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The purpose of this study is to look for evidence of bacteria in the urine or bladder of people with overactive bladder. Because you do not have overactive bladder, your participation in this study will be used as a comparison to those who have overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Subjects with urge incontinence due to overactive bladder | ||
| 2 | women with no urge symptoms |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation | Sterile specimens were obtained from subjects. The urethra was prepared with Betadine and an 8Fr urethral catheter passed into the bladder and urine obtained in a sterile container. Bladder washings were obtained after urine was completely emptied from the bladder via the catheter. Saline (60ccs) was used to vigorously irrigate the bladder 2-3 times through the 8 Fr catheter. The bladder washings were then collected and placed in a sterile container. The experimental cultures included 100ml inoculated on Blood Agar, MacConkey Agar and Brucella Blood Agar, incubated for 72 hours at 35-37 C in ambient atmosphere supplemented with 5-8% carbon dioxide. Colonies were counted to quantify the cfu/ml and all growth of any organism was reported. Organisms were then identified using standard microbiologic techniques. | within one week of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Urogynecology clinic
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| Name | Affiliation | Role |
|---|---|---|
| Michael K. Flynn, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urogynecology and Reconstructive Pelvic Surgery Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overactive Bladder Subjects | Subjects with urge incontinence due to overactive bladder |
| FG001 | Control Subjects | Control subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overactive Bladder Subjects | Subjects with urge incontinence due to overactive bladder |
| BG001 | Control Subjects | Control subjects |
| 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 | Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation | Sterile specimens were obtained from subjects. The urethra was prepared with Betadine and an 8Fr urethral catheter passed into the bladder and urine obtained in a sterile container. Bladder washings were obtained after urine was completely emptied from the bladder via the catheter. Saline (60ccs) was used to vigorously irrigate the bladder 2-3 times through the 8 Fr catheter. The bladder washings were then collected and placed in a sterile container. The experimental cultures included 100ml inoculated on Blood Agar, MacConkey Agar and Brucella Blood Agar, incubated for 72 hours at 35-37 C in ambient atmosphere supplemented with 5-8% carbon dioxide. Colonies were counted to quantify the cfu/ml and all growth of any organism was reported. Organisms were then identified using standard microbiologic techniques. | One overactive bladder subject had greater than 100,000 cfu in routine culture and their specimens were excluded from the analysis. | Posted | Number | participants | within one week of enrollment |
|
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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 | Overactive Bladder Subjects | Subjects with urge incontinence due to overactive bladder |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael K. Flynn, MD | University of Rochester | 585-273-3232 | michael_flynn@urmc.rochester.edu |
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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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Urine specimen
| 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 |
|
| OG000 | Overactive Bladder Subjects | |
| OG001 | Control Subjects |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control Subjects | Control subjects | 0 | 8 | 0 | 8 |
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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 |