Sensitivity of Extended Cultures in Diagnosing Urinary Tract Infections

NCT03080389 | Terminated

• 1 other identifier: FLA 16-108
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

There is some evidence to suggest standard urine cultures may not be adequate in identifying patients with low grade urinary tract infections. Therefore, there are patients with symptoms of frequency and urgency, being misdiagnosed with overactive bladder due to negative urine cultures. If this is true, could extended cultures be used to identify the false negative patients?

Conditions

Overactive Bladder; Overactive Detrusor; Urgency-Frequency Syndrome; UTI

Keywords

overactive bladder; overactive detrusor; urgency-frequency; urinary tract infection

Outcome Measures

Primary Outcomes (1)

• Sensitivity of extended urine cultures compared to standard urine cultures.

  Extended urine cultures are more sensitive in the identification of urinary tract infections in patients with symptoms of urgency and frequency then standard cultures as measured by a positive urine extended culture.

  one year

Secondary Outcomes (2)

• Treatment of uropathogens found on extended cultures result in negative repeat extended urine culture.

  one year

• Treatment of uropathogens found on extended cultures improves urinary tract symptoms measured by the Bother and UDI-6 questionnaires

  one year

Study Arms (1)

Extended urine culture

Each patient will be their own control and two specimens will be obtained from each participant. The first will be a catheterized urine sample to be sent for routine culture and the second will be collected from the same catheterized specimen and sent for extended culture.

Procedure: Extended Urine Culture

Interventions

Extended Urine Culture PROCEDURE

Extended Urine Culture Standard cultures will include 0.001 ml of specimen plated on sheep blood agar and MacConkey agar. Plates were inoculated and incubated at 35 degrees Celsius for 24 hours. Samples were considered positive if there were 10\^3 cfu or greater. The extended urine culture will be spun down by centrifuge (3000 rpm for 5 min) and 0.1 ml of the sediment will be cultured for 48 hours. The participants will fill out the Bother, UDI-6, and PUF questionnaires before the cultures. If a patient has a positive urine culture, the patient will be asked to repeat the questionnaires 7-30 days post treatment with antibiotics. A comparison will be made between the standard and extended urine cultures to assess for a difference in identification and treatment of uropathogens.

Extended urine culture

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be included in the study if they have a history of overactive bladder or urgency and frequency with or without incontinence, they must be female, able to speak English, and must be 18 years old or older and able to provide informed consent. Patients must have a PUF score of less than or equal to 4 and answer "a moderate amount" or "a lot" on the Bother questionnaire number 2 or 3. They must also not be a prisoner. Patients will be excluded if they have are pregnant, have urinary retention, greater than stage 2 prolapse, renal calculi, immune-suppressed, those with neurologic disorders, prior use of antibiotics in the past month, had prior radiation to the pelvic floor, or chronic pelvic pain defined by more than 6 months of pelvic pain, or dysuria.

You may qualify if:

• y/o-70 y/o
• Able to consent
• Urgency /Frequency
• Urge incontinence
• PUF score ≤ 4
• Bother questionnaire #2 or #3 answered either "a moderate amount" or "a lot"

You may not qualify if:

• Pregnant
• Pelvic radiation
• Chronic pelvic pain
• Urinary retention
• Greater than Stage 2 prolapse
• Renal calculi
• Recurrent UTI (2 in 6 months)
• Immunosuppressed
• Neurologic disorder
• No antibiotics in the past 4 weeks

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (4)

• Hilt EE, McKinley K, Pearce MM, Rosenfeld AB, Zilliox MJ, Mueller ER, Brubaker L, Gai X, Wolfe AJ, Schreckenberger PC. Urine is not sterile: use of enhanced urine culture techniques to detect resident bacterial flora in the adult female bladder. J Clin Microbiol. 2014 Mar;52(3):871-6. doi: 10.1128/JCM.02876-13. Epub 2013 Dec 26.

  PMID: 24371246 BACKGROUND

• Pearce MM, Hilt EE, Rosenfeld AB, Zilliox MJ, Thomas-White K, Fok C, Kliethermes S, Schreckenberger PC, Brubaker L, Gai X, Wolfe AJ. The female urinary microbiome: a comparison of women with and without urgency urinary incontinence. mBio. 2014 Jul 8;5(4):e01283-14. doi: 10.1128/mBio.01283-14.

  PMID: 25006228 BACKGROUND

• Thomas-White KJ, Hilt EE, Fok C, Pearce MM, Mueller ER, Kliethermes S, Jacobs K, Zilliox MJ, Brincat C, Price TK, Kuffel G, Schreckenberger P, Gai X, Brubaker L, Wolfe AJ. Incontinence medication response relates to the female urinary microbiota. Int Urogynecol J. 2016 May;27(5):723-33. doi: 10.1007/s00192-015-2847-x. Epub 2015 Sep 30.

  PMID: 26423260 BACKGROUND

• Tanaka Dune, Evann Hilt, Travis Price, Colleen Fitzgerald, Cynthia Brincat, Linda Brubaker, Alan J. Wolfe, Paul Schreckenberger, Elizabeth R. Mueller. False negatives of standard urine cultures may delay patient treatment. AUGS. October 13-17, 2015.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine specimens will be retained.

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Tract Infections

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; Infections

Study Officials

• Eric Hurtado, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urogynecology Staff

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: March 15, 2017
• Study Start: July 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)