T-Control® Safety for Cytostatics Management

Safety and Usability of the T-Control® Catheter in Cytostatics Management: a Pilot Study

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.

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.