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New treatment option for Acute Urinary Retention
Official title Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT07654413
What this study is testing
What is Tamsulosin?
Tamsulosin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute urinary retention.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Banī Suwayf, Beni Suweif Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banī Suwayf, Beni Suweif Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.