Trial · NCT00549939
Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
NCT00549939, Phase 3, Completed, Sanofi; results first posted 2011-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction. Trials, record NCT00549939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00549939
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
- NCT number
- NCT00549939
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 172 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Neurogenic Urinary Bladder
- Interventions
- Alfuzosin, Placebo
- First posted
- 2007-10-26
- Last updated
- 2014-10-29
- Other registries' IDs
- eudract:2004-002397-38
- Results first posted
- 2011-02-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O | 12 weeks (double blind treatment period) | Detrusor Leak Point Pressure (LPP) was measured by cystometry. For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained. Investigators reading was then consolidated by the review of all cystometry data by 2 external "Expert Reviewers", who were blinded for the study treatment. The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion). |
| Secondary | Detrusor Leak Point Pressure (LPP) | baseline and 12 weeks (double blind treatment period) | Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure. |
| Secondary | Absolute Change in Detrusor LPP | 12 weeks ((double blind treatment period) | Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline |
| Secondary | Relative Change in Detrusor LPP | 12 weeks (double blind treatment period) | Relative change = 100 \* (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline |
| Secondary | Detrusor Compliance | baseline and 12 weeks (double blind treatment period) | Detrusor compliance is defined as the relationship between change in detrusor volume and change in detrusor pressure. It was calculated by dividing the volume change (ΔV) by the change in detrusor pressure (Δpdet) during that change in detrusor volume at leak point (C= ΔV/Δpdet). |
| Secondary | Relative Change in Detrusor Compliance | 12 weeks (double blind treatment period) | Relative change = 100 \* (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline |
| Secondary | Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes | 12 weeks (double blind treatment period) | When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture. A symptomatic UTI was defined as the presence of symptoms and a positive culture with \> 100 000 Colony Forming Units (CFUs) with a single organism. |
| Secondary | Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes | 52 weeks (double blind treatment period + open label extension treatment period) | Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O | 12 weeks (double blind treatment period) | The Intent-to-treat (ITT) population was used for the analysis. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization. | participants | NUMBER |
| SECONDARY | Detrusor Leak Point Pressure (LPP) | baseline and 12 weeks (double blind treatment period) | The analysis was performed on the Intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post-baseline LPP values. Patients were included in the treatment group to which they were allocated as per randomization. | cmH2O | MEAN |
| SECONDARY | Absolute Change in Detrusor LPP | 12 weeks ((double blind treatment period) | The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value). | cmH2O | LEAST_SQUARES_MEAN |
| SECONDARY | Relative Change in Detrusor LPP | 12 weeks (double blind treatment period) | The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value). | percentage of cmH2O | LEAST_SQUARES_MEAN |
| SECONDARY | Detrusor Compliance | baseline and 12 weeks (double blind treatment period) | The analysis was performed on the intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post baseline detrusor compliance values. Patients were included in the treatment group to which they were allocated as per randomization. | mL/cmH20 | MEAN |
| SECONDARY | Relative Change in Detrusor Compliance | 12 weeks (double blind treatment period) | The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value). | percentage of mL/cmH2O | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes | 12 weeks (double blind treatment period) | The analysis was performed on the intent-to-treat (ITT) population. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization. | participants | NUMBER |
| SECONDARY | Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes | 52 weeks (double blind treatment period + open label extension treatment period) | The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received). It included 3 + 3 patients treated during the 1st treatment period only, 26 + 28 patients treated during the 2nd treatment period only and 54 + 55 patients treated during both periods. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O | Placebo | < 40 cmH2O (Success) | 23 | participants | |
| Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O | Alfuzosin 0.1 mg/kg/Day | < 40 cmH2O (Success) | 23 | participants | |
| Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O | Alfuzosin 0.2 mg/kg/Day | < 40 cmH2O (Success) | 28 | participants | |
| Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O | Placebo | ≥ 40 cmH2O or missing (Failure) | 34 | participants | |
| Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O | Alfuzosin 0.1 mg/kg/Day | ≥ 40 cmH2O or missing (Failure) | 34 | participants | |
| Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O | Alfuzosin 0.2 mg/kg/Day | ≥ 40 cmH2O or missing (Failure) | 30 | participants | |
| Detrusor Leak Point Pressure (LPP) | Placebo | Baseline | 54.2 | Standard Deviation 12.6 | cmH2O |
| Detrusor Leak Point Pressure (LPP) | Alfuzosin 0.1 mg/kg/Day | Baseline | 53.3 | Standard Deviation 13.4 | cmH2O |
| Detrusor Leak Point Pressure (LPP) | Alfuzosin 0.2 mg/kg/Day | Baseline | 50.9 | Standard Deviation 10.0 | cmH2O |
| Detrusor Leak Point Pressure (LPP) | Placebo | 12 Weeks | 48.2 | Standard Deviation 23.4 | cmH2O |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 12-week Double Blind Treatment Period | STARTED | Placebo | 57 | |
| 12-week Double Blind Treatment Period | STARTED | Alfuzosin 0.1 mg/kg/Day | 57 | |
| 12-week Double Blind Treatment Period | STARTED | Alfuzosin 0.2 mg/kg/Day | 58 | |
| 12-week Double Blind Treatment Period | COMPLETED | Placebo | 56 | |
| 12-week Double Blind Treatment Period | COMPLETED | Alfuzosin 0.1 mg/kg/Day | 55 | |
| 12-week Double Blind Treatment Period | COMPLETED | Alfuzosin 0.2 mg/kg/Day | 56 | |
| 12-week Double Blind Treatment Period | NOT COMPLETED | Placebo | 1 | |
| 12-week Double Blind Treatment Period | NOT COMPLETED | Alfuzosin 0.1 mg/kg/Day | 2 | |
| 12-week Double Blind Treatment Period | NOT COMPLETED | Alfuzosin 0.2 mg/kg/Day | 2 | |
| 40-week Open Label Treatment Period | STARTED | Placebo | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NASOPHARYNGITIS | Infections and infestations | Alfuzosin 0.1 mg/kg/Day | 6 | 83 | |
| other | NASOPHARYNGITIS | Infections and infestations | Alfuzosin 0.2 mg/kg/Day | 12 | 86 | |
| other | CYSTITIS | Infections and infestations | Alfuzosin 0.1 mg/kg/Day | 5 | 83 | |
| other | CYSTITIS | Infections and infestations | Alfuzosin 0.2 mg/kg/Day | 9 | 86 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Alfuzosin 0.1 mg/kg/Day | 9 | 83 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Alfuzosin 0.2 mg/kg/Day | 6 | 86 | |
| other | PHARYNGITIS | Infections and infestations | Alfuzosin 0.1 mg/kg/Day | 8 | 83 | |
| other | PHARYNGITIS | Infections and infestations | Alfuzosin 0.2 mg/kg/Day | 5 | 86 | |
| other | RESPIRATORY TRACT INFECTION | Infections and infestations | Alfuzosin 0.1 mg/kg/Day | 7 | 83 | |
| other | RESPIRATORY TRACT INFECTION | Infections and infestations | Alfuzosin 0.2 mg/kg/Day | 5 | 86 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alfuzosin 0.1 mg/kg/Day | ||
| Total, all-cause mortality | Alfuzosin 0.2 mg/kg/Day | ||
| Total, other adverse events | Alfuzosin 0.1 mg/kg/Day | 37 | 83 |
| Total, other adverse events | Alfuzosin 0.2 mg/kg/Day | 43 | 86 |
| Total, serious adverse events | Alfuzosin 0.1 mg/kg/Day | 10 | 83 |
| Total, serious adverse events | Alfuzosin 0.2 mg/kg/Day | 7 | 86 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Alfuzosin 0.1 mg/kg/Day vs Alfuzosin 0.2 mg/kg/Day: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00549939
GET https://conductscience.org/api/trials/v1/NCT00549939/results?page=2