Prevention of Recurrent Symptomatic Urinary Tract Infections in Participants with Chronic Neurogenic Bladder Dysfunction: A Mixed Method Study (The PReSUTINeB Study)

Buckinghamshire Healthcare NHS Trust0 个研究点目标入组 48 人开始时间: 2016年5月11日最近更新: 2019年9月2日

适应症

试验速览

•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.

发起方