Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention

NCT07650968 | Recruiting Phase 4

• 1 other identifier: TAMS-TWOC-2026
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Urinary Retention; Benign Prostatic Hyperplasia

Keywords

Trial Without Catheter; Tamsulosin; Silodosin; Catheter-free status

Outcome Measures

Primary Outcomes (1)

• Successful Trial Without Catheter at Day 7

  Proportion of participants with successful Trial Without Catheter at Day 7. Success is defined as spontaneous voiding within 6 hours after urethral catheter removal, voided volume ≥100 mL, post-void residual urine \<150 mL measured by ultrasound within 10-15 minutes after voiding, no painful bladder distension or clinically significant voiding difficulty requiring immediate re-catheterization, and no need for re-catheterization within 24 hours after catheter removal.

  Day 7, with assessment continuing for 24 hours after catheter removal

Secondary Outcomes (3)

• Catheter-Free Status at Day 14

  Day 14

• Recurrent Acute Urinary Retention Within 30 Days

  Up to 30 days

• Adverse Drug Events

  Up to 30 days

Study Arms (3)

Tamsulosin 0.4 mg Continuation

ACTIVE COMPARATOR

Participants will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.

Drug: Tamsulosin 0.4 mg

Tamsulosin 0.8 mg Dose Escalation

EXPERIMENTAL

Participants will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.

Drug: Tamsulosin 0.8 mg

Switch to Silodosin 8 mg

EXPERIMENTAL

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.

Drug: Silodosin 8 mg

Interventions

Tamsulosin 0.4 mg DRUG

Participants assigned to this intervention will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.

Tamsulosin 0.4 mg Continuation

Silodosin 8 mg DRUG

Participants assigned to this intervention 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.

Switch to Silodosin 8 mg

Tamsulosin 0.8 mg DRUG

Participants assigned to this intervention will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.

Tamsulosin 0.8 mg Dose Escalation

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, 02456, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; silodosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Mohamed M Dogha, MD

CONTACT

+20 10 10044612; mma16@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor evaluating Trial Without Catheter outcome, post-void residual urine by ultrasound, and uroflowmetry will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants will be randomized in a 1:1:1 ratio to one of three parallel treatment arms for 7 days during urethral catheterization before Trial Without Catheter at Day 7: continuation of tamsulosin 0.4 mg once daily, escalation to tamsulosin 0.8 mg once daily, or switching to silodosin 8 mg once daily.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)