Early versus delayed catheter removal in men with sudden urinary retention
Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention: a Randomized Controlled Trial (the RELIEF Study).
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 478 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Isala Academic / other |
| Locations | 11 sites (Harderwijk, Gelderland and 10 other locations) |
| Trial ID | NCT07283484 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Harderwijk, Gelderland and 10 other locations
- St. Jansdal — Harderwijk, Gelderland, Netherlands (Not_yet_recruiting)
- Canisius Wilhelmina Hospital — Nijmegen, Gelderland, Netherlands (Recruiting)
- Zuyderland Ziekenhuis — Heerlen, Limburg, Netherlands (Not_yet_recruiting)
- Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands (Recruiting)
- Catharina Hospital — Eindhoven, North Brabant, Netherlands (Recruiting)
- Olvg — Amsterdam, North Holland, Netherlands (Recruiting)
- Spaarne Gasthuis — Hoofddorp, North Holland, Netherlands (Not_yet_recruiting)
- Ziekenhuisgroep Twente — Hengelo, Overijssel, Netherlands (Not_yet_recruiting)
- Isala — Zwolle, Overijssel, Netherlands (Recruiting)
- Martini Hospital — Groningen, Provincie Groningen, Netherlands (Recruiting)
- Alrijne Hospital — Leiderdorp, South Holland, Netherlands (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.