Antibiotic prophylaxis for clean intermittent catheterisatio

Not Applicable

Completed

• Conditions: Topic: Primary Care Research Network for England, Renal and Urogenital; Subtopic: Not Assigned, Renal and Urogenital (all Subtopics); Disease: All Diseases, Renal; Urological and Genital Diseases; Urinary tract infection, site not specified

• Registration Number: ISRCTN67145101
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27259552 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29766842 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30037647

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-25
• Study Completion: 2017-02-28
• Last Update Posted: 9 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

1. Adult men and women aged = 18 years
2. Completed training of CISC and predicted to continue use for at least 12 months
3. Able to give informed consent for participation in trial
4. Able and willing to adhere to a 12-month follow-up period
5. Have either suffered at least two episodes of symptomatic UTI related to CISC within the last 12 months or, for those previously prescribed prophylactic antibiotics for UTI, have completed a 3-month washout period without antibiotic prophylaxis
6. Able to take a once daily oral dose of at least one of nitrofurantoin, trimethoprim or cefalexin
7. Intermittent catheterisation may be performed by participant, spouse or carer
8. No restriction on type of catheter used

Exclusion Criteria

1. Age < 18 years
2. In learning phase of CISC
3. Presence of symptomatic UTI; this will be treated and symptoms resolved prior to randomisation
4. Already taking prophylactic antibiotics against UTI and declining 3-month washout period without antibiotic prophylaxis (this will be specifically monitored)
5. Inability to take any one of the three prophylactic antibiotic agents due to multiple drug sensitivities
6. Women who intend to become pregnant during planned period of trial participation or who are pregnant or who are breastfeeding
7. Previous participation in this study
8. Inability to give informed consent or complete trial documentation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative incidence of symptomatic antibiotic-treated UTI between the trial groups; Timepoint(s): 12 months