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

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT00714792
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-14
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2011-09-27
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Results First Posted: 2017-04-28
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Urogynecology and Reconstructive Pelvic Surgery Center; 🇺🇸 Rochester, New York, United States