R33
Conditions
Interventions
Group 1: Coated catheters (Suprapubic and transurethral indwelling catheters, as well as transurethral catheters after radical prostatectomy)
Group 2: Conventional catheters (comparator, Suprapubic an
Sponsors
UroNova GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients requiring the use of a transurethral or suprapubic indwelling catheter - Patients after radical prostatectomy - Expected catheter indwelling time of at least one week after medical indication - Written informed consent is available
Exclusion criteria
Exclusion criteria: • Patients in whom a balloon catheter cannot be inserted due to anatomical conditions, particularly the transurethral CH 16 and suprapubic CH 12, 16, and 20 types • Patients with prostatitis, urethral stricture, urethritis, or an insufficiently filled and contracted bladder • Catheterized patients with an existing symptomatic urinary tract infection • Insufficient mental, verbal, or physical ability to participate in the study • ECOG >3 (Eastern Cooperative Oncology Group) • Taking immunosuppressants • Refusal to participate in the clinical trial • Participation in another clinical trial within the last 30 days • Patients who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incrustation weight by measuring the difference in catheter weights before and after use | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the questionnaires on handling, pain, quality of life and problems with infections and encrustation | — |
Countries
Germany
Contacts
Public ContactHagen Loertzer
Westpfalzklinikum Kaiserslautern
Outcome results
None listed