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The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).
Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia.
The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively.
Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solifenacin | Active Comparator |
| |
| Solifenacin plus Tamsulosin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin | Drug | Solifenacin (5mg, qd, oral) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Number of Micturition Episodes Per 24 Hours | at week 24 relative to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Change of Urgency Episodes Per 24 Hours | at week 24 relative to baseline | |
| Change in Total Score of OABSS | Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwang Woo Lee, Ph.D | Soonchunhyang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 420-767 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Solifenacin | Solifenacin: Solifenacin (5mg, qd, oral) |
| FG001 | Solifenacin Plus Tamsulosin | Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Solifenacin | Solifenacin: Solifenacin (5mg, qd, oral) |
| BG001 | Solifenacin Plus Tamsulosin | Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Number of Micturition Episodes Per 24 Hours | Posted | Mean | 95% Confidence Interval | episodes | at week 24 relative to baseline |
|
|
24weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Solifenacin | Solifenacin: Solifenacin (5mg, qd, oral) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | Systematic Assessment |
small study population
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kwang-Woo Lee | Soonchunhyang Bucheon Hospital | +82 32 621 5465 | urolkw@schmc.ac.kr |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| Solifenacin plus Tamsulosin | Drug | Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral) |
|
|
| at week 24 relative to baseline |
| Change in Score of IPSS | Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points. | at week 24 relative to baseline |
| Change of PVR | Change from baseline in Post-Void Residual (PVR) volume | at week 24 relative to baseline |
| Change of Qmax | maximal urinary flow rate (Qmax) assessed by uroflowmetry | at week 24 relative to baseline |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Numeric Change of Urgency Episodes Per 24 Hours | Posted | Mean | 95% Confidence Interval | episodes | at week 24 relative to baseline |
|
|
|
| Secondary | Change in Total Score of OABSS | Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome) | Posted | Mean | 95% Confidence Interval | units on a scale | at week 24 relative to baseline |
|
|
|
| Secondary | Change in Score of IPSS | Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points. | Posted | Mean | 95% Confidence Interval | units on a scale | at week 24 relative to baseline |
|
|
|
| Secondary | Change of PVR | Change from baseline in Post-Void Residual (PVR) volume | Posted | Mean | 95% Confidence Interval | mL | at week 24 relative to baseline |
|
|
|
| Secondary | Change of Qmax | maximal urinary flow rate (Qmax) assessed by uroflowmetry | Posted | Mean | 95% Confidence Interval | mL/sec | at week 24 relative to baseline |
|
|
|
| 0 |
| 35 |
| 2 |
| 35 |
| EG001 | Solifenacin Plus Tamsulosin | Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral) | 0 | 35 | 2 | 35 |
| dry mouth | Endocrine disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |