Not provided
Not provided
Not provided
Not provided
Not provided
Insufficient subject availability/findings for data analysis
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.
Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vesicare | Active Comparator | Vesicare alone |
|
| Vesicare/behavioral modification | Active Comparator | Vesicare plus behavioral modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vesicare (solifenacin) | Drug | 5mg po qd |
| |
| Vesicare (solifenacin) plus behavioral modification |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. | 0 week - 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Symptom Severity | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John T Stoffel, M.D. | Lahey Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vesicare Alone | Vesicare alone in treatment of incontinence |
| FG001 | Vesicare Plus Behavioral Modification | Vesicare plus behavioral modification for treatment of incontinence |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vesicare Alone | Vesicare alone in treatment of incontinence |
| BG001 | Vesicare Plus Behavioral Modification | Vesicare plus behavioral modification for treatment of incontinence |
| 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 From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. | Posted | Mean | Full Range | incontinence episodes per 24 hours | 0 week - 12 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vesicare Alone | Vesicare alone in treatment of incontinence |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John T. Stoffel, MD | Lahey Clinic | 781-744-5481 | John.T.Stoffel@lahey.org |
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
5 mg dose po once daily plus behavioral modification |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Improvement of Symptom Severity | data were not collected | Posted | 3 months |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Vesicare Plus Behavioral Modification | Vesicare plus behavioral modification for treatment of incontinence | 0 | 6 | 0 | 6 |
Not provided
Not provided
| 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 |
| D014555 | Urination Disorders |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |