Trial Outcomes & Findings for Pilot Study: Is Overactive Bladder Caused by Subacute Urinary Tract Infections? (NCT NCT00714792)

NCT ID: NCT00714792

Last Updated: 2017-04-28

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 18 participants
• Primary outcome timeframe: within one week of enrollment
• Results posted on: 2017-04-28

Participant Flow

Participant milestones

Measure	Overactive Bladder Subjects Subjects with urge incontinence due to overactive bladder	Control Subjects Control subjects
Overall Study STARTED	10	8
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study: Is Overactive Bladder Caused by Subacute Urinary Tract Infections?

Baseline characteristics by cohort

Measure	Overactive Bladder Subjects n=10 Participants Subjects with urge incontinence due to overactive bladder	Control Subjects n=8 Participants Control subjects	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Age, Categorical >=65 years	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Age, Continuous	66 years STANDARD_DEVIATION 14.3 • n=93 Participants	54 years STANDARD_DEVIATION 12.4 • n=4 Participants	60 years STANDARD_DEVIATION 13.5 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	8 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	10 participants n=93 Participants	8 participants n=4 Participants	18 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Overactive Bladder Subjects n=9 Participants	Control Subjects n=8 Participants
Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation	8 participants	1 participants

Adverse Events

Overactive Bladder Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael K. Flynn, MD

University of Rochester

Phone: 585-273-3232

Email: michael_flynn@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place