Acute urinary retention (AUR) is a sudden and painful condition. It occurs when a person is unable to urinate. In men, AUR is most often caused by an enlarged prostate, known as benign prostatic hyperplasia (BPH), which blocks the urethra. The first steps in treatment are to insert a catheter to empty the bladder and to start medication that acts on the prostate (an alpha-blocker). After some time, the catheter is removed during a so-called "Trial Without Catheter" (TWOC) to see whether the patient can urinate normally again.
At present, it is unclear how long a catheter should remain in place before this trial is performed. In Dutch hospitals, the duration varies widely: in some hospitals, the catheter is removed after only a few days, while in others it stays in place for two weeks or longer. A longer catheter duration can cause more discomfort and complications, such as urinary tract infections or blood in the urine. Therefore, it is important to determine whether a shorter catheterization period is equally effective and safe compared to a longer one.
The RELIEF study investigates whether a short catheter duration of three days is as safe and effective as the current average of fourteen days. A total of 478 men with acute urinary retention will participate in this nationwide randomized controlled trial. All participants will receive a catheter and start (or continue) treatment with an alpha-blocker. They will then be randomly assigned to one of two groups: one group will have the catheter removed after three days, and the other group after fourteen days.
The main question is whether a shorter catheter duration is as successful as a longer one. Success means that the patient can urinate normally after catheter removal, without needing to have the catheter replaced. The study will also compare the number of complications, patients' experiences with the catheter, their quality of life, and the overall healthcare costs.
By conducting this study, doctors will gain better evidence on the optimal timing of catheter removal in men with AUR. The goal is to avoid unnecessarily long catheterization, reduce discomfort and complications, and improve the quality of care for men with AUR. The results of the RELIEF study may help improve the management of AUR, making care more consistent, efficient, and patient-friendly both in the Netherlands and abroad.
Adult men (≥18 years)
Diagnosis of acute urinary retention (AUR) treated with a transurethral catheter (TUC) and alpha-blocker therapy (tamsulosin, silodosin, or alfuzosin)
Mentally competent and able to understand the potential benefits and burdens of study participation
Provision of written or digital informed consent
Failed prior TWOC within the preceding 30 days
Initial urinary retention volume >1500 mL
Neurogenic bladder dysfunction (e.g., multiple sclerosis, spinal cord injury, spina bifida)
History of prostate cancer with ISUP grade group ≥2
Parallel
TWOC after 3 days
Procedure/SurgeryA ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
TWOC after 14 days
Procedure/SurgeryA ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
Re-catheterization rate after TWOC.
Patient reported outcomes - IPSS
Lower urinary tract symptoms measured by the International Prostate Symptom Score (IPSS). IPSS is a self-reported score assessing urinary symptoms, including voiding and storage symptoms. Range: 0 to 35 (higher scores indicate more severe symptoms).
Patient reported outcomes - EQ-5D-5L
General health-related quality of life measured by the EuroQol 5 Dimensions, 5 Levels questionnaire (EQ-5D-5L) EQ-5D-5L assesses health status across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Range: 0 to 1 for the index score (higher scores indicate better health); Visual Analogue Scale (VAS) range: 0 to 100 (higher scores indicate better health).
Patient reported outcomes - ICIQ-LTCqol
Catheter-related symptoms and concerns measured by the International Consultation on Incontinence Questionnaire - Long-Term Catheter Quality of Life (ICIQ-LTCQoL) ICIQ-LTCQoL assesses the impact of long-term catheter use on quality of life, including symptoms and concerns. Range: 0 to 21 (higher scores indicate more concern and poorer quality of life).
Process related outcomes - Catheter-related complications
Catheter related complications (e.g., macroscopic hematuria, CAUTI, urosepsis, catheter related pain or other catheter related problems, urethral strictures), assessed through medical record review and telephone evaluation.
Click on the lead sponsor to view all of their trials.
Liselot Ribbert
Lead sponsor
Isala
Sponsor institution
Alrijne Hospital
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
Canisius-Wilhelmina Hospital
Collaborator
Martini Hospital Groningen
Collaborator
Maastricht University Medical Center
Collaborator
Spaarne Gasthuis
Collaborator
St Jansdal Hospital
Collaborator
Ziekenhuisgroep Twente
Collaborator
Zuyderland Medical Centre
Collaborator
