742 RESULTS OF A MULTI-INSTITUTIONAL, PROSPECTIVE, OPEN-LABEL STUDY EVALUATING SAFETY AND EFFICACY OF TAMSULOSIN HYDROCHLORIDE FOR MANAGING CHILDREN WITH NEUROPATHIC BLADDER AND HIGH LEAK POINT PRESSURE

742 RESULTS OF A MULTI-INSTITUTIONAL, PROSPECTIVE, OPEN-LABEL STUDY EVALUATING SAFETY AND EFFICACY OF TAMSULOSIN HYDROCHLORIDE FOR MANAGING CHILDREN WITH NEUROPATHIC BLADDER AND HIGH LEAK POINT PRESSURE

e290 THE JOURNAL OF UROLOGY姞 protocol evaluating the effect of a clinical or in patient voiding reeducation programme or urotherapy. Sixteen childre...

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e290

THE JOURNAL OF UROLOGY姞

protocol evaluating the effect of a clinical or in patient voiding reeducation programme or urotherapy. Sixteen children on the waiting list for the same programme were included as control receiving no treatment while on the waiting list. The clinical voiding re-education programme consisted in instructions on voiding and drinking, individualised voiding diaries, pelvic floor biofeedback training, uroflowmetry, cognitive therapy and psychological support. Data on voiding, drinking, pelvic floor control, voided volume, uroflow, incontinence and stool habits were gathered before the programme, during the programme and 6 months after the programme. In the control group the same data were gathered when they were put on the waiting list and 6 months later. RESULTS: In the study group a positive effect of the VS was observed in 92% of children. Forty two% became completely dry, 24% changed from incontinence during day and night to incontinence day or night only while in 26% incontinence remained but in all patients the number of incontinence periods and the amount decreased. In the control group no differences were observed between intake and 6 months later. The study group did significantly better on voided volume and incontinence compared to the control group. CONCLUSIONS: In this prospective controlled study a positive effect on voided volume and on incontinence with a clinical voiding re-education programme or voiding school is reported. This is the first prospective controlled study on the effects of urotherapy Source of Funding: None

741 URINARY INCONTINENCE IN PHYSICALLY AND/OR INTELLECTUALLY DISABLED CHILDREN: A MULTIFACTORIAL PROBLEM. Erik Van Laecke*, Piet Hoebeke, Ann Raes, Johan Vande Walle, Gent, Belgium INTRODUCTION AND OBJECTIVES: Urinary incontinence in physically and/or intellectually disabled children is a common problem. In these patients we prospectively studied possible causal factors. METHODS: In a prospective study, 111 children, 66 boys and 45 girls, mean age 9.1 years, were included. Twenty-two were motor disabled, 16 were mental disabled and 73 suffered mental- and motor disability. Patients were evaluated with a questionnaire, diary, uroflow and bladderscan. RESULTS: At the study intake 39.6% were continent, 36.9% suffered urinary incontinence during day and night, 9.6% during the day and 13.5% had nocturnal enuresis. No significant difference was found between the intellectually, the physically and intellectually and physically disabled children. Mental retardation: a significant correlation between the type of mental retardation and the continence was found. The more severe the retardation the lower the chance to become continent. Motor capacity: There is a significant correlation between mobility, degree of spasticity, degree of functional autonomy and degree of continence. Maximum voided volume: 55.9% had a maximum voided volume ⬍ 65% of the expected bladder capacity. There is a significant correlation between maximum voided volume and the urinary continence. Fluid intake: only 9.9% had a normal fluid intake. Normalization of the fluid intake resulted in a significant increase in continence. Uroflow pattern: 74.8% were dysfunctional voiding. This was not significantly affected by the type of disability. No correlation between uroflowpattern and degree of continence could be illustrated. Faecal incontinence: a significant correlation between constipation and urinary incontinence was shown. CONCLUSIONS: Urinary incontinence in developmentally challenged children is multifactorial. Optimalization of the fluid intake is an easy and effective therapeutical option in the treatment of the urinary incontinence. Source of Funding: None

Vol. 183, No. 4, Supplement, Monday, May 31, 2010

742 RESULTS OF A MULTI-INSTITUTIONAL, PROSPECTIVE, OPENLABEL STUDY EVALUATING SAFETY AND EFFICACY OF TAMSULOSIN HYDROCHLORIDE FOR MANAGING CHILDREN WITH NEUROPATHIC BLADDER AND HIGH LEAK POINT PRESSURE Mark Cain*, Indianapolis, IN; John McKay, Jan Wruck, Ridgefield, CT INTRODUCTION AND OBJECTIVES: Alpha blockers have been used as off-label therapy for children with either neuropathic or non-neuropathic functional outlet obstruction and urinary retention. No prospective studies evaluating long term safety and clinical outcomes has been reported. The objective of this study was to determine the long term (12 month) efficacy and safety of tamsulosin in patients with neuropathic bladder and elevated leak point pressure (LPP). METHODS: Patients between 2-16 yrs. with elevated LPP with/without hydronephrosis (HN) due to neuropathic bladder were prospectively enrolled and treated with oral tamsulosin. Patients were placed in either low, medium or high dose tamsulosin based on weight. Drug was titrated to lowest dosage that achieved LPP⬍40 cm. Patients were evaluated weekly with urodynamic studies during titration and at subsequent visits. Renal ultrasound was obtained at onset, 6, and 12 months. Physical exam, EKG, urinalysis, vision/cognitive testing, and adverse events (AE) were documented at various study visits. RESULTS: There were 88 patients that received tamsulosin, and of these 70 patients completed the 52 week analysis. LPP ⬍ 40 cm was achieved in 32/70 (46%) at 52 weeks. Median change in LPP was -16 cm (29% from baseline). 13/16 pts considered failures in low/ medium dose groups also had at least one documented LPP ⬍ 40 at some time during study. Hydronephrosis improved or stabilized in 82%. AE related to study medication occured in 9%: dizziness (3.4%), orthostatic hypotension (3.4%), and headache, hypotension, diarrhea, nausea, photophobia, or incontinence (1% each). No drug related serious AE, death or change in laboratory values were documented during study. CONCLUSIONS: This study documents that tamsulosin was well tolerated in children with neuropathic bladder. Mild side effects occur in ⬍ 10% of patients. A reduction in LPP to ⬍ 40 cm and decreased/stabilized hydronephrosis may be expected in almost half (46%) of patients treated. Although this treatment response appears optimistic, the results from a short term (3 month) double-blind tamsulosin study for children with neuropathic bladder failed to demonstrate any difference between placebo and tamsulosin. Given these findings, we would recommend caution in using tamsulosin as primary or adjunct therapy in children with neuropathic bladder and elevated LPP. Source of Funding: This clinical trial was supported by Boehringer Ingelheim Pharmaceuticals, Inc (BIPI). Dr. Cain has received no compensation related to development of this abstract. Dr. Cain has received financial support for participation in the clinical trial, and as coordinating investigator of the multiinstitutional study.

743 VARIABILITY IN URODYNAMIC FINDINGS IN CHILDREN WITH CENTRAL NERVOUS SYSTEM TUMORS: TUMOR LOCATION DOES NOT PREDICT BLADDER OUTCOME Andres Silva Waissbluth*, Arzu Sencan, Stuart Bauer, Hiep Nguyen, Boston, MA INTRODUCTION AND OBJECTIVES: Neurogenic bladder dysfunction is a frequent consequence of neoplasms involving the central nervous system (CNS). Based on the level of involvement, it is expected that intracranial lesions will cause detrusor overactivity (OAB), while upper spinal cord lesions result in OAB and external urethral sphincter dyssynergy. In contrast, sacral lesions are likely to result in sensation loss, detrusor arreflexia and sphincter denervation. The purpose of this study is to validate whether tumor location in children