Trial Outcomes & Findings for Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction (NCT NCT00549939)

Last Updated: 2014-10-29

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

172 participants

Primary outcome timeframe

12 weeks (double blind treatment period)

Results posted on

2014-10-29

Participant Flow

The study was conducted at 55 sites in 18 countries. A total of 261 patients were screened between September 2007 and November 2008.

172/261 patients were randomized in the 12-week double blind phase. 89/261 patients were not randomized for the following reasons: * Adverse event (1 patient\*), * Inclusion/Exclusion criteria not met (69 patients\*), * Subject's request (11 patients\*), * Other (13 patients\*). '\*' Patients could have several reasons.

Participant milestones

Participant milestones
Measure	Placebo Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day	Alfuzosin 0.2 mg/kg/Day
12-week Double Blind Treatment Period STARTED	57	57	58
12-week Double Blind Treatment Period COMPLETED	56	55	56
12-week Double Blind Treatment Period NOT COMPLETED	1	2	2
40-week Open Label Treatment Period STARTED	0	80	83
40-week Open Label Treatment Period COMPLETED	0	75	78
40-week Open Label Treatment Period NOT COMPLETED	0	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day	Alfuzosin 0.2 mg/kg/Day
12-week Double Blind Treatment Period Adverse Event	1	1	2
12-week Double Blind Treatment Period Too many blood draws	0	1	0
40-week Open Label Treatment Period Adverse Event	0	2	1
40-week Open Label Treatment Period Lack of Efficacy	0	1	0
40-week Open Label Treatment Period Protocol Violation	0	1	0
40-week Open Label Treatment Period Other	0	1	4

Baseline Characteristics

Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=57 Participants Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day n=57 Participants	Alfuzosin 0.2 mg/kg/Day n=58 Participants	Total n=172 Participants Total of all reporting groups
Age, Continuous	8.3 years STANDARD_DEVIATION 4.4 • n=93 Participants	7.9 years STANDARD_DEVIATION 3.9 • n=4 Participants	8.7 years STANDARD_DEVIATION 3.9 • n=27 Participants	8.3 years STANDARD_DEVIATION 4.0 • n=483 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	27 Participants n=4 Participants	30 Participants n=27 Participants	85 Participants n=483 Participants
Sex: Female, Male Male	29 Participants n=93 Participants	30 Participants n=4 Participants	28 Participants n=27 Participants	87 Participants n=483 Participants
Region of Enrollment United States	6 participants n=93 Participants	7 participants n=4 Participants	5 participants n=27 Participants	18 participants n=483 Participants
Region of Enrollment Portugal	2 participants n=93 Participants	1 participants n=4 Participants	3 participants n=27 Participants	6 participants n=483 Participants
Region of Enrollment Serbia	4 participants n=93 Participants	6 participants n=4 Participants	7 participants n=27 Participants	17 participants n=483 Participants
Region of Enrollment Taiwan	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants	2 participants n=483 Participants
Region of Enrollment Estonia	1 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants	3 participants n=483 Participants
Region of Enrollment Slovakia	6 participants n=93 Participants	7 participants n=4 Participants	1 participants n=27 Participants	14 participants n=483 Participants
Region of Enrollment Spain	2 participants n=93 Participants	3 participants n=4 Participants	2 participants n=27 Participants	7 participants n=483 Participants
Region of Enrollment Turkey	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants	6 participants n=483 Participants
Region of Enrollment Russian Federation	8 participants n=93 Participants	7 participants n=4 Participants	4 participants n=27 Participants	19 participants n=483 Participants
Region of Enrollment India	2 participants n=93 Participants	9 participants n=4 Participants	9 participants n=27 Participants	20 participants n=483 Participants
Region of Enrollment France	1 participants n=93 Participants	2 participants n=4 Participants	4 participants n=27 Participants	7 participants n=483 Participants
Region of Enrollment Canada	3 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants	6 participants n=483 Participants
Region of Enrollment Malaysia	3 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	3 participants n=483 Participants
Region of Enrollment Poland	15 participants n=93 Participants	10 participants n=4 Participants	14 participants n=27 Participants	39 participants n=483 Participants
Region of Enrollment Germany	3 participants n=93 Participants	0 participants n=4 Participants	2 participants n=27 Participants	5 participants n=483 Participants
Urinary Tract Infection (UTI) history in the last 3 months No UTI episode	48 participants n=93 Participants	50 participants n=4 Participants	40 participants n=27 Participants	138 participants n=483 Participants
Urinary Tract Infection (UTI) history in the last 3 months One UTI episode	8 participants n=93 Participants	5 participants n=4 Participants	16 participants n=27 Participants	29 participants n=483 Participants
Urinary Tract Infection (UTI) history in the last 3 months Two UTI episodes	1 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants	5 participants n=483 Participants
Study drug formulation Solution (2-7 years)	28 participants n=93 Participants	28 participants n=4 Participants	28 participants n=27 Participants	84 participants n=483 Participants
Study drug formulation Solution (8-16 years)	8 participants n=93 Participants	10 participants n=4 Participants	9 participants n=27 Participants	27 participants n=483 Participants
Study drug formulation Tablets (8-16 years)	21 participants n=93 Participants	19 participants n=4 Participants	21 participants n=27 Participants	61 participants n=483 Participants

PRIMARY outcome

Timeframe: 12 weeks (double blind treatment period)

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day n=57 Participants	Alfuzosin 0.2 mg/kg/Day n=58 Participants
Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O < 40 cmH2O ("Success")	23 participants	23 participants	28 participants
Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O ≥ 40 cmH2O or missing ("Failure")	34 participants	34 participants	30 participants

SECONDARY outcome

Timeframe: baseline and 12 weeks (double blind treatment period)

Population: 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.

Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day n=53 Participants	Alfuzosin 0.2 mg/kg/Day n=56 Participants
Detrusor Leak Point Pressure (LPP) Baseline	54.2 cmH2O Standard Deviation 12.6	53.3 cmH2O Standard Deviation 13.4	50.9 cmH2O Standard Deviation 10.0
Detrusor Leak Point Pressure (LPP) 12 Weeks	48.2 cmH2O Standard Deviation 23.4	41.6 cmH2O Standard Deviation 18.2	39.4 cmH2O Standard Deviation 19.5

SECONDARY outcome

Timeframe: 12 weeks ((double blind treatment period)

Population: 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).

Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day n=53 Participants	Alfuzosin 0.2 mg/kg/Day n=56 Participants
Absolute Change in Detrusor LPP	-5.4 cmH2O Standard Error 2.8	-11.7 cmH2O Standard Error 2.8	-12.5 cmH2O Standard Error 2.8

SECONDARY outcome

Timeframe: 12 weeks (double blind treatment period)

Population: 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).

Relative change = 100 \* (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day n=53 Participants	Alfuzosin 0.2 mg/kg/Day n=56 Participants
Relative Change in Detrusor LPP	-9.2 percentage of cmH2O Standard Error 5.53	-20.6 percentage of cmH2O Standard Error 5.56	-23.5 percentage of cmH2O Standard Error 5.51

SECONDARY outcome

Timeframe: baseline and 12 weeks (double blind treatment period)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day n=52 Participants	Alfuzosin 0.2 mg/kg/Day n=55 Participants
Detrusor Compliance Baseline	3.4 mL/cmH20 Standard Deviation 2.8	3.4 mL/cmH20 Standard Deviation 2.8	3.3 mL/cmH20 Standard Deviation 2.5
Detrusor Compliance 12 weeks	4.8 mL/cmH20 Standard Deviation 5.0	5.3 mL/cmH20 Standard Deviation 4.9	5.8 mL/cmH20 Standard Deviation 5.9

SECONDARY outcome

Timeframe: 12 weeks (double blind treatment period)

Population: 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).

Relative change = 100 \* (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day n=52 Participants	Alfuzosin 0.2 mg/kg/Day n=55 Participants
Relative Change in Detrusor Compliance	113.6 percentage of mL/cmH2O Standard Error 35.26	126.6 percentage of mL/cmH2O Standard Error 35.76	98.6 percentage of mL/cmH2O Standard Error 35.24

SECONDARY outcome

Timeframe: 12 weeks (double blind treatment period)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day n=57 Participants	Alfuzosin 0.2 mg/kg/Day n=58 Participants
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes No symptomatic UTI	50 participants	53 participants	51 participants
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes One symptomatic UTI	5 participants	3 participants	6 participants
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes Two symptomatic UTI	2 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: 52 weeks (double blind treatment period + open label extension treatment period)

Population: 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.

Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period.

Outcome measures

Outcome measures
Measure	Placebo n=83 Participants Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo	Alfuzosin 0.1 mg/kg/Day n=86 Participants	Alfuzosin 0.2 mg/kg/Day
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes No symptomatic UTI	66 participants	70 participants	—
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes One symptomatic UTI	12 participants	13 participants	—
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes Two symptomatic UTI	3 participants	0 participants	—
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes Three symptomatic UTI	1 participants	1 participants	—
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes Four symptomatic UTI	1 participants	2 participants	—

Adverse Events

Alfuzosin 0.1 mg/kg/Day

Serious events: 10 serious events

Other events: 37 other events

Deaths: 0 deaths

Alfuzosin 0.2 mg/kg/Day

Serious events: 7 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Alfuzosin 0.1 mg/kg/Day n=83 participants at risk	Alfuzosin 0.2 mg/kg/Day n=86 participants at risk
Infections and infestations NASOPHARYNGITIS	7.2% 6/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	14.0% 12/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Infections and infestations CYSTITIS	6.0% 5/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	10.5% 9/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Infections and infestations URINARY TRACT INFECTION	10.8% 9/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	7.0% 6/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Infections and infestations PHARYNGITIS	9.6% 8/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	5.8% 5/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Infections and infestations RESPIRATORY TRACT INFECTION	8.4% 7/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	5.8% 5/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	4.8% 4/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	5.8% 5/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Gastrointestinal disorders DIARRHOEA	9.6% 8/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	11.6% 10/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Gastrointestinal disorders VOMITING	4.8% 4/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	7.0% 6/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
General disorders PYREXIA	8.4% 7/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	11.6% 10/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).

Additional Information

Trial Transparency Team

Sanofi

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months after trial completion, the investigators can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not to exceed 90 days. To protect by a property right any information the sponsor can postpone the publication, for a period not to exceed 18 months.
Publication restrictions are in place

Restriction type: OTHER

Measure	Alfuzosin 0.1 mg/kg/Day n=83 participants at risk	Alfuzosin 0.2 mg/kg/Day n=86 participants at risk
Infections and infestations VIRAL INFECTION	0.00% 0/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	1.2% 1/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Infections and infestations PYELONEPHRITIS	0.00% 0/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	1.2% 1/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Infections and infestations PNEUMONIA	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	1.2% 1/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Infections and infestations LOBAR PNEUMONIA	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	0.00% 0/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Metabolism and nutrition disorders MALNUTRITION	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	0.00% 0/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Nervous system disorders EPILEPSY	2.4% 2/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	0.00% 0/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Nervous system disorders TETHERED CORD SYNDROME	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	1.2% 1/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	0.00% 0/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Respiratory, thoracic and mediastinal disorders TONSILLAR HYPERTROPHY	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	0.00% 0/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.00% 0/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	2.3% 2/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Renal and urinary disorders RENAL IMPAIRMENT	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	0.00% 0/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Renal and urinary disorders URETHRAL HAEMORRHAGE	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	0.00% 0/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Congenital, familial and genetic disorders ARNOLD-CHIARI MALFORMATION	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	0.00% 0/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	1.2% 1/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Injury, poisoning and procedural complications VENTRICULOPERITONEAL SHUNT MALFUNCTION	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	1.2% 1/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
Injury, poisoning and procedural complications CONTUSION	1.2% 1/83 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).	0.00% 0/86 • All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected. The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).