CompletedNot Applicable

Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

United Kingdom20 participantsStarted 2010-11

Plain-language summary

The main objective is to investigate two types of antibacterial catheters regarding their antibacterial efficacy. The study will investigate if silver added to the coating of a urinary catheter exerts antibacterial activity that will have an impact on bacteria quantity in the urine bladder among users of intermittent catheterization.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provision of informed consent * Female/male aged 18 years and over * Practicing intermittent catheterization at least 4 times daily for at least 6 weeks * A minimum of 104 CFU of bacteriuria Exclusion Criteria: * Ongoing, symptomatic UTI at enrollment * Known urethral stricture * Basic tumorous disease * Previous prostate surgery * Subjects known to be immunocompromised e.g. HIV or diabetes * Treatment with antibiotics and/or intravesical antiseptics for the past 30 days before study start * Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site) * Pregnancy or breast feeding * Previous enrolment or randomisation of treatment in the present study * Participation in a clinical study that possibly might interfere with the present study, as deemed by the investigator * Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Bacteria Count Change From Baseline and After 24 Hours.

Timeframe: Baseline and after 24 hours

Total Bacteria Count Change From Baseline and After 48 Hours.

Timeframe: Baseline and after 48 hours

Total Bacteria Count Change From Baseline and After 7-14 Days.

Timeframe: Baseline and after 7-14 days

Trial details

NCT IDNCT01143116

SponsorWellspect HealthCare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-05

Results submitted2021-04-29

View on ClinicalTrials.gov More Bacteriuria trials