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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
231
Oral
Oral
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.
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.
Time frame: Week 14
Change From Baseline in LPP at Week 14 (End of Treatment)
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.
Time frame: Baseline and Week 14
Percentage Change From Baseline in LPP at Week 14 (End of Treatment)
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.
Time frame: Baseline and Week 14.
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
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
Time frame: Baseline and Week 14
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
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Los Angeles, California, United States
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Tampa, Florida, United States
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St Louis, Missouri, United States
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Buffalo, New York, United States
Unnamed facility
Tarrytown, New York, United States
Unnamed facility
Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
Unnamed facility
Ghent, Belgium
Unnamed facility
Santo André, Brazil
Unnamed facility
São Paulo, Brazil
...and 42 more locations
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.
Time frame: Baseline and Week 14
Change From Baseline in Urine Volume at Week 14
Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.
Time frame: Baseline and Week 14
Change From Baseline in Number of Times Patient Was Wet at Catheterisation
Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.
Time frame: Baseline and Week 14
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.
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.
Time frame: From first drug administration until 28 days after last study drug administration, upto 160 days
Post Void Residual Volume at Week 14
Median change from baseline to Week 14 in post void residual (mL) by study treatment.
Time frame: Baseline and Week 14.