasonography and physical examination, with specific emphasis on the voiding pattern. Anticholinergic treatment with tolterodine (1 mg twice daily) was started in all patients; they were also informed about conservative management, including timed voiding, double voiding and relaxation of the pelvic floor during voiding. At the start and after 3 months, the dysfunctional voiding symptom score (DVSS) was completed twice by all patients.RESULTSFor all patients the mean (sd) DVSS was 14.0 (2.67) and 6.68 (3.67) before and after treatment, respectively; the difference was statistically significant (P < 0.001). The mean scores for girls and boys, respectively, were 13.8 (2.79) and 14.5 (2.44) before and 6.43 (3.79) and 7.50 (3.34) after treatment.For all patients the mean (sd) DVSS was 14.0 (2.67) and 6.68 (3.67) before and after treatment, respectively; the difference was statistically significant (P < 0.001). The mean scores for girls and boys, respectively, were 13.8 (2.79) and 14.5 (2.44) before and 6.43 (3.79) and 7.50 (3.34) after treatment.CONCLUSIONTolterodine combined with behavioural modification for dysfunctional voiding in children with no neurological or anatomical abnormality can be recommended as a first-line treatment before invasive evaluation. Additionally, the DVSS appears to provide accurate and objective data for monitoring the effect of treatment in such children.Tolterodine combined with behavioural modification for dysfunctional voiding in children with no neurological or anatomical abnormality can be recommended as a first-line treatment before invasive evaluation. Additionally, the DVSS appears to provide accurate and objective data for monitoring the effect of treatment in such children.
The Journal of Urology, 2007
This randomized blinded clinical study was designed to compare the efficacy of tolterodine treatment combined with behavioral modification, behavioral modification alone and behavioral modification plus placebo in children with nonneurogenic, nonanatomical voiding dysfunction. A total of 72 children meeting inclusion criteria were randomly allocated to 1 of 3 groups. One group received tolterodine (1 mg twice daily) along with behavioral modification, 1 received behavioral modification only and 1 received placebo with behavioral modification. A dysfunctional voiding scoring system questionnaire was completed for all patients at the beginning of the study, and at 1 and 3 months of treatment. A total of 71 patients were evaluated. The groups did not differ with respect to age, gender and symptom score before study enrollment (p >0.05). Repeated calculations of symptom scores at 1 month of the treatment revealed a significant decrease in symptoms in all 3 groups, with a significant decrease in patients receiving tolterodine. In addition, at month 3 the symptom score of the tolterodine group was significantly lower compared to month 1, while scores remained steady in the behavioral modification and behavioral modification plus placebo groups. Tolterodine combined with behavioral modification for voiding dysfunction in children without neurological or anatomical abnormality can be recommended as a first line treatment before invasive evaluation.
European Urology, 2002
Background: The objective of the present study was to examine the long-term safety, tolerability and ef®cacy of tolterodine extended-release (ER) in patients who had completed 12 weeks' treatment in a randomised, double-blind study comparing tolterodine ER 4 mg once daily (qd), tolterodine immediate-release (IR) 2 mg twice daily and placebo. Methods: Of the 1377 patients completing the 12-week study, a total of 1077 (78%) chose to continue with 12 months' open-label treatment with tolterodine ER 4 mg once daily, irrespective of their previous treatment. Safety was assessed after 3, 6, 9 and 12 months' treatment in the study. Ef®cacy was evaluated from micturition diary variables and patients' perception of bladder condition and urgency following 3 and 12 months' treatment. Results: 71% of patients completed the 12-month study. Tolterodine ER was safe and well tolerated. Adverse events of the general (14.5%), autonomic (13.2%), gastrointestinal (11.4%), respiratory (9.8%) and urinary (9.1%) systems were the most frequently reported. Dry mouth was the most common event, occurring in 12.9% of patients, and was generally mild in severity. Other adverse events occurred in less than 5% of patients. There was no increase in the frequency of adverse events with long-term relative to short-term treatment. The ef®cacy of tolterodine was maintained over the 12-month treatment period; relative to baseline there were reductions in the number of incontinence episodes per week (median change À83%) and micturitions per 24 hours (median change À21%) and an increase in volume voided (median change 25%) after 12 months' treatment. An improvement in patient perception of their bladder condition was found in 75% of patients completing the study, and 51% had an improvement in patient perception of urgency. Conclusions: Tolterodine ER 4 mg qd displayed a favourable safety, tolerability and ef®cacy pro®le during 12 months' treatment of patients with overactive bladder.
Tolterodine reduces the number of urge incontinence episodes in patients with an overactive bladder
European Journal of Obstetrics & Gynecology and Reproductive Biology, 2001
Objective: To evaluate the ef®cacy, safety and tolerability of tolterodine compared to placebo in patients with an overactive bladder. Study design: A double-blind, multi-centre phase III study in France and Belgium 251 patients with overactive bladder symptoms, and urodynamically veri®ed detrusor overactivity, were randomised to receive 4-week treatment with either placebo or tolterodine 1 or 2 mg twice daily (bd). Ef®cacy was evaluated from patient micturition diaries. Safety and tolerability endpoints were also evaluated. Results: After 4-week treatment, the number of incontinence episodes/24 h decreased signi®cantly relative to placebo in the tolterodine 1 and 2 mg bd groups (P 0:045 and P 0:0089, respectively). Both dosages of tolterodine increased volume voided per micturition compared with placebo (P 0:055 and P 0:056, respectively), although signi®cant decreases in micturition frequency were not apparent. Tolterodine was safe and well tolerated, few patients were withdrawn due to adverse events. Dry mouth, mainly of mild-to-moderate intensity, was the most common adverse event. No clinically relevant changes in blood pressure or laboratory safety variables were reported. Conclusion: Tolterodine is effective, safe and well tolerated for the treatment of symptoms of an overactive bladder, particularly urge incontinence.