T-Control® Safety for Cytostatics Management

This is a comparative, randomised, prospective and crossover pilot study with two arms that aims to compare the T-Control® catheter versus a conventional Foley-type catheter (Folysil®, Colopalst) in bladder cancer patients who require intravesical chemotherapy or immunotherapy treatment, monitoring the patient from the insertion of the catheter until its removal or change (1 to 2 hours) during each of the two visits programmed for the study (one for each treatment).

The general purpose of this pilot study is to determine the feasibility of a clinical study analysing the advantages that T-Control® can provide, compared with usual clinical practice in the participating center, with respect to chemotherapy and immunotherapy administration and waste management in a prospective, randomised, comparative crossover pilot study, in patients with bladder cancer who need intravesical therapy. This will allow to optimise the design, assess whether recruitment and interventions are sufficient to allow the trial to progress, and gather preliminary data with the following objectives:

• To determine the safety of T-Control® versus the usual clinical practice in the participating center, by comparing the rate of accidental spillages due to the catheter in patients that require oncological intravesical treatments.
• To determine and compare the usability of T-Control® versus the usual clinical practice in the participating center.

All those patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy will be invited to participate and will be interviewed in an initial visit, where the inclusion and exclusion criteria will be checked. The patients will receive information about the study, they will decide whether or not they want to participate, they will sign and deliver the written informed consent and they will be included in the study and randomised into one of the two study interventions. In the subsequent visit, patients will receive the treatment with the alternate catheter. Thus, each patient will receive the intravesical oncological treatment with both catheters assessed in the study.

After the end of each treatment the health professionals who have participated, and after giving their informed consent, will be asked to record all the spillages and leakages occurred during the therapy, whereas at the end of the study they will be asked to measure the usability perceived with both types of catheters

Inclusion criteria

• Men or women aged ≥18 years.
• Patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy.
• Patients requiring recurrent intravesical instillations for their treatment.
• Signed consent agreement.

Exclusion criteria

• Patients with difficult catheterisation who require a urologist to perform the catheter insertion.
• Inability to read and understand Portuguese or english.