Prevention of recurrent symptomatic urinary tract Infections in participants with chronic neurogenic bladder dysfunctio
- Conditions
- rinary tract infections in patients with neurogenic bladder dysfunctionUrological and Genital DiseasesUrinary tract infections in patients with neurogenic bladder dysfunction
- Registration Number
- ISRCTN11666384
- Lead Sponsor
- Buckinghamshire Healthcare NHS Trust
- Brief Summary
2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30992071 (added 05/08/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1. Aged 18 years to 75 years
2. At least one year post onset of neurological condition and now living in the community
3. Neurological status stable for past 9 months, as confirmed by treating physician
4. NBD due to SCI, CES, TM or M
5. Suffered at least three symptomatic UTI within previous twelve months requiring antibiotic course of treatment
6. Able to provide Written Informed Consent and complete study procedures
7. For women able and willing to use contraception during study participation
1. Having a microbiologically confirmed symptomatic infection at time of randomisation.
2. Use of antibiotics within 14 days of study screening.*
3. Use of immunosuppressant medication (e.g. anti-rejection drugs, oral or intramuscular steroids or chemotherapy).
4. Involvement in any other IMP related clinical trial within 24 weeks of screening (Screening Visit 1).
5. Surgical intervention of the urinary tract (i.e cystoscopy) 2 months prior to study recruitment.
6. Women who are pregnant or intending to become pregnant or who are breast feeding
7. Known hypersensitivity to any known ingredients in Uro-Vaxom
*Recruitment can be postponed until antibiotics have not been used for a period of 14 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Study feasibility is determined by recording the recruitment rate for each part of the study and through patient feedback questionnaires completed at baseline, 3 and 6 months
- Secondary Outcome Measures
Name Time Method <br> 1. Urinary tract infection rate is determined using the study booklet (completed from baseline-six months) and interviews at baseline, 1, 3 and 6 months<br> 2. Compliance to the study drug is measured through examining drug blister packs at 3 months<br> 3. Species and amount of bacteria in urine is measured using a urine culture and sensitivity test at baseline, 1, 3 and 6 months<br>