Acute Urinary RetentionRELIEFNCT07283484
Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention.
A study testing TWOC after 3 days and TWOC after 14 days in people with Acute Urinary Retention and Benign Prostate Obstruction, run by Liselot Ribbert at 11 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Acute Urinary Retention, Benign Prostate Obstruction, Benign Prostate Hyperplasia
- What is being tested?
- TWOC after 3 days and TWOC after 14 days
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 11 sitesNetherlands
- Study dates
- 21 Aug 2025to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Netherlands11 sites, 11 recruiting
- Recruiting
OLVG
Amsterdam, North Holland, 1091 AC
Ernst van Haarst, MD, PhD, +31205108694, e.vanhaarst@olvg.nl
- Recruiting
Catharina Hospital
Eindhoven, North Brabant, 5623 EJ
Evert Koldewijn, MD, PhD, +31402397040, evert.koldewijn@catharinaziekenhuis.nl
- Recruiting
Martini Hospital
Groningen, Provincie Groningen, 9728NT
Jaap Poerink, MD, 0505245245, j.poerink@mzh.nl
- Not yet recruiting
St. Jansdal
Harderwijk, Gelderland, 3844 DG
Celine ten Donkelaar, MD, PhD, +31341463558, cs.ten.donkelaar@stjansdal.nl
- Not yet recruiting
Zuyderland Ziekenhuis
Heerlen, Limburg, 6419 PC
Kevin Rademakers, MD, PhD, +31884599704
- Not yet recruiting
Ziekenhuisgroep Twente
Hengelo, Overijssel, 7555 DL
Christa van der Fels, MD, PhD, +31887083390, c.vfels@zgt.nl
- Not yet recruiting
Spaarne Gasthuis
Hoofddorp, North Holland, 2134 TM
Lieke Gietelink, MD, PhD, +31232240160, lgietelink@spaarnegasthuis.nl
- Recruiting
Alrijne Hospital
Leiderdorp, South Holland, 2353 GA
Barbara Schout, MD, PhD, +31715828060, bmaschout@alrijne.nl
- Recruiting
Maastricht University Medical Center+
Maastricht, Limburg, 6229 HX
John Heesakkers, MD, PhD, +31433877400, john.heesakkers@mumc.nl
- Recruiting
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, 6532SZ
Diederick Duijvesz, MD, PhD, d.duijvesz@cwz.nl ext. +3243658255, d.duijvesz@cwz.nl
- Recruiting
Isala
Zwolle, Overijssel, 8025AB
Liselot L.A. Ribbert, MD, PhD candidate, +31653182448, liselotribbert@hotmail.com
About this study
Official title: Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention: a Randomized Controlled Trial (the RELIEF Study).
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.
Read more
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.
Read the detailed description
not aplicable
- Conditions
- Acute Urinary Retention, Benign Prostate Obstruction, Benign Prostate Hyperplasia, Benign Prostate Hypertrophy(BPH)
- Being tested
- TWOC after 3 days, TWOC after 14 days
- Keywords
- RELIEF, Acute Urinary Retention, Urinary Retention, TWOC, Trial Without Catheter, bladder catheter, urinary catheter, catheter removal, catheter withdrawal, Benign prostate obstruction, BPO, Benign prostate hyperplasia, BPH
- Medical subject headings
- Prostatic Hyperplasia, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWOC after 3 daysProcedure or surgery
A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
TWOC after 14 daysProcedure or surgery
A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
| Study group | Role | What they receive |
|---|---|---|
| TWOC after 3 days | Experimental | Not described Receives: Procedure: TWOC after 3 days |
| TWOC after 14 days | Active comparator | Not described Receives: Procedure: TWOC after 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-catheterization rate after TWOC.
Measured: Either 3 or 14 days after catheterization, depending on study group allocation.
Secondary outcomes (6)
Patient reported outcomes - IPSS
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).
Measured: Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.
Patient reported outcomes - EQ-5D-5L
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).
Measured: Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.
Patient reported outcomes - ICIQ-LTCqol
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).
Measured: Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.
Process related outcomes - Catheter-related complications
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.
Measured: Up to 18 months after catheter insertion.
Resource related outcomes - Health care costs
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).
Measured: Up to 6 months after catheter insertion (iMCQ assessed at 3 and 6 months).
Resource related outcomes - Productivity losses
Productivity losses (social costs) assessed using the iMTA Productivity Cost Questionnaire (iPCQ).
Measured: Up to 6 months after catheter insertion (iPCQ assessed at 1, 2, 3, and 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start21 Aug 2025
- Primary completion4 Sep 2027 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, parallel-group, non-inferiority trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liselot Ribbert
- Sponsor type
- University, hospital or other
- Collaborators
- Alrijne Hospital, Catharina Ziekenhuis Eindhoven, Canisius-Wilhelmina Hospital, Martini Hospital Groningen, Maastricht University Medical Center, Spaarne Gasthuis, St Jansdal Hospital, Ziekenhuisgroep Twente, Zuyderland Medical Centre
- Responsible party
- Sponsor-investigator, Liselot Ribbert, Isala
- Investigators
- Bart P.W. Witte, MD, PhD, Principal investigator, IsalaMarco H. Blanker, Professor, MD, PhD, Study chair, University Medical Center GroningenLiselot L.A. Ribbert, MD, PhD candidate, Study director, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283484
- Sponsor's protocol ID
- NL-009284
- Other IDs
- 10390032310057
- Acronym
- RELIEF
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention: a Randomized Controlled Trial (the RELIEF Study).
- ClinicalTrials.gov ID
- NCT07283484
- Acronym / sponsor ID
- RELIEF / NL-009284
- Conditions
- Acute Urinary Retention, Benign Prostate Obstruction, Benign Prostate Hyperplasia, Benign Prostate Hypertrophy(BPH)
- Keywords
- RELIEF, Acute Urinary Retention, Urinary Retention, TWOC, Trial Without Catheter, bladder catheter, urinary catheter, catheter removal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 478 participants (estimated)
- Lead sponsor
- Liselot RibbertUniversity, hospital or other
- Collaborators
- Alrijne Hospital, Catharina Ziekenhuis Eindhoven, Canisius-Wilhelmina Hospital, Martini Hospital Groningen, Maastricht University Medical Center, Spaarne Gasthuis, St Jansdal Hospital, Ziekenhuisgroep Twente, Zuyderland Medical Centre
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 4 Sep 2027 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
not aplicable
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, parallel-group, non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| TWOC after 3 days | Experimental | Procedure: TWOC after 3 days |
| TWOC after 14 days | Active comparator | Procedure: TWOC after 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TWOC after 3 daysA ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization. | Procedure or surgery | TWOC after 3 days |
| TWOC after 14 daysA ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization. | Procedure or surgery | TWOC after 14 days |
Primary outcome
Re-catheterization rate after TWOC.
Time frame: Either 3 or 14 days after catheterization, depending on study group allocation.
6 secondary outcomes
Patient reported outcomes - IPSS
Time frame: Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.
Patient reported outcomes - EQ-5D-5L
Time frame: Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.
Patient reported outcomes - ICIQ-LTCqol
Time frame: Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.
Process related outcomes - Catheter-related complications
Time frame: Up to 18 months after catheter insertion.
Resource related outcomes - Health care costs
Time frame: Up to 6 months after catheter insertion (iMCQ assessed at 3 and 6 months).
Resource related outcomes - Productivity losses
Time frame: Up to 6 months after catheter insertion (iPCQ assessed at 1, 2, 3, and 6 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bart P.W. Witte, MD, PhD principal investigator
Isala
Marco H. Blanker, Professor, MD, PhD study chair
University Medical Center Groningen
Liselot L.A. Ribbert, MD, PhD candidate study director
Isala
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TWOC after 3 days and TWOC after 14 days in people with Acute Urinary Retention and Benign Prostate Obstruction, run by Liselot Ribbert at 11 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liselot L.A. Ribbert, MD,. PhD candidate (+31653182448, liselotribbert@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-catheterization rate after TWOC. (time frame: Either 3 or 14 days after catheterization, depending on study group allocation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.