Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT07283484

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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