The study investigates biopsy-associated complications and pain related to diagnostic tissue sampling of the prostate in men with suspected prostate cancer. The focus is on urinary problems, blood in the urine, infection-related complications, and patient-reported pain following the procedure. C61 R33 R31 N39.0
Conditions
Interventions
Group 1: Intervention group. Biopsy with intraoperative transurethral catheter placement
Participants undergo a transperineal MRI-ultrasound fusion biopsy of the prostate in accordance with clinical s
Sponsors
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible for participation are adult men aged 18 years or older who are scheduled to undergo transperineal prostate tissue sampling for diagnostic reasons. Participants must be able to understand the study information and provide written informed consent. At the time of the procedure, participants must not have an existing transurethral or suprapubic bladder catheter and must have no known medical contraindications to the biopsy procedure or to transurethral catheterization. In addition, participation requires that there is no mandatory clinical indication for bladder catheterization independent of randomization.
Exclusion criteria
Exclusion criteria: Excluded from participation are individuals who are unable or unwilling to provide written informed consent. Patients with a pre-existing transurethral or suprapubic bladder catheter are excluded. Individuals with known medical contraindications to transperineal prostate tissue sampling or to transurethral catheterization, including known urethral strictures or stenosis, are not eligible. In addition, patients who require mandatory intraoperative catheterization for clinical reasons and therefore cannot be randomized are excluded. Individuals who have undergone gender-affirming surgery or reconstructive procedures of the urethra or lower urinary tract are also excluded due to anatomical heterogeneity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT: Acute urinary retention requiring transurethral catheterization, macroscopic hematuria requiring medical consultation and/or intervention (e.g. placement of a bladder irrigation catheter or hospital admission), infection-related events defined as a body temperature = 38.0 °C or initiation of antibiotic therapy at the physician’s discretion, and any urological hospitalization. WHEN: within 7 days after transperineal MRI-ultrasound fusion biopsy of the prostate. HOW: Structured standardized telephone interview conducted during routine post-biopsy result communication using a study-specific questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| WHAT: Patient-reported pain intensity after transperineal MRI-ultrasound fusion biopsy of the prostate. WHEN: within 7 days after the biopsy procedure. HOW: Assessment using the Numeric Rating Scale, NRS, 0 to 10, during a structured standardized telephone interview. | — |
Countries
Germany
Contacts
Public ContactHendrik Eike Fender
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Lübeck
Outcome results
None listed