
Summary of the NextCath study
Full titel:
Comparative study of the incrustation behaviour of silicone balloon catheters with anti-adhesive coating and uncoated balloon catheters
Urologic balloon catheters are inserted into the patient's bladder and feature a balloon that is inflated after the catheter is inserted and holds it in the patient's bladder. Balloon catheters can be inserted directly into the bladder through the urethra (urethral catheter) or through an incision in the abdominal wall (suprapubic catheter).
Catheterization with urological balloon catheters carries a high risk of urinary tract infections because bacterial colonization of the catheter often occurs. Catheter-associated urinary tract infections are the most common infections occurring in hospitals and long-term care facilities. Bacterial colonization often promotes the formation of crystalline deposits, known as incrustation. These hard and sharp-edged deposits can damage the tissue and cause the catheter to become blocked.
The aim of the study is to demonstrate a reduction in the amount of incrustation and infection problems with coated catheters under comparable conditions compared to conventional catheters. The study is designed as a double-blind randomized comparative study. Randomly coated and uncoated balloon catheters are used on the patient. Since the products look completely identical, the investigator and the patient cannot determine whether it is the test product or the comparison product.

Performing clinic:
Clinic for Urology and Pediatric Urology
Westpfalz-Klinikum Kaiserslautern
Prof. Dr. med. Hagen Loertzer
Hellmut-Hartert-Straße 1
67655 Kaiserslautern, Germany
Sponsor:
Uronovis GmbHMerkurstraße 50
67663 Kaiserslautern
Germany
What are urological balloon catheters used for?
Urological balloon catheters are inserted into the urinary bladder to treat urination disorders. The urine is drained through the catheter into a urine bag if the patient cannot urinate autonomously. They are often used in connection with operations, incontinence or diseases such as prostatic hyperplasia.
The catheters are inserted into the urinary bladder by trained personnel via the urethra (transurethral version) or via a puncture site directly above the symphysis (suprapubic version).
Already in the 19th century, catheters of various shapes were made from vulcanized rubber. In 1927, the American urologist Frederic Foley developed the balloon catheter that is now commonly used as an indwelling catheter and is internationally known as the Foley catheter.

Which problems can occur when using urological balloon catheters?
Urinary tract infections, which most commonly occur in patients with permanent catheterization, are promoted by biofilm formation on the surface of the catheter. Bacteria settle on the surface, multiply and form an association that protects them from external influences, such as administered antibiotics, and renders them ineffective.
Furthermore, so-called incrustation of bladder catheters often occurs. Crystalline deposits that formfrom urine components can cause the catheter to become blocked. Affected patients often become emergencies because the accumulation of urine must be resolved immediately. The removal of heavily encrusted catheters is also extremely problematic, as the removal of encrusted catheters is painful and can lead to injuries.
The problem described also represents a health economic problem, as the treatment of patients in such situations leads to large additional costs for the health system. If this could be reliably prevented, care with bladder catheters would become cheaper, more effective and safer.


Why is the NextCath study being conducted?
The aim of the study is to examine the effectiveness and clinical benefits of the new coated urinary catheter in an unbiased manner.
In addition to the infection problem, the change in encrustation behaviour compared to commercially available catheters is examined, i.e. the question should be answered whether there are fewer occlusions with coated catheters and whether fewer complications occur during removal.
Another important aspect of the study is the quality of life of the patients, which is determined using scientifically validated questionnaires. It is investigated whether coated catheters have less negative impact on patients' quality of life than conventional catheters.

German Clinical Trials Register
This is the link to the entry of the NextCath study in the German Clinical Trials Register with further details on the study design:
in work.
