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This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling.
This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in post void dribbling episodes (events) as the primary endpoint.
Secondary endpoints will include:
We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solifenacin | Active Comparator | patients in this arm will receive drug |
|
| placebo | Placebo Comparator | patients is this arm will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solifenacin | Drug | patient will receive solifenacin 5mg daily or placebo daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percent Reduction in Post Void Dribbling Episodes (Events) | outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12 |
| Measure | Description | Time Frame |
|---|---|---|
| the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes | outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12 | |
| Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tova S Ablove, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | study subjects who received solifenacin 5mg daily |
| FG001 | Placebo | study subjects who received placebo daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Solifenacin | patients in this arm will receive drug solifenacin: patient will receive solifenacin 5mg daily or placebo daily |
| BG001 | Placebo | patients is this arm will receive placebo solifenacin: patient will receive solifenacin 5mg daily or placebo daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Percent Reduction in Post Void Dribbling Episodes (Events) | one subject was excluded from analysis because of missing baseline data | Posted | Mean | Full Range | percent reduction | outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12 |
|
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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 | patients in this arm will receive drug solifenacin: patient will receive solifenacin 5mg daily or placebo daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| small bowel obstruction | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| blurry eyes | Eye disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tova Ablove | University at Buffalo | 716-878-7138 | tablove@buffalo.edu |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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The difference between baseline and follow up (last 20 days on drug) scores was the recorded measure. The larger the negative # the greater the effect. The survey was divided into 3 sections, each section worth 100 points. Total scores could range from 0 to 300 (0 no disease, 300 severe disease). |
| outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| post void dribbling episodes per day | Mean | Standard Deviation | post void dribbling episodes |
|
| voids per day | Mean | Standard Deviation | voids per day |
|
| urgency episodes per day | Mean | Standard Deviation | urgency episodes per day |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes | one study subject was excluded form analysis due to missing baseline data | Posted | Number | percent | outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12 |
|
|
|
|
| Secondary | Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions) | The difference between baseline and follow up (last 20 days on drug) scores was the recorded measure. The larger the negative # the greater the effect. The survey was divided into 3 sections, each section worth 100 points. Total scores could range from 0 to 300 (0 no disease, 300 severe disease). | one subject was excluded from analysis because of missing baseline data | Posted | Mean | Full Range | change in score | outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment |
|
|
|
|
| 2 |
| 58 |
| 23 |
| 58 |
| EG001 | Placebo | patients is this arm will receive placebo solifenacin: patient will receive solifenacin 5mg daily or placebo daily | 0 | 60 | 16 | 60 |
| elective surgery | Musculoskeletal and connective tissue disorders | patient was hospitalized for elective total knee replacement |
|
| dry eyes | Eye disorders |
|
| constipation | Gastrointestinal disorders |
|
| dry mouth | Gastrointestinal disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| upset stomach | Gastrointestinal disorders |
|
| nausea | Gastrointestinal disorders |
|
| vomiting | Gastrointestinal disorders |
|
| cold | Infections and infestations |
|
| pneumonia | Infections and infestations |
|
| UTI | Infections and infestations |
|
| headache | Nervous system disorders |
|
| worsening incontinence | Renal and urinary disorders |
|
| increased urinary frequency | Renal and urinary disorders |
|
| hot flashes | Reproductive system and breast disorders |
|
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| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |