Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention. (RELIEF)

Liselot Ribbert

Status

Enrolling

Conditions

Benign Prostate Hypertrophy(BPH)

Acute Urinary Retention

Benign Prostate Hyperplasia

Benign Prostate Obstruction

Treatments

Procedure: TWOC after 14 days

Procedure: TWOC after 3 days

Study type

Interventional

Funder types

Other

Identifiers

NCT07283484

NL-009284

10390032310057 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full description

not aplicable

Enrollment

478 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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