Overactive BladderNCT03080389
Sensitivity of Extended Cultures in Diagnosing Urinary Tract Infections
An observational study of Overactive Bladder and Overactive Detrusor, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Overactive Bladder, Overactive Detrusor, Urgency-Frequency Syndrome
- What is being tested?
- Extended Urine Culture
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 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"
Who cannot join
- Pregnant
- Pelvic radiation
- Chronic pelvic pain
- Urinary retention
- Greater than Stage 2 prolapse
- Renal calculi
Show all 10Show fewer
- Recurrent UTI (2 in 6 months)
- Immunosuppressed
- Neurologic disorder
- No antibiotics in the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Extended Urine Cultures More Sensitive Than Standard Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Urgency and Frequency?
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?
Read the detailed description
In 2014, Hilt, Evann et al published a study called "Urine is not sterile," in which it was found via PCR and extended urine cultures, there is a microbiome that exists within the urinary bladder. In this study, 92% of the bacteria failed to be identified by a standard urine culture but 80% were identified with extended urine cultures. In further explorations of the significance of this microbiome, Pearce, Meghan et al. found that the female bladder consists of increased abundance of bacteria in patients with UUI; including Gardnerella and Lactobacilus gasseri. Then in 2015, a study by Thomas-White, Krystal et al. found that patients with urge urinary incontinence (UUI) who responded to treatment with Solifenacin had fewer and less diverse communities of bacteria when evaluated by PCR and extended urine cultures.
The clinical significance of the bacteria identified is not well understood. However, these studies show that the presence of bacteria is being missed by standard cultures. Dune et al. found that of patients with UTI symptoms, 27.5% were standard culture negative but extended quantitative urine culture positive. This demonstrates that practitioners may be overlooking urinary tract infections in patients with frequency and urgency. Therefore, if bacteria within the urine can be detected with extended cultures, can this technique be used to improve detection and treatment of urinary infections in patients with symptoms of frequency and urgency?
The hypotheses states that extended urine cultures are more sensitive in the identification of urinary tract infections in patients with symptoms of urgency and frequency. The secondary hypothesis is that treatment of the uropathogen identified on extended urine cultures will improve patient symptoms.
- Being tested
- Extended Urine Culture
- Keywords
- overactive bladder, overactive detrusor, urgency-frequency, urinary tract infection
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Urine CultureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Extended Urine Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (2)
Treatment of uropathogens found on extended cultures result in negative repeat extended urine culture.
Treatment of uropathogens found on extended cultures result in negative repeat extended urine culture.
Measured: one year
Treatment of uropathogens found on extended cultures improves urinary tract symptoms measured by the Bother and UDI-6 questionnaires
Treatment of the uropathogen identified on extended urine cultures improve patient's urgency and frequency symptoms measured by the Bother and UDI-6 questionnaires
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start1 Jul 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Why it stopped: Study staff not available to complete the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Hurtado, The Cleveland Clinic
- Investigators
- Eric Hurtado, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080389
- Sponsor's protocol ID
- FLA 16-108
- Status last verified
- Aug 2018
- First submitted
- 20 Dec 2016
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Patient information will not be shared with outside researchers.
Publications
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.
PubMed 24371246Pearce 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.
PubMed 25006228Thomas-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.
PubMed 26423260Tanaka 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Extended Urine Cultures More Sensitive Than Standard Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Urgency and Frequency?
- ClinicalTrials.gov ID
- NCT03080389
- Acronym / sponsor ID
- FLA 16-108
- Keywords
- overactive bladder, overactive detrusor, urgency-frequency, urinary tract infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study staff not available to complete the trial
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
In 2014, Hilt, Evann et al published a study called "Urine is not sterile," in which it was found via PCR and extended urine cultures, there is a microbiome that exists within the urinary bladder. In this study, 92% of the bacteria failed to be identified by a standard urine culture but 80% were identified with extended urine cultures. In further explorations of the significance of this microbiome, Pearce, Meghan et al. found that the female bladder consists of increased abundance of bacteria in patients with UUI; including Gardnerella and Lactobacilus gasseri. Then in 2015, a study by Thomas-White, Krystal et al. found that patients with urge urinary incontinence (UUI) who responded to treatment with Solifenacin had fewer and less diverse communities of bacteria when evaluated by PCR and extended urine cultures.
The clinical significance of the bacteria identified is not well understood. However, these studies show that the presence of bacteria is being missed by standard cultures. Dune et al. found that of patients with UTI symptoms, 27.5% were standard culture negative but extended quantitative urine culture positive. This demonstrates that practitioners may be overlooking urinary tract infections in patients with frequency and urgency. Therefore, if bacteria within the urine can be detected with extended cultures, can this technique be used to improve detection and treatment of urinary infections in patients with symptoms of frequency and urgency?
The hypotheses states that extended urine cultures are more sensitive in the identification of urinary tract infections in patients with symptoms of urgency and frequency. The secondary hypothesis is that treatment of the uropathogen identified on extended urine cultures will improve patient symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended urine culture | – | Procedure: Extended Urine CultureEach 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 18 y/o-70 y/o
- Able to consent
- Urgency /Frequency
- Urge incontinence
- PUF score ≤ 4
Key exclusion criteria (10 listed)
- Pregnant
- Pelvic radiation
- Chronic pelvic pain
- Urinary retention
- Greater than Stage 2 prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended Urine CultureExtended 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. | Procedure or surgery | Extended urine culture |
Primary outcome
Sensitivity of extended urine cultures compared to standard urine cultures.
Time frame: one year
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.
2 secondary outcomes
Treatment of uropathogens found on extended cultures result in negative repeat extended urine culture.
Time frame: one year
Treatment of uropathogens found on extended cultures improves urinary tract symptoms measured by the Bother and UDI-6 questionnaires
Time frame: one year
Results and safety
The study was stopped early (reason given: Study staff not available to complete the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Background: PubMed 24371246Hilt 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.
- Background: PubMed 25006228Pearce 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.
- Background: PubMed 26423260Thomas-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.
- BackgroundTanaka 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.
- Individual participant dataSharing planned: No. Patient information will not be shared with outside researchers.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hurtado, MD principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder and Overactive Detrusor, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study staff not available to complete the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of extended urine cultures compared to standard urine cultures. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080389, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.