| Primary | Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks | Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF). | Modified intention-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study. | Posted | | Least Squares Mean | Standard Error | mL | | baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF) | | | | ID | Title | Description |
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| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00044.993± 9.2774
- OG00136.948± 8.7786
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable. | ANCOVA | | 0.5293 | Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P<0.05. | Mean Difference (Final Values) | -8.045 | | | | 95 | -33.194 | 17.104 | | | | No | |
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| Primary | Change From Baseline in Average Number of Daily Micturitions at 6 Weeks | Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF). | Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who "completed". | Posted | | Least Squares Mean | Standard Error | micturitions per day | | baseline and up to 6 weeks of treatment LOCF | | | | ID | Title | Description |
|---|
| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
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| Secondary | Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks | Detrusor pressure was measured by means of urodynamic assessment (cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF). | Modified intent-to-treat (mITT) population: participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study. | Posted | | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | | baseline and up to 6 weeks of treatment LOCF | | | | ID | Title | Description |
|---|
| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
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| Secondary | Change From Baseline in Volume at First Detectable Leakage at 6 Weeks | First detectable leakage was determined by means of cystometry as an obligatory urodynamic measure. Missing data was imputed by last observation carried forward (LOCF). | Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study. | Posted | | Least Squares Mean | Standard Error | mL | | baseline and up to 6 weeks of treatment LOCF | | | | ID | Title | Description |
|---|
| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
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| Secondary | Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks | Maximum cystometric bladder capacity was defined as the volume at which either significant leakage or discomfort/pain occurred. Missing data were imputed by last observation carried forward (LOCF). | Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study. | Posted | | Least Squares Mean | Standard Error | mL | | baseline and up to 6 weeks of treatment LOCF | | | | ID | Title | Description |
|---|
| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
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| Secondary | Change From Baseline in Volume at First Desire to Void at 6 Weeks | Volume at first desire to void was recorded during urodynamic assessments. Missing data were imputed by last observation carried forward (LOCF). | Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who "completed" the study. | Posted | | Least Squares Mean | Standard Error | mL | | baseline and up to 6 weeks of treatment LOCF | | | | ID | Title | Description |
|---|
| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
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| Secondary | Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks | The average number of urgencies was derived from the number of urgencies reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward. | Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who "completed". | Posted | | Least Squares Mean | Standard Error | urgencies per day | | baseline and up to 6 weeks of treatment LOCF | | | | ID | Title | Description |
|---|
| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
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| Secondary | Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks | The average number of daily involuntary discharges of urine was derived from the number of discharges reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward. | Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who "completed". | Posted | | Least Squares Mean | Standard Error | involuntary discharges per day | | baseline and up to 6 weeks of treatment LOCF | | | | ID | Title | Description |
|---|
| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
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| Secondary | Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older | Peak urinary flow (Qmax) was measured using urodynamic assessments (voiding / flow cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF). | mITT: Participants who received at least one dose, randomized correctly according to Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. Qmax is based on men predominantly aged 50 years and older but includes a few males who had Qmax collected even if younger than 50 years. | Posted | | Least Squares Mean | Standard Error | milliliter per second (mL/s) | | baseline and up to 6 weeks of treatment LOCF | | | | ID | Title | Description |
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| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
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| Secondary | Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks | The OAB-q is a validated, self-administered questionnaire that quantifies bladder symptoms and quality of life. It comprises 33 items (6-point scale for each item). The total score ranges from 33 (minimum symptoms) to 198 (maximum symptoms). On each item, participants provide their rating over the past 4 weeks. Missing data were imputed by LOCF. | Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who "completed". | Posted | | Least Squares Mean | Standard Error | scores on a scale | | baseline and up to 6 weeks of treatment LOCF | | | | ID | Title | Description |
|---|
| OG000 | Vardenafil HCl (Levitra, BAY38-9456) | vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks | | OG001 | Placebo | vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks |
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