Bladder, Neurogenic
Conditions
Keywords
tamsulosin, pediatric, neurogenic bladder
Brief 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
Interventions
Oral
DRUGPlacebo
Oral
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in LPP at Week 14 (End of Treatment) | 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. |
| 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 | 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 |
| 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 | 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. |
| Change From Baseline in LPP at Week 14 (End of Treatment) | 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. |
| Change From Baseline in Number of Times Patient Was Wet at Catheterisation | Baseline and Week 14 | Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary. |
| 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. | 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. |
| Post Void Residual Volume at Week 14 | Baseline and Week 14. | Median change from baseline to Week 14 in post void residual (mL) by study treatment. |
| Change From Baseline in Urine Volume at Week 14 | Baseline and Week 14 | Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14. |
Countries
Belgium, Brazil, Germany, India, Italy, Mexico, Philippines, Russia, South Africa, South Korea, Spain, Ukraine, United States
Participant flow
Recruitment details
The trial included children from 2-16 years of age, with elevated detrusor leak point pressure associated with a known neurologic defect (e.g., spina bifida). The three age strata were 2-\<5 years, 5-\<10 years and 10-16 years of age. In this study, 231 subjects were enrolled, 162 subjects were randomised and 161 subjects were treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | 41 |
| Tamsulosin - Low Dose Level Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | 40 |
| Tamsulosin - Medium Dose Level Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | 39 |
| Tamsulosin - High Dose Level Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt. | 41 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 | 1 | 0 |
| Overall Study | Other than stated | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Tamsulosin - Low Dose Level | Tamsulosin - Medium Dose Level | Tamsulosin - High Dose Level | Total |
|---|---|---|---|---|---|
| Age, Continuous | 8.4 Years STANDARD_DEVIATION 3.7 | 8.1 Years STANDARD_DEVIATION 4.2 | 8.1 Years STANDARD_DEVIATION 3.8 | 8.2 Years STANDARD_DEVIATION 4.3 | 8.2 Years STANDARD_DEVIATION 4 |
| Age, Customized 10 to 16 years | 16 participants | 15 participants | 15 participants | 15 participants | 61 participants |
| Age, Customized 2 to < 5 years | 7 participants | 8 participants | 7 participants | 8 participants | 30 participants |
| Age, Customized 5 to < 10 years | 18 participants | 17 participants | 17 participants | 18 participants | 70 participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 14 Participants | 16 Participants | 64 Participants |
| Sex: Female, Male Male | 25 Participants | 22 Participants | 25 Participants | 25 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 41 | 19 / 120 | 14 / 80 | 8 / 40 |
| serious Total, serious adverse events | 1 / 41 | 1 / 120 | 0 / 80 | 0 / 40 |
Outcome results
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.
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
Population: Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 Percentage of participants |
| Tamsulosin - Low Dose Level | 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. | 45.7 Percentage of participants |
| Tamsulosin - Medium Dose Level | 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. | 27.3 Percentage of participants |
| Tamsulosin - High Dose Level | 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. | 42.4 Percentage of participants |
Comparison: Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.p-value: 0.538895% CI: [0.5, 3.8]Regression, Logistic
Comparison: Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.p-value: 0.34395% CI: [0.2, 1.76]Regression, Logistic
Comparison: Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.p-value: 0.520995% CI: [0.5, 3.97]Regression, Logistic
Comparison: A test of trend across the four treatment groups was performed as a secondary analysis in the proportion of responders across the dose levels using Cochran-Armitage trend test.p-value: 0.9436Cochran-Armitage trend test
Secondary
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
Population: Full analysis set-LPP (FAS-LPP), OT
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in LPP at Week 14 (End of Treatment) | -11.4 cm H2O | Standard Error 4.6 |
| Tamsulosin - Low Dose Level | Change From Baseline in LPP at Week 14 (End of Treatment) | -17.6 cm H2O | Standard Error 4.5 |
| Tamsulosin - Medium Dose Level | Change From Baseline in LPP at Week 14 (End of Treatment) | -4.6 cm H2O | Standard Error 4.4 |
| Tamsulosin - High Dose Level | Change From Baseline in LPP at Week 14 (End of Treatment) | -14.3 cm H2O | Standard Error 4.3 |
Comparison: ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.p-value: 0.3097ANCOVA
Comparison: ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.p-value: 0.2676ANCOVA
Comparison: ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.p-value: 0.6265ANCOVA
Secondary
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
Population: Full analysis set-catheter (FAS-CATH)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Number of Times Patient Was Wet at Catheterisation | 0.3 Times patient wet at catheterization | Standard Error 0.8 |
| Tamsulosin - Low Dose Level | Change From Baseline in Number of Times Patient Was Wet at Catheterisation | -1.7 Times patient wet at catheterization | Standard Error 0.9 |
| Tamsulosin - Medium Dose Level | Change From Baseline in Number of Times Patient Was Wet at Catheterisation | 0.0 Times patient wet at catheterization | Standard Error 0.9 |
| Tamsulosin - High Dose Level | Change From Baseline in Number of Times Patient Was Wet at Catheterisation | -0.4 Times patient wet at catheterization | Standard Error 0.8 |
Comparison: ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.0808ANCOVA
Comparison: ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.8244ANCOVA
Comparison: ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.5045ANCOVA
Secondary
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
Population: Full analysis set-catheter (FAS-CATH): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment, were on a catheterisation regimen, and had at least one on-treatment catheterisation assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Urine Volume at Week 14 | -2.3 mL | Standard Error 14 |
| Tamsulosin - Low Dose Level | Change From Baseline in Urine Volume at Week 14 | -32.2 mL | Standard Error 15.5 |
| Tamsulosin - Medium Dose Level | Change From Baseline in Urine Volume at Week 14 | 4.4 mL | Standard Error 16.3 |
| Tamsulosin - High Dose Level | Change From Baseline in Urine Volume at Week 14 | 3.3 mL | Standard Error 14.2 |
Comparison: ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.1373ANCOVA
Comparison: ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.744ANCOVA
Comparison: ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.7703ANCOVA
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.
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
Population: Treated Set (TS).~All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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. | Occurrence of treatment emergent adverse events | 18 Participants |
| Placebo | 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. | Sinus tachycardia | 0 Participants |
| Placebo | 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. | Premature discontinuation of study drug due to AE | 1 Participants |
| Tamsulosin - Low Dose Level | 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. | Occurrence of treatment emergent adverse events | 39 Participants |
| Tamsulosin - Low Dose Level | 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. | Sinus tachycardia | 0 Participants |
| Tamsulosin - Low Dose Level | 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. | Premature discontinuation of study drug due to AE | 2 Participants |
| Tamsulosin - Medium Dose Level | 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. | Premature discontinuation of study drug due to AE | 0 Participants |
| Tamsulosin - Medium Dose Level | 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. | Occurrence of treatment emergent adverse events | 24 Participants |
| Tamsulosin - Medium Dose Level | 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. | Sinus tachycardia | 0 Participants |
| Tamsulosin - High Dose Level | 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. | Occurrence of treatment emergent adverse events | 15 Participants |
| Tamsulosin - High Dose Level | 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. | Sinus tachycardia | 1 Participants |
| Tamsulosin - High Dose Level | 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. | Premature discontinuation of study drug due to AE | 0 Participants |
Secondary
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.
Population: Full analysis set-LPP (FAS-LPP), OT
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage Change From Baseline in LPP at Week 14 (End of Treatment) | -19.9 Percentage change | Standard Error 7.3 |
| Tamsulosin - Low Dose Level | Percentage Change From Baseline in LPP at Week 14 (End of Treatment) | -27.4 Percentage change | Standard Error 7.1 |
| Tamsulosin - Medium Dose Level | Percentage Change From Baseline in LPP at Week 14 (End of Treatment) | -1.9 Percentage change | Standard Error 7 |
| Tamsulosin - High Dose Level | Percentage Change From Baseline in LPP at Week 14 (End of Treatment) | -23.9 Percentage change | Standard Error 6.9 |
Comparison: ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.p-value: 0.4359ANCOVA
Comparison: ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.p-value: 0.0658ANCOVA
Comparison: ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.p-value: 0.6709ANCOVA
Secondary
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.
Population: Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo | Post Void Residual Volume at Week 14 | 3 mL | Standard Deviation 80.28 |
| Tamsulosin - Low Dose Level | Post Void Residual Volume at Week 14 | -19 mL | Standard Deviation 66.4 |
| Tamsulosin - Medium Dose Level | Post Void Residual Volume at Week 14 | -1.5 mL | Standard Deviation 92.33 |
| Tamsulosin - High Dose Level | Post Void Residual Volume at Week 14 | 0.00 mL | Standard Deviation 58.67 |
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
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
Population: Full analysis set-renal (FAS-RENAL): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment and had at least one on-treatment renal ultrasound measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | Right Kidney [N= 33; 34; 34; 40] | 31 Participants |
| Placebo | 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 | Left Kidney [N= 34; 34; 33; 40] | 32 Participants |
| Tamsulosin - Low Dose Level | 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 | Right Kidney [N= 33; 34; 34; 40] | 33 Participants |
| Tamsulosin - Low Dose Level | 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 | Left Kidney [N= 34; 34; 33; 40] | 31 Participants |
| Tamsulosin - Medium Dose Level | 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 | Right Kidney [N= 33; 34; 34; 40] | 30 Participants |
| Tamsulosin - Medium Dose Level | 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 | Left Kidney [N= 34; 34; 33; 40] | 31 Participants |
| Tamsulosin - High Dose Level | 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 | Left Kidney [N= 34; 34; 33; 40] | 37 Participants |
| Tamsulosin - High Dose Level | 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 | Right Kidney [N= 33; 34; 34; 40] | 38 Participants |
Comparison: Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.5672Regression, Logistic
Comparison: Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.8724Regression, Logistic
Comparison: Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.7674Regression, Logistic
Comparison: Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.5545Regression, Logistic
Comparison: Patient responded to tamsulosin-Medium dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.4774Regression, Logistic
Comparison: Patient responded to tamsulosin-High dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use,and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.8626Regression, Logistic
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
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
Population: Full analysis set-renal (FAS-RENAL)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | Left Kidney (N= 34, 34, 33, 40) | 33 Participants |
| Placebo | 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 | Right Kidney (N= 33, 34, 34, 40) | 33 Participants |
| Tamsulosin - Low Dose Level | 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 | Right Kidney (N= 33, 34, 34, 40) | 33 Participants |
| Tamsulosin - Low Dose Level | 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 | Left Kidney (N= 34, 34, 33, 40) | 33 Participants |
| Tamsulosin - Medium Dose Level | 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 | Left Kidney (N= 34, 34, 33, 40) | 32 Participants |
| Tamsulosin - Medium Dose Level | 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 | Right Kidney (N= 33, 34, 34, 40) | 32 Participants |
| Tamsulosin - High Dose Level | 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 | Left Kidney (N= 34, 34, 33, 40) | 38 Participants |
| Tamsulosin - High Dose Level | 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 | Right Kidney (N= 33, 34, 34, 40) | 38 Participants |
Comparison: Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.9669Regression, Logistic
Comparison: Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.9231Regression, Logistic
Comparison: Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.p-value: 0.636Regression, Logistic
Comparison: Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.p-value: 1Fisher Exact
Comparison: Patient responded to tamsulosin-medium dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.p-value: 0.4925Fisher Exact
Comparison: Patient responded to tamsulosin-high dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.p-value: 0.4977Fisher Exact