Trials
Search / Trial NCT05643950

Effectiveness and Cost-effectiveness of the T-Control® Catheter in Patients With Acute Urine Retention

Launched by RETHINK MEDICAL SL · Dec 1, 2022

Trial Information

Current as of February 05, 2025

Withdrawn

Keywords

Catheterisation T Control Urinary Catheter Foley Catheter

ClinConnect Summary

Potential participants will be identified by the team of healthcare professionals of the emergency department according to the inclusion and exclusion criteria of the study. If the patient meets the criteria, the emergency department team will be able to refer patients directly to the urology department, where the investigator or research assistant will again check the inclusion and exclusion criteria, will invite the patient or their relative/caregiver (if necessary) to participate in the study and will request their informed consent. The catheter insertion will be carried out by the resea...

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Males with Acute Urine Retention
  • Equal or over 50 years of age
  • Absence of symptoms of infection on the inclusion day
  • Not having been previously catheterized on the day of inclusion
  • Indication of bladder catheterization for 2 weeks
  • Maintained cognitive and physical capacity for self-monitoring the catheter valve
  • Signed consent agreement
  • Exclusion Criteria:
  • Current or recent urinary tract infection in the last 2 weeks
  • Use of current treatment/antibiotic in the last 2 weeks
  • Immunocompromised patients (diagnosed with advance cancer, Acquired Immunodeficiency Syndrome,...)
  • Catheter insertion requiring more than 1 attempt
  • Overactive bladder
  • Patients with bilateral obstructive uropathy

Trial Officials

Laura Vera, Dr.

Principal Investigator

Hospital Universitario Insular de Gran Canaria

Adrián Amador, Dr.

Principal Investigator

University Hospital of the Nuestra Señora de Candelaria

About Rethink Medical Sl

Rethink Medical SL is a pioneering clinical trial sponsor focused on advancing innovative healthcare solutions through rigorous research and development. Committed to improving patient outcomes, the company specializes in designing and managing clinical trials that evaluate cutting-edge therapies and medical technologies. With a multidisciplinary team of experts, Rethink Medical SL emphasizes collaboration, transparency, and adherence to the highest ethical standards, ensuring robust data integrity and compliance throughout the clinical research process. Their mission is to bridge the gap between scientific discovery and practical application, ultimately transforming the landscape of modern medicine.

Locations

Santa Cruz De Tenerife, , Spain

Las Palmas De Gran Canaria, Las Palmas, Spain

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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