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New treatment option for Acute Urinary Retention
Official title Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention
ClinicalTrials.gov ID: NCT07650968
What this study is testing
What is Tamsulosin 0.4 mg?
Tamsulosin 0.4 mg is an investigational medicine, given as an once-daily, 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
- This randomized controlled trial will compare three medication strategies before trial without catheter in men with acute urinary retention due to benign prostatic hyperplasia who were already taking tamsulosin 0.4 mg once daily before the retention episode. After urethral catheterization, eligible participants will be randomly assigned to one of three groups for 7 days: continuation of tamsulosin 0.4 mg once daily, escalation to tamsulosin 0.8 mg once daily, or switching to silodosin 8 mg once daily.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
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 patients aged 50 years or older.
- Acute urinary retention requiring urethral catheterization.
- Presumed acute urinary retention secondary to benign prostatic enlargement or benign prostatic obstruction.
- Already receiving tamsulosin 0.4 mg once daily for at least 4 weeks before the acute urinary retention episode.
- Successful urethral catheterization at presentation.
You likely can't join if
- Known or suspected prostate cancer.
- Previous prostate surgery.
- Previous urethral stricture disease or urethral surgery.
- Neurogenic bladder or known neurological disease affecting voiding.
- Chronic urinary retention rather than acute painful retention.
- Acute urinary retention due to non-BPH causes, including clot retention, bladder stone obstruction, acute prostatitis, urethral trauma, or...
See the full eligibility criteria
- Male patients aged 50 years or older.
- Acute urinary retention requiring urethral catheterization.
- Presumed acute urinary retention secondary to benign prostatic enlargement or benign prostatic obstruction.
- Already receiving tamsulosin 0.4 mg once daily for at least 4 weeks before the acute urinary retention episode.
- Successful urethral catheterization at presentation.
- Initial catheterized urine volume ≤1000 mL, with a clinical presentation consistent with painful acute urinary retention.
- Prostate enlargement on ultrasound or clinical assessment consistent with benign prostatic hyperplasia or benign prostatic obstruction.
- Ability to provide written informed consent.
- Known or suspected prostate cancer.
- Previous prostate surgery.
- Previous urethral stricture disease or urethral surgery.
- Neurogenic bladder or known neurological disease affecting voiding.
- Chronic urinary retention rather than acute painful retention.
- Acute urinary retention due to non-BPH causes, including clot retention, bladder stone obstruction, acute prostatitis, urethral trauma, or drug-induced retention.
- Severe urinary tract infection, sepsis, or fever at presentation.
- Gross hematuria requiring irrigation.
- Failed urethral catheterization or need for suprapubic catheterization.
- Current use of silodosin, alfuzosin, doxazosin, terazosin, tadalafil, anticholinergics, beta-3 agonists, or other drugs that may significantly affect voiding.
- Severe renal impairment requiring urgent intervention.
- Symptomatic postural hypotension or recurrent syncope.
- Known hypersensitivity to silodosin.
- Severe hepatic impairment.
- Inability to comply with follow-up.
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.