Clinical trial Recruiting at 7 sites Interventional Ages 18 and up Men only

Early versus delayed catheter removal in men with sudden urinary retention

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

Run by Isala · NCT07283484 · Data updated 2026-11-12

This trial will test whether removing the catheter after 3 days or after 14 days helps men with sudden urinary retention (usually from an enlarged prostate) urinate without the catheter.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment478 (estimated)
SponsorIsala
Academic / other
Locations11 sites (Harderwijk, Gelderland and 10 other locations)
StatusRecruiting
StartedAugust 21, 2025
Main results expectedSeptember 4, 2027
Study endsMarch 1, 2029
Registry record updatedDecember 22, 2025
Trial IDNCT07283484 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adult men (age ≥18) with acute urinary retention treated with a transurethral catheter and started on an alpha-blocker who can give informed consent are ideal candidates.

Probably not a fit

Men with neurogenic bladder dysfunction, very large initial retention (>1500 mL), recent failed TWOC, suspected urethral stricture, or relevant prior prostate/bladder cancer or surgery are unlikely to benefit or are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adult men who present with acute urinary retention and are treated with a transurethral catheter plus an alpha-blocker will be enrolled and assigned to have a Trial Without Catheter (TWOC) after either 3 days or 14 days. Outcomes such as successful voiding, catheter-related complications, and urinary tract infections will be recorded and compared between the two timing groups. The trial excludes men with neurogenic bladder, large initial retention volumes, recent failed TWOC, or certain prostate/bladder cancer histories. Participating sites are regional hospitals in the Netherlands where procedures and follow-up visits will take place.

Why it matters

Potential benefit: If successful, the trial could identify a shorter safe catheter duration that reduces discomfort and catheter-related complications while allowing earlier return to normal urination.

How similar studies have gone: Previous clinical experience and small studies report mixed results and variable timing for TWOC, so while early removal has sometimes been safe, strong consistent evidence is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Canisius Wilhelmina Hospital
    Nijmegen, Gelderland, Netherlands
    Recruiting
  • Maastricht University Medical Center+
    Maastricht, Limburg, Netherlands
    Recruiting
  • Catharina Hospital
    Eindhoven, North Brabant, Netherlands
    Recruiting
  • Olvg
    Amsterdam, North Holland, Netherlands
    Recruiting
  • Isala
    Zwolle, Overijssel, Netherlands
    Recruiting
  • Martini Hospital
    Groningen, Provincie Groningen, Netherlands
    Recruiting
Show 5 more locations
  • Alrijne Hospital
    Leiderdorp, South Holland, Netherlands
    Recruiting
  • St. Jansdal
    Harderwijk, Gelderland, Netherlands
    Not yet recruiting
  • Zuyderland Ziekenhuis
    Heerlen, Limburg, Netherlands
    Not yet recruiting
  • Spaarne Gasthuis
    Hoofddorp, North Holland, Netherlands
    Not yet recruiting
  • Ziekenhuisgroep Twente
    Hengelo, Overijssel, Netherlands
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.