Conditions: Bladder, Neurogenic
Keywords: tamsulosin pediatric neurogenic bladder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 231
Healthy volunteers: no

Brief summary:
Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit

Detailed description:

Arms:
arm 1: Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks arm 2: Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks arm 3: Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks arm 4: Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks

Interventions: intervention 1: tamsulosin hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol document: