Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention.
NCT ID: NCT07283484
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
478 participants
INTERVENTIONAL
2025-08-21
2029-03-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TWOC after 3 days
TWOC after 3 days
A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
TWOC after 14 days
TWOC after 14 days
A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
Interventions
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TWOC after 3 days
A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
TWOC after 14 days
A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Alrijne Hospital
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
Canisius Wilhelmina Ziekenhuis (CWZ)
UNKNOWN
Martini Hospital Groningen
OTHER
Maastricht University Medical Center
OTHER
Spaarne Gasthuis
OTHER
St Jansdal Hospital
OTHER
Ziekenhuisgroep Twente
OTHER
Zuyderland Medical Centre
OTHER
Liselot Ribbert
OTHER
Responsible Party
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Liselot Ribbert
Study Director
Principal Investigators
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Bart P.W. Witte, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Isala
Marco H. Blanker, Professor, MD, PhD
Role: STUDY_CHAIR
University Medical Center Groningen
Liselot L.A. Ribbert, MD, PhD candidate
Role: STUDY_DIRECTOR
Isala
Locations
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St. Jansdal
Harderwijk, Gelderland, Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
Zuyderland Ziekenhuis
Heerlen, Limburg, Netherlands
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands
Catharina Hospital
Eindhoven, North Brabant, Netherlands
OLVG
Amsterdam, North Holland, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
Ziekenhuisgroep Twente
Hengelo, Overijssel, Netherlands
Isala
Zwolle, Overijssel, Netherlands
Martini Hospital
Groningen, Provincie Groningen, Netherlands
Alrijne Hospital
Leiderdorp, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Celine ten Donkelaar, MD, PhD
Role: primary
Diederick Duijvesz, MD, PhD
Role: primary
Kevin Rademakers, MD, PhD
Role: primary
John Heesakkers, MD, PhD
Role: primary
Evert Koldewijn, MD, PhD
Role: primary
Ernst van Haarst, MD, PhD
Role: primary
Lieke Gietelink, MD, PhD
Role: primary
Christa van der Fels, MD, PhD
Role: primary
Liselot L.A. Ribbert, MD, PhD candidate
Role: primary
Jaap Poerink, MD
Role: primary
Barbara Schout, MD, PhD
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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10390032310057
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NL-009284
Identifier Type: -
Identifier Source: org_study_id