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NCT Number: NCT07283484

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

St. Jansdal, Harderwijk, Gelderland, Netherlands

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About this study

not aplicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TWOC after 3 days

Procedure

A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.

TWOC after 14 days

Procedure

A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.

Primary outcomes

  1. Re-catheterization rate after TWOC.

    Time frame: Either 3 or 14 days after catheterization, depending on study group allocation.

Secondary outcomes

  1. Patient reported outcomes - IPSS

    Time frame: 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).

  2. Patient reported outcomes - EQ-5D-5L

    Time frame: 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).

  3. Patient reported outcomes - ICIQ-LTCqol

    Time frame: 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).

  4. Process related outcomes - Catheter-related complications

    Time frame: 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.

  5. Resource related outcomes - Health care costs

    Time frame: 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).

  6. Resource related outcomes - Productivity losses

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Bart P.W. Witte, MD, PhD

CONTACT

[email protected]

+31886244357

Liselot L.A. Ribbert, MD,. PhD candidate

CONTACT

[email protected]

+31653182448

Sponsors and collaborators

Lead sponsor

Liselot Ribbert

Other

Collaborators

  • Alrijne Hospital
  • Canisius-Wilhelmina Hospital
  • Catharina Ziekenhuis Eindhoven
  • Maastricht University Medical Center
  • Martini Hospital Groningen
  • Spaarne Gasthuis
  • St Jansdal Hospital
  • Ziekenhuisgroep Twente
  • Zuyderland Medical Centre

Registry information

Official study title

Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention: a Randomized Controlled Trial (the RELIEF Study).

Acronym: RELIEF

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Dec 15, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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