Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder

Phase 2

Completed

• Conditions: Bladder, Neurogenic
• Interventions: Drug: Placebo; Drug: tamsulosin hydrochloride

• Registration Number: NCT00796614
• Lead Sponsor: Boehringer Ingelheim

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

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-24
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2012-08-06
• Results First Submitted QC: 2012-08-06
• Results First Posted: 2012-09-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

• Neuropathic bladder secondary to a known neurologic deficit (e.g. spina bifida)
• Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements

Exclusion Criteria

• Clinically significant abnormalities as determined by the investigator
• A history of relevant orthostatic hypotension, fainting spells or blackouts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks
Low dose	tamsulosin hydrochloride	Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
Medium dose	tamsulosin hydrochloride	Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
High dose	tamsulosin hydrochloride	Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks

Primary Outcome Measures

Name	Time	Method
Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.	Week 14	The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in LPP at Week 14 (End of Treatment)	Baseline and Week 14	Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.
Percentage Change From Baseline in LPP at Week 14 (End of Treatment)	Baseline and Week 14.	Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.
Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline	Baseline and Week 14	Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading.; The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization
Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline	Baseline and Week 14	Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14).; Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14.
Change From Baseline in Urine Volume at Week 14	Baseline and Week 14	Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.
Change From Baseline in Number of Times Patient Was Wet at Catheterisation	Baseline and Week 14	Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.
Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.	From first drug administration until 28 days after last study drug administration, upto 160 days	Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis.; Relevant findings or worsening of baseline conditions were reported as adverse events.
Post Void Residual Volume at Week 14	Baseline and Week 14.	Median change from baseline to Week 14 in post void residual (mL) by study treatment.