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Tamsulosin 0.4 mg Continuation Versus Dose Escalation to 0.8 mg Versus Switch to Silodosin 8 mg for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Department of Urology- Beni-Suef University Hospitals
RECRUITING
Banī Suwayf
Contact Information
Primary
Hany F Badawy, MD
HANYFATHY86@GMAIL.COM
+201149525028
Backup
Mohamed M Dogha, MD
mma16@fayoum.edu.eg
+20 10 10044612
Time Frame
Start Date: 2026-06-08
Estimated Completion Date: 2027-06
Participants
Target number of participants: 378
Treatments
Active_comparator: Tamsulosin 0.4 mg Continuation
Participants will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Experimental: Tamsulosin 0.8 mg Dose Escalation
Participants will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Experimental: Switch to Silodosin 8 mg
Participants will stop tamsulosin 0.4 mg and switch to silodosin 8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Related Therapeutic Areas
Sponsors
Leads: Beni-Suef University

This content was sourced from clinicaltrials.gov