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

NCT02536872 | Completed

• 1 other identifier: 19/06/2015
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Urogynaecology

Keywords

infection overactive bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  6 weeks

• Change in Patient Perception of Bladder Condition (PPBC)

  6 weeks

• To identify adherence to the treatment regime

  6 weeks

• To identify adverse effects of the treatment

  6 weeks

• Changes in symptoms using (change from baseline to assessment)

  6 weeks

Interventions

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women with overactive bladder syndrome

You may qualify if:

• \> 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead

Study Sites (1)

Medway Hospital

Gillingham, Kent, ME17 3AN, United Kingdom

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Urogynaecologist

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 1, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

GB (1)