Skip to main content
OpenTrials
Completed

NCT Number: NCT02536872

A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urogynaecology

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Medway Hospital

Gillingham, Kent, ME17 3AN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

None - this is a prospective observational study. Patients will be prescribed their usual treatment (antibiotics) and the effect on urine studied

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in the overactive bladder questionnaire (OAB-q) before and after treatment

    Time frame: 6 weeks

    questionnaire

  2. Change in Patient Perception of Bladder Condition (PPBC)

    Time frame: 6 weeks

    questionnaire

  3. 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%

  4. To identify adverse effects of the treatment

    Time frame: 6 weeks

    Patients will be asked report side effects of antibiotic treatment

  5. 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)

Sponsors and collaborators

Lead sponsor

Medway NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2015
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.