Adhesive versus elastic leg devices to secure urinary catheters in critically ill adults
Official title: Dispositivos Adhesivos Frente a Dispositivos elásticos Para la sujeción de la Sonda Urinaria en el Paciente crítico Estudio Experimental
Run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT07093437 · Data updated 2026-11-12
This trial will test whether adhesive or elastic leg securement devices better prevent meatal injuries, reduce discomfort, and lower catheter-associated urinary tract infections in critically ill adults with urinary catheters.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 188 (estimated) |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | September 22, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT07093437 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) in the ICU who had a urinary catheter placed within the past 24 hours and are expected to need catheterization and remain in the ICU for more than 48 hours, without contraindications to thigh securement, are ideal candidates.
✕Probably not a fit
Patients with existing meatal lesions, active or suspected urinary tract infection, urological or prostatic disease, allergy to adhesives, or conditions preventing thigh securement (for example wounds, burns, or amputations) are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study assigns critically ill adult ICU patients who recently had a urinary catheter placed to receive either an adhesive thigh securement device or an elastic leg band to hold the catheter. Participants are monitored during their ICU stay for urethral meatal injuries, reported discomfort or pain, and catheter-associated urinary tract infections, with regular clinical assessments and patient feedback where possible. Key exclusions include existing meatal lesions, current or suspected urinary infection, urological/prostatic pathology, allergy to adhesive tape, or any condition that prevents thigh securement such as wounds or amputations. Outcomes will compare rates of meatal injury, patient comfort, and CAUTI between the two device groups.
Why it matters
Potential benefit: If the better device is identified, it could reduce meatal injuries, lessen patient discomfort, and lower catheter-associated urinary tract infection rates in ICU patients.
How similar studies have gone: Previous studies indicate that securing catheters to the thigh can reduce meatal injuries and related complications, but direct comparisons between adhesive and elastic securement devices are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Pacients with an urinary catheter inserted within the past 24 hours * Expected duration of catheterization \>48 hours * Estimated ICU lenght os stay \> 48 hours Exclusion Criteria: * Known allergy to adhesive tape * Patients with lesions at the urinary meatus, ongoing urinary tract infection or suspected infection * Presence of urological or prostatic pathology * Any condition that prevents securing the urinary catheter to the thigh, such as wounds, burns, or amputations
Where it's running
-
Institut de Recerca Sant Pau
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Neus Calpe Damians, PhD
- Email: ncalpe@santpau.cat
- Phone: +34 932 91 90 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.