Clinical trial NCT02536872: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urogynaecology
Keywords: infection overactive bladder
Lead sponsor: Medway NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with overactive bladder syndrome

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.

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.

Primary outcomes:
measure: Change in bladder microbiology in patients treated with antibiotics.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in the overactive bladder questionnaire (OAB-q) before and after treatment
timeFrame: 6 weeks
measure: Change in Patient Perception of Bladder Condition (PPBC)
timeFrame: 6 weeks
measure: To identify adherence to the treatment regime
timeFrame: 6 weeks
measure: To identify adverse effects of the treatment
timeFrame: 6 weeks
measure: Changes in symptoms using (change from baseline to assessment)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gillingham
country: United Kingdom
facility: Medway Hospital
state: Kent
Study officials:
References: