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

NCT07283484 | Recruiting

• 2 other identifiers: NL-00928410390032310057
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 11

Brief 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. 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.

Conditions

Benign Prostate Obstruction; Benign Prostate Hypertrophy(BPH); Acute Urinary Retention; Benign Prostate Hyperplasia

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

Outcome Measures

Primary Outcomes (1)

• Re-catheterization rate after TWOC.

  Either 3 or 14 days after catheterization, depending on study group allocation.

Secondary Outcomes (6)

• Patient reported outcomes - IPSS

  Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.

• Patient reported outcomes - EQ-5D-5L

  Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.

• Patient reported outcomes - ICIQ-LTCqol

  Days 3 and 12 after catheter insertion, and at 1, 2, 3, and 6 months.

• Process related outcomes - Catheter-related complications

  Up to 18 months after catheter insertion.

• Resource related outcomes - Health care costs

  Up to 6 months after catheter insertion (iMCQ assessed at 3 and 6 months).

Study Arms (2)

TWOC after 3 days

EXPERIMENTAL

Procedure: TWOC after 3 days

TWOC after 14 days

ACTIVE COMPARATOR

Procedure: TWOC after 14 days

Interventions

TWOC after 14 days PROCEDURE

A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.

TWOC after 14 days

TWOC after 3 days PROCEDURE

A ''trial without catheter'' (TWOC procedure) will be conducted 3 days after catheterization.

TWOC after 3 days

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medical Centre: collaborator
• Alrijne Hospital: collaborator
• Canisius Wilhelmina Ziekenhuis (CWZ): collaborator
• Martini Hospital Groningen: collaborator
• Maastricht University Medical Center: collaborator
• Spaarne Gasthuis: collaborator
• St Jansdal Hospital: collaborator
• Ziekenhuisgroep Twente: collaborator
• Liselot Ribbert: lead
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (11)

St. Jansdal

Harderwijk, Gelderland, 3844 DG, Netherlands

NOT YET RECRUITING

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, 6532SZ, Netherlands

RECRUITING

Zuyderland Ziekenhuis

Heerlen, Limburg, 6419 PC, Netherlands

NOT YET RECRUITING

Maastricht University Medical Center+

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

OLVG

Amsterdam, North Holland, 1091 AC, Netherlands

RECRUITING

Spaarne Gasthuis

Hoofddorp, North Holland, 2134 TM, Netherlands

NOT YET RECRUITING

Ziekenhuisgroep Twente

Hengelo, Overijssel, 7555 DL, Netherlands

NOT YET RECRUITING

Isala

Zwolle, Overijssel, 8025AB, Netherlands

RECRUITING

Martini Hospital

Groningen, Provincie Groningen, 9728NT, Netherlands

RECRUITING

Alrijne Hospital

Leiderdorp, South Holland, 2353 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Retention

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Bart P.W. Witte, MD, PhD

  Isala

  PRINCIPAL INVESTIGATOR

• Marco H. Blanker, Professor, MD, PhD

  University Medical Center Groningen

  STUDY CHAIR

• Liselot L.A. Ribbert, MD, PhD candidate

  Isala

  STUDY DIRECTOR

Central Study Contacts

Liselot L.A. Ribbert, MD,. PhD candidate

CONTACT

+31653182448; liselotribbert@hotmail.com

Bart P.W. Witte, MD, PhD

CONTACT

+31886244357; l.p.w.witte@isala.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Model Details: Randomized, controlled, parallel-group, non-inferiority trial.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 15, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): September 4, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (11)