Onabotulinum toxin-A vs extended release tolterodine in the management of idiopathic overactive bladder in children: A Pilot Randomized Controlled Trial (original) (raw)
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International Urology and Nephrology, 2018
Objective We aimed to evaluate the efficacy and safety of intravesical onabotulinum toxin A (onaBoNTA) injections for the treatment of children diagnosed with refractory overactive bladder (OAB) by using non-invasive methods. Methods A total of 31 pediatric patients with a mean age of 10.2 years received intravesical onaBoNTA injection at the dose of 10 U/kg (max: 200 U). Twenty-one patients who failed to respond to the first injection, received second injection 6 months after the first one. The patients were retrospectively evaluated after the 1st and the 2nd injections by means of standardized questionnaire forms and voiding diary records. Results In the 6-month follow-up, 10 patients (32.2%) were determined to have full response after the first injection. The number of patients with partial response and no response were found to be 15 (48.4%) and 6 (19.4%), respectively. The mean value of Dysfunctional Voiding and Incontinence Symptom Score (DVISS) of the patients with full response was 8.5 before the injection, which decreased to 1 at 6-month follow-up and to 0.5 at 12-month follow-up (p < 0.001). Twenty-one patients without full response after the first injection received a second injection 6 months after the first one. Full response was achieved in 9 (42.9%) of the 21 patients who had a second injection, but only partial response was achieved in 9 (42.9%). Three (14.3%) of the remaining patients did not respond to the second injection either. 1-year follow-up evaluations revealed that the rates of the full response, partial response, and no response were 61.3, 29, and 9.7%, respectively. Conclusions Based on our results, onaBoNTA therapy is an effective and reliable second-line off-label therapy in the management of patients with non-neurogenic OAB that is refractory to medical therapy. Asking the patients/guardians to fill out a standardized questionnaire form before and after the therapy enables easy and non-invasive assessment of the response to the therapy.
International Urology and Nephrology, 2012
Background To evaluate the efficacy of intradetrusor botulinum toxin-A (BTX-A) in idiopathic overactive bladder patients (OAB) refractory to antimuscarinic therapy, without detrusor overactivity (DOA) on urodynamics. Methods Patients with refractory idiopathic OAB without DOA on urodynamics were prospectively enrolled. Subjects completed a 3-day voiding diary (3-VD), urogenital distress inventory-6 questionnaire (UDI-6) and graded their quality of life on a 10-cm visual analog scale (VAS) prior to study enrollment and at week 12 postinjection. All patients underwent multichannel urodynamics at study enrollment and 12 weeks postinjection. Improvement was analyzed based on 3-VD, UDI-6 questionnaire, VAS scores, and urodynamic parameters at week 12 postinjection compared to study enrollment. Results The study included 32 patients. Mean ± SD age was 56 ± 16. There were 27 women and 5 men. Nineteen patients had OAB without incontinence (OAB-dry) and 13 patients had OAB with incontinence (OAB-wet). In OAB-dry patients, mean ± SD urinary frequency dropped from 24 ± 11 to 10 ± 4 by week 12. In OAB-wet patients, mean ± SD urge incontinence episodes dropped from 7.9 ± 5 to 0 ± 2.6 by week 12. Mean UDI-6 and VAS scores improved significantly in both groups by week 12 (P = 0.0001). On comparing urodynamic parameters, OAB-wet patients showed significant decrease in maximum detrusor pressure during the voiding phase at week 12 compared to baseline values (P = 0.02). Conclusions Refractory idiopathic OAB patients without DOA on urodynamics may benefit from intradetrusor BTX-A.
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 ...
Diagnosis and Management of Bladder Dysfunction in Neurologically Normal Children
Frontiers in Pediatrics
Normal bladder and urethral sphincter development as well as neural/volitional control over bladder-sphincter function are essential steps for regular lower urinary tract function. These maturational sequences are clinically evident by the age of 5 years. However, in 17-22% of children, symptoms persist beyond that age, characterizing lower urinary tract dysfunction (LUTD). The clinical spectrum is wide and includes overactive bladder, voiding postponement, underactive bladder, infrequent voiding, extraordinary daytime only urinary frequency, vaginal reflux, bladder neck dysfunction, and giggle incontinence. LUTD may lead to vesicoureteral reflux and recurrent urinary tract infections, increasing the likelihood of renal scarring. LUTD is often associated with constipation and emotional/behavioral disorders such as anxiety, depression, aggressiveness, and social isolation, making diagnosis, and treatment imperative. Diagnosis of LUTD is essentially based on clinical history, investigation of bladder storage, voiding symptoms (urinary frequency, daytime incontinence, enuresis, urgency) and constipation. Dysfunctional Voiding Score System (DVSS) is a helpful tool. Physical examination focuses on the abdomen to investigate a distended bladder or palpable fecal mass, the lumbosacral spine, and reflex testing. Bladder diaries are important for recording urinary frequency and water balance, while uroflowmetry is used to assess voided volume, maximum flow, and curve patterns. Bladder ultrasonography to measure post-void residual urine volume and urodynamics are used as supplemental tests. Current first line treatment is urotherapy, a combination of behavioral measures to avoid postponing micturition, and a restricted diet for at least 2 months. Anticholinergics, β3 agonists and neuromodulation are alternative therapies to manage refractory overactive bladder. Cure rates, at around 40%, are considered satisfactory, with daytime symptoms improving in 32% of cases. Furthermore, children who are also constipated need treatment, preferentially with polyethylene glycol at doses of 1-1.5 g/kg in the 1st 3 days and 0.25-0.5 g/kg thereafter until the 2-month period of behavioral therapy is complete. If urotherapy fails in cases of dysfunctional voiding, the next step is biofeedback to teach the child how to relax the external urethral sphincter during micturition. Success rate is around 80%. Children with underactive bladder usually need a combination of clean intermittent catheterization, alpha-blockers, biofeedback and neuromodulation; however, cure rates are uncertain.
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.
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.
Scandinavian Journal of Urology and Nephrology, 2011
Objective. This study aimed to investigate changes in urodynamic findings and symptoms after detrusor injections of botulinum toxin A (BTX-A) in children with idiopathic detrusor overactivity (IDO) and urge incontinence. Material and methods. Eight girls and five boys, aged 7-19 years, who had urge incontinence refractory to scheduled voiding and anticholinergics, were included this prospective study. Urodynamic studies showed postoperative IDO in 12 patients. A dose of 50-100 IU (1.3-4.8 IU/kg) BTX-A was primarily administered at 15-20 detrusor sites. A control urodynamic study was performed within 3 months after the injections. Seven patients had a repeated procedure 16 (range 6-24) months on the average after the first one. Results. Eleven of the 13 patients had daily incontinence and two had incontinence a couple of times a week in association with urge symptoms. Postoperatively, no patient had urinary retention, but one girl had a urinary tract infection 4 months after the therapy. Five patients had a full response, seven partial responses and one no response 1-3 months after the first treatment. After 1 year, three of nine patients still have full response. Maximum cystometric capacity increased after the first treatment from a median of 227 ml to 379 ml (p = 0.005) and the number of patients with uninhibited detrusor contractions more than 30 cmH 2 O during the filling phase decreased from eight to two out of 13 (p = 0.041). Conclusions. Intradetrusor BTX-A injections effectively reduce daytime wetting, significantly increase bladder volume and decrease detrusor overactivity in children with urge incontinence refractory to scheduled voidings and anticholinergics.
Detrusor underactivity: A plea for new approaches to a common bladder dysfunction
Neurourology and Urodynamics, 2011
Aims: Detrusor underactivity (DU) is defined by the International Continence Society as a contraction of reduced strength and/or duration resulting in prolonged or incomplete emptying of the bladder but has yet received only little attention. The purpose of this report is to summarize the ICI-RS meeting in Bristol in 2010 exploring current knowledge on DU and outline directions for future research. Methods: A think tank discussion was held and the summary of discussions was presented to all ICI-RS participants. This report is based on the final discussions. Results: The understanding of the pathophysiology, epidemiology, assessment, and treatment of DU remains rudimentary. DU is defined by pressure-flow analysis but no consensus exists regarding which of the available formulae should be used for quantification of detrusor work. DU is likely to be multifactorial. Aging causes a decay in detrusor activity but other concomitant causes, either myogenic or neurogenic, may aggravate the problem resulting in decrease of detrusor contractility. No effective pharmacotherapy for the condition exists. Only a few surgical therapeutic strategies have been explored, such as neuromodulation and skeletal muscle myoplasties. Consequently, the management of affected individuals remains unsatisfactory. Conclusions: Future directions recommended by the ICI-RS panel include assessment of pathogenesis by developing novel animal models in addition to new non-invasive tests allowing longitudinal trials. Furthermore, optimizing the existing evaluation algorithms to support standard testing for DU and further epidemiological studies to quantify the size of the problem are required for the development of future treatment modalities. Neurourol. Urodynam.
Botulinum toxin injections in the management of non-neurogenic overactive bladders in children
Journal of pediatric surgery, 2014
Non-neurogenic detrusor overactivity in children leads to varying degrees of functional impairments (urinary urgency, pollakiuria, urge incontinence, nocturia). Botulinum toxin has shown its effectiveness in the management of detrusor overactivity in neurological patients. To evaluate the relevance of intravesical Botulinum toxin injections for the treatment of non-neurogenic overactive bladders in children. These pediatric patients were resistant to all the usual therapeutics (e.g. bladder/bowel rehabilitation, anticholinergic drugs, management of diet/hygiene habits and constipation, percutaneous posterior tibial nerve stimulation). 8 children (mean age: 12.5years), 5 girls, 3 boys with daytime and/or nighttime incontinence and non-neurogenic detrusor overactivity validated by urodynamic testing. Urodynamic testing was conducted before the injections as well as 6weeks and 1year post injections. We used Dysport® 8 Speywood Units/kg injected via cystoscopy into 25 different sites. W...