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

NCT00714792 | Completed Results

• 1 other identifier: 23123
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

Subjects with urge incontinence due to overactive bladder

2

women with no urge symptoms

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Urogynecology clinic

You may qualify if:

• 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.
• years or older
• Healthy volunteers for control subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Urogynecology and Reconstructive Pelvic Surgery Center

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine specimen

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael K. Flynn, MD
• Organization: University of Rochester

michael_flynn@urmc.rochester.edu

585-273-3232

Study Officials

• Michael K. Flynn, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 14, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-04

Locations

US (1)