A Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
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|ClinicalTrials.gov Identifier: NCT02536872|
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : October 17, 2016
|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|
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|
|Actual Enrollment :||25 participants|
|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|
- 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
- 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)
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
|Gillingham, Kent, United Kingdom, ME17 3AN|