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A Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536872
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Professor Jonathan Duckett, Medway NHS Foundation Trust

Brief 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. 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.

Condition or disease Intervention/treatment
Urogynaecology Other: None - this is a prospective observational study. Patients will be prescribed their usual treatment (antibiotics) and the effect on urine studied

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.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
Study Start Date : October 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in the overactive bladder questionnaire (OAB-q) before and after treatment [ Time Frame: 6 weeks ]
    questionnaire

  2. Change in Patient Perception of Bladder Condition (PPBC) [ Time Frame: 6 weeks ]
    questionnaire

  3. To identify adherence to the treatment regime [ Time Frame: 6 weeks ]
    Patients will be asked to identify if they took all of the antibiotics; 75% of the time; 50 or 25%

  4. To identify adverse effects of the treatment [ Time Frame: 6 weeks ]
    Patients will be asked report side effects of antibiotic treatment

  5. Changes in symptoms using (change from baseline to assessment) [ Time Frame: 6 weeks ]
    Measured by the International consultation on Incontinence female lower urinary tract syptome questionnaire. (ICI FLUTs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women with overactive bladder syndrome
Criteria

Inclusion Criteria:

  1. > age 18 years
  2. Negative urine dipstick (nitrites) and culture (x10 to the power 5 colony forming units) x105 cfu
  3. Idiopathic overactive bladder as per International Continence Society definition

Exclusion Criteria:

  1. Patients treated with antibiotics for any infection within the last 6 weeks.
  2. Patients with known multiple sclerosis, stroke, spinal injury, or other neurological disease
  3. Urinary tract infection diagnosed by nitrite positivity or positive urine culture (x105 cfu)
  4. Undiagnosed macroscopic or persistent microscopic haematuria needing investigation
  5. Previous or current cancer of the urogenital tract.
  6. Contraindication to multiple antibiotics
  7. No suitable oral antibiotic regime
  8. Patients unable to understand the study or complete the questionnaires.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536872


Locations
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United Kingdom
Medway Hospital
Gillingham, Kent, United Kingdom, ME17 3AN
Sponsors and Collaborators
Medway NHS Foundation Trust
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Responsible Party: Professor Jonathan Duckett, Consultant Urogynaecologist, Medway NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02536872    
Other Study ID Numbers: 19/06/2015
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Keywords provided by Professor Jonathan Duckett, Medway NHS Foundation Trust:
infection overactive bladder
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents