Overactive Bladder
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
University of Rochester
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Urge urinary incontinence based on clinical history and bladder diary; subjects must have 3 or more urge incontinence episodes/day and 10 or more voids/day. * 21 years or older * Healthy volunteers for control subjects
Exclusion criteria
* Active cystitis performed on a catheterized urine specimen * Known or suspected correctable etiology for her urge incontinence * History of urinary tract stones, foreign bodies or malignancy * History of recurrent Urinary Tract Infections * Pregnant women, children * Evidence of urge urinary incontinence or more than 1 episode of stress incontinence/day by control subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation | within one week of enrollment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overactive Bladder Subjects Subjects with urge incontinence due to overactive bladder | 10 |
| Control Subjects Control subjects | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | Control Subjects | Overactive Bladder Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 7 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 12.4 | 66 years STANDARD_DEVIATION 14.3 | 60 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment United States | 8 participants | 10 participants | 18 participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 |
Outcome results
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.
Time frame: within one week of enrollment
Population: One overactive bladder subject had greater than 100,000 cfu in routine culture and their specimens were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overactive Bladder Subjects | Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation | 8 participants |
| Control Subjects | Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation | 1 participants |