UrogynaecologyNCT02536872
A Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
An observational study of Urogynaecology, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The concept of organisms living on or in the human body without causing overt signs of an infection is common in medicine and has been termed a microbiome. Urine from patients with Overactive bladder (OAB) grows different organisms from controls without OAB. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Urogynaecology
- What is being tested?
- None - this is a prospective observational study. Patients will be prescribed their usual treatment (antibiotics) and the effect on urine studied
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Oct 2016
- 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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with overactive bladder syndrome
Who may be able to join
- > age 18 years
- Negative urine dipstick (nitrites) and culture (x10 to the power 5 colony forming units) x105 cfu
- Idiopathic overactive bladder as per International Continence Society definition
Who cannot join
- Patients treated with antibiotics for any infection within the last 6 weeks.
- Patients with known multiple sclerosis, stroke, spinal injury, or other neurological disease
- Urinary tract infection diagnosed by nitrite positivity or positive urine culture (x105 cfu)
- Undiagnosed macroscopic or persistent microscopic haematuria needing investigation
- Previous or current cancer of the urogenital tract.
- Contraindication to multiple antibiotics
- No suitable oral antibiotic regime
- Patients unable to understand the study or complete the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
The concept of organisms living on or in the human body without causing overt signs of an infection is common in medicine and has been termed a microbiome. Urine from patients with Overactive bladder (OAB) grows different organisms from controls without OAB. However, it is not known if the bacteria that have been identified are innocent commensals or pathogenic organism responsible for the symptoms of OAB. Previous data suggests that treatment with antibiotics does lead to an improvement in overactive bladder symptoms in a large number of patients. On this basis the investigators now treat are patients with similar antibiotic regimes. If antibiotics improve symptoms it would be expected that they would return the microbiome back to how it is in patients without OAB. This study aims to identify the effects of antibiotics on the urinary microbiome and to identify/confirm if antibiotic treatments cause improvement in OAB.
Read the detailed description
This study is a consecutive cohort study. Subjects will be recruited from Urogynaecology clinics at Medway NHS Foundation Trust. Patients will be identified from previous records and also prospectively from new patients. They will be sent information regarding the trial before attending their first appointment.
Patients attending urogynaecology clinics will provide a fresh clean catch specimen of urine. A conventional hospital Mid stream speciemn of urine (MSU) will be sent. Urine will be dipsticked for nitrites and leucocyte esterase. The urine will then be spun and undergo microscopy using a special stain (looking for intracellular organisms in shed urothelial cells). The urothelial cells will be cleaned with antibiotics. The cells will then be lysed and their contents cultured. The contents will undergo Polymerase Chain Reaction (PCR) sequencing to identify bacteria. Sensitivity testing will be used to assess and deliver the appropriate antibiotic regime.
Women will be treated with a 6 week course of antibiotics as per their usual treatment. Broad spectrum antibiotics will be prescribed to all women based on the previous successful therapeutic regime as described by Vijaya. Six weeks after the end of antibiotic therapy patients will be reviewed and their urine retested.
- Conditions
- Urogynaecology
- Being tested
- None - this is a prospective observational study. Patients will be prescribed their usual treatment (antibiotics) and the effect on urine studied
- Keywords
- infection overactive bladder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - this is a prospective observational study. Patients will be prescribed their usual treatment (antibiotics) and the effect on urine studiedOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bladder microbiology in patients treated with antibiotics.
The number and type of different organisms will be quantified and compared to the pre treatment organisms
Measured: 6 weeks
Secondary outcomes (5)
Change in the overactive bladder questionnaire (OAB-q) before and after treatment
questionnaire
Measured: 6 weeks
Change in Patient Perception of Bladder Condition (PPBC)
questionnaire
Measured: 6 weeks
To identify adherence to the treatment regime
Patients will be asked to identify if they took all of the antibiotics; 75% of the time; 50 or 25%
Measured: 6 weeks
To identify adverse effects of the treatment
Patients will be asked report side effects of antibiotic treatment
Measured: 6 weeks
Changes in symptoms using (change from baseline to assessment)
Measured by the International consultation on Incontinence female lower urinary tract syptome questionnaire. (ICI FLUTs)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrogynaecologyStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medway NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Jonathan Duckett, Medway NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536872
- Sponsor's protocol ID
- 19/06/2015
- Status last verified
- Oct 2016
- First submitted
- 24 Aug 2015
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT02536872
- Acronym / sponsor ID
- 19/06/2015
- Conditions
- Urogynaecology
- Keywords
- infection overactive bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medway NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Sep 2015 (estimated)
- 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.
The concept of organisms living on or in the human body without causing overt signs of an infection is common in medicine and has been termed a microbiome. Urine from patients with Overactive bladder (OAB) grows different organisms from controls without OAB. However, it is not known if the bacteria that have been identified are innocent commensals or pathogenic organism responsible for the symptoms of OAB. Previous data suggests that treatment with antibiotics does lead to an improvement in overactive bladder symptoms in a large number of patients. On this basis the investigators now treat are patients with similar antibiotic regimes. If antibiotics improve symptoms it would be expected that they would return the microbiome back to how it is in patients without OAB. This study aims to identify the effects of antibiotics on the urinary microbiome and to identify/confirm if antibiotic treatments cause improvement in OAB.
Detailed description
This study is a consecutive cohort study. Subjects will be recruited from Urogynaecology clinics at Medway NHS Foundation Trust. Patients will be identified from previous records and also prospectively from new patients. They will be sent information regarding the trial before attending their first appointment.
Patients attending urogynaecology clinics will provide a fresh clean catch specimen of urine. A conventional hospital Mid stream speciemn of urine (MSU) will be sent. Urine will be dipsticked for nitrites and leucocyte esterase. The urine will then be spun and undergo microscopy using a special stain (looking for intracellular organisms in shed urothelial cells). The urothelial cells will be cleaned with antibiotics. The cells will then be lysed and their contents cultured. The contents will undergo Polymerase Chain Reaction (PCR) sequencing to identify bacteria. Sensitivity testing will be used to assess and deliver the appropriate antibiotic regime.
Women will be treated with a 6 week course of antibiotics as per their usual treatment. Broad spectrum antibiotics will be prescribed to all women based on the previous successful therapeutic regime as described by Vijaya. Six weeks after the end of antibiotic therapy patients will be reviewed and their urine retested.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with overactive bladder syndrome
Key inclusion criteria (3 listed)
- > age 18 years
- Negative urine dipstick (nitrites) and culture (x10 to the power 5 colony forming units) x105 cfu
- Idiopathic overactive bladder as per International Continence Society definition
Key exclusion criteria (8 listed)
- Patients treated with antibiotics for any infection within the last 6 weeks.
- Patients with known multiple sclerosis, stroke, spinal injury, or other neurological disease
- Urinary tract infection diagnosed by nitrite positivity or positive urine culture (x105 cfu)
- Undiagnosed macroscopic or persistent microscopic haematuria needing investigation
- Previous or current cancer of the urogenital tract.
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 |
|---|---|---|
| None - this is a prospective observational study. Patients will be prescribed their usual treatment (antibiotics) and the effect on urine studied | Other | – |
Primary outcome
Change in bladder microbiology in patients treated with antibiotics.
Time frame: 6 weeks
The number and type of different organisms will be quantified and compared to the pre treatment organisms
5 secondary outcomes
Change in the overactive bladder questionnaire (OAB-q) before and after treatment
Time frame: 6 weeks
Change in Patient Perception of Bladder Condition (PPBC)
Time frame: 6 weeks
To identify adherence to the treatment regime
Time frame: 6 weeks
To identify adverse effects of the treatment
Time frame: 6 weeks
Changes in symptoms using (change from baseline to assessment)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
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Obstetric Anal Sphincter Injury, Severe Perineal Trauma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Urogynaecology, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 17 Oct 2016. 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in bladder microbiology in patients treated with antibiotics. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2016.