Actively Recruiting
Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention.
Led by Liselot Ribbert · Updated on 2025-12-22
478
Participants Needed
11
Research Sites
184 weeks
Total Duration
On this page
Sponsors
L
Liselot Ribbert
Lead Sponsor
A
Alrijne Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men (≥18 years)
- Diagnosis of acute urinary retention treated with a transurethral catheter 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
You will not qualify if you...
- Failed prior trial without catheter within the preceding 30 days
- Initial urinary retention volume greater than 1500 mL
- Neurogenic bladder dysfunction (e.g., multiple sclerosis, spinal cord injury, spina bifida)
- History of prostate cancer with ISUP grade group 2 or higher
- 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)
- Acute urinary retention suspected to be caused by bladder stones
- Suspected urethral stricture, clot retention, or urosepsis
- Contraindication to alpha-blocker therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
St. Jansdal
Harderwijk, Gelderland, Netherlands, 3844 DG
Not Yet Recruiting
2
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands, 6532SZ
Actively Recruiting
3
Zuyderland Ziekenhuis
Heerlen, Limburg, Netherlands, 6419 PC
Not Yet Recruiting
4
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
5
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5623 EJ
Actively Recruiting
6
OLVG
Amsterdam, North Holland, Netherlands, 1091 AC
Actively Recruiting
7
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands, 2134 TM
Not Yet Recruiting
8
Ziekenhuisgroep Twente
Hengelo, Overijssel, Netherlands, 7555 DL
Not Yet Recruiting
9
Isala
Zwolle, Overijssel, Netherlands, 8025AB
Actively Recruiting
10
Martini Hospital
Groningen, Provincie Groningen, Netherlands, 9728NT
Actively Recruiting
11
Alrijne Hospital
Leiderdorp, South Holland, Netherlands, 2353 GA
Actively Recruiting
Research Team
L
Liselot L.A. Ribbert, MD,. PhD candidate
CONTACT
B
Bart P.W. Witte, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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