Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention. (RELIEF)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostate Hyperplasia; Benign Prostate Obstruction; Acute Urinary Retention; Benign Prostate Hypertrophy(BPH)
• Intervention / Treatment: Procedure: TWOC after 3 days; Procedure: TWOC after 14 days

Detailed Description

not aplicable

• Study Type: Interventional
• Enrollment (Estimated): 478
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liselot L.A. Ribbert, MD,. PhD candidate; Phone Number: +31653182448; Email: liselotribbert@hotmail.com
• Study Contact Backup: Name: Bart P.W. Witte, MD, PhD; Phone Number: +31886244357; Email: l.p.w.witte@isala.nl

Study Locations

• Netherlands
  • Gelderland
    • Harderwijk, Gelderland, Netherlands, 3844 DG
      • Not yet recruiting
      • St. Jansdal
      • Contact: Celine ten Donkelaar, MD, PhD; Phone Number: +31341463558; Email: cs.ten.donkelaar@stjansdal.nl
    • Nijmegen, Gelderland, Netherlands, 6532SZ
      • Recruiting
      • Canisius Wilhelmina Hospital
      • Contact: Diederick Duijvesz, MD, PhD; Phone Number: +3243658255 d.duijvesz@cwz.nl; Email: d.duijvesz@cwz.nl
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419 PC
      • Not yet recruiting
      • Zuyderland Ziekenhuis
      • Contact: Kevin Rademakers, MD, PhD; Phone Number: +31884599704
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Recruiting
      • Maastricht University Medical Center+
      • Contact: John Heesakkers, MD, PhD; Phone Number: +31433877400; Email: john.heesakkers@mumc.nl
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623 EJ
      • Recruiting
      • Catharina Hospital
      • Contact: Evert Koldewijn, MD, PhD; Phone Number: +31402397040; Email: evert.koldewijn@catharinaziekenhuis.nl
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1091 AC
      • Recruiting
      • OLVG
      • Contact: Ernst van Haarst, MD, PhD; Phone Number: +31205108694; Email: e.vanhaarst@olvg.nl
    • Hoofddorp, North Holland, Netherlands, 2134 TM
      • Not yet recruiting
      • Spaarne Gasthuis
      • Contact: Lieke Gietelink, MD, PhD; Phone Number: +31232240160; Email: lgietelink@spaarnegasthuis.nl
  • Overijssel
    • Hengelo, Overijssel, Netherlands, 7555 DL
      • Not yet recruiting
      • Ziekenhuisgroep Twente
      • Contact: Christa van der Fels, MD, PhD; Phone Number: +31887083390; Email: c.vfels@zgt.nl
    • Zwolle, Overijssel, Netherlands, 8025AB
      • Recruiting
      • Isala
      • Contact: Liselot L.A. Ribbert, MD, PhD candidate; Phone Number: +31653182448; Email: liselotribbert@hotmail.com
  • Provincie Groningen
    • Groningen, Provincie Groningen, Netherlands, 9728NT
      • Recruiting
      • Martini Hospital
      • Contact: Jaap Poerink, MD; Phone Number: 0505245245; Email: j.poerink@mzh.nl
  • South Holland
    • Leiderdorp, South Holland, Netherlands, 2353 GA
      • Recruiting
      • Alrijne Hospital
      • Contact: Barbara Schout, MD, PhD; Phone Number: +31715828060; Email: bmaschout@alrijne.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TWOC after 3 days	Procedure: TWOC after 3 days; A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.
Active Comparator: TWOC after 14 days	Procedure: TWOC after 14 days; A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Re-catheterization rate after TWOC.	Either 3 or 14 days after catheterization, depending on study group allocation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	Up to 6 months after catheter insertion (iPCQ assessed at 1, 2, 3, and 6 months).
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).	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).	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).	Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.

Collaborators and Investigators

• Sponsor: Liselot Ribbert
• Collaborators: Maastricht University Medical Center; Catharina Ziekenhuis Eindhoven; Spaarne Gasthuis; Ziekenhuisgroep Twente; Zuyderland Medical Centre; Martini Hospital Groningen; St Jansdal Hospital; Alrijne Hospital; Canisius Wilhelmina Ziekenhuis (CWZ)
• Investigators: Principal Investigator: Bart P.W. Witte, MD, PhD, Isala; Study Chair: Marco H. Blanker, Professor, MD, PhD, University Medical Center Groningen; Study Director: Liselot L.A. Ribbert, MD, PhD candidate, Isala

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2025
• Primary Completion (Estimated): September 4, 2027
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Estimated): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: BPH; Urinary Retention; Benign prostate hyperplasia; BPO; urinary catheter; TWOC; Benign prostate obstruction; bladder catheter; Acute Urinary Retention; Trial Without Catheter; RELIEF; catheter removal; catheter withdrawal
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Prostatic Hyperplasia; Urinary Retention
• Other Study ID Numbers: NL-009284; 10390032310057 (Other Grant/Funding Number: ZonMw)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No