Trial · NCT00507455
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
NCT00507455, Phase 2, Completed, Astellas Pharma Inc; results first posted 2014-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction. Trials, record NCT00507455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00507455
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
- NCT number
- NCT00507455
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 222 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Lower Urinary Tract Symptoms, Bladder Outlet Obstruction
- Interventions
- solifenacin succinate, tamsulosin hydrochloride, Placebo to solifenacin, Placebo to tamsulosin
- First posted
- 2007-07-26
- Last updated
- 2014-08-06
- Other registries' IDs
- eudract:2007-001268-57
- Results first posted
- 2014-08-06
- Limitations and caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | Baseline and Week 12 | Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry. |
| Primary | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | Baseline and Week 12 | The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine. |
| Secondary | Change From Baseline in Post Void Residual Volume (PVR) | Baseline and Weeks 2, 4, 8 and 12 | Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation. End-of-treatment is the last post-baseline assessment during the treatment period. Least squares (LS) means were adjusted for pooled center and the Baseline value. |
| Secondary | Change From Baseline to End of Treatment in Bladder Contractility Index (BCI) | Baseline and Week 12 | The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula: BCI = pdetQmax + 5Qmax. Strong contractility is a BCI \> 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of \< 100. LS means were adjusted for pooled center and Baseline value. |
| Secondary | Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE) | Baseline and Week 12 | Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula: Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity. A higher number indicates a higher voiding efficiency. LS means were adjusted for pooled center and Baseline value. |
| Secondary | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks). | Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. |
| Secondary | Change From Baseline in International Prostate Symptoms Score (IPSS) | Baseline and Weeks 2, 4, 8 and 12 | The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms: * Sensation of incomplete emptying * Repeat urinating after 2 hours (frequency) * Start and stop several times (intermittency) * Urgency * Weak stream * Straining * Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Least squares (LS) means were adjusted for pooled center and the Baseline value. |
| Secondary | Change From Baseline in IPSS Voiding Score | Baseline and Weeks 2, 4, 8 and 12 | The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic). Least squares (LS) means were adjusted for pooled center and the Baseline value. |
| Secondary | Change From Baseline in IPSS Storage Score | Baseline and Weeks 2, 4, 8 and 12 | The IPSS is a validated global questionnaire used to assess the degree of "bother" from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic). Least squares (LS) means were adjusted for pooled center and the Baseline value. |
| Secondary | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Baseline and Weeks 2, 4, 8 and 12 | The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems). Least squares (LS) means were adjusted for pooled center and the Baseline value. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | Baseline and Week 12 | Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had both urodynamic measurements at baseline and one or both measured at any post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used. | cmH2O | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Post Void Residual Volume (PVR) | Baseline and Weeks 2, 4, 8 and 12 | Full analysis set (FAS) population with available data at each time point (as indicated by N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method. | mL | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | Baseline and Week 12 | Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had urodynamic measurements at baseline and post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used. | mL/sec | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to End of Treatment in Bladder Contractility Index (BCI) | Baseline and Week 12 | Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE) | Baseline and Week 12 | Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used. | Percent voiding efficiency | LEAST_SQUARES_MEAN |
| SECONDARY | Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests | From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks). | Safety analysis set population consisted of participants who received at least 1 dose of double-blind treatment. | participants | NUMBER |
| SECONDARY | Change From Baseline in International Prostate Symptoms Score (IPSS) | Baseline and Weeks 2, 4, 8 and 12 | Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IPSS Voiding Score | Baseline and Weeks 2, 4, 8 and 12 | Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IPSS Storage Score | Baseline and Weeks 2, 4, 8 and 12 | Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Patient Perception of Bladder Condition (PPBC) | Baseline and Weeks 2, 4, 8 and 12 | Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group219
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | Placebo | -1.69 | Standard Error 3.15 | cmH2O | |
| Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | 6 mg Solifenacin + 0.4 mg Tamsulosin | -7.84 | Standard Error 2.95 | cmH2O | |
| Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) | 9 mg Solifenacin + 0.4 mg Tamsulosin | -6.69 | Standard Error 3.20 | cmH2O | |
| Change From Baseline in Post Void Residual Volume (PVR) | Placebo | Week 2 (N=61, 67, 58) | -10.21 | Standard Error 6.912 | mL |
| Change From Baseline in Post Void Residual Volume (PVR) | 6 mg Solifenacin + 0.4 mg Tamsulosin | Week 2 (N=61, 67, 58) | 16.78 | Standard Error 6.525 | mL |
| Change From Baseline in Post Void Residual Volume (PVR) | 9 mg Solifenacin + 0.4 mg Tamsulosin | Week 2 (N=61, 67, 58) | 8.97 | Standard Error 7.015 | mL |
| Change From Baseline in Post Void Residual Volume (PVR) | Placebo | Week 4 (N=60, 67, 59) | -7.86 | Standard Error 6.225 | mL |
| Change From Baseline in Post Void Residual Volume (PVR) | 6 mg Solifenacin + 0.4 mg Tamsulosin | Week 4 (N=60, 67, 59) | 14.92 | Standard Error 5.830 | mL |
| Change From Baseline in Post Void Residual Volume (PVR) | 9 mg Solifenacin + 0.4 mg Tamsulosin | Week 4 (N=60, 67, 59) | 9.65 | Standard Error 6.229 | mL |
| Change From Baseline in Post Void Residual Volume (PVR) | Placebo | Week 8 (N=58, 66, 58) | -12.44 | Standard Error 6.434 | mL |
1 to 10 of 219Source ClinicalTrials.gov
See all 219 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 74 | |
| Overall Study | STARTED | 6 mg Solifenacin + 0.4 mg Tamsulosin | 74 | |
| Overall Study | STARTED | 9 mg Solifenacin + 0.4 mg Tamsulosin | 74 | |
| Overall Study | COMPLETED | Placebo | 62 | |
| Overall Study | COMPLETED | 6 mg Solifenacin + 0.4 mg Tamsulosin | 68 | |
| Overall Study | COMPLETED | 9 mg Solifenacin + 0.4 mg Tamsulosin | 62 | |
| Overall Study | NOT COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | 6 mg Solifenacin + 0.4 mg Tamsulosin | 6 | |
| Overall Study | NOT COMPLETED | 9 mg Solifenacin + 0.4 mg Tamsulosin | 12 |
Source ClinicalTrials.gov
Adverse events39
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 | Vision blurred | Eye disorders | Placebo | 1 | 74 | |
| other | Vision blurred | Eye disorders | 6 mg Solifenacin + 0.4 mg Tamsulosin | 1 | 74 | |
| other | Vision blurred | Eye disorders | 9 mg Solifenacin + 0.4 mg Tamsulosin | 4 | 74 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 74 | |
| other | Constipation | Gastrointestinal disorders | 6 mg Solifenacin + 0.4 mg Tamsulosin | 3 | 74 | |
| other | Constipation | Gastrointestinal disorders | 9 mg Solifenacin + 0.4 mg Tamsulosin | 6 | 74 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 3 | 74 | |
| other | Dry mouth | Gastrointestinal disorders | 6 mg Solifenacin + 0.4 mg Tamsulosin | 9 | 74 | |
| other | Dry mouth | Gastrointestinal disorders | 9 mg Solifenacin + 0.4 mg Tamsulosin | 14 | 74 | |
| other | Fatigue | General disorders | Placebo | 2 | 74 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 6 mg Solifenacin + 0.4 mg Tamsulosin | ||
| Total, all-cause mortality | 9 mg Solifenacin + 0.4 mg Tamsulosin | ||
| Total, other adverse events | Placebo | 10 | 74 |
| Total, other adverse events | 6 mg Solifenacin + 0.4 mg Tamsulosin | 17 | 74 |
| Total, other adverse events | 9 mg Solifenacin + 0.4 mg Tamsulosin | 19 | 74 |
| Total, serious adverse events | Placebo | 1 | 74 |
| Total, serious adverse events | 6 mg Solifenacin + 0.4 mg Tamsulosin | 2 | 74 |
| Total, serious adverse events | 9 mg Solifenacin + 0.4 mg Tamsulosin | 2 | 74 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22831853 | RESULT |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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