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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Urogynecology and Reconstructive Pelvic Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Urogynecology clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Michael K. Flynn, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Urinary Tract Infections
• Other Study ID Numbers: 23123