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

This study is currently recruiting participants.

Verified by University of Rochester, June 2009

First Received: July 8, 2008 Last Updated: June 10, 2009 History of Changes

Sponsor:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00714792

Purpose

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
Overactive Bladder

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Pilot Study: Is Overactive Bladder Caused by Subacute Urinary Tract Infections?

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Cytologic and microbiologic evaluation [ Time Frame: Delivery of samples within 1 hour to microbiology laboratory ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Urine specimen

Estimated Enrollment:	20
Study Start Date:	June 2008

Groups/Cohorts
1 Subjects with urge incontinence due to overactive bladder
2 Control subjects

Eligibility

Ages Eligible for Study:	21 Years and older
Genders 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 UTI's
Pregnant women, children
Evidence of urge urinary incontinence or more than 1 episode of stress incontinence/day by control subject

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714792

Contacts

Contact: Michael K. Flynn, MD	585-273-3232
Contact: Mare Perevich, RN, CCRC	585-273-2996

Locations

United States, New York
Urogynecology and Reconstructive Pelvic Surgery Center	Recruiting
Rochester, New York, United States, 14642
Contact: Michael K. Flynn, MD 585-273-3232
Principal Investigator: Michael K. Flynn, MD

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Michael K. Flynn, MD

University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester ( Michael K. Flynn, MD )
Study ID Numbers:	23123
Study First Received:	July 8, 2008
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00714792 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urologic Diseases
Urinary Bladder, Overactive

Urinary Tract Infections
Urinary Bladder Diseases
Infection

ClinicalTrials.gov processed this record on November 20, 2009