Question 1

What is T-Control®?

Accepted Answer

T-Control® is a two-way silicone Foley-type urethral catheter with an integrated flow-control valve for indwelling urinary drainage. It is a sterile, latex-free, single-use medical device, available in sizes FR12, FR14, FR16 and FR18.

Question 2

Who is T-Control® intended for?

Accepted Answer

T-Control® is intended for adult men and women who require urinary catheterisation for one of the indications described in the Instructions for Use, such as urinary retention, incontinence with sacral wounds or wounds in areas that may come into contact with urine, monitoring of urine output, palliative care and surgery. Your healthcare professional will determine whether T-Control® is appropriate for your individual clinical situation.

Question 3

Who inserts and removes the catheter?

Accepted Answer

T-Control® must be inserted and removed by a competent healthcare professional using aseptic technique. The Instructions for Use include a section on daily use — emptying the bladder, connecting a drainage bag and securing the catheter. If your care plan involves you or your carer carrying out any of these steps, you should do so only after receiving appropriate instruction from your healthcare professional, and always in accordance with the Instructions for Use. Do not change how your catheter is managed without professional guidance.

Question 4

Are there situations where T-Control® should not be used?

Accepted Answer

Yes. The Instructions for Use list contraindications, including urinary tract infection (cystitis or urethritis), injury to the urethra, urethral stricture, injury to the penis, ureteral reflux, overactive bladder, and insufficient mental or physical capacity to handle the device. Your healthcare professional will assess these before deciding whether T-Control® is suitable for you.

Question 5

Can T-Control® be connected to a urine drainage bag?

Accepted Answer

Yes. T-Control® can be connected to a urine drainage bag for continuous drainage when clinically indicated. The valve should be in the CLOSED position before the bag is connected, to prevent leakage. The integrated valve also allows drainage to the bag to be interrupted — for example during transfer or mobilisation — as described in the Instructions for Use. Your healthcare professional should advise you on the drainage method appropriate for your situation.

Question 6

Can T-Control® be used without a continuously connected drainage bag?

Accepted Answer

In selected situations, the integrated valve allows controlled drainage without a continuously connected collection bag. Whether this is appropriate depends on the individual patient's clinical situation and should be determined by a healthcare professional in accordance with the Instructions for Use. T-Control® does not eliminate the possibility of using a drainage bag when continuous drainage is clinically required.

Question 7

How long can T-Control® remain in place?

Accepted Answer

According to the Instructions for Use, continuous use of a single T-Control® device must not exceed 30 days. Cumulative use of successive T-Control® devices may exceed 30 days. The appropriate duration of catheterisation and when the catheter should be replaced must be determined by your healthcare professional according to your clinical needs.

Question 8

Can I remove T-Control® myself?

Accepted Answer

No. The catheter must be removed by a competent healthcare professional. Do not attempt to remove the catheter yourself.

Question 9

What should I do if I experience discomfort, pain or signs of infection?

Accepted Answer

Contact your doctor or healthcare professional if you experience discomfort or any sign that may suggest trauma or infection. Seek professional advice and refer to the Instructions for Use rather than attempting to remove or modify the catheter yourself.

Question 10

What should I do if the valve appears to be blocked or is not working correctly?

Accepted Answer

Do not attempt to repair or modify the device yourself. Contact your healthcare professional. The Instructions for Use state that the catheter should be changed if the valve becomes blocked.

Question 11

What should I do if urine is not draining, or if there is leakage?

Accepted Answer

Contact your healthcare professional. Do not attempt to unblock, flush, clamp or modify the catheter yourself. The Instructions for Use warn that the catheter body should not be clamped, as this may damage the device.

Question 12

What should I do if the catheter comes out?

Accepted Answer

Contact your healthcare professional or seek urgent medical advice. Do not attempt to reinsert the catheter. A catheter that has been removed or has come out must not be reused, and reinsertion must be carried out by a competent healthcare professional. Refer to the Instructions for Use for further guidance.

Question 13

Can I exercise or carry out normal daily activities while using T-Control®?

Accepted Answer

Your healthcare professional should advise you according to your individual condition and the way your catheter is being managed. The Instructions for Use specify that the catheter should not be used without appropriate fixation during moderate or intense physical activity.

Question 14

Can I swim or bathe while using T-Control®?

Accepted Answer

The Instructions for Use do not provide a general recommendation authorising swimming or bathing with the device. Ask your healthcare professional before swimming, bathing or undertaking activities that may affect the catheter, its fixation or hygiene.

Question 15

What is the T-Control® Holder?

Accepted Answer

The Holder is a component that helps secure T-Control® at the external end of the catheter. According to the Instructions for Use, the Holder can be used multiple times by the same patient, and daily washing with soap and water is recommended.

Question 16

Does T-Control® contain latex?

Accepted Answer

No. T-Control® is latex-free. If you have any known allergy or sensitivity, discuss it with your healthcare professional before use.

Question 17

Does T-Control® prevent urinary tract infections?

Accepted Answer

No urinary catheter eliminates the risk of urinary tract infection, and T-Control® is not intended to prevent or reduce catheter-associated urinary tract infections. As with all Foley-type catheters, possible adverse reactions include catheter-associated urinary tract infection (CAUTI), biofilm formation, septicaemia, urethral or bladder injury, urethral or meatal erosion, urethral narrowing and bladder spasms. Follow your healthcare professional's guidance on hygiene and catheter care.

Question 18

How is T-Control® obtained?

Accepted Answer

T-Control® is supplied through healthcare providers and authorised distributors. It is not intended for self-selection or purchase without professional assessment. For availability in your country, contact us at info@rethinkmedical.es.

Question 19

Who manufactures T-Control®?

Accepted Answer

T-Control® is manufactured by: Rethink Medical S.L., Calle Practicante Ignacio Rodríguez S/N, Edificio Polivalente II, Campus Universitario de Tafira (Tercera Planta), 35017 Las Palmas de Gran Canaria, Spain. info@rethinkmedical.es

Question 20

How do I report a problem or a serious incident?

Accepted Answer

Any serious incident that occurs in relation to T-Control® should be reported to Rethink Medical at info@rethinkmedical.es and to the competent health authority of the country where you are located. UK only: In the United Kingdom, incidents can also be reported to the MHRA through its device reporting system.

Question 21

Where can I find the official Instructions for Use?

Accepted Answer

The current Instructions for Use are available in the Instructions for Use section of this website. Always refer to the current approved version supplied by Rethink Medical.

Information about T-Control®

What T-Control® is

An indwelling urinary catheter

Controlled drainage

Drainage bag compatibility

Clinical procedures and professional guidance

Experiences from people who use a catheter

Frequently asked questions

Before using the device

Important information