Urogynaecology Clinical Trial
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.
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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Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06143072 -
CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence
|