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Completed

NCT Number: NCT00796614

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

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

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Key information

Conditions

Bladder, Neurogenic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin Hydrochloride

Drug

Oral

Other names: Flomax, Omnic

Placebo

Drug

Oral

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Change From Baseline in LPP at Week 14 (End of Treatment)

    Time frame: 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.

  2. Percentage Change From Baseline in LPP at Week 14 (End of Treatment)

    Time frame: 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.

  3. 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

    Time frame: 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

  4. 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

    Time frame: 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.

  5. Change From Baseline in Urine Volume at Week 14

    Time frame: Baseline and Week 14

    Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.

  6. Change From Baseline in Number of Times Patient Was Wet at Catheterisation

    Time frame: Baseline and Week 14

    Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.

  7. 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.

    Time frame: 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.

  8. Post Void Residual Volume at Week 14

    Time frame: Baseline and Week 14.

    Median change from baseline to Week 14 in post void residual (mL) by study treatment.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase IIb/III, Multi-centre, Double-blind, Randomised, Placebo-controlled, Dose Ranging Study of Tamsulosin Hydrochloride (Low, Medium and High Dose) as Treatment in Children With Neuropathic Bladder for Three Months

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 24, 2008
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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