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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00714792
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
University of Rochester

Study Description
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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.

Condition or disease
Overactive Bladder

Study Design
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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: Is Overactive Bladder Caused by Subacute Urinary Tract Infections?
Study Start Date : June 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Groups and Cohorts
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Group/Cohort
1
Subjects with urge incontinence due to overactive bladder
2
women with no urge symptoms


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Urine specimen

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Urogynecology clinic
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714792


Locations
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United States, New York
Urogynecology and Reconstructive Pelvic Surgery Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Michael K. Flynn, MD University of Rochester
More Information
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Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00714792    
Other Study ID Numbers: 23123
First Posted: July 14, 2008    Key Record Dates
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Urinary Tract Infections
Urinary Bladder, Overactive
Infections
Urinary Bladder Diseases
 Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations