Clinical trials

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Condition / disease
Location
Status: Recruiting

Comparative Study Between Foley and T-Control® Catheter in Patients With Long-term Catheterization

This is a comparative, randomized, controlled pilot study. The main objective of this study is to evaluate the efficacy, comfort, and patient experience in people with long-term bladder catheterization with T-Control® versus patients with a conventional Foley-type catheter.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Rethink Medical SLUpdated: Sep 4, 2026Locations: 2
Eligibility criteria

Man or women equal or over 18 years old [+4]

Symptoms of infection at the time of inclusion in the study. [+7]

Status: Not yet recruiting

T-Control® Safety for Cytostatics Management

The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the conventional Foley-type catheter during intravesical therapy with oncological patients. It will also learn about the usability of T-Control®. The main questions it aims to answer are: * Does T-Control® lower the rate of spillages occurred during intravesical treatments? * Is T-Control® a better device in terms of usability during intravesical treatments? Researchers will compare T-Control® catheter to a conventional Foley-type catheter (Folysil® Silicone catheter, Coloplast) to see if T-Control® reduce the rate of accidental spillages. Participants will: * Undergo intravesical therapy with the 2 devices used in the study (in two seuqencial cycles of intravesical treatment): T-Control® catheter (experimental intervention) or Folysil® silicone catheter (control intervention). * At the end of the procedure (1-2 hours), the catheter will be removed or changed. During the first visit, patients will be catheterised with the catheter for the randomly assigned intervention, while in the subsequent visit they will be catheterised with the alternate catheter. * Healthcare professionals involved in the procedure will take note of spillages and others adverse events occurred during the intravesical instillation. * At the end of the study, healthcare proffesionals will evaluate the usability perceived of both devices used for intravesical treatment.

Participants needed: 16
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Rethink Medical SLUpdated: May 29, 2025
Eligibility criteria

Men or women aged ≥18 years. [+3]

Patients with difficult catheterisation who require a urologist to perform the c... [+1]