Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due… (NCT07654413) | Clinical Trial Compass
RecruitingPhase 4
Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia
Egypt320 participantsStarted 2026-06-08
Plain-language summary
Acute urinary retention is a common emergency in men with benign prostatic hyperplasia. After bladder drainage with a urethral catheter, patients usually undergo a trial without catheter to determine whether they can pass urine again without recatheterization.
This study will evaluate whether adding tadalafil 5 mg once daily to tamsulosin 0.4 mg once daily improves the chance of successful trial without catheter in men with first-episode acute urinary retention due to presumed benign prostatic hyperplasia.
Participants will be randomly assigned to receive either tamsulosin plus tadalafil or tamsulosin plus a matching placebo. Study medication will start within 24 hours after catheterization. The catheter will be removed on Day 7. If the first trial without catheter fails, the catheter will be reinserted and a second rescue trial without catheter will be performed on Day 14.
The main outcome is overall catheter-free success by Day 14. Participants will also be followed for recurrent urinary retention, post-void residual urine, urinary flow, catheter-related complications, drug-related adverse events, and the need for benign prostatic hyperplasia-related surgery within 3 months.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male patient aged 50 years or older.
* First episode of spontaneous painful acute urinary retention.
* Successful urethral catheterization at presentation.
* Drained urine volume at presentation of at least 300 mL.
* Clinical impression of benign prostatic obstruction or benign prostatic hyperplasia based on history, digital rectal examination, and/or ultrasound evidence of enlarged prostate.
* Ability to provide written informed consent.
Exclusion Criteria:
* Previous episode of acute urinary retention.
* Chronic painless urinary retention phenotype.
* Active urinary tract infection or sepsis.
* Gross hematuria with clot retention.
* Suspected or known urethral stricture.
* Neurogenic bladder or major neurologic disease affecting voiding.
* History of prostate cancer or bladder cancer.
* Previous prostate surgery.
* Current use of nitrates or guanylate cyclase stimulators.
* Contraindication to tadalafil or tamsulosin.
* Severe hypotension or unstable cardiovascular disease.
* Severe renal impairment.
* Severe hepatic impairment.
* Current or recent use of phosphodiesterase type 5 inhibitors before enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.