Phase 3
N=161
Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder
Bladder, Neurogenic
Bottom Line
View on ClinicalTrials.gov: NCT00796614 ↗Enrolled (actual)
161
Serious AEs
0.7%
Results posted
Sep 2012
Primary outcome: Primary: 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. — 35.3; 45.7; 27.3; 42.4 Percentage of participants — p=0.5388
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tamsulosin hydrochloride (Drug); Placebo (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
35.3; 45.7; 27.3; 42.4 | 0.5388 |
| SECONDARY Change From Baseline in LPP at Week 14 (End of Treatment) |
-11.4; -17.6; -4.6; -14.3 | 0.3097 |
| SECONDARY Percentage Change From Baseline in LPP at Week 14 (End of Treatment) |
-19.9; -27.4; -1.9; -23.9 | 0.4359 |
| SECONDARY 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 |
32; 31; 31; 37; 31; 33 | 0.5672 |
| SECONDARY 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 |
33; 33; 32; 38; 33; 33 | 0.9669 |
| SECONDARY Change From Baseline in Urine Volume at Week 14 |
-2.3; -32.2; 4.4; 3.3 | 0.1373 |
| SECONDARY Change From Baseline in Number of Times Patient Was Wet at Catheterisation |
0.3; -1.7; 0.0; -0.4 | 0.0808 |
| SECONDARY 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. |
18; 39; 24; 15; 1; 2 | — |
| SECONDARY Post Void Residual Volume at Week 14 |
3; -19; -1.5; 0.00 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00796614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.