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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 478 (estimated) |
| Sponsor | Isala Academic / other |
| Locations | 11 sites (Harderwijk, Gelderland and 10 other locations) |
| Status | Recruiting |
| Started | August 21, 2025 |
| Main results expected | September 4, 2027 |
| Study ends | March 1, 2029 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT07283484 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
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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
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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
- Principal investigator: Bart P.W. Witte, MD, PhD — Isala
- Study coordinator: Liselot L.A. Ribbert, MD,. PhD candidate
- Email: liselotribbert@hotmail.com
- Phone: +31653182448
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.