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NCT05643950
Effectiveness and Cost-effectiveness of the T-Control® Catheter in Patients With Acute Urine Retention
Conditions: Urinary Retention, Catheter-Associated Urinary Tract Infection, Catheter Complications
Sex: Male
Ages: 18 Years – 100 Years
Phase: NA
Enrollment: 50
Sponsor: Rethink Medical SL
Location: Spain
Summary
The general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the T-Control® catheter versus the Foley type catheter in patients with Acute Urine Retention.
Eligibility Criteria
Inclusion Criteria:Males with Acute Urine RetentionOver 18 years of ageAbsence of symptoms of infection on the inclusion dayNot having been previously catheterized on the day of inclusionIndication of bladder catheterization for 2 weeksMaintained cognitive and physical capacity for self-monitoring the catheter valveSigned consent agreementExclusion Criteria:Current or recent urinary tract infection in the last 2 weeksUse of current treatment/antibiotic in the last 2 weeksImmunocompromised patients, diagnosed with cancer or Acquired Immunodeficiency SyndromeCatheter insertion requiring more than 1 attemptOveractive bladderPatients with bilateral obstructive uropathy
Source: ClinicalTrials.gov (NCT05643950). StuddyBuddy aggregates publicly available trial information.
