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

RecruitingNAAges 18 Years - anyMaleLiselot Ribbert
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult men (โ‰ฅ18 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 โ‰ฅ2 * 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
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What it tests

  • TWOC after 3 days
  • TWOC after 14 days
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Where

11 sites
St. Jansdal
Harderwijk, Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Netherlands
Zuyderland Ziekenhuis
Heerlen, Netherlands
Maastricht University Medical Center+
Maastricht, Netherlands
Catharina Hospital
Eindhoven, Netherlands
OLVG
Amsterdam, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Ziekenhuisgroep Twente
Hengelo, Netherlands

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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