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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714792
• Other study ID #: 23123
• Status: Completed
• Phase: N/A
• First received: July 8, 2008
• Last updated: April 26, 2017
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2017
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Tract Infections

Locations

Country	Name	City	State
United States	Urogynecology and Reconstructive Pelvic Surgery Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	within one week of enrollment