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

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.

Study Overview

• Status: Completed
• Conditions: Urogynaecology
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Gillingham, Kent, United Kingdom, ME17 3AN
      • Medway Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women with overactive bladder syndrome

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bladder microbiology in patients treated with antibiotics.	The number and type of different organisms will be quantified and compared to the pre treatment organisms	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the overactive bladder questionnaire (OAB-q) before and after treatment	questionnaire	6 weeks
Change in Patient Perception of Bladder Condition (PPBC)	questionnaire	6 weeks
To identify adherence to the treatment regime	Patients will be asked to identify if they took all of the antibiotics; 75% of the time; 50 or 25%	6 weeks
To identify adverse effects of the treatment	Patients will be asked report side effects of antibiotic treatment	6 weeks
Changes in symptoms using (change from baseline to assessment)	Measured by the International consultation on Incontinence female lower urinary tract syptome questionnaire. (ICI FLUTs)	6 weeks

Collaborators and Investigators

• Sponsor: Medway NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: August 27, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: infection overactive bladder
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 19/06/2015