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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

Tracking Information
First Submitted Date August 24, 2015
First Posted Date September 1, 2015
Last Update Posted Date October 17, 2016
Study Start Date October 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2015)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 27, 2015)
  • Change in the overactive bladder questionnaire (OAB-q) before and after treatment [ Time Frame: 6 weeks ]
    questionnaire
  • Change in Patient Perception of Bladder Condition (PPBC) [ Time Frame: 6 weeks ]
    questionnaire
  • 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%
  • To identify adverse effects of the treatment [ Time Frame: 6 weeks ]
    Patients will be asked report side effects of antibiotic treatment
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
Official Title An Observational Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population women with overactive bladder syndrome
Condition Urogynaecology
Intervention Other: None - this is a prospective observational study. Patients will be prescribed their usual treatment (antibiotics) and the effect on urine studied
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 13, 2016)
25
Original Estimated Enrollment
 (submitted: August 27, 2015)
100
Actual Study Completion Date October 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02536872
Other Study ID Numbers 19/06/2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Professor Jonathan Duckett, Medway NHS Foundation Trust
Study Sponsor Medway NHS Foundation Trust
Collaborators Not Provided
Investigators Not Provided
PRS Account Medway NHS Foundation Trust
Verification Date October 2016