Actively Recruiting
Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention: a Randomized Controlled Trial (the RELIEF Study).
Led by Liselot Ribbert · Updated on 2025-12-22
478
Participants Needed
11
Research Sites
77 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 where a man cannot urinate, often caused by an enlarged prostate known as benign prostatic hyperplasia (BPH). Treatment usually starts with inserting a catheter to empty the bladder and taking medication called alpha-blockers. This study compares two different lengths of catheter use before trying to urinate again, known as the "Trial Without Catheter" (TWOC), to find out if a shorter catheter period is as effective and safe as a longer one. The trial includes 478 men with AUR who all receive a catheter and start or continue alpha-blocker treatment. Participants are randomly assigned to have the catheter removed either after three days or after fourteen days. The study examines if the shorter catheter duration works as well as the longer one in allowing normal urination without needing catheter replacement. It also looks at complications, patient comfort, quality of life, and healthcare costs. During the study, researchers will monitor how many men need re-catheterization after their TWOC, assess patient-reported symptoms and quality of life at multiple time points up to six months, and track complications and healthcare expenses up to 18 months after catheter insertion. The goal is to identify the best timing for catheter removal to reduce discomfort and complications and improve care. Participation lasts through these assessments and follow-ups as scheduled by the research team.
CONDITIONS
Brief 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 or older)
- 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
- Provided written or digital informed consent
You will not qualify if you...
- Failed prior trial without catheter (TWOC) within the past 30 days
- Initial urinary retention volume over 1500 mL
- Neurogenic bladder dysfunction such as multiple sclerosis, spinal cord injury, or spina bifida
- History of prostate cancer with ISUP grade group 2 or higher
- History of active bladder cancer or under surveillance for bladder cancer
- Urinary retention occurring within 72 hours after surgery
- History of lower urinary tract surgery including 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 14 days after catheterization
Participants undergo a trial without catheter (TWOC) procedure either 3 days or 14 days after catheterization, based on study group allocation.
1 to 2 visits depending on group assignment
Duration - Up to 18 months after catheter insertion
Participants complete patient reported outcome assessments and monitoring of catheter-related complications and healthcare resource use.
Visits at Days 3 and 12, and at 1, 2, 3, and 6 months, with some assessments up to 18 months
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
B
Bart P.W. Witte, MD, PhD
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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