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

Sponsor

Medway NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02536872

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urogynaecology	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 Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Outcome Measures

Primary Outcome Measures

Change in bladder microbiology in patients treated with antibiotics. [6 weeks]
The number and type of different organisms will be quantified and compared to the pre treatment organisms

Secondary Outcome Measures

Change in the overactive bladder questionnaire (OAB-q) before and after treatment [6 weeks]
questionnaire
Change in Patient Perception of Bladder Condition (PPBC) [6 weeks]
questionnaire
To identify adherence to the treatment regime [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 [6 weeks]
Patients will be asked report side effects of antibiotic treatment
Changes in symptoms using (change from baseline to assessment) [6 weeks]
Measured by the International consultation on Incontinence female lower urinary tract syptome questionnaire. (ICI FLUTs)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

age 18 years
Negative urine dipstick (nitrites) and culture (x10 to the power 5 colony forming units) x105 cfu
Idiopathic overactive bladder as per International Continence Society definition

Exclusion Criteria:

Patients treated with antibiotics for any infection within the last 6 weeks.
Patients with known multiple sclerosis, stroke, spinal injury, or other neurological disease
Urinary tract infection diagnosed by nitrite positivity or positive urine culture (x105 cfu)
Undiagnosed macroscopic or persistent microscopic haematuria needing investigation
Previous or current cancer of the urogenital tract.
Contraindication to multiple antibiotics
No suitable oral antibiotic regime
Patients unable to understand the study or complete the questionnaires.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medway Hospital	Gillingham	Kent	United Kingdom	ME17 3AN

Sponsors and Collaborators

Medway NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Jonathan Duckett, Consultant Urogynaecologist, Medway NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT02536872

Other Study ID Numbers:

19/06/2015

First Posted:

Sep 1, 2015

Last Update Posted:

Oct 17, 2016

Last Verified:

Oct 1, 2016

Keywords provided by Professor Jonathan Duckett, Consultant Urogynaecologist, Medway NHS Foundation Trust

infection overactive bladder

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Anti-Bacterial Agents

Study Results

No Results Posted as of Oct 17, 2016