NCT07650968 Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention
| NCT ID | NCT07650968 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beni-Suef University |
| Condition | Acute Urinary Retention |
| Study Type | INTERVENTIONAL |
| Enrollment | 378 participants |
| Start Date | 2026-06-08 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 378 participants in total. It began in 2026-06-08 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The urethral catheter will be removed on Day 7, and the ability to void successfully without re-catheterization will be assessed. Follow-up will continue to Day 30, with additional recording of catheter-free status, recurrent urinary retention, urinary flow, post-void residual urine, symptom scores, adverse drug events, catheter-related complications, and the need for later benign prostatic hyperplasia-related surgery.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07650968 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Acute Urinary Retention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07650968 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07650968 currently recruiting?
Yes, NCT07650968 is actively recruiting participants. Contact the research team at HANYFATHY86@GMAIL.COM for enrollment information.
Where is the NCT07650968 trial being conducted?
This trial is being conducted at Banī Suwayf, Egypt.
Who is sponsoring the NCT07650968 clinical trial?
NCT07650968 is sponsored by Beni-Suef University. The trial plans to enroll 378 participants.