Acute Urinary Retention, Benign Prostate Hyperplasia, Benign Prostate Hypertrophy(BPH), Benign Prostate Obstruction
Conditions
Keywords
RELIEF, Acute Urinary Retention, Urinary Retention, TWOC, Trial Without Catheter, bladder catheter, urinary catheter, catheter removal, catheter withdrawal, Benign prostate obstruction, BPO, Benign prostate hyperplasia, BPH
Brief summary
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.
Detailed description
not aplicable
Interventions
PROCEDURETWOC after 3 days
A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
PROCEDURETWOC after 14 days
A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
Sponsors
Alrijne Hospital
Catharina Ziekenhuis Eindhoven
Canisius Wilhelmina Ziekenhuis (CWZ)
Martini Hospital Groningen
Maastricht University Medical Center
Spaarne Gasthuis
St Jansdal Hospital
Ziekenhuisgroep Twente
Zuyderland Medical Centre
Liselot Ribbert
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized, controlled, parallel-group, non-inferiority trial.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * History of active bladder cancer or ongoing surveillance for bladder cancer * Urinary retention occurring within 72 hours after surgery (postoperative urinary retention) * History of lower urinary tract surgery (e.g., bladder augmentation, urethral surgery, or prostate surgery) * AUR suspected to be caused by bladder stones * Suspected urethral stricture, clot retention, or urosepsis * Contraindication to alpha-blocker therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Re-catheterization rate after TWOC. | Either 3 or 14 days after catheterization, depending on study group allocation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcomes - EQ-5D-5L | Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months. | 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 | Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months. | 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). |
| Patient reported outcomes - IPSS | Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months. | 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). |
| Resource related outcomes - Health care costs | Up to 6 months after catheter insertion (iMCQ assessed at 3 and 6 months). | Direct health care costs, including costs of (re)catheterization, diagnosis and treatment of complications, and hospital admissions, assessed through medical record review and the iMTA Medical Consumption Questionnaire (iMCQ). |
| Resource related outcomes - Productivity losses | Up to 6 months after catheter insertion (iPCQ assessed at 1, 2, 3, and 6 months). | Productivity losses (social costs) assessed using the iMTA Productivity Cost Questionnaire (iPCQ). |
| Process related outcomes - Catheter-related complications | Up to 18 months after catheter insertion. | 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. |
Countries
Netherlands
Contacts
Primary ContactLiselot L.A. Ribbert, MD,. PhD candidate
Backup ContactBart P.W. Witte, MD, PhD
Outcome results
None listed